2010/0146(NLE)

EU/Australia Agreement: mutual recognition in relation to conformity assessment, certificates and markings (amendment)

Procedure completed

General
Activities
Documents
Votes
History

2010/0146(NLE) EU/Australia Agreement: mutual recognition in relation to conformity assessment, certificates and markings (amendment)

Role	Committee	Rapporteur	Shadows
Lead	INTA	MOREIRA Vital (S&D)	FJELLNER Christofer (EPP), KAZAK Metin (ALDE)

Lead committee dossier: INTA/7/03045
Legal Basis TFEU TFEU 207-p4, TFEU TFEU 218-p6a

Subjects

Links

Activites

2012/12/29 Final act published in Official Journal
#3198
2012/11/13 Council Meeting
2012/11/13 End of procedure in Parliament
2012/11/13 Act adopted by Council after consultation of Parliament
2012/09/12 Text adopted by Parliament, 1st reading/single reading
- T7-0330/2012 summary
  
  The European Parliament adopted by 665 votes to 7, with 7 abstentions, a legislative resolution on the draft Council decision on the conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. The European Parliament gives its consent to the conclusion of the agreement.
- Results of vote in Parliament
2012/06/25 Committee report tabled for plenary, 1st reading/single reading
- A7-0211/2012 summary
  
  The Committee on International Trade unanimously adopted the report drafted by Vital MOREIRA (ADLE, PT) in which it recommends the European Parliament to give its consent to the conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. Members welcome the improvements made to this Agreement which aim in particular to: allow greater flexibility in the structure of sectoral annexes, remove unnecessary restrictions on trade between the parties, reduce the administrative burden related to management of the MRA, facilitate and clarify the operation of the MRA.
- INTA INTA/7/03045 MOREIRA Vital S&D
2012/06/21 Vote in committee, 1st reading/single reading
- INTA INTA/7/03045 MOREIRA Vital S&D
2012/03/13 Committee referral announced in Parliament, 1st reading/single reading
- INTA INTA/7/03045 MOREIRA Vital S&D
2011/07/13 Legislative proposal
- 12124/2010 summary
  
  PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Unions budget.
- 12150/2010
2011/07/13 Legislative proposal published
- 12124/2010 summary
  
  PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Unions budget.
- DG {u'url': u'http://ec.europa.eu/trade/', u'title': u'Trade'}, DE GUCHT Karel
2010/10/08 Committee draft report
- PE450.683
2010/05/31 Initial legislative proposal
- COM(2010)0270 summary
  
  PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties' legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union's budget.
- DG {u'url': u'http://ec.europa.eu/trade/', u'title': u'Trade'}, DE GUCHT Karel

Documents

Initial legislative proposal published: COM(2010)0270
Committee draft report: PE450.683
Legislative proposal: 12124/2010
Document attached to the procedure: 12150/2010
Legislative proposal published: 12124/2010
Committee report tabled for plenary, 1st reading/single reading: A7-0211/2012
Decision by Parliament, 1st reading/single reading: T7-0330/2012
Results of vote in Parliament: Results of vote in Parliament

Votes

A7-0211/2012 - Vital Moreira - Vote unique

2012/09/12

Position	Total	ALDE	ECR	EFD	GUE/NGL	NI	PPE	S&D	Verts/ALE	correctional
For	665	77	45	26	28	14	245	175	55	1
Against	7	0	0	2	0	5	0	0	0	0
Abstain	7	0	0	1	4	2	0	0	0	0

A7-0211/2012 - Vital Moreira - Single vote

2012/09/12

Position	Total	ALDE	ECR	EFD	GUE/NGL	NI	PPE	S&D	Verts/ALE	correctional
For	665	77	45	26	28	14	245	175	55	1
Against	7	0	0	2	0	5	0	0	0	0
Abstain	7	0	0	1	4	2	0	0	0	0

History

(these mark the time of scraping, not the official date of the change)

2013-01-27

activities/11

added

date: 2012-12-29

type: Final act published in Official Journal

procedure/final

added

url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012D0837

title: Decision 2012/837

procedure/stage_reached

changed

Old

Procedure completed, awaiting publication in Official Journal

New

Procedure completed

2013-01-07

activities/0	added	date 2010-05-31 docs url http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_EN.pdf text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties' legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union's budget. title COM(2010)0270 type Initial legislative proposal published celexid CELEX:52010PC0270:EN body EC type Initial legislative proposal commission DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel
activities/1	added	date 2010-10-08 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.683 type Committee draft report title PE450.683 body EP type Committee draft report
activities/2/body	changed	Old unknown New CSL
activities/2/date	changed	Old 2012-03-13 New 2011-07-13
activities/2/docs	added	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget. type Legislative proposal title 12124/2010 url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12150%2F10&fc=REGAISEN&srm=25&md=100 type Document attached to the procedure title 12150/2010
activities/2/type	changed	Old Annonce en plénière de la saisine de la commission, 1ère lecture/lecture unique New Legislative proposal
activities/3/body	changed	Old unknown New EC
activities/3/commission	added	DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel
activities/3/docs/0/text/0	changed	Old OBJECTIF: conclure d’un accord entre l’Union européenne et l’Australie portant modification de l’accord sur la reconnaissance mutuelle en matière d’évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l’Australie. ACTE PROPOSÉ : Décision du Conseil. CONTEXTE : l’accord sur la reconnaissance mutuelle en matière d’évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l’Australie est entré en vigueur le 1^er janvier 1999. Afin d’améliorer et de simplifier davantage son fonctionnement, les parties ont décidé de revoir certaines de ses dispositions. Conformément à une décision du Conseil, l'accord entre l'Union européenne et l'Australie portant modification de l'accord sur la reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l'Australie a été signé par la Commission, sous réserve de sa conclusion à une date ultérieure. Il convient maintenant de procéder à la conclusion de l'accord au nom de l’UE. ANALYSE D’IMPACT : aucune analyse d'impact n'a été réalisée BASE JURIDIQUE : article 207, par. 4, 1^er alinéa, en liaison avec article 218, par. 6, point a) v) du traité sur le fonctionnement de l’Union européenne (TFUE). CONTENU : les modifications apportées visent à : ménager davantage de souplesse dans la structure des annexes sectorielles de l’accord sur la reconnaissance mutuelle, éliminer les restrictions inutiles aux échanges commerciaux entre les parties, réduire les charges administratives liées à la gestion de l’accord, faciliter et clarifier son fonctionnement. En outre, l’annexe sectorielle relative à l’inspection BPF (bonnes pratiques de fabrication) des médicaments et à la certification des lots, d’une part, et l’annexe sectorielle relative aux dispositifs médicaux, d’autre part, sont rendues obsolètes par l’évolution des pratiques techniques et administratives ainsi que par des changements concernant les organisations qui y sont énumérées, de sorte qu’il a été jugé nécessaire de les modifier. Les principales modifications techniques apportées à l’accord peuvent se résumer comme suit : champ d’application : afin d’éliminer les restrictions inutiles au commerce, la disposition de l’article 4 qui limite l’application de l’accord aux produits industriels originaires des parties conformément aux règles d’origine non préférentielles est supprimée. Dans sa version modifiée, l’accord sur la reconnaissance mutuelle concernera tous les produits relevant de son champ d’application, quelle que soit leur origine ; comitologie : la référence au président du comité mixte est supprimée aux articles 8 et 12 de manière à souligner le fait que le comité mixte est coprésidé par les parties ; simplification du fonctionnement de l’accord : afin de faciliter le fonctionnement de l’accord sur la reconnaissance mutuelle, une procédure simplifiée est prévue à l’article 12 concernant la désignation, le retrait de la désignation et la suspension d’organismes d’évaluation de la conformité. Il ne sera désormais plus nécessaire de modifier une annexe sectorielle pour donner effet à une décision d’une autorité compétente désignant un organisme d’évaluation de la conformité ou retirant la désignation d’un tel organisme ; la nécessité d’une intervention du comité mixte sera limitée aux cas donnant lieu à contestation par l’autre partie; adaptation des annexes : pour pouvoir adapter les annexes sectorielles en temps utile afin de tenir compte des progrès techniques et d’autres facteurs tels que l’élargissement de l’Union, l’article 12 est modifié de manière à habiliter explicitement le comité mixte à modifier les annexes sectorielles à d’autres fins que pour donner effet à la décision d’une autorité compétente de désigner ou de retirer la désignation d’un organisme particulier d’évaluation de la conformité, ainsi que pour permettre au comité mixte d’adopter de nouvelles annexes sectorielles ; annexes sectorielles : l’annexe sectorielle relative à l’inspection BPF des médicaments et à la certification des lots et celle relative aux dispositifs médicaux ont été révisées de manière à tenir compte de l’évolution des pratiques techniques et administratives, des changements apportés par la modification au dispositif de l’accord sur la reconnaissance mutuelle, des mises à jour des listes d’organisations et de l’évolution de la législation des parties applicable au secteur. Le fonctionnement des annexes continue de reposer sur les mêmes principes. L’accord sur la reconnaissance mutuelle en matière d’évaluation de la conformité, de certificats et de marquage entre la Communauté européenne et la Nouvelle-Zélande est, de par ses effets, identique à l’accord sur la reconnaissance mutuelle passé avec l’Australie. Un accord modifiant l’accord conclu avec la Nouvelle-Zélande est proposé en parallèle. INCIDENCE BUDGÉTAIRE : la proposition n'a pas d'incidence sur le budget de l'UE. New PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget.
activities/3/docs/0/type	changed	Old Publication de la proposition législative New Legislative proposal published
activities/3/docs/0/url	changed	Old http://register.consilium.europa.eu/servlet/driver?page=Result&lang=FR&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISFR&srm=25&md=100 New http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100
activities/3/type	changed	Old Publication de la proposition législative New Legislative proposal published
activities/4/body	changed	Old unknown New EP
activities/4/committees	added	body EP shadows group EPP name FJELLNER Christofer group ALDE name KAZAK Metin responsible True committee INTA date 2010-06-23 committee_full International Trade rapporteur group S&D name MOREIRA Vital
activities/4/date	changed	Old 2012-06-25 New 2012-03-13
activities/4/docs	deleted	url http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2012-211&language=FR text En adoptant à l’unanimité le rapport Vital MOREIRA (ADLE, PT), la commission du commerce international recommande que le Parlement européen donne son approbation à la conclusion de l'accord entre l'Union européenne et l'Australie portant modification de l'accord sur la reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l'Australie. D’une manière générale, les députés se félicitent des améliorations apportées à l’accord initial qui visent à : ménager davantage de souplesse dans la structure des annexes sectorielles, éliminer les restrictions inutiles aux échanges commerciaux entre les parties, réduire les charges administratives liées à la gestion de l'accord, faciliter et clarifier son fonctionnement. type Dépôt du rapport de la commission, 1ère lecture/lecture unique title A7-0211/2012
activities/4/type	changed	Old Dépôt du rapport de la commission, 1ère lecture/lecture unique New Committee referral announced in Parliament, 1st reading/single reading
activities/5/body	changed	Old unknown New EP
activities/5/committees	added	body EP shadows group EPP name FJELLNER Christofer group ALDE name KAZAK Metin responsible True committee INTA date 2010-06-23 committee_full International Trade rapporteur group S&D name MOREIRA Vital
activities/5/type	changed	Old Vote en commission, 1ère lecture/lecture unique New Vote in committee, 1st reading/single reading
activities/6	added	body EP docs url http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2012-211&language=EN text The Committee on International Trade unanimously adopted the report drafted by Vital MOREIRA (ADLE, PT) in which it recommends the European Parliament to give its consent to the conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. Members welcome the improvements made to this Agreement which aim in particular to: allow greater flexibility in the structure of sectoral annexes, remove unnecessary restrictions on trade between the parties, reduce the administrative burden related to management of the MRA, facilitate and clarify the operation of the MRA. type Committee report tabled for plenary, 1st reading/single reading title A7-0211/2012 type Committee report tabled for plenary, 1st reading/single reading committees body EP shadows group EPP name FJELLNER Christofer group ALDE name KAZAK Metin responsible True committee INTA date 2010-06-23 committee_full International Trade rapporteur group S&D name MOREIRA Vital date 2012-06-25
activities/7	added	date 2012-09-12 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2012-330 text The European Parliament adopted by 665 votes to 7, with 7 abstentions, a legislative resolution on the draft Council decision on the conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. The European Parliament gives its consent to the conclusion of the agreement. type Decision by Parliament, 1st reading/single reading title T7-0330/2012 url http://www.europarl.europa.eu/oeil/popups/sda.do?id=21793&l=en type Results of vote in Parliament title Results of vote in Parliament body EP type Text adopted by Parliament, 1st reading/single reading
activities/8/body	changed	Old unknown New CSL
activities/8/council	added	Economic and Financial Affairs ECOFIN
activities/8/date	changed	Old 2012-09-12 New 2012-11-13
activities/8/docs	deleted	url http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=FR&reference=P7-TA-2012-330 text Le Parlement européen a adopté par 665 voix pour, 7 voix contre et 7 abstentions, une résolution législative sur le projet de décision du Conseil concernant le projet de décision du Conseil relatif à la conclusion de l'accord entre l'Union européenne et l'Australie portant modification de l'accord sur la reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l'Australie. Le Parlement européen donne son approbation à la conclusion de l'accord. type Décision du Parlement, 1ère lecture/lecture unique title T7-0330/2012 url http://www.europarl.europa.eu/oeil/popups/sda.do?id=21793&l=fr type Résultat du vote au parlement title Résultat du vote au parlement
activities/8/meeting_id	added	3198
activities/8/type	changed	Old Décision du Parlement, 1ère lecture/lecture unique New Council Meeting
activities/9/body	changed	Old unknown New EP
activities/9/date	changed	Old 2010-05-31 New 2012-11-13
activities/9/docs	deleted	url http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_FR.pdf text OBJECTIF: conclusion d'un accord entre l'Union européenne et l'Australie portant modification de l'accord sur la reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l'Australie. ACTE PROPOSÉ : Décision du Conseil. CONTEXTE : l'accord sur la reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l'Australie est entré en vigueur le 1^er janvier 1999. Afin d'améliorer et de simplifier davantage son fonctionnement, les parties ont décidé de revoir certaines de ses dispositions. Sur la base des directives de négociation du Conseil, la Commission a négocié et paraphé une modification de l'accord sur la reconnaissance mutuelle qu'il convient maintenant d'approuver au nom de l'Union européenne. ANALYSE D'IMPACT : aucune analyse d'impact n'a été réalisée BASE JURIDIQUE : article 207, par. 4, premier alinéa, en liaison avec article 218, par. 6, point a) du traité sur le fonctionnement de l'Union européenne (TFUE). CONTENU : les modifications apportées visent à : ménager davantage de souplesse dans la structure des annexes sectorielles de l'accord sur la reconnaissance mutuelle, éliminer les restrictions inutiles aux échanges commerciaux entre les parties, réduire les charges administratives liées à la gestion de l'accord, faciliter et clarifier son fonctionnement. En outre, l'annexe sectorielle relative à l'inspection BPF (bonnes pratiques de fabrication) des médicaments et à la certification des lots, d'une part, et l'annexe sectorielle relative aux dispositifs médicaux, d'autre part, sont rendues obsolètes par l'évolution des pratiques techniques et administratives ainsi que par des changements concernant les organisations qui y sont énumérées, de sorte qu'il a été jugé nécessaire de les modifier. Les principales modifications techniques apportées à l'accord peuvent se résumer comme suit : champ d'application : afin d'éliminer les restrictions inutiles au commerce, la disposition de l'article 4 qui limite l'application de l'accord aux produits industriels originaires des parties conformément aux règles d'origine non préférentielles est supprimée. Dans sa version modifiée, l'accord sur la reconnaissance mutuelle concernera tous les produits relevant de son champ d'application, quelle que soit leur origine ; comitologie : la référence au président du comité mixte est supprimée aux articles 8 et 12 de manière à souligner le fait que le comité mixte est coprésidé par les parties ; simplification du fonctionnement de l'accord : afin de faciliter le fonctionnement de l'accord sur la reconnaissance mutuelle, une procédure simplifiée est prévue à l'article 12 concernant la désignation, le retrait de la désignation et la suspension d'organismes d'évaluation de la conformité. Il ne sera désormais plus nécessaire de modifier une annexe sectorielle pour donner effet à une décision d'une autorité compétente désignant un organisme d'évaluation de la conformité ou retirant la désignation d'un tel organisme ; la nécessité d'une intervention du comité mixte sera limitée aux cas donnant lieu à contestation par l'autre partie; adaptation des annexes : pour pouvoir adapter les annexes sectorielles en temps utile afin de tenir compte des progrès techniques et d'autres facteurs tels que l'élargissement de l'Union, l'article 12 est modifié de manière à habiliter explicitement le comité mixte à modifier les annexes sectorielles à d'autres fins que pour donner effet à la décision d'une autorité compétente de désigner ou de retirer la désignation d'un organisme particulier d'évaluation de la conformité, ainsi que pour permettre au comité mixte d'adopter de nouvelles annexes sectorielles ; annexes sectorielles : l'annexe sectorielle relative à l'inspection BPF des médicaments et à la certification des lots et celle relative aux dispositifs médicaux ont été révisées de manière à tenir compte de l'évolution des pratiques techniques et administratives, des changements apportés par la modification au dispositif de l'accord sur la reconnaissance mutuelle, des mises à jour des listes d'organisations et de l'évolution de la législation des parties applicable au secteur. Le fonctionnement des annexes continue de reposer sur les mêmes principes. L'accord sur la reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquage entre la Communauté européenne et la Nouvelle-Zélande est, de par ses effets, identique à l'accord sur la reconnaissance mutuelle passé avec l'Australie. Un accord modifiant l'accord conclu avec la Nouvelle-Zélande est proposé en parallèle. INCIDENCE BUDGÉTAIRE : la proposition n'a pas d'incidence sur le budget de l'UE. title COM(2010)0270 type Publication de la proposition législative initiale celexid CELEX:52010PC0270:EN
activities/9/type	changed	Old Publication de la proposition législative initiale New End of procedure in Parliament
activities/10/body	changed	Old unknown New EP/CSL
activities/10/type	changed	Old Adoption de l'acte par le Conseil suite à la consultation du Parlement New Act adopted by Council after consultation of Parliament
committees/0	added	body EP shadows group EPP name FJELLNER Christofer group ALDE name KAZAK Metin responsible True committee INTA date 2010-06-23 committee_full International Trade rapporteur group S&D name MOREIRA Vital
links/Commission européenne	deleted	url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=NLE&DocYear=2010&DocNum=0146 title PreLex
links/European Commission	added	url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=NLE&DocYear=2010&DocNum=0146 title PreLex
links/National parliaments	added	url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=EN title IPEX
links/Parlements nationaux	deleted	url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=FR title IPEX
other/0	added	body EC dg url http://ec.europa.eu/trade/ title Trade commissioner DE GUCHT Karel
procedure/Base juridique	deleted	Traité sur le fonctionnement de l'UE TFEU 207-p4; Traité sur le fonctionnement de l'UE TFEU 218-p6a
procedure/Dossier de la commission parlementaire	deleted	INTA/7/03045
procedure/Etape de la procédure	deleted	Procédure terminée, en attente de publication au Journal officiel
procedure/Instrument législatif	deleted	Décision
procedure/Référence de procédure	deleted	2010/0146(NLE)
procedure/Sous-type de procédure	deleted	Approbation du Parlement
procedure/Type de procédure	deleted	NLE - Procédures non législatives
procedure/dossier_of_the_committee	added	INTA/7/03045
procedure/geographical_area	added	Australia
procedure/instrument	added	Decision
procedure/legal_basis	added	Treaty on the Functioning of the EU TFEU 207-p4 Treaty on the Functioning of the EU TFEU 218-p6a
procedure/stage_reached	changed	Old Procédure terminée, en attente de publication au Journal officiel New Procedure completed, awaiting publication in Official Journal
procedure/subject	added	2.10.03 Standardisation, EC standards and trade-mark, certification, compliance 6.20.03 Bilateral economic and trade agreements and relations
procedure/subtype	added	Consent by Parliament
procedure/sujet	deleted	2.10.03 Normalisation, norme et marque CE, certification, conformité 6.20.03 Accords et relations commerciales et économiques bilatérales
procedure/title	changed	Old Accord UE/Australie: reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages (modification) New EU/Australia Agreement: mutual recognition in relation to conformity assessment, certificates and markings (amendment)
procedure/type	changed	Old NLE - Procédures non législatives New NLE - Non-legislative enactments
procedure/zone_géographique	deleted	Australie

2013-01-06

activities/0/body	changed	Old EC New unknown
activities/0/commission	deleted	DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel
activities/0/docs/0/text/0	changed	Old PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties' legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union's budget. New OBJECTIF: conclusion d'un accord entre l'Union européenne et l'Australie portant modification de l'accord sur la reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l'Australie. ACTE PROPOSÉ : Décision du Conseil. CONTEXTE : l'accord sur la reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l'Australie est entré en vigueur le 1^er janvier 1999. Afin d'améliorer et de simplifier davantage son fonctionnement, les parties ont décidé de revoir certaines de ses dispositions. Sur la base des directives de négociation du Conseil, la Commission a négocié et paraphé une modification de l'accord sur la reconnaissance mutuelle qu'il convient maintenant d'approuver au nom de l'Union européenne. ANALYSE D'IMPACT : aucune analyse d'impact n'a été réalisée BASE JURIDIQUE : article 207, par. 4, premier alinéa, en liaison avec article 218, par. 6, point a) du traité sur le fonctionnement de l'Union européenne (TFUE). CONTENU : les modifications apportées visent à : ménager davantage de souplesse dans la structure des annexes sectorielles de l'accord sur la reconnaissance mutuelle, éliminer les restrictions inutiles aux échanges commerciaux entre les parties, réduire les charges administratives liées à la gestion de l'accord, faciliter et clarifier son fonctionnement. En outre, l'annexe sectorielle relative à l'inspection BPF (bonnes pratiques de fabrication) des médicaments et à la certification des lots, d'une part, et l'annexe sectorielle relative aux dispositifs médicaux, d'autre part, sont rendues obsolètes par l'évolution des pratiques techniques et administratives ainsi que par des changements concernant les organisations qui y sont énumérées, de sorte qu'il a été jugé nécessaire de les modifier. Les principales modifications techniques apportées à l'accord peuvent se résumer comme suit : champ d'application : afin d'éliminer les restrictions inutiles au commerce, la disposition de l'article 4 qui limite l'application de l'accord aux produits industriels originaires des parties conformément aux règles d'origine non préférentielles est supprimée. Dans sa version modifiée, l'accord sur la reconnaissance mutuelle concernera tous les produits relevant de son champ d'application, quelle que soit leur origine ; comitologie : la référence au président du comité mixte est supprimée aux articles 8 et 12 de manière à souligner le fait que le comité mixte est coprésidé par les parties ; simplification du fonctionnement de l'accord : afin de faciliter le fonctionnement de l'accord sur la reconnaissance mutuelle, une procédure simplifiée est prévue à l'article 12 concernant la désignation, le retrait de la désignation et la suspension d'organismes d'évaluation de la conformité. Il ne sera désormais plus nécessaire de modifier une annexe sectorielle pour donner effet à une décision d'une autorité compétente désignant un organisme d'évaluation de la conformité ou retirant la désignation d'un tel organisme ; la nécessité d'une intervention du comité mixte sera limitée aux cas donnant lieu à contestation par l'autre partie; adaptation des annexes : pour pouvoir adapter les annexes sectorielles en temps utile afin de tenir compte des progrès techniques et d'autres facteurs tels que l'élargissement de l'Union, l'article 12 est modifié de manière à habiliter explicitement le comité mixte à modifier les annexes sectorielles à d'autres fins que pour donner effet à la décision d'une autorité compétente de désigner ou de retirer la désignation d'un organisme particulier d'évaluation de la conformité, ainsi que pour permettre au comité mixte d'adopter de nouvelles annexes sectorielles ; annexes sectorielles : l'annexe sectorielle relative à l'inspection BPF des médicaments et à la certification des lots et celle relative aux dispositifs médicaux ont été révisées de manière à tenir compte de l'évolution des pratiques techniques et administratives, des changements apportés par la modification au dispositif de l'accord sur la reconnaissance mutuelle, des mises à jour des listes d'organisations et de l'évolution de la législation des parties applicable au secteur. Le fonctionnement des annexes continue de reposer sur les mêmes principes. L'accord sur la reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquage entre la Communauté européenne et la Nouvelle-Zélande est, de par ses effets, identique à l'accord sur la reconnaissance mutuelle passé avec l'Australie. Un accord modifiant l'accord conclu avec la Nouvelle-Zélande est proposé en parallèle. INCIDENCE BUDGÉTAIRE : la proposition n'a pas d'incidence sur le budget de l'UE.
activities/0/docs/0/type	changed	Old Initial legislative proposal published New Publication de la proposition législative initiale
activities/0/docs/0/url	changed	Old http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_EN.pdf New http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_FR.pdf
activities/0/type	changed	Old Initial legislative proposal New Publication de la proposition législative initiale
activities/1	deleted	date 2010-10-08 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.683 type Committee draft report title PE450.683 body EP type Committee draft report
activities/1/body	changed	Old CSL New unknown
activities/1/docs/0/text/0	changed	Old PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget. New OBJECTIF: conclure d’un accord entre l’Union européenne et l’Australie portant modification de l’accord sur la reconnaissance mutuelle en matière d’évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l’Australie. ACTE PROPOSÉ : Décision du Conseil. CONTEXTE : l’accord sur la reconnaissance mutuelle en matière d’évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l’Australie est entré en vigueur le 1^er janvier 1999. Afin d’améliorer et de simplifier davantage son fonctionnement, les parties ont décidé de revoir certaines de ses dispositions. Conformément à une décision du Conseil, l'accord entre l'Union européenne et l'Australie portant modification de l'accord sur la reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l'Australie a été signé par la Commission, sous réserve de sa conclusion à une date ultérieure. Il convient maintenant de procéder à la conclusion de l'accord au nom de l’UE. ANALYSE D’IMPACT : aucune analyse d'impact n'a été réalisée BASE JURIDIQUE : article 207, par. 4, 1^er alinéa, en liaison avec article 218, par. 6, point a) v) du traité sur le fonctionnement de l’Union européenne (TFUE). CONTENU : les modifications apportées visent à : ménager davantage de souplesse dans la structure des annexes sectorielles de l’accord sur la reconnaissance mutuelle, éliminer les restrictions inutiles aux échanges commerciaux entre les parties, réduire les charges administratives liées à la gestion de l’accord, faciliter et clarifier son fonctionnement. En outre, l’annexe sectorielle relative à l’inspection BPF (bonnes pratiques de fabrication) des médicaments et à la certification des lots, d’une part, et l’annexe sectorielle relative aux dispositifs médicaux, d’autre part, sont rendues obsolètes par l’évolution des pratiques techniques et administratives ainsi que par des changements concernant les organisations qui y sont énumérées, de sorte qu’il a été jugé nécessaire de les modifier. Les principales modifications techniques apportées à l’accord peuvent se résumer comme suit : champ d’application : afin d’éliminer les restrictions inutiles au commerce, la disposition de l’article 4 qui limite l’application de l’accord aux produits industriels originaires des parties conformément aux règles d’origine non préférentielles est supprimée. Dans sa version modifiée, l’accord sur la reconnaissance mutuelle concernera tous les produits relevant de son champ d’application, quelle que soit leur origine ; comitologie : la référence au président du comité mixte est supprimée aux articles 8 et 12 de manière à souligner le fait que le comité mixte est coprésidé par les parties ; simplification du fonctionnement de l’accord : afin de faciliter le fonctionnement de l’accord sur la reconnaissance mutuelle, une procédure simplifiée est prévue à l’article 12 concernant la désignation, le retrait de la désignation et la suspension d’organismes d’évaluation de la conformité. Il ne sera désormais plus nécessaire de modifier une annexe sectorielle pour donner effet à une décision d’une autorité compétente désignant un organisme d’évaluation de la conformité ou retirant la désignation d’un tel organisme ; la nécessité d’une intervention du comité mixte sera limitée aux cas donnant lieu à contestation par l’autre partie; adaptation des annexes : pour pouvoir adapter les annexes sectorielles en temps utile afin de tenir compte des progrès techniques et d’autres facteurs tels que l’élargissement de l’Union, l’article 12 est modifié de manière à habiliter explicitement le comité mixte à modifier les annexes sectorielles à d’autres fins que pour donner effet à la décision d’une autorité compétente de désigner ou de retirer la désignation d’un organisme particulier d’évaluation de la conformité, ainsi que pour permettre au comité mixte d’adopter de nouvelles annexes sectorielles ; annexes sectorielles : l’annexe sectorielle relative à l’inspection BPF des médicaments et à la certification des lots et celle relative aux dispositifs médicaux ont été révisées de manière à tenir compte de l’évolution des pratiques techniques et administratives, des changements apportés par la modification au dispositif de l’accord sur la reconnaissance mutuelle, des mises à jour des listes d’organisations et de l’évolution de la législation des parties applicable au secteur. Le fonctionnement des annexes continue de reposer sur les mêmes principes. L’accord sur la reconnaissance mutuelle en matière d’évaluation de la conformité, de certificats et de marquage entre la Communauté européenne et la Nouvelle-Zélande est, de par ses effets, identique à l’accord sur la reconnaissance mutuelle passé avec l’Australie. Un accord modifiant l’accord conclu avec la Nouvelle-Zélande est proposé en parallèle. INCIDENCE BUDGÉTAIRE : la proposition n'a pas d'incidence sur le budget de l'UE.
activities/1/docs/0/type	changed	Old Legislative proposal New Publication de la proposition législative
activities/1/docs/0/url	changed	Old http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 New http://register.consilium.europa.eu/servlet/driver?page=Result&lang=FR&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISFR&srm=25&md=100
activities/1/docs/1	deleted	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12150%2F10&fc=REGAISEN&srm=25&md=100 type Document attached to the procedure title 12150/2010
activities/1/type	changed	Old Legislative proposal New Publication de la proposition législative
activities/2/body	changed	Old EP New unknown
activities/2/committees	deleted	body EP shadows group EPP name FJELLNER Christofer group ALDE name KAZAK Metin responsible True committee INTA date 2010-06-23 committee_full International Trade rapporteur group S&D name MOREIRA Vital
activities/2/type	changed	Old Committee referral announced in Parliament, 1st reading/single reading New Annonce en plénière de la saisine de la commission, 1ère lecture/lecture unique
activities/3/body	changed	Old EC New unknown
activities/3/commission	deleted	DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel
activities/3/date	changed	Old 2011-07-13 New 2012-06-21
activities/3/docs	deleted	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget. type Legislative proposal published title 12124/2010
activities/3/type	changed	Old Legislative proposal published New Vote en commission, 1ère lecture/lecture unique
activities/4/body	changed	Old EP New unknown
activities/4/committees	deleted	body EP shadows group EPP name FJELLNER Christofer group ALDE name KAZAK Metin responsible True committee INTA date 2010-06-23 committee_full International Trade rapporteur group S&D name MOREIRA Vital
activities/4/docs/0/text/0	changed	Old The Committee on International Trade unanimously adopted the report drafted by Vital MOREIRA (ADLE, PT) in which it recommends the European Parliament to give its consent to the conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. Members welcome the improvements made to this Agreement which aim in particular to: allow greater flexibility in the structure of sectoral annexes, remove unnecessary restrictions on trade between the parties, reduce the administrative burden related to management of the MRA, facilitate and clarify the operation of the MRA. New En adoptant à l’unanimité le rapport Vital MOREIRA (ADLE, PT), la commission du commerce international recommande que le Parlement européen donne son approbation à la conclusion de l'accord entre l'Union européenne et l'Australie portant modification de l'accord sur la reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l'Australie. D’une manière générale, les députés se félicitent des améliorations apportées à l’accord initial qui visent à : ménager davantage de souplesse dans la structure des annexes sectorielles, éliminer les restrictions inutiles aux échanges commerciaux entre les parties, réduire les charges administratives liées à la gestion de l'accord, faciliter et clarifier son fonctionnement.
activities/4/docs/0/type	changed	Old Committee report tabled for plenary, 1st reading/single reading New Dépôt du rapport de la commission, 1ère lecture/lecture unique
activities/4/docs/0/url	changed	Old http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2012-211&language=EN New http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2012-211&language=FR
activities/4/type	changed	Old Committee report tabled for plenary, 1st reading/single reading New Dépôt du rapport de la commission, 1ère lecture/lecture unique
activities/5/body	changed	Old EP/CSL New unknown
activities/5/date	changed	Old 2012-11-13 New 2012-09-12
activities/5/docs	added	url http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=FR&reference=P7-TA-2012-330 text Le Parlement européen a adopté par 665 voix pour, 7 voix contre et 7 abstentions, une résolution législative sur le projet de décision du Conseil concernant le projet de décision du Conseil relatif à la conclusion de l'accord entre l'Union européenne et l'Australie portant modification de l'accord sur la reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l'Australie. Le Parlement européen donne son approbation à la conclusion de l'accord. type Décision du Parlement, 1ère lecture/lecture unique title T7-0330/2012 url http://www.europarl.europa.eu/oeil/popups/sda.do?id=21793&l=fr type Résultat du vote au parlement title Résultat du vote au parlement
activities/5/type	changed	Old Act adopted by Council after consultation of Parliament New Décision du Parlement, 1ère lecture/lecture unique
activities/6/body	changed	Old EP New unknown
activities/6/committees	deleted	body EP shadows group EPP name FJELLNER Christofer group ALDE name KAZAK Metin responsible True committee INTA date 2010-06-23 committee_full International Trade rapporteur group S&D name MOREIRA Vital
activities/6/date	changed	Old 2012-06-21 New 2012-11-13
activities/6/type	changed	Old Vote in committee, 1st reading/single reading New Adoption de l'acte par le Conseil suite à la consultation du Parlement
activities/7	deleted	date 2012-09-12 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2012-330 text The European Parliament adopted by 665 votes to 7, with 7 abstentions, a legislative resolution on the draft Council decision on the conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. The European Parliament gives its consent to the conclusion of the agreement. type Decision by Parliament, 1st reading/single reading title T7-0330/2012 url http://www.europarl.europa.eu/oeil/popups/sda.do?id=21793&l=en type Results of vote in Parliament title Results of vote in Parliament body EP type Text adopted by Parliament, 1st reading/single reading
activities/8	deleted	date 2012-11-13 body CSL type Council Meeting council Economic and Financial Affairs ECOFIN meeting_id 3198
activities/9	deleted	date 2012-11-13 body EP type End of procedure in Parliament
committees/0	deleted	body EP shadows group EPP name FJELLNER Christofer group ALDE name KAZAK Metin responsible True committee INTA date 2010-06-23 committee_full International Trade rapporteur group S&D name MOREIRA Vital
links/Commission européenne	added	url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=NLE&DocYear=2010&DocNum=0146 title PreLex
links/European Commission	deleted	url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=NLE&DocYear=2010&DocNum=0146 title PreLex
links/National parliaments	deleted	url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=EN title IPEX
links/Parlements nationaux	added	url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=FR title IPEX
other/0	deleted	body EC dg url http://ec.europa.eu/trade/ title Trade commissioner DE GUCHT Karel
procedure/Base juridique	added	Traité sur le fonctionnement de l'UE TFEU 207-p4; Traité sur le fonctionnement de l'UE TFEU 218-p6a
procedure/Dossier de la commission parlementaire	added	INTA/7/03045
procedure/Etape de la procédure	added	Procédure terminée, en attente de publication au Journal officiel
procedure/Instrument législatif	added	Décision
procedure/Référence de procédure	added	2010/0146(NLE)
procedure/Sous-type de procédure	added	Approbation du Parlement
procedure/Type de procédure	added	NLE - Procédures non législatives
procedure/dossier_of_the_committee	deleted	INTA/7/03045
procedure/geographical_area	deleted	Australia
procedure/instrument	deleted	Decision
procedure/legal_basis	deleted	Treaty on the Functioning of the EU TFEU 207-p4 Treaty on the Functioning of the EU TFEU 218-p6a
procedure/stage_reached	changed	Old Procedure completed, awaiting publication in Official Journal New Procédure terminée, en attente de publication au Journal officiel
procedure/subject	deleted	2.10.03 Standardisation, EC standards and trade-mark, certification, compliance 6.20.03 Bilateral economic and trade agreements and relations
procedure/subtype	deleted	Consent by Parliament
procedure/sujet	added	2.10.03 Normalisation, norme et marque CE, certification, conformité 6.20.03 Accords et relations commerciales et économiques bilatérales
procedure/title	changed	Old EU/Australia Agreement: mutual recognition in relation to conformity assessment, certificates and markings (amendment) New Accord UE/Australie: reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages (modification)
procedure/type	changed	Old NLE - Non-legislative enactments New NLE - Procédures non législatives
procedure/zone_géographique	added	Australie

2012-12-21

2012-09-23

2012-09-19

2012-09-15

activities/0	deleted	date 2010-05-31 docs url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties' legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union's budget. title COM(2010)0270 type Initial legislative proposal published celexid CELEX:52010PC0270:EN body EC type Initial legislative proposal commission DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel
activities/0/body	changed	Old EP New EC
activities/0/commission	added	DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel
activities/0/date	changed	Old 2010-10-08 New 2010-05-31
activities/0/docs/0/celexid	added	CELEX:52010PC0270:EN
activities/0/docs/0/text	added	PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties' legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union's budget.
activities/0/docs/0/title	changed	Old PE450.683 New COM(2010)0270
activities/0/docs/0/type	changed	Old Committee draft report New Initial legislative proposal published
activities/0/docs/0/url	changed	Old http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.683 New http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270
activities/0/type	changed	Old Committee draft report New Initial legislative proposal
activities/1/date	changed	Old 2012-06-01 New 2010-10-08
activities/1/docs	added	url http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.683 type Committee draft report title PE450.683
activities/1/type	changed	Old Deadline Amendments New Committee draft report
activities/2	deleted	date 2011-07-13 docs url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget. type Legislative proposal title 12124/2010 url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12150%2F10&fc=REGAISEN&srm=25&md=100 type Document attached to the procedure title 12150/2010 body CSL type Legislative proposal
activities/2/body	changed	Old EP New CSL
activities/2/date	changed	Old 2012-02-29 New 2011-07-13
activities/2/docs	added	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget. type Legislative proposal title 12124/2010 url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12150%2F10&fc=REGAISEN&srm=25&md=100 type Document attached to the procedure title 12150/2010
activities/2/type	changed	Old EP officialisation New Legislative proposal
activities/7/docs	added	url http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2012-330 type Decision by Parliament, 1st reading/single reading title T7-0330/2012
activities/7/type	changed	Old Vote scheduled New Text adopted by Parliament, 1st reading/single reading
activities/10	deleted	body EC date 2012-09-12 type Prev DG PRES commission DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel
procedure/stage_reached	changed	Old Awaiting Parliament 1st reading / single reading / budget 1st stage New Awaiting final decision

2012-09-01

2012-07-06

2012-06-25

2012-06-22

activities/0	deleted	date 2010-05-31 docs url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties' legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union's budget. title COM(2010)0270 type Initial legislative proposal published celexid CELEX:52010PC0270:EN body EC commission DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel type Initial legislative proposal
activities/0/body	changed	Old EP New EC
activities/0/commission	added	DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel
activities/0/date	changed	Old 2010-10-08 New 2010-05-31
activities/0/docs/0/celexid	added	CELEX:52010PC0270:EN
activities/0/docs/0/text	added	PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties' legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union's budget.
activities/0/docs/0/title	changed	Old PE450.683 New COM(2010)0270
activities/0/docs/0/type	changed	Old Committee draft report New Initial legislative proposal published
activities/0/docs/0/url	changed	Old http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.683 New http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270
activities/0/type	changed	Old Committee draft report New Initial legislative proposal
activities/1/date	changed	Old 2012-06-20 New 2010-10-08
activities/1/docs	added	url http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.683 type Committee draft report title PE450.683
activities/1/type	changed	Old EP 1R Committee New Committee draft report
activities/7/committees	added	body EP shadows group EPP name FJELLNER Christofer group ALDE name KAZAK Metin responsible True committee INTA date 2010-06-23 committee_full International Trade rapporteur group S&D name MOREIRA Vital
activities/7/type	changed	Old Vote scheduled in committee, 1st reading/single reading New Vote in committee, 1st reading/single reading

2012-06-13

activities/0/docs/0/text

added

PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia.

PROPOSED ACT: Council Decision.

BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions.

On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition.

IMPACT ASSESSMENT: no impact assessment was carried out.

LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a) of the Treaty on the Functioning of the European Union (TFEU).

CONTENT: the amendment is intended to:
- allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition,
- remove unnecessary restrictions on trade between the Parties,
- reduce the administrative burden related to management of the Agreement,
- facilitate and clarify the operation of the Agreement.
In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them.

A detailed assessment of the amendment follows.
- scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin.
- comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties;
- simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party;
- adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes;
- sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties' legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged.
The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed.

BUDGETARY IMPLICATION: this proposal has no implications for the European Union's budget.

2012-06-08

2012-05-31

2012-05-24

2012-05-10

activities/0/body	changed	Old unknown New EC
activities/0/commission	added	DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel
activities/0/docs/0/type	changed	Old Publication de la proposition législative initiale New Initial legislative proposal published
activities/0/docs/0/url	changed	Old http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=FR&type_doc=COMfinal&an_doc=2010&nu_doc=270 New http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270
activities/0/type	changed	Old Publication de la proposition législative initiale New Initial legislative proposal
activities/1/body	changed	Old unknown New EP
activities/1/date	changed	Old 2012-09-10 New 2010-10-08
activities/1/docs	added	url http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.683 type Committee draft report title PE450.683
activities/1/type	changed	Old Date indicative de la séance plénière, 1ère lecture/lecture unique New Committee draft report
activities/2	deleted	body EP date 2011-07-13 type Date
activities/2/body	changed	Old unknown New CSL
activities/2/date	changed	Old 2012-06-20 New 2011-07-13
activities/2/docs	added	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget. type Legislative proposal title 12124/2010 url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12150%2F10&fc=REGAISEN&srm=25&md=100 type Document attached to the procedure title 12150/2010
activities/2/type	changed	Old Vote prévu en commission, 1ère lecture/lecture unique New Legislative proposal
activities/3/body	changed	Old unknown New EC
activities/3/commission	added	DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel
activities/3/docs/0/text/0	changed	Old OBJECTIF: conclure d’un accord entre l’Union européenne et l’Australie portant modification de l’accord sur la reconnaissance mutuelle en matière d’évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l’Australie. ACTE PROPOSÉ : Décision du Conseil. CONTEXTE : l’accord sur la reconnaissance mutuelle en matière d’évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l’Australie est entré en vigueur le 1^er janvier 1999. Afin d’améliorer et de simplifier davantage son fonctionnement, les parties ont décidé de revoir certaines de ses dispositions. Conformément à une décision du Conseil, l'accord entre l'Union européenne et l'Australie portant modification de l'accord sur la reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l'Australie a été signé par la Commission, sous réserve de sa conclusion à une date ultérieure. Il convient maintenant de procéder à la conclusion de l'accord au nom de l’UE. ANALYSE D’IMPACT : aucune analyse d'impact n'a été réalisée BASE JURIDIQUE : article 207, par. 4, 1^er alinéa, en liaison avec article 218, par. 6, point a) v) du traité sur le fonctionnement de l’Union européenne (TFUE). CONTENU : les modifications apportées visent à : ménager davantage de souplesse dans la structure des annexes sectorielles de l’accord sur la reconnaissance mutuelle, éliminer les restrictions inutiles aux échanges commerciaux entre les parties, réduire les charges administratives liées à la gestion de l’accord, faciliter et clarifier son fonctionnement. En outre, l’annexe sectorielle relative à l’inspection BPF (bonnes pratiques de fabrication) des médicaments et à la certification des lots, d’une part, et l’annexe sectorielle relative aux dispositifs médicaux, d’autre part, sont rendues obsolètes par l’évolution des pratiques techniques et administratives ainsi que par des changements concernant les organisations qui y sont énumérées, de sorte qu’il a été jugé nécessaire de les modifier. Les principales modifications techniques apportées à l’accord peuvent se résumer comme suit : champ d’application : afin d’éliminer les restrictions inutiles au commerce, la disposition de l’article 4 qui limite l’application de l’accord aux produits industriels originaires des parties conformément aux règles d’origine non préférentielles est supprimée. Dans sa version modifiée, l’accord sur la reconnaissance mutuelle concernera tous les produits relevant de son champ d’application, quelle que soit leur origine ; comitologie : la référence au président du comité mixte est supprimée aux articles 8 et 12 de manière à souligner le fait que le comité mixte est coprésidé par les parties ; simplification du fonctionnement de l’accord : afin de faciliter le fonctionnement de l’accord sur la reconnaissance mutuelle, une procédure simplifiée est prévue à l’article 12 concernant la désignation, le retrait de la désignation et la suspension d’organismes d’évaluation de la conformité. Il ne sera désormais plus nécessaire de modifier une annexe sectorielle pour donner effet à une décision d’une autorité compétente désignant un organisme d’évaluation de la conformité ou retirant la désignation d’un tel organisme ; la nécessité d’une intervention du comité mixte sera limitée aux cas donnant lieu à contestation par l’autre partie; adaptation des annexes : pour pouvoir adapter les annexes sectorielles en temps utile afin de tenir compte des progrès techniques et d’autres facteurs tels que l’élargissement de l’Union, l’article 12 est modifié de manière à habiliter explicitement le comité mixte à modifier les annexes sectorielles à d’autres fins que pour donner effet à la décision d’une autorité compétente de désigner ou de retirer la désignation d’un organisme particulier d’évaluation de la conformité, ainsi que pour permettre au comité mixte d’adopter de nouvelles annexes sectorielles ; annexes sectorielles : l’annexe sectorielle relative à l’inspection BPF des médicaments et à la certification des lots et celle relative aux dispositifs médicaux ont été révisées de manière à tenir compte de l’évolution des pratiques techniques et administratives, des changements apportés par la modification au dispositif de l’accord sur la reconnaissance mutuelle, des mises à jour des listes d’organisations et de l’évolution de la législation des parties applicable au secteur. Le fonctionnement des annexes continue de reposer sur les mêmes principes. L’accord sur la reconnaissance mutuelle en matière d’évaluation de la conformité, de certificats et de marquage entre la Communauté européenne et la Nouvelle-Zélande est, de par ses effets, identique à l’accord sur la reconnaissance mutuelle passé avec l’Australie. Un accord modifiant l’accord conclu avec la Nouvelle-Zélande est proposé en parallèle. INCIDENCE BUDGÉTAIRE : la proposition n'a pas d'incidence sur le budget de l'UE. New PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget.
activities/3/docs/0/type	changed	Old Publication de la proposition législative New Legislative proposal published
activities/3/docs/0/url	changed	Old http://register.consilium.europa.eu/servlet/driver?page=Result&lang=FR&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISFR&srm=25&md=100 New http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100
activities/3/type	changed	Old Publication de la proposition législative New Legislative proposal published
activities/4	deleted	date 2012-03-13 body unknown type Annonce en plénière de la saisine de la commission, 1ère lecture/lecture unique
activities/5/committees	added	body EP shadows group EPP name FJELLNER Christofer group ALDE name KAZAK Metin responsible True committee INTA date 2010-06-23 committee_full International Trade rapporteur group S&D name MOREIRA Vital
activities/5/date	changed	Old 2012-09-10 New 2012-03-13
activities/5/type	changed	Old EP 1R Plenary New Committee referral announced in Parliament, 1st reading/single reading
activities/6/type	changed	Old EP 1R Committee New Vote scheduled in committee, 1st reading/single reading
activities/7/body	changed	Old EC New EP
activities/7/commission	deleted
activities/7/type	changed	Old Prev DG PRES New Indicative plenary sitting date, 1st reading/single reading
committees/0	added	body EP shadows group EPP name FJELLNER Christofer group ALDE name KAZAK Metin responsible True committee INTA date 2010-06-23 committee_full International Trade rapporteur group S&D name MOREIRA Vital
links/Commission européenne	deleted	url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=NLE&DocYear=2010&DocNum=0146 title PreLex
links/European Commission	added	url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=NLE&DocYear=2010&DocNum=0146 title PreLex
links/National parliaments	added	url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=EN title IPEX
links/Parlements nationaux	deleted	url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=FR title IPEX
other/0	added	body EC dg url http://ec.europa.eu/trade/ title Trade commissioner DE GUCHT Karel
procedure/Dossier de la commission parlementaire	deleted	INTA/7/03045
procedure/Etape de la procédure	deleted	En attente de la 1ère lecture du Parlement / lecture unique / 1ère phase du budget
procedure/Instrument législatif	deleted	Décision
procedure/Référence de procédure	deleted	2010/0146(NLE)
procedure/Sous-type de procédure	deleted	Approbation du Parlement
procedure/Type de procédure	deleted	NLE - Procédures non législatives
procedure/dossier_of_the_committee	added	INTA/7/03045
procedure/geographical_area	added	Australia
procedure/instrument	added	Decision
procedure/stage_reached	changed	Old En attente de la 1ère lecture du Parlement / lecture unique / 1ère phase du budget New Awaiting Parliament 1st reading / single reading / budget 1st stage
procedure/subject	added	2.10.03 Standardisation, EC standards and trade-mark, certification, compliance 6.20.03 Bilateral economic and trade agreements and relations
procedure/subtype	added	Consent by Parliament
procedure/sujet	deleted	2.10.03 Normalisation, norme et marque CE, certification, conformité 6.20.03 Accords et relations commerciales et économiques bilatérales
procedure/title	changed	Old Accord UE/Australie: reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages (modification) New EU/Australia Agreement: mutual recognition in relation to conformity assessment, certificates and markings (amendment)
procedure/type	changed	Old NLE - Procédures non législatives New NLE - Non-legislative enactments
procedure/zone_géographique	deleted	Australie

2012-05-08

activities/0	added	date 2010-05-31 docs url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=FR&type_doc=COMfinal&an_doc=2010&nu_doc=270 title COM(2010)0270 type Publication de la proposition législative initiale celexid CELEX:52010PC0270:EN body unknown type Publication de la proposition législative initiale
activities/1	added	date 2011-07-13 docs url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=FR&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISFR&srm=25&md=100 text OBJECTIF: conclure d’un accord entre l’Union européenne et l’Australie portant modification de l’accord sur la reconnaissance mutuelle en matière d’évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l’Australie. ACTE PROPOSÉ : Décision du Conseil. CONTEXTE : l’accord sur la reconnaissance mutuelle en matière d’évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l’Australie est entré en vigueur le 1^er janvier 1999. Afin d’améliorer et de simplifier davantage son fonctionnement, les parties ont décidé de revoir certaines de ses dispositions. Conformément à une décision du Conseil, l'accord entre l'Union européenne et l'Australie portant modification de l'accord sur la reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages entre la Communauté européenne et l'Australie a été signé par la Commission, sous réserve de sa conclusion à une date ultérieure. Il convient maintenant de procéder à la conclusion de l'accord au nom de l’UE. ANALYSE D’IMPACT : aucune analyse d'impact n'a été réalisée BASE JURIDIQUE : article 207, par. 4, 1^er alinéa, en liaison avec article 218, par. 6, point a) v) du traité sur le fonctionnement de l’Union européenne (TFUE). CONTENU : les modifications apportées visent à : ménager davantage de souplesse dans la structure des annexes sectorielles de l’accord sur la reconnaissance mutuelle, éliminer les restrictions inutiles aux échanges commerciaux entre les parties, réduire les charges administratives liées à la gestion de l’accord, faciliter et clarifier son fonctionnement. En outre, l’annexe sectorielle relative à l’inspection BPF (bonnes pratiques de fabrication) des médicaments et à la certification des lots, d’une part, et l’annexe sectorielle relative aux dispositifs médicaux, d’autre part, sont rendues obsolètes par l’évolution des pratiques techniques et administratives ainsi que par des changements concernant les organisations qui y sont énumérées, de sorte qu’il a été jugé nécessaire de les modifier. Les principales modifications techniques apportées à l’accord peuvent se résumer comme suit : champ d’application : afin d’éliminer les restrictions inutiles au commerce, la disposition de l’article 4 qui limite l’application de l’accord aux produits industriels originaires des parties conformément aux règles d’origine non préférentielles est supprimée. Dans sa version modifiée, l’accord sur la reconnaissance mutuelle concernera tous les produits relevant de son champ d’application, quelle que soit leur origine ; comitologie : la référence au président du comité mixte est supprimée aux articles 8 et 12 de manière à souligner le fait que le comité mixte est coprésidé par les parties ; simplification du fonctionnement de l’accord : afin de faciliter le fonctionnement de l’accord sur la reconnaissance mutuelle, une procédure simplifiée est prévue à l’article 12 concernant la désignation, le retrait de la désignation et la suspension d’organismes d’évaluation de la conformité. Il ne sera désormais plus nécessaire de modifier une annexe sectorielle pour donner effet à une décision d’une autorité compétente désignant un organisme d’évaluation de la conformité ou retirant la désignation d’un tel organisme ; la nécessité d’une intervention du comité mixte sera limitée aux cas donnant lieu à contestation par l’autre partie; adaptation des annexes : pour pouvoir adapter les annexes sectorielles en temps utile afin de tenir compte des progrès techniques et d’autres facteurs tels que l’élargissement de l’Union, l’article 12 est modifié de manière à habiliter explicitement le comité mixte à modifier les annexes sectorielles à d’autres fins que pour donner effet à la décision d’une autorité compétente de désigner ou de retirer la désignation d’un organisme particulier d’évaluation de la conformité, ainsi que pour permettre au comité mixte d’adopter de nouvelles annexes sectorielles ; annexes sectorielles : l’annexe sectorielle relative à l’inspection BPF des médicaments et à la certification des lots et celle relative aux dispositifs médicaux ont été révisées de manière à tenir compte de l’évolution des pratiques techniques et administratives, des changements apportés par la modification au dispositif de l’accord sur la reconnaissance mutuelle, des mises à jour des listes d’organisations et de l’évolution de la législation des parties applicable au secteur. Le fonctionnement des annexes continue de reposer sur les mêmes principes. L’accord sur la reconnaissance mutuelle en matière d’évaluation de la conformité, de certificats et de marquage entre la Communauté européenne et la Nouvelle-Zélande est, de par ses effets, identique à l’accord sur la reconnaissance mutuelle passé avec l’Australie. Un accord modifiant l’accord conclu avec la Nouvelle-Zélande est proposé en parallèle. INCIDENCE BUDGÉTAIRE : la proposition n'a pas d'incidence sur le budget de l'UE. type Publication de la proposition législative title 12124/2010 body unknown type Publication de la proposition législative
activities/2/body	changed	Old CSL New EP
activities/2/docs	deleted	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget. type Legislative proposal title 12124/2010 url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12150%2F10&fc=REGAISEN&srm=25&md=100 type Document attached to the procedure title 12150/2010
activities/2/type	changed	Old Legislative proposal New Date
activities/4/body	changed	Old EP New unknown
activities/4/date	changed	Old 2010-10-08 New 2012-03-13
activities/4/docs	deleted	url http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.683 type Committee draft report title PE450.683
activities/4/type	changed	Old Committee draft report New Annonce en plénière de la saisine de la commission, 1ère lecture/lecture unique
activities/5/body	changed	Old EP New unknown
activities/5/type	changed	Old Vote scheduled in committee, 1st reading/single reading New Vote prévu en commission, 1ère lecture/lecture unique
activities/6/body	changed	Old EC New EP
activities/6/commission	deleted	DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel
activities/6/date	changed	Old 2010-05-31 New 2012-06-20
activities/6/docs	deleted	url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270 title COM(2010)0270 type Initial legislative proposal published celexid CELEX:52010PC0270:EN
activities/6/type	changed	Old Initial legislative proposal New EP 1R Committee
activities/7/body	changed	Old EP New unknown
activities/7/type	changed	Old Indicative plenary sitting date, 1st reading/single reading New Date indicative de la séance plénière, 1ère lecture/lecture unique
activities/8/committees	deleted	body EP shadows group EPP name FJELLNER Christofer group ALDE name KAZAK Metin responsible True committee INTA date 2010-06-23 committee_full International Trade rapporteur group S&D name MOREIRA Vital
activities/8/date	changed	Old 2012-03-13 New 2012-09-10
activities/8/type	changed	Old Committee referral announced in Parliament, 1st reading/single reading New EP 1R Plenary
activities/9/commission/0	deleted	DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel
activities/9/date	changed	Old 2011-07-13 New 2012-09-10
activities/9/docs	deleted	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget. type Legislative proposal published title 12124/2010
activities/9/type	changed	Old Legislative proposal published New Prev DG PRES
committees/0	deleted	body EP shadows group EPP name FJELLNER Christofer group ALDE name KAZAK Metin responsible True committee INTA date 2010-06-23 committee_full International Trade rapporteur group S&D name MOREIRA Vital
links/Commission européenne	added	url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=NLE&DocYear=2010&DocNum=0146 title PreLex
links/European Commission	deleted	url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=NLE&DocYear=2010&DocNum=0146 title PreLex
links/National parliaments	deleted	url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=EN title IPEX
links/Parlements nationaux	added	url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=FR title IPEX
other/0	deleted	body EC dg url http://ec.europa.eu/trade/ title Trade commissioner DE GUCHT Karel
procedure/Dossier de la commission parlementaire	added	INTA/7/03045
procedure/Etape de la procédure	added	En attente de la 1ère lecture du Parlement / lecture unique / 1ère phase du budget
procedure/Instrument législatif	added	Décision
procedure/Référence de procédure	added	2010/0146(NLE)
procedure/Sous-type de procédure	added	Approbation du Parlement
procedure/Type de procédure	added	NLE - Procédures non législatives
procedure/dossier_of_the_committee	deleted	INTA/7/03045
procedure/geographical_area	deleted	Australia
procedure/instrument	deleted	Decision
procedure/stage_reached	changed	Old Awaiting Parliament 1st reading / single reading / budget 1st stage New En attente de la 1ère lecture du Parlement / lecture unique / 1ère phase du budget
procedure/subject	deleted	2.10.03 Standardisation, EC standards and trade-mark, certification, compliance 6.20.03 Bilateral economic and trade agreements and relations
procedure/subtype	deleted	Consent by Parliament
procedure/sujet	added	2.10.03 Normalisation, norme et marque CE, certification, conformité 6.20.03 Accords et relations commerciales et économiques bilatérales
procedure/title	changed	Old EU/Australia Agreement: mutual recognition in relation to conformity assessment, certificates and markings (amendment) New Accord UE/Australie: reconnaissance mutuelle en matière d'évaluation de la conformité, de certificats et de marquages (modification)
procedure/type	changed	Old NLE - Non-legislative enactments New NLE - Procédures non législatives
procedure/zone_géographique	added	Australie

2012-05-06

2012-04-23

activities/0/docs/0/url	added	http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270
activities/1/docs/0/url	added	http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.683
activities/2/docs/0	added	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget. type Legislative proposal title 12124/2010
activities/2/docs/1/text	deleted	PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget.
activities/2/docs/1/url	added	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12150%2F10&fc=REGAISEN&srm=25&md=100
activities/3/docs/0/url	added	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100

2012-04-05

activities/0/docs/0/url	deleted	http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270
activities/2/docs/0/title	changed	Old 12124/2010 New 12150/2010
activities/2/docs/0/type	changed	Old Legislative proposal New Document attached to the procedure
activities/2/docs/0/url	deleted	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100
activities/2/docs/1	deleted	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12150%2F10&fc=REGAISEN&srm=25&md=100 type Document attached to the procedure title 12150/2010
activities/3/docs/0/url	deleted	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100
links/European Commission	added	url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=NLE&DocYear=2010&DocNum=0146 title PreLex
links/National parliaments	added	url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=EN title IPEX

2012-04-04

activities/0/docs/0/url	added	http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270
activities/2/docs/0	added	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget. type Legislative proposal title 12124/2010
activities/2/docs/1/text	deleted	PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget.
activities/2/docs/1/url	added	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12150%2F10&fc=REGAISEN&srm=25&md=100
activities/3/docs/0/url	added	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100
links/European Commission	deleted	url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=NLE&DocYear=2010&DocNum=0146 title PreLex
links/National parliaments	deleted	url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=EN title IPEX

2012-04-04

activities/0/docs/0/url	deleted	http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270
activities/1/docs/0/url	deleted	http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.683
activities/2/docs/0/title	changed	Old 12124/2010 New 12150/2010
activities/2/docs/0/type	changed	Old Legislative proposal New Document attached to the procedure
activities/2/docs/0/url	deleted	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100
activities/2/docs/1	deleted	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12150%2F10&fc=REGAISEN&srm=25&md=100 type Document attached to the procedure title 12150/2010
activities/3/docs/0/url	deleted	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100

2012-04-02

activities/2/docs/0	added	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget. type Legislative proposal title 12124/2010
activities/2/docs/1/text	deleted	PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget.
activities/2/docs/1/url	added	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12150%2F10&fc=REGAISEN&srm=25&md=100
activities/3/docs/0/url	added	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100

2012-04-01

2012-03-27

activities/0/docs/0/url	added	http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270
activities/1/docs/0/url	added	http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.683
activities/2/docs/0	added	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget. type Legislative proposal title 12124/2010
activities/2/docs/1/text	deleted	PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget.
activities/2/docs/1/url	added	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12150%2F10&fc=REGAISEN&srm=25&md=100
activities/3/docs/0/url	added	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100
links/National parliaments	added	url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=EN title IPEX

2012-03-26

activities/0/docs/0/url	deleted	http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270
activities/1/docs/0/url	deleted	http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.683
activities/2/docs/0	deleted	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget. type Legislative proposal title 12124/2010
activities/2/docs/0/text	added	PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget.
activities/3/docs/0/url	deleted	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100

2012-03-23

2012-03-21

activities/2/docs/0/text	added	PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget.
activities/3/docs/0/text	added	PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a)(v) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties’ legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget.
activities/5	added	date 2012-03-13 body EP type Committee referral announced in Parliament, 1st reading/single reading committees body EP shadows group EPP name FJELLNER Christofer group ALDE name KAZAK Metin responsible True committee INTA date 2010-06-23 committee_full International Trade rapporteur group S&D name MOREIRA Vital
activities/6/date	changed	Old 2011-01-25 New 2012-06-20
activities/6/type	changed	Old Prev Adopt in Cte New Vote scheduled in committee, 1st reading/single reading
procedure/dossier_of_the_committee	added	INTA/7/03045
procedure/stage_reached	changed	Old Preparatory phase in Parliament New Awaiting Parliament 1st reading / single reading / budget 1st stage

2012-03-14

activities/0/docs/0/url	added	http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270
activities/3/docs/0	added	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 type Legislative proposal title 12124/2010
activities/3/docs/1/url	added	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12150%2F10&fc=REGAISEN&srm=25&md=100
activities/4/docs/0/url	added	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100
links/European Commission	added	url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=NLE&DocYear=2010&DocNum=0146 title PreLex
links/National parliaments	added	url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=EN title IPEX
procedure/legal_basis/0	changed	Old TFEU 207-p4 New Treaty on the Functioning of the EU TFEU 207-p4
procedure/legal_basis/1	changed	Old TFEU 218-p6a New Treaty on the Functioning of the EU TFEU 218-p6a

2012-03-12

activities/0/docs/0/url	deleted	http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270
activities/3/docs/0/title	changed	Old 12124/2010 New 12150/2010
activities/3/docs/0/type	changed	Old Legislative proposal New Document attached to the procedure
activities/3/docs/0/url	deleted	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100
activities/3/docs/1	deleted	url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12150%2F10&fc=REGAISEN&srm=25&md=100 type Document attached to the procedure title 12150/2010
activities/4/docs/0/url	deleted	http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100
links/European Commission	deleted	url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=NLE&DocYear=2010&DocNum=0146 title PreLex
links/National parliaments	deleted	url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=EN title IPEX

2012-03-02

activities/0	added	date 2010-05-31 docs url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270 celexid CELEX:52010PC0270:EN type Initial legislative proposal published title COM(2010)0270 body EC commission DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel type Initial legislative proposal
activities/0	deleted	date 2010-05-31 docs url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=0270 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties' legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union's budget. title COM(2010)0270 type Legislative proposal published celexid CELEX:52010PC0270:EN type Legislative proposal body EC commission DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel
activities/3	added	date 2011-07-13 docs url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 type Legislative proposal title 12124/2010 url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12150%2F10&fc=REGAISEN&srm=25&md=100 type Document attached to the procedure title 12150/2010 body CSL type Legislative proposal
activities/4	added	date 2011-07-13 docs url http://register.consilium.europa.eu/servlet/driver?page=Result&lang=EN&typ=Advanced&cmsid=639&ff_COTE_DOCUMENT=12124%2F10&fc=REGAISEN&srm=25&md=100 type Legislative proposal published title 12124/2010 body EC commission DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel type Legislative proposal published
activities/5	added	body EP date 2012-02-29 type EP officialisation
procedure/legal_basis/1	added	TFEU 218-p6a
procedure/legal_basis/1	deleted	TFEU 218-p6a-aa

2012-02-20

2012-02-15

2012-02-12

2012-02-11

2012-02-10

2012-02-09

activities	added	date 2010-05-31 docs url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=0270 text PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia on mutual recognition in relation to conformity assessment entered into force on 1 January 1999. With a view to further improving and simplifying the functioning of the Agreement on Mutual Recognition, the Parties have decided to amend some of its provisions. On the basis of the negotiating directives from the Council, the Commission initialled negotiated and initialled an Amendment to the Agreement on Mutual Recognition. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207(4), first subparagraph, in conjunction with Article 218(6)(a) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the amendment is intended to: allow greater flexibility in the structure of Sectoral Annexes to the Agreement on Mutual Recognition, remove unnecessary restrictions on trade between the Parties, reduce the administrative burden related to management of the Agreement, facilitate and clarify the operation of the Agreement. In addition, the Sectoral Annexes on medicinal products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them. A detailed assessment of the amendment follows. scope: in order to remove unnecessary restrictions on trade, the restriction in Article 4 of the application of the Agreement to industrial products that originate in the Parties according to non-preferential rules of origin will be deleted. As amended, the Agreement on Mutual Recognition will apply to all products covered by it, irrespective of their origin. comitology: the references to the Chair of the Joint Committee will be deleted from Articles 8 and 12, in order to reflect the fact that the Joint Committee is co-chaired by the Parties; simplification of the operation of the Agreement: in order to simplify operation of the Agreement on Mutual Recognition, a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies will be set up in Article 12. As a result, a decision by a designating authority to designate or withdraw designation of a conformity assessment body will no longer need to be given effect by an amendment to a Sectoral Annex; the need for the Joint Committee to take action will be limited to cases that have been contested by the other Party; adaptations to the Annexes: in order to make timely adaptations to the Sectoral Annexes to take account of technical progress and other factors such as enlargement of the European Union, Article 12 will also be amended in order to explicitly empower the Joint Committee to amend the Sectoral Annexes in areas other than to give effect to the decision by a designating authority to designate or withdraw designation of a particular conformity assessment body, and also to adopt new Sectoral Annexes; sectoral Annex: the Sectoral Annex on medicinal products and medical devices have been revised to take account of developments in technical and administrative practice, changes introduced by the Amendment to the main body of the Agreement on Mutual Recognition, updates in the organisations listed, and changes to the Parties' legislation affecting this sector. The principle of operation of this Sectoral Annex remains unchanged. The Agreement between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union's budget. celexid CELEX:52010PC0270:EN type Legislative proposal published title COM(2010)0270 body EC commission DG Trade Commissioner DE GUCHT Karel type Legislative proposal date 2010-10-08 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.683 type Committee draft report title PE450.683 body EP type Committee draft report body EP date 2011-01-25 type Prev Adopt in Cte
committees	added	body EP shadows group EPP name FJELLNER Christofer group ALDE name KAZAK Metin responsible True committee INTA date 2010-06-23 committee_full International Trade rapporteur group S&D name MOREIRA Vital
links	added	National parliaments url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=EN title IPEX European Commission url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=NLE&DocYear=2010&DocNum=0146 title PreLex
other	added	body EC dg Trade commissioner DE GUCHT Karel
procedure	added	legal_basis Treaty on the Functioning of the EU TFEU 207-p4 Treaty on the Functioning of the EU TFEU 218-p6a-aa reference 2010/0146(NLE) subtype Consent by Parliament geographical_area Australia stage_reached Preparatory phase in Parliament instrument Decision title EU/Australia Agreement: mutual recognition in relation to conformity assessment, certificates and markings (amendment) type NLE - Non-legislative enactments subject 2.10.03 Standardisation, EC standards and trade-mark, certification, compliance 6.20.03 Bilateral economic and trade agreements and relations

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A7-0211/2012 - Vital Moreira - Vote unique

A7-0211/2012 - Vital Moreira - Single vote

History

activities/8/docs/0/text	added	The Committee on International Trade unanimously adopted the report drafted by Vital MOREIRA (ADLE, PT) in which it recommends the European Parliament to give its consent to the conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. Members welcome the improvements made to this Agreement which aim in particular to: allow greater flexibility in the structure of sectoral annexes, remove unnecessary restrictions on trade between the parties, reduce the administrative burden related to management of the MRA, facilitate and clarify the operation of the MRA.
activities/8/docs/0/url	added	http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2012-211&language=EN

activities/0/commission/0	added	DG url http://ec.europa.eu/trade/ title Trade Commissioner DE GUCHT Karel
activities/0/commission/0	deleted	DG Trade Commissioner DE GUCHT Karel
other/0	added	body EC dg url http://ec.europa.eu/trade/ title Trade commissioner DE GUCHT Karel
other/0	deleted	body EC dg Trade commissioner DE GUCHT Karel

procedure/legal_basis/0	added	TFEU 207-p4
procedure/legal_basis/0	deleted	Treaty on the Functioning of the EU TFEU 207-p4
procedure/legal_basis/1	added	TFEU 218-p6a-aa
procedure/legal_basis/1	deleted	Treaty on the Functioning of the EU TFEU 218-p6a-aa