Parltrack

Proposal for a directive – amending act
Citation 2 a (new)

Having regard to the opinion of the European Data Protection Supervisor1, 1 OJ C 229, 23.9.2009, p. 19.

Amendment 24 #

Proposal for a directive – amending act
Recital 9

(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, identified by a corresponding explanatory sentence on the summary of product characteristics, and on the patient information leaflet, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).

Amendment 25 #

Proposal for a directive – amending act
Recital 9

(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be ~~intensive~~continuously monitored on the market. PAs with all medicines, patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).

Amendment 26 #

Proposal for a directive – amending act
Recital 10

(10) In order to make it possible for the healthcare professionals and patients to identify easily the most relevant information about the medicines they use, the summary of the product characteristics and the package leaflet should include a concise section on the key information about the medicinal product and information how to minimize its risks and maximize its benefits.deleted

Amendment 27 #

Proposal for a directive – amending act
Recital 12

(12) In order to ensure close cooperation between the Member States in the area of pharmacovigilance~~, the mandate of the coordination group set up by Article 27 of Directive 2001/83/EC should be enlarged to include the examination of~~ based on the expertise of the pharmacovigilance systems of the Member States, a new coordination group should be set up with specific responsibility for these pharmacovigilance issues, to examine questions related to the pharmacovigilance of all medicinal products authorised by the Member States. In order to fulfil its ~~new~~ tasks, the new coordination group should be further strengthened through the adoption of clear rules as regards the expertise required, the adoption of opinions, transparency, independence and professional secrecy of its members, and the need for cooperation between Community and national bodies.

Amendment 28 #

Proposal for a directive – amending act
Recital 13

(13) With a view to ensuring ~~that~~ the same level of scientific expertise in the area of pharmacovigilance decision-making at both Community and national level, when fulfilling pharmacovigilance tasks the coordination group should be able to rely on the advice of the Agency’s Pharmacovigilance Risk-Benefit Balance Assessment Advisory Committee ~~of the Agency~~.

Amendment 29 #

Proposal for a directive – amending act
Recital 17

(17) To ~~further~~ increase ~~the coordination of resources between the Member States~~pharmacovigilance expertise at Community level, Member States should ~~be authorised to delegate certain pharmacovigilance tasks to~~have the option of arranging for their teams to be trained by the specialist teams of another Member State.

Amendment 30 #

Proposal for a directive – amending act
Recital 22

(22) Requirements for periodic safety update reports should be proportional to the risks posed by medicinal products. Periodic safety update reporting should therefore be linked to the risk management system for newly authorised medicinal products and ~~routine~~the intervals between report~~ing~~s should ~~not be necessary~~be extended for generic, well- established use, informed consent, homeopathic, or traditional use registered herbal medicinal products. However, in the interest of public health the authorities should require ~~periodic~~ safety update reports for such products at specific intervals when there is a need to assess their risk or review the adequacy of product information.

Amendment 31 #

Proposal for a directive – amending act
Recital 28

(28) In order to protect public health, there should be adequate funding of activities related to pharmacovigilance by the national competent authorities. ~~It should be possible to ensure adequate funding for pharmacovigilance activities through the collection of fees~~The indirect collection of additional resources should be possible for this purpose. However, the management of those collected funds should be under the permanent control of the national competent authorities in order to guarantee their independence.

Amendment 32 #

Proposal for a directive – amending act
Article 1 – point 3

Directive 2001/83/EC
Article 11

3. Article 11 is amended as follows: (a) the following point 3a is inserted: “3a. a summary of the essential information necessary to use the medicine safely and effectively; (b) the following subparagraph is added: “For the purposes of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the statement: “This medicinal product is under intensive monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>.”deleted

Amendment 33 #

Proposal for a directive – amending act
Article 1 – point 3

Directive 2001/83/EC
Article 11

3. Article 11 is amended as follows: (a) the following point 3a is inserted: “(3a) a summary of the essential information necessary to use the medicine safely and effectively; (b) the following subparagraph is added: “For the purposes of point (3a) of the first subparagraph, fsubparagraph is added: “For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the following statement: “This medicinal product is ~~under intensive~~subject to a post- authorisation safety monitoring. All suspected adverse reactions should be reported to your doctor, pharmacist or <name and web -address of the national competent authority>.”

Amendment 34 #

Proposal for a directive – amending act
Article 1 – point 3 – point b

Directive 2001/83/EC
Article 11

“For the purpose of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No. 726/2004, the summary shall include the statement: “This medicinal product ~~is under intensive~~has been proven to be of benefit for patients with your condition. As with all medicines it is subject to safety monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>“

Amendment 35 #

Bernadette VERGNAUD, Claude TURMES, Antonyia PARVANOVA, Philippe JUVIN

Proposal for a directive – amending act
Article 1 – point 7

Directive 2001/83/EC
Article 21 – paragraph 3

“3. The national competent authorities shall make publicly available without delay the marketing authorisation together with the package leaflet, the summary of the product characteristics and any conditions established in accordance with Articles 21a, 22 and 22a, together with any deadlines for their fulfilment, for each medicinal product which they have authorised.

Amendment 36 #

Proposal for a directive – amending act
Article 1 – point 8

Directive 2001/83/EC
Article 21 a – introductory part

AIn addition to the provisions of Article 19, marketing authorisation may be granted subject to one or more of the following conditions:

Amendment 37 #

Proposal for a directive – amending act
Article 1 – point 9

Directive 2001/83/EC
Article 22 – paragraph 3

Continuation of the authorisation shall be linked to the annual reassessment of these conditions. The list of these conditions shall be made accessible to the public without delay, together with deadlines and dates of fulfilment.

Amendment 38 #

Proposal for a directive – amending act
Article 1 – point 10

Directive 2001/83/EC
Article 22 a (new)

1. After the granting of a marketing authorisation, the national competent authority may require a marketing authorisation holder to conduct a post- authorisation safety study if there are concerns about the risks of an authorised medicinal product. The requirement shall be made in writing, provide a detailed justification and include the objectives and timeframe for submission and conduct of the study. It shall be made public without delay. 2. The national competent authority shall provide the marketing authorisation holder with an opportunity to present explanations on the requirement within a time limit which it shall specify, if the marketing authorisation holder requests this, in writing and with a detailed justification, within 30- days of receipt of the written requirement. Such requests shall be made public without delay. 3. On the basis of explanations submitted by the marketing authorisation holder, the national competent authority shall withdraw or confirm the requirement. That decision shall be made public without delay. Where the national competent authority confirms the requirement, the marketing authorisation shall be varied to include the requirement as a condition of the marketing authorisation and the risk management system shall be updated accordingly.

Amendment 39 #

Proposal for a directive – amending act
Article 1 – point 14 – point a

Directive 2001/83/EC
Article 27 – paragraph 1

“1. ATwo coordination groups shall be set up: (a) a coordination group for mutual recognition and decentralised procedures, responsible for the following ~~purpose~~tasks: (ai) the examination of any question relating to a marketing authorisation of a medicinal product in two or more Member States in accordance with the procedures laid down in Chapter 4; (bii) the examination of questions related to the ~~pharmacovigilance of medicinal products authoris~~variations to the terms of marketing authorisations granted by the Member States, in accordance with Article~~s 107c, 107e, 107g, 107l and 107r; (c)~~ 35(1), with the ex~~amina~~ception of all questions relat~~ed to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1)~~ing to pharmacovigilance. The Agency shall provide the secretariat of this coordination group. For the fulfilment of its ~~pharmacovigilance~~ tasks, the coordination group ~~shall be assisted by the Pharmacovigilance Risk Assessment Advisory Committe~~for mutual recognition and decentralised procedures shall be assisted by the Committee for Medicinal Products for Human Use referred to in Article 56(1)~~(aa)~~ of Regulation (EC) No 726/2004.

Amendment 40 #

Proposal for a directive – amending act
Article 1 – point 14 – point a

Directive 2001/83/EC
Article 27 – paragraph 1 – point a a (new)

(aa) A coordination group for pharmacovigilance risk assessment shall be responsible for the following tasks: (i) the examination of questions relating to the pharmacovigilance of medicinal products authorised by the Member States, in accordance with Articles 107c, 107e, 107g, 107l and 107r; (ii) the examination of questions relating to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1), for all questions relating to pharmacovigilance. The Agency shall provide the secretariat of this coordination group.

Amendment 41 #

Proposal for a directive – amending act
Article 1 – point 14 – point a

Directive 2001/83/EC
Article 27 – paragraph 1 – subparagraph 3

For the fulfilment of its pharmacovigilance tasks, the coordination group shall be assisted by the ~~Pharmacovigilance Risk Assessment Advisory Committe~~Agency’s advisory committee to assess the risk-benefit balance as regards pharmacovigilance referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004.”

Amendment 42 #

Proposal for a directive – amending act
Article 1 – point 14 – point b

Directive 2001/83/EC
Article 27 – paragraph 2

“Members of the coordination groups and experts shall, for the fulfilment of their tasks, rely on the scientific and regulatory resources available to the national ~~marketing authorisation bodies~~bodies responsible for, respectively, issuing marketing authorisations and pharmacovigilance. Each national competent authority shall monitor the level of expertise of the evaluations carried out and facilitate the activities of nominated coordination group members and experts. Article 63 of Regulation (EC) No 726/2004 shall apply to the coordination groups as regards the transparency and independence of ~~its member~~their members. Their members may be members only of one coordination group at a time. The members of the coordination group for pharmacovigilance risk assessment shall be hierarchically independent of the national marketing authorisation bodies.”

Amendment 43 #

Proposal for a directive – amending act
Article 1 – point 14 – point c

Directive 2001/83/EC
Article 27 – paragraph 4

“4. The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all meetings of the coordination groups.

Amendment 44 #

Proposal for a directive – amending act
Article 1 – point 14 – point c

Directive 2001/83/EC
Article 27 – paragraph 5

5. The members of the coordination groups shall ensure that there is appropriate coordination between the tasks of thateir group and the work of national competent authorities, including, respectively, the consultative bodies concerned with the marketing authorisation and those concerned with the surveillance of medicinal products.

Amendment 45 #

Proposal for a directive – amending act
Article 1 – point 14 – point c

Directive 2001/83/EC
Article 27 – paragraph 6

6. Save where otherwise provided for in this Directive, the coordination groups shall use ~~its~~their best endeavours to take decisions by consensus. If such a consensus cannot be reached, the position of the majority of members shall prevail.

Amendment 46 #

Proposal for a directive – amending act
Article 1 – point 14 – point c

Directive 2001/83/EC
Article 27 – paragraph 7

7. ~~Member~~Detailed agendas of ~~the~~ coordination group ~~shall be required, even after their d~~meetings shall be made public at the latest the day before the meeting concerned. Detailed minuties ~~have ceased, not to disclose inform~~of coordination group meetings, containing the decisions taken, details of votes and explanations of ~~the kind covered by the obligation of professional secrecy~~votes, including minority opinions, shall be made public in the month following the meeting.”

Amendment 47 #

Proposal for a directive – amending act
Article 1 – point 18

Directive 2001/83/EC
Article 59 – paragraph 1

18. Article 59(1) is amended as follows: a) the following point (aa) is inserted: «a bis) a summary of the essential information necessary to use the medicine safely and effectively;” b) the following second and third subparagraphs are added: “The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. Any new or amended text shall for a period of 1-year be presented in bold text and preceded by the following symbol “ ” and text “New information”. For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included “This medicinal product is under intensive monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>.”deleted

Amendment 48 #

Proposal for a directive – amending act
Article 1 – point 18

Directive 2001/83/EC
Article 59 - paragraph 1

Article 59(1) is amended as follows: (a) the following point (aa) is inserted: “(aa) a summary of the essential information necessary to use the medicine safely and effectively;” (b) the following second and third subparagraphs are added: “The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. Any new or amended text shall for a period of 1-year be presented in bold text and preceded by the following symbol and text “New information”. For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included “This medicinal product is under intensive‘For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the following statement: “This medicinal product is subject to post-authorisation safety monitoring. All suspected adverse reactions should be reported to your doctor, pharmacist or <name and web- address of the national competent authority>“’.”

Amendment 49 #

Proposal for a directive – amending act
Article 1 – point 18 – point b

Directive 2001/83/EC
Article 59 – paragraph 1

For medicinal products included on the list referred to in Article 23 of Regulation (EC) No. 726/2004, the following additional statement shall be included “This medicinal product ~~is under intensive~~has been proven to be of benefit for patients with your condition. As with all medicines, it is subject to safety monitoring.. All suspected adverse reactions should be reported to your healthcare professional or to <name and web-address of the national competent authority >“.

Amendment 50 #

Proposal for a directive – amending act
Article 1 – point 20

Directive 2001/83/EC
Article 65 – point g and point g a (new)

In Article 65, the following points (g) isand (ga) are added: “(g) the summary of the essential information necessary to use the medicine safely and effectively provided for in Article 11(3a) and Article 59(1)(aa).” (ga) the Community procedure defining a procedural timeline, a clear structure and defined roles for all the stakeholders involved, including for the conduct of public hearings.

Amendment 51 #

Proposal for a directive – amending act
Article 1 – point 20

Directive 2001/83/EC
Article 65 – point g

20. In Article 65, the following point (g) is added: “(g) the summary of the essential information necessary to use the medicine safely and effectively provided for in Article 11(3a) and Article 59(1)(aa).”deleted

Amendment 52 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – point 1

1) take all appropriate measures to encourage doctors, pharmacists ~~and~~, other health-care professionals and patients to report suspected adverse reactions to the national competent authority ~~or the marketing authorisation holder~~;

Amendment 53 #

Bernadette VERGNAUD, Claude TURMES

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 103

A Member State may not delegate ~~any of~~ the tasks entrusted to it under this Title to. It may request training and assistance from another Member State, subject to athe written agreement of the latter. The ~~delega~~requesting Member State ~~shall inform the Commission, the Agency and all other Member States of the delegation in writing. The delegating Member State and the Agency shall make that informat~~and the training Member State shall submit a detailed and budgeted training and assistance plan to the Commission and the Agency, which shall finance it from the Union’s public funds.

Amendment 54 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 105

~~The management of funds intended for activities connected with~~Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall receive adequate public funding commensurate with the tasks conferred. Management of the funds to finance such activities shall be under the permanent control of the national competent authorities in order to guarantee their independence. The first paragraph shall not preclude ~~the~~indirect collection ~~of fees to be paid by marketing authorisation holder~~by the national authorities of further resources for ~~the~~ carrying out of those activities ~~by the national competent authorities~~, provided that their independence is strictly guaranteed.

Amendment 55 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point 1

(1) a summary of risk management systems for medicinal products authorised in accordance with this Directive;

Amendment 56 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point 1

Each Member State shall set up and maintain a national medicines safety web- portal which shall be linked to the European medicines safety web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004. By means of the national medicines safety web-portals, the Member States shall make public at least the following: (1) a summary of risk management systems for medicinal products authorised in accordance with this Directive;

Amendment 57 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point 2

(2) the list of medicinal products ~~under intensive monitoring~~ referred to in Article 23 of Regulation (EC) No 726/2004 whose authorisation is subject to certain conditions or requirements;

Amendment 58 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point 2

(2) the list of medicinal products ~~under intensive monitoring~~ referred to in Article 23 of Regulation (EC) No 726/2004 whose authorisation is subject to certain conditions or requirements;

Amendment 59 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point 3 a (new)

(3a) the most up-to-date electronic version of the package leaflet and Summary of Product Characteristics for all existing and new medicinal products;

Amendment 60 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point 3 b (new)

(3b) a brief document history of changes made to the product information. All information on the safety web-portals, including that set out in points 1 to 3a of this Article, shall be presented in an understandable way for the general public. Information on safety and potential risks of a medicinal product shall be provided in the context of the overall proven benefits.

Amendment 61 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point 3 a (new) and point 3 b (new)

(3a) the most up-to-date electronic version of the package leaflet and Summary of Product Characteristics for all existing and new medicinal products; (3b) a brief document history of changes made to the product information. All information on the safety web-portals, including all of the information set out in points 1 to 3b, shall be presented in an understandable way for the general public.

Amendment 62 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 a – paragraph 4

4. When the Agency or national competent authorities make information referred to in paragraphs 2 and 3 public, any information of a personal or commercially confidential nature shall be deleted in consultation with the marketing authorisation holder unless its public disclosure is necessary for the protection of public health.

Amendment 63 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 – paragraph 1 – subparagraph 1

1. Marketing authorisation holders shall be required to record all suspected adverse reactions in the Community or in third countries which are brought to their attention, stating that they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics, whether reported spontaneously by patients or healthcare professionals or occurring in the context of a post- authorisation safety study.

Amendment 64 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 – paragraph 2

2. The marketing authorisation holder may not refuse reports of suspected adverse reactions received electronically or by any other suitable means from patients and health-care professionals.

Amendment 65 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 – paragraph 3 – subparagraphs 1 and 2

3. Marketing authorisation holders shall be required to submit electronically to the database and data-processing network referred to in Article 24 of Regulation (EC) No 726/2004 (hereinafter referred to as ‘the Eudravigilance database’) information on all serious suspected adverse reactions that occur in the Community and in third countries, stating whether they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics, within 15 days following the receipt of the report or, in the absence of a report, ~~following~~within 15 days of the dayte on which the holder concerned gained knowledge of the event. Marketing authorisation holders shall be required to submit electronically to the Eudravigilance database information on all non-serious suspected adverse reactions that occur in the Community, stating whether they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics, within 90 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event.

Amendment 66 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107a – paragraph 1 – subparagraph 1

1. The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention from healthcare professionals and patients, stating whether they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics.

Amendment 67 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107a – paragraph 1 – subparagraph 2

Member States shall ensure that reports of such reactions are submitted by means of the national medicines ~~safety web-portal~~web portals or by any other appropriate means.

Amendment 68 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107a – paragraph 2– subparagraph 1

2. Member States shall, within 15 days following the receipt of the reports referred to in paragraph 1, submit the reports electronically to the Eudravigilance database, stating whether they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics.

Amendment 69 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107b – paragraph 3 – introductory wording

3. By way of derogation from paragraph 1 of this Article, holders of marketing authorisations for medicinal products referred to in Articles 10, 10a or 10c, and holders of registrations for medicinal products referred to in Articles 14 or 16a, shall be required to submit periodic safety update reports for such products only every three years, save in the following cases:

Amendment 70 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107k – paragraph 2 – subparagraph 1

2. The Pharmacovigilance Risk Assessment Advisory Committee shall assess the matter which has been submitted. For the purposes of that assessment, it may hold a public hearing, together with representatives from the Committee for Medicinal Products for Human Use. The Agency, in consultation with stakeholders, shall develop guidelines for the organisation and conduct of public hearings. The public hearing should also consider the effectiveness and benefits of the product as well as prior evaluations of benefit / risk carried out by the Committee for Medicinal Products or the coordination group under the procedure for granting marketing authorisation as described in paragraph 107l.

Amendment 71 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107k – paragraph 2 – subparagraph 1

2. The Pharmacovigilance Risk-Benefit Balance Assessment Advisory Committee shall ~~assess the matter which has been submitted. F~~consider the situation concerned. It may hold a public hearing for theat purpose~~s of that assessment, it may hold a public hearing~~ in connection with a risk-benefit analysis.

Amendment 72 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107k – paragraph 2 – subparagraph 4 a (new)

In cases where a public hearing is held, a preliminary report shall be published following the hearing.

Amendment 73 #

Proposal for a directive – amending act
Article 2 – paragraph 1

1. With regard to the requirement for the inclusion of a summary of the essential information necessary to use the medicine safely and effectively in the summary of the product characteristics and the package leaflet provided for in point 3a of Article 11 and in point (aa) of Article 59(1) of Directive 2001/83/EC as amended by this Directive, the Member States shall ensure that the requirement applies to a marketing authorisation granted before the date set out in the second subparagraph of Article 3(1) of this Directive from renewal of that authorisation or from the expiry of a period of three years starting from that date, whichever is the earliest.deleted

Amendment 74 #

Sylvana RAPTI

Proposal for a directive – amending act
Article 2 – paragraph 2 a (new)

2a. Until the Agency can ensure the functionalities of the Eudravigilance database, all the periodic safety update reports should also be submitted to the National Competent Authorities where the product is authorised.

source: PE-438.448

2010/03/15 ENVI 244 amendments...

Amendment 27 #

Proposal for a directive – amending act
Recital 5

(5) For the sake of clarity, the definition of ~~adverse reaction~~“medication error” should be ~~amend~~introduced, to ensure that ~~it not only covers noxious and unintended effects~~preventable non-intentional and inappropriate incidents, resulting in an adverse reaction, derived from the authorised use of a medicinal product at the normal doses, but also medication errors and uses outside the authorised summary of the product characteristics, ~~including the misuse and abuse of the product~~are covered by this Directive.

Amendment 28 #

Proposal for a directive – amending act
Recital 5

(5) For the sake of clarity, the definition of adverse reaction should be amended to ensure that it ~~not only~~ covers noxious and unintended effects derived not only from the authorised use of a medicinal product at the normal doses, but also from medication errors and uses outside the authorised summary of the product characteristics, including the misuse and abuse of the product.

Amendment 29 #

Crescenzio RIVELLINI

Proposal for a directive – amending act
Recital 5

(5) For the sake of clarity, the definition of adverse reaction should be amended to ensure that it not only covers noxious and unintended effects derived from the authorised use of a medicinal product at the normal doses, but also those derived from medication errors and from uses outside the authorised summary of the product characteristics, including the misuse and abuse of the product.

Amendment 30 #

Proposal for a directive – amending act
Recital 5

(5) For the sake of clarity, the definition of adverse reaction should be amended to ensure that it not only covers noxious and unintended effects derived from the authorised use of a medicinal product at the normal doses, but also medication errors and uses outside the authorised summary of the product characteristics, including the misuse and abuse of the product.deleted

Amendment 31 #

Proposal for a directive – amending act
Recital 5 a (new)

(5a) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem and an emerging public health concern. Actions to reduce the potentially harmful impacts on the European environment especially on surface water, groundwater and drinking water and public health are needed. Therefore, measures should also be taken to monitor the adverse environmental effects of medicinal products on public health or the environment. This must not lead to the withdrawal of the authorisation for drugs necessary for treating life-threatening or serious diseases.

Amendment 32 #

Proposal for a directive – amending act
Recital 5 a (new)

(5a) Research must be promoted to develop more targeted drugs to avoid side effects for patients and address environmental effects.

Amendment 33 #

Pilar AYUSO, Antonyia PARVANOVA, Françoise GROSSETÊTE

Proposal for a directive – amending act
Recital 5 a (new)

(5a) Pharmaceutical substances are biologically active in humans due to their inherent properties and are often engineered so that they remain unchanged during their passage through the human body. This stability means that they also persist outside the human body, which can create environmental problems, which in turn can affect public health. In order to address the pollution of waters and soils with pharmaceutical residues, undesirable effects on the environment should be included in the assessment of the risk-benefit balance. Moreover, competent authorities should monitor adverse environmental effects of medicinal products with a view to reassessing the risk-benefit balance.

Amendment 34 #

Proposal for a directive – amending act
Recital 6

(6) The marketing authorisation holder should establish a pharmacovigilance system to ensure the monitoring and supervision of one or more of its authorised medicinal products, recorded in a Pharmacovigilance System Master File permanently accessible for inspection. The competent authorities should undertake the supervision of those systems. A summary of the pharmacovigilance system should be therefore submitted with the marketing authorisation application and include a reference to the site where the Pharmacovigilance System Master File for the medicinal product concerned is maintained and accessible for inspection by the competent authorities.

Amendment 35 #

Proposal for a directive – amending act
Recital 7

(7) The planning of pharmacovigilance for each individual medicinal product by the marketing authorisation holder should also take place in the context of a risk management system and should be proportionate to the identified risks, potential risks, and the need for additional information on the medicinal product. It should also be foreseen that any key measures contained in a risk management system are included in the marketing authorisation as conditions. If the conditions included in the marketing authorisation are not fulfilled by the relevant deadline, competent authorities should have the power and appropriate resources to immediately suspend or revoke the marketing authorisation.

Amendment 36 #

Proposal for a directive – amending act
Recital 9

(9) Where, in the case of an unmet medical need, a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, which should be identified by a specific symbol on the outer packaging and by a corresponding explanatory sentence in the leaflet, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).

Amendment 37 #

Proposal for a directive – amending act
Recital 9

(9) ~~Where a medicinal product is~~For newly authorised medicinal products and for medicinal products that are authorizsed subject to the requirement to conduct a post-authorisation safety study or ~~where there are~~are subject to conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to ~~such medicinal products~~all newly authorised medicinal products on the market for less then 3 years, identified as such by a black triangle and a corresponding explanatory sentence on the summary of product characteristics and on the patient information leaflet, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).

Amendment 38 #

Proposal for a directive – amending act
Recital 9

(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be ~~intensive~~continuously monitored on the market. PAs applies to all medicines, patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).

Amendment 39 #

Proposal for a directive – amending act
Recital 9

(9) WFor any newly authorised product or where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to ~~such medicinal products~~all newly authorised medicinal products on the market for less than 3 years, identified as such by a black triangle and a corresponding explanatory sentence on the summary of product characteristics, on the outer packaging and on the patient information leaflet, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).

Amendment 40 #

Daciana Octavia SÂRBU

Proposal for a directive – amending act
Recital 9

(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. It is essential that a strengthened system of pharmacovigilance does not lead to the premature granting of market authorisations. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency12 (hereinafter referred to as the ‘Agency’).

Amendment 41 #

Proposal for a directive – amending act
Recital 9

(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. It is essential that a strengthened system of pharmacovigilance does not lead to the premature granting of market authorisations. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency12 (hereinafter referred to as the ‘Agency’).

Amendment 42 #

Elena Oana ANTONESCU

Proposal for a directive – amending act
Recital 9

(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. It is essential that a strengthened system of pharmacovigilance does not lead to the premature granting of market authorisations. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency12 (hereinafter referred to as the ‘Agency’).

Amendment 43 #

Proposal for a directive – amending act
Recital 10

(10) In order to make it possible for the healthcare professionals and patients to identify easily the most relevant information about medicines they use, the summary of the product characteristics and the package leaflet should include, for all medicinal products except those referred to in Articles 10, 10a and 10c, 14, 16 and 16a of Directive 2001/83/EC, a concise section on the key information about the medicinal product and information how to minimize its risks and maximize its benefits.

Amendment 44 #

Proposal for a directive – amending act
Recital 10

(10) In order to make it possible for the healthcare professionals and patients to identify easily the most relevant information about the medicines they use, the summary of the product characteristics and the package leaflet should include a concise section ~~on the key information about the medicinal product and information how to minimize its risks and maximize its benefits~~describing the benefits and possible adverse effects of the medicinal product and information aimed at ensuring its safe and effective use.

Amendment 45 #

Proposal for a directive – amending act
Recital 10

Amendment 46 #

Proposal for a directive – amending act
Recital 10

(10) ~~In order to make it possible for the healthcare professionals an~~Within five years of the entry into force of this Directive, the Commission shall, following consultations with organisations representing patients, consumers and healthcare professionals, Member States and other interested parties, presents to ~~identify easily the most relevant information about the medicines they use,~~the European Parliament and the Council an assessment report regarding the readability of the summar~~y of the~~ies of product characteristics and the package leaflet ~~should include a concise section on the key information about the medicinal product and information how to minimize its risks and maximize its benefit~~s. Following analysis of the above data, the Commission shall, if appropriate, put forward proposal to improve the layout and the content of the summaries of product characteristics and of the package leaflet to ensure they are a valuable source of information for the general public and healthcare professionals.

Amendment 47 #

Proposal for a directive – amending act
Recital 10

(10) ~~In order to make it possible for the healthcare professionals an~~Within five years of the entry into force of this Directive, the Commission shall, following consultations with organisations representing patients, consumers and healthcare professionals, Member States and other interested parties, presents to ~~identify easily the most relevant information about the medicines they use,~~the European Parliament and the Council an assessment report regarding the readability of the summar~~y of the~~ies of product characteristics and the packageing leaflet ~~should include a concise section on the key information about the medicinal product and information how to minimize its risks and maximize its benefit~~s. Following an analysis of such data, the Commission shall, if appropriate, put forward proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and health care professionals.

Amendment 48 #

Proposal for a directive – amending act
Recital 10

(10) In order to make it possible for the healthcare professionals and patients to identify easily the most relevant information about the medicines they use, the summary of the product characteristics and the package leaflet should include a concise section ~~on the key information about the medicinal product and information how to minimize its risks and maximize its benefits~~describing the benefits and possible adverse effects of the medicinal product and information aimed at ensuring its safe and effective use.

Amendment 49 #

Proposal for a directive – amending act
Recital 10

(10) In order to make it possible for the healthcare professionals and patients to ~~identify easily the most~~have access to relevant information about the medicines they use, there should also be available, in addition to the summary of the product characteristics and the package leaflet ~~should include~~, a reference to the existence of a website or a toll-free telephone line provided by the competent authorities and/or the marketing authorisation holder, including, for each product, a concise section on the key information about the medicinal product and information how to minimize its risks and maximize its benefits.

Amendment 50 #

Proposal for a directive – amending act
Recital 10 a (new)

(10a) Within one year of the entry into force of this Directive, the Commission shall, following consultations with patients and consumers organizations, health care professionals organizations, Member States and other interested parties, present to the European Parliament and the Council an assessment report regarding the readability of the summaries of product characteristics and the package leaflets in the Member States. Following analysis of the above data, the Commission shall, if appropriate, put forward proposal to harmonise and improve the layout and the content of the summaries of product characteristics and of the package leaflet to ensure they are a valuable source of information for the general public and healthcare professionals.

Amendment 51 #

Proposal for a directive – amending act
Recital 10 a (new)

(10a) Without any delay, the Commission shall, in collaboration with EMEA, and following consultations with organisations representing patients, consumers, doctors and pharmacists, social health insurers, and Member States and other interested parties, present to the European Parliament and the Council an assessment report regarding the readability of the summaries of product characteristics and the packaging leaflets and their value to the general public and healthcare professionals. Following an analysis of the above data, the Commission shall, if appropriate, put forward proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and healthcare professionals.

Amendment 52 #

Proposal for a directive – amending act
Recital 10 a (new)

(10a) Within 24 months of the publication of this directive in the Official Journal of the European Union, the Commission shall present to the European Parliament and the Council an assessment report regarding the relevance of the summaries of product characteristics and the package leaflets to the needs of patients and healthcare professionals. On the basis of this, the Commission shall issue, as required, legal recommendations and/or proposals in order to improve these two documents.

Amendment 53 #

Proposal for a directive – amending act
Recital 13

(13) With a view to ensuring that the same level of scientific expertise in the area of pharmacovigilance decision-making at both Community and national level, when fulfilling pharmacovigilance tasks the coordination group should be able to rely on the advice of the Pharmacovigilance Risk-Benefit Ratio Assessment Advisory Committee of the Agency.

Amendment 54 #

Linda McAVAN

Proposal for a directive – amending act
Recital 16

(16) Member States should operate a pharmacovigilance system to collect information useful in the surveillance of medicinal products including information on suspected adverse drug reactions~~, on~~ occurring from normal conditions of use, off-label use, misuse, abuse and medication errors, and ensure its quality through the follow up of suspected adverse drug reaction cases.

Amendment 55 #

Proposal for a directive – amending act
Recital 17

(17) ~~To further increase the coordination of resources between the Member States~~Each Member State should be responsible for the oversight of the adverse reactions occurring in its territory. To further increase the level of expertise in pharmacovigilance, Member States should be ~~authorised to delegate certain pharmacovigil~~encouraged to organise training and to regularly exchancge ~~tasks to another Member Stat~~information and expertise.

Amendment 56 #

Proposal for a directive – amending act
Recital 17

(17) ~~To further increase the coordination of resources between the Member States~~Each Member State should be responsible for the detection and follow- up of adverse events occurring on its territory. To further increase the level of expertise on pharmacovigilance, Member States should be ~~authorised to delegate certain pharmacovigil~~encouraged to organise training and regular exchancge ~~tasks to another Member Stat~~of information and expertise.

Amendment 57 #

Proposal for a directive – amending act
Recital 18

(18) In order to simplify the reporting of suspected adverse reactions the marketing authorisation holders should report those reactions only to the competent authorities of the Member States where it occurred and the Member States should report those reactions ondirectly to the Community pharmacovigilance database and data-processing network referred to in Article 57(1)(d) of Regulation (EC) No 726/2004 (hereinafter ‘the Eudravigilance database’). Any change in the national database should be immediately and automatically reflected in the Eudravigilance database.

Amendment 58 #

Proposal for a directive – amending act
Recital 18

(18) In order to simplify the reporting of suspected adverse reactions and to enable Member States to access the same information simultaneously, the marketing authorisation holders and the Member States should report those reactions only to the Community pharmacovigilance database and data-processing network referred to in Article 57(1)(d) of Regulation (EC) No 726/2004 (hereinafter ‘the Eudravigilance database’). From this perspective, and in order to achieve the objectives referred to above, Member States should not impose any further requirements on marketing authorisation holders in respect of the prompt and regular reporting of suspected adverse reactions.

Amendment 59 #

Proposal for a directive – amending act
Recital 18

(18) In order to simplify the reporting of suspected adverse reactions the marketing authorisation holders should report those reactions only to the Member States and the Member States should report those reactions ondirectly to the Community pharmacovigilance database and data- processing network referred to in Article 57(1)(d) of Regulation (EC) No 726/2004 (hereinafter ‘the Eudravigilance database’). Any change in the national database should be immediately and automatically reflected in the Eudravigilance database. The Eudravingilance database and the national database should be fully interoperable.

Amendment 60 #

Proposal for a directive – amending act
Recital 18

(18) In order to simplify the reporting of suspected adverse reactions the marketing authorisation holders and the Member States should report those reactions only to the Community pharmacovigilance database and data-processing network referred to in Article 57(1)(d) of Regulation (EC) No 726/2004 (hereinafter ‘the Eudravigilance database’). The Eudravigilance database should simultaneously and electronically notify the relevant Member States of reports submitted by market authorisation holders.

Amendment 61 #

Proposal for a directive – amending act
Recital 19

(19) In order to increase the level of transparency on the processes of pharmacovigilance, the Member States should create and maintain medicines safety web-portals. To the same end, the marketing authorisation holders should ~~provide~~submit to the authorities ~~with prior warning about safety announcements~~safety announcements for prior authorisation and the authorities should provide each other with such a warning.

Amendment 62 #

Proposal for a directive – amending act
Recital 19

(19) In order to increase the level of transparency on the processes of pharmacovigilance, the Member States should create and maintain medicines safety web-portals. T~~o the same end, t~~he marketing authorisation holders should ~~provide the authorities with prior warning about safety announcements and the authorities should provide each other with such a warning~~be required to submit to the authorities the safety announcements which they plan to disseminate for prior authorisation. Without delay following such authorisation, the authorities should provide each other with a prior warning about these safety announcements.

Amendment 63 #

Daciana Octavia SÂRBU

Proposal for a directive – amending act
Recital 20 a (new)

(20a) Reporting through health professionals should be especially encouraged in cases where their input could be essential to understanding the adverse reaction. In order to facilitate this reporting, health professionals’ access to medication data contained in the patient health record should be facilitated, in accordance with data protection rules.

Amendment 64 #

Proposal for a directive – amending act
Recitals 20 a (new)

(20a) Reporting through health professionals should be especially encouraged in cases where their input could be essential to understand the significance of the adverse reaction, and in such cases adverse reaction linked to medication errors. In order to facilitate this reporting, health professionals’ access to medication data contained in the patient health record should be facilitated.

Amendment 65 #

Crescenzio RIVELLINI

Proposal for a directive – amending act
Recital 20 a (new)

(20a) Reporting by healthcare professionals should be particularly encouraged in cases where their contribution is essential in order to understand the significance of the adverse reaction and of adverse reactions derived from medication errors. To facilitate this type of reporting and to protect the citizen, access to data contained in patients’ medical files should be accessible to healthcare professionals.

Amendment 66 #

Proposal for a directive – amending act
Recital 22

(22) Requirements for periodic safety update reports should be proportional to the risks posed by medicinal products. Periodic safety update reporting should therefore be linked to the risk management system for newly authorised medicinal products and ~~routine~~ report~~ing~~s should ~~not be necessary~~be required at longer intervals for generic, well- established use, informed consent, homeopathic, or traditional use registered herbal medicinal products. However, in the interest of public health the authorities should require periodic safety update reports for such products at specific intervals when there is a need to assess their risk or review the adequacy of product information.

Amendment 67 #

Proposal for a directive – amending act
Recital 22

(22) Requirements for periodic safety update reports should be proportional to the risks posed by medicinal products. Periodic safety update reporting should therefore be linked to the risk management system for newly authorised medicinal products and routine reporting should ~~not be necessary~~be required for generic, well-established use, informed consent, homeopathic, or traditional use registered herbal medicinal products. However, in the interest of public health the authorities should require periodic safety update reports for such products when there is a need to assess their risk or review the adequacy of product information.

Amendment 68 #

Proposal for a directive – amending act
Recital 28

(28) In order to protect public health, there should be adequate funding of activities related to pharmacovigilance by the national competent authorities. It should be possible to ensure adequate funding for pharmacovigilance activities through the collection of fees. However, the management of those collected funds should be under the permanent control of the national competent authorities in order to guarantee their independence.

Amendment 69 #

Proposal for a directive – amending act
Recital 28

Amendment 70 #

Proposal for a directive – amending act
Recital 28

Amendment 71 #

Proposal for a directive – amending act
Recital 29 a (new)

(29a) This Directive should apply without prejudice to Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data1 and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data2. In order to detect, assess, understand and prevent adverse reactions, identify and take action to reduce the risks and increase the benefits of medicinal products for the purpose of safeguarding public health, it should be possible to process personal data within the Eudravigilance system while complying with EU data protection legislation. That purpose constitutes a substantial public interest which can be justified if identifiable health data are processed only when necessary and the parties involved assess such necessity at every stage of the pharmacovigilance process. 1 OJ L 281, 23.11.1995, p. 31. 2 OJ L 8, 12.1.2001, p. 1.

Amendment 72 #

Proposal for a directive – amending act
Article 1 – point 1 – point a

Directive 2001/83/EC
Article 1 – point 11

~~(a) point 11 is replaced by the following: “(11) Adverse reaction: A response to a medicinal product which is noxious and unintended”~~deleted

Amendment 73 #

Proposal for a directive – amending act
Article 1 – point 1 – point a

Directive 2001/83/EC
Article 1 – point 11

~~“(11) Adverse reaction: A response to a medicinal product which is noxious and unintended.”~~In the German text, replace “Nebenwirkung” by “unerwünschte Arzneimittelwirkung”.

Amendment 74 #

Proposal for a directive – amending act
Article 1 – point 1 – point a

Directive 2001/83/EC
Article 1 – point 11

11) adverse reaction: a response to a medicinal product which is noxious and Uunintended, and which occurs at doses normally used in the human body for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.

Amendment 75 #

Proposal for a directive – amending act
Article 1 – point 1 – point a

Directive 2001/83/EC
Article 1 – point 11

(11) adverse reaction: a response to a medicinal product which is noxious and unintended and which occurs at doses normally used in the human body in accordance with the summary of product characteristics for the prophylaxis, diagnosis or therapy or modification of physiological function; 11a) off-label use of medicinal product: use of a medicinal product which is not in accordance with the summary of product characteristics, including medication errors, and is accompanied by noxious effects which are unintended;

Amendment 76 #

Proposal for a directive – amending act
Article 1 – point 1 – point a

Directive 2001/83/EC
Article 1 – point 11

(11) Adverse reaction: A response to a medicinal product which is noxious and unintended and which occurs at doses normally used in the human body for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.

Amendment 77 #

Proposal for a directive – amending act
Article 1 – point 1 – point a

Directive 2001/83/EC
Article 1 – point 11

~~“(11) Adverse reaction: A response to a medicinal product which is noxious and unintended.”~~In the German text, replace “Nebenwirkung” by “unerwünschte Arzneimittelwirkung”.

Amendment 78 #

Peter LIESE

Proposal for a directive – amending act
Article 1 – point 1 – point a

Directive 2001/83/EC
Article 1 – point 11

~~“(11) Adverse reaction: A response to a medicinal product which is noxious and unintended.”~~In the German text, replace “Nebenwirkung” by “unerwünschte Arzneimittelwirkung”.

Amendment 79 #

Proposal for a directive – amending act
Article 1 – point 1 – point a a (new)

Directive 2001/83/EC
Article 1 – point 11 a (new)

(aa) The following point is inserted: “11a. Medication error: A response that is not an adverse reaction but that is due to errors and uses of a medicinal product outside the authorised summary of product characteristics, including the misuse and abuse of the product.”

Amendment 80 #

Proposal for a directive – amending act
Article 1 – point 1 – point a a (new)

Directive 2001/83/EC
Article 1 – point 13 a (new)

(aa) The following point is inserted: “(13a) Adverse environmental effect: An undesirable effect on the environment or on public health via the environment of a medicinal product or its degradation products”

Amendment 81 #

Peter LIESE

Proposal for a directive – amending act
Article 1 – point 1 – point b

Directive 2001/83/EC
Article 1 – point 14

“(14) Suspected adverse reaction: An ~~adverse reaction in respect of~~unintended event in which a causal relationship between the event and the medicinal product cannot be excluded.”;

Amendment 82 #

Proposal for a directive – amending act
Article 1 – point 1 – point b

Directive 2001/83/EC
Article 1 – point 14

“(14) Suspected adverse reaction: An ~~adverse reaction in respect of~~unintended event in which a causal relationship between the event and the medicinal product cannot be excluded.”;

Amendment 83 #

Proposal for a directive – amending act
Article 1 – point 1 – point b

Directive 2001/83/EC
Article 1 – point 14

“(14) Suspected adverse reaction: An ~~adverse reaction in respect of~~unintended event in which a causal relationship between the event and the medicinal product cannot be excluded.”;

Amendment 84 #

Proposal for a directive – amending act
Article 1 – point 1 – point b

Directive 2001/83/EC
Article 1 – point 14

“(14) ~~Suspected adverse reaction: An adverse reaction in respect of which a causal relationship between the event and the medici~~Medication error: Any preventable non-intentional and inappropriate event or incident that led, or could have led, to an adverse effect, while the medication was under the control of a healthcare professional, p~~roduct cannot be excluded.~~atient or consumer. Medication errors leading to adverse effects should, for reporting purposes, be considered adverse reactions”

Amendment 85 #

Proposal for a directive – amending act
Article 1 – point 1 – point b a (new)

Directive 2001/83/EC
Article 1 – point 14 a (new)

(ba) The following point is inserted: “(14a) Adverse environmental effect: This includes noxious effect on public health or the environment, especially in surface water, groundwater and drinking water related to the environmental appearance of pharmaceuticals or their degradation products, or mixtures of pharmaceuticals and their degradation products.”

Amendment 86 #

Proposal for a directive – amending act
Article 1 – point 1 – point c

Directive 2001/83/EC
Article 1 – point 15

“(15) Post-authorisation ~~safety~~pharmacovigilance study: Any study with a~~n authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product~~ medicinal product authorised early for reasons of public health in the absence of a therapeutic alternative, or carried out at the request of the health authorities once a medicinal product has been placed on the market, with the aim of identifying, characterising or quantifying adverse reaction risks or of assessing the adverse reaction profile of the medicinal product, or of reassessing its risk/benefit balance, or of measuring the effectiveness of risk management measures.”

Amendment 87 #

Proposal for a directive – amending act
Article 1 – point 1 – point c

Directive 2001/83/EC
Article 1 – point 15

(c) point 15 is replaced by the following: “(15) Post-authorisation safety study: Any study with an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.”;deleted

Amendment 88 #

Proposal for a directive – amending act
Article 1 – point 1 – point c

Directive 2001/83/EC
Article 1 – point 15

“(15) Post-authorisation ~~safety~~pharmacovigilance study: Any study with a~~n authorised medicinal product conducted~~ medicinal product authorised early for reasons of public health in the absence of a therapeutic alternative, or carried out at the request of the health authorities once a medicinal product has been placed on the market, with the aim of identifying, characterising or quantifying a ~~safety hazard, confirming the safety~~n adverse reaction risk or of assessing the adverse reaction profile of the medicinal product and its risk/benefit balance, or of measuring the effectiveness of risk management measures.”;

Amendment 89 #

Proposal for a directive – amending act
Article 1 – point 1 – point (c a) (new)

Directive 2001/83/EC
Article 1 – point 28 a (new)

(ca) point 28a is replaced by the following: “(28a) Risk-benefit balance: An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks defined in point 28 […].”

Amendment 90 #

Proposal for a directive – amending act
Article 1 – point 1 – point (c a) (new)

Directive 2001/83/EC
Article 1 – point 28 a (new)

Amendment 91 #

Proposal for a directive – amending act
Article 1 – point 1 – point d

Directive 2001/83/EC
Article 1 – point 28b

(28b) Risk management system: a set of specific pharmacovigilance activities and interventions designed to ~~ide~~quantify~~, characterise, prevent or minimise~~ or prevent risks relating to a medicinal product, including the assessment of the effectiveness of those interventions, or to ensure early identification of new risks.

Amendment 92 #

Proposal for a directive – amending act
Article 1 – point 1 – point d

Directive 2001/83/EC
Article 1 – point 28b

Amendment 93 #

Proposal for a directive – amending act
Article 1 – point 1 – point d

Directive 2001/83/EC
Article 1 – point 28b

Amendment 94 #

Proposal for a directive – amending act
Article 1 – point 1 – point d

Directive 2001/83/EC
Article 1 – point 28c

(28c) Pharmacovigilance system: a system ~~utilized by~~enabling marketing authorisation holders and by Member States, with a view to fulfilling the tasks and responsibilities listed in Title IX ~~and designed to monitor the safety of authorised medicinal products and~~: (a) to collect information useful for the surveillance of medicinal products, with particular reference to adverse reactions in human beings, including misuse and abuse of medicinal products and medication errors; and (b) to evaluate such information scientifically in order to detect any change to the~~ir risk-~~ benefit-risk balance of authorised medicinal products.

Amendment 95 #

Proposal for a directive – amending act
Article 1 – point 1 – point d

Directive 2001/83/EC
Article 1 – point 28c

(28c) Pharmacovigilance system: a system ~~utilized by~~which marke~~ting authorisation holders and by Member States to fulfil the tasks and responsibilities listed in Title IX and designed to moni~~s it possible: (a) to collect information useful in the surveillance of medicinal products, with particular reference to adverse reactions in human beings, including in cases of misuse, medication abuse or medication error; (b) to assess this information scientifically in order to detect any change tor the ~~safety~~risk- benefit balance of authorised medicinal products ~~and detect any change to their risk-benefit balance.~~ ; (c) for marketing authorisation holders and for Member States to fulfil the tasks and responsibilities listed in Title IX

Amendment 96 #

Proposal for a directive – amending act
Article 1 – point 1 – point d a (new)

Directive 2001/83/EC
Article 1 – points 32 a, 32 b and 32 c (new)

(da) The following points 32a, 32b and 32c are inserted: “(32a) Medication error: a non- intentional, preventable omission or action relating to a medicinal product which can be the cause of a risk or of an adverse event for the patient, and which can concern one or more stages in the medicinal product’s cycle, such as formulary selection, prescription, dispensing, validation, preparation, storage, delivery, administration and therapeutic monitoring and information, but also its interfaces, such as communications and transcriptions. (32b) Medication misuse: use of a medicinal product not in compliance with the recommendations in the summary of the product characteristics (SPC). (32c) Medically justified use outside the approved indications: specific case of use deliberately not in compliance with the recommendations under the ‘indications’ section of the SPC but based on the assessment data.”

Amendment 97 #

Proposal for a directive – amending act
Article 1 – point 1 – point d a (new)

Directive 2001/83/EC
Article 1 – points 32 a, 32 b and 32 c (new)

(da) The following point 32a is inserted: “(32a) Medication error: a non- intentional omission or action relating to a medicinal product which can be the cause of a risk or of an adverse event for the patient. By definition, medication error is avoidable because it indicates what should have been done but was not done during the medical treatment of the patient. Medication error can concern one or more stages in the medicinal product’s cycle, such as formulary selection, prescription, dispensing, validation, preparation, storage, delivery, administration and therapeutic monitoring and information, but also its interfaces, such as communications and transcriptions.”

Amendment 98 #

Proposal for a directive – amending act
Article 1 – point 1 – point d a (new)

Directive 2001/83/EC
Article 1 – point 32 b (new)

(da) The following point 32b is inserted: “(32b) Medication misuse: use of a medicinal product not in compliance with the recommendations in the summary of the product characteristics (SPC).”

Amendment 99 #

Proposal for a directive – amending act
Article 1 – point 1 – point d a (new)

Directive 2001/83/EC
Article 1 – point 32 c (new)

(da) The following point 32c is inserted: “(32c) Medically justified use outside the approved indications: specific case of use deliberately not in compliance with the recommendations under the ‘indications’ section of the SPC but based on the assessment data.”

Amendment 100 #

Proposal for a directive – amending act
Article 1 – point 1 – point d a (new)

Directive 2001/83/EC
Article 1 – point 32 d (new)

(da) The following point 32d is inserted: “(32d) Commercially confidential information: parts of documents, data or information are regarded as being commercially confidential, for a determined period which must be specified, if it is shown that divulging them is likely to cause disproportionate harm to the commercial interests of a marketing authorisation holder, except in cases in which, notwithstanding this damage, there is a major public-interest justification for divulgation. Information about public health, especially pre- clinical, clinical and pharmacovigilance data, can never be regarded as commercially confidential information. Data about sales volumes should also be made public as they are scientific data that make it possible to assess the level of exposure of the population to adverse reactions to a given medicinal product.”

Amendment 101 #

Proposal for a directive – amending act
Article 1 – point 2 – point -a (new)

Directive 2001/83/EC
Article 8 – paragraph 3 – point (i) – indent 2 a (new)

(-a) a new indent is inserted after the second indent in point (i); “– ecotoxicological tests, and”

Amendment 102 #

Proposal for a directive – amending act
Article 1 – point 2 – point -a (new)

Directive 2001/83/EC
Article 8 – paragraph 3 – point (i)

(-a) a new indent ) is inserted after the second indent in point (i): “– ecotoxicological tests,”

Amendment 103 #

Proposal for a directive – amending act
Article 1 – point 2 – point a

Directive 2001/83/EC
Article 8 – paragraph 3 – point “ia” - introductory sentence

(ia) A detailed description and summary of the applicant's pharmacovigilance system which shall include the following elements:

Amendment 104 #

Proposal for a directive – amending act
Article 1 – point 3

Directive 2001/83/EC
Article 11 – paragraph 1 – point 3a – and Article 11 – paragraph 3

3. Article 11 is amended as follows: (a) the following point 3a is inserted: “(3a) a summary of the essential information necessary to use the medicine safely and effectively;” (b) the following subparagraph is added: “For the purposes of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the statement: “This medicinal product is under intensive monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>.”deleted

Amendment 105 #

Proposal for a directive – amending act
Article 1 – point 3 – point a

Directive 2001/83/EC
Article 11 – paragraph 1 – point 3a

“(3a) for all medicinal products, except for those referred to in Articles 10, 10a and 10c, 14, 16 and 16a, a summary of the essential information necessary to use the medicine safely and effectively.”

Amendment 106 #

Proposal for a directive – amending act
Article 1 – point 3 – point a

Directive 2001/83/EC
Article 11 – paragraph 1 – point 3a

~~(a) the following point 3a is inserted: “(3a) a summary of the essential information necessary to use the medicine safely and effectively;”~~deleted

Amendment 107 #

Antonyia PARVANOVA, Françoise GROSSETÊTE

Proposal for a directive – amending act
Article 1 – point 3

Directive 2001/83/EC
Article 11 – paragraph 1 – point 3a and Article 11 – paragraph 3

“(3a) ~~a summary of the essential information necessary to use the medicine safely and effectively;” (b) The following subparagraph is added: “For~~Within 24 months of the publication of this directive in the Official Journal of the pEurposes of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the statement: “This medicinal product is under intensive monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>opean Union, the Commission shall present to the European Parliament and the Council an assessment report regarding the relevance of the summaries of product characteristics and the package leaflets to the needs of patients and healthcare professionals. On the basis of this, the Commission shall issue, as required, legal recommendations and/or proposals in order to improve these two documents.”

Amendment 108 #

Proposal for a directive – amending act
Article 1 – point 3 – point a

Directive 2001/83/EC
Article 11 – paragraph 1 – point 3a

~~(a) the following point 3a is inserted: “(3a) a summary of the essential information necessary to use the medicine safely and effectively;”~~deleted

Amendment 109 #

Antonyia PARVANOVA, Françoise GROSSETÊTE

Proposal for a directive – amending act
Article 1 – point 3 – point b

Directive 2001/83/EC
Article 11 – paragraph 3

“For the purposes of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the ~~statement: “This medicinal product~~following statement, preceded by the symbol : “This medicinal product has been new on the market for less then 3 years or is under intensive monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>.”

Amendment 110 #

Proposal for a directive – amending act
Article 1 – point 3 – point b

Directive 2001/83/EC
Article 11 – paragraph 3

“For ~~the purposes of point (3a) of the first subparagraph, for~~ medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the following statement: “This medicinal product is ~~under intensive~~subject to a post- authorisation safety monitoring. All suspected adverse reactions should be reported to your doctor, pharmacist or <name and web -address of the national competent authority>.”

Amendment 111 #

Proposal for a directive – amending act
Article 1 – point 3

Directive 2001/83/EC
Article 11 – paragraph 1 – point 3a and Article 11 – paragraph 2 a (new)

(a) the following point 3a is inserted: “(3a) a summary of the essential information necessary to use the medicine safely and effectively;” (b) the following subparagraph is added: “For the purposes of point (3a) of the first subparagraph, fsubparagraph is added: “For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the statement: “This medicinal product is under intensive monitoring. All suspected adverse reactions should be reported to <name and web- address of the national competent authority>.”

Amendment 112 #

Proposal for a directive – amending act
Article 1 – point 3 – point b

Directive 2001/83/EC
Article 11 – paragraph 3

“For the purposes of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the ~~statement: “This medicinal product~~following statement, preceded by the symbol : “This medicinal product is new and has been on the market for less than 3 years or is under intensive monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>.”

Amendment 113 #

Marina YANNAKOUDAKIS

Proposal for a directive – amending act
Article 1 – point 3 – point b

Directive 2001/83/EC
Article 11 – paragraph 3

“For the purposes of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the ~~statement: “This medicinal product is under intensive monitoring.~~following statement, preceded by the symbol : All suspected adverse reactions should be reported to <name and web-address of the national competent authority>.”

Amendment 114 #

Proposal for a directive – amending act
Article 1 – point 3 – point b

Directive 2001/83/EC
Article 11 – paragraph 3

“For ~~the purposes of point (3a) of the first subparagraph, for~~ medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the ~~summary~~leaflet shall include the statement: “This newly authorised medicinal product is under intensive monitoring in order to increase knowledge on its adverse reactions. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>“. The statement shall be accompanied by an inverted black triangle . The black triangle shall also appear on the outer packaging.”

Amendment 115 #

Proposal for a directive – amending act
Article 1 – point 3 – point b

Directive 2001/83/EC
Article 11 – paragraph 3

“For the purposes of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No. 726/2004, the summary shall include the statement: “This medicinal product ~~is under intensive~~has been proven to be of benefit to patients with your condition. As with all medicines it is subject to safety monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>“.”

Amendment 116 #

Proposal for a directive – amending act
Article 1 – point 3 – point b

Directive 2001/83/EC
Article 11 – paragraph 3

“For ~~the purposes of point (3a) of the first subparagraph, for~~ medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the statement: “This medicinal product is under ~~intensive~~thorough post- authorisation monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority> or to your doctor, pharmacist or another healthcare professional.”

Amendment 117 #

Marina YANNAKOUDAKIS

Proposal for a directive – amending act
Article 1 – point 3 – point b a (new)

Directive 2001/83/EC
Article 11 – paragraph 3 a (new)

(b a) the following paragraph is added: “This summary of essential information shall be reviewed after the entry into force of a new directive on information to patients, to be proposed by the Commission”:

Amendment 118 #

Dagmar ROTH-BEHRENDT

Proposal for a directive – amending act
Article 1 – point 3 a (new)

Directive 2001/83/EC
Article 16c – paragraph 4 – subparagraph 2

3a. In Article 16c(4), subparagraph 2 is replaced by the following: The Committee shall consider whether the other criteria for a simplified registration as referred to in Article 16a are fully complied with. If the Committee considers it possible, it shall establish a Community herbal monograph as referred to in Article 16h(3) which shall be complied with by the Member State when taking its final decision.

Amendment 119 #

Mairead McGUINNESS

Proposal for a directive – amending act
Article 1 – point 7

Directive 2001/83/EC
Article 21 – paragraph 3

“3. The national competent authorities shall make publicly available without delay the marketing authorisation together with the package leaflet, summary of the product characteristics and any conditions established in accordance with Articles 21a, 22 and 22a, together with any deadlines for their fulfilment, for each medicinal product which they have authorised.

Amendment 120 #

Proposal for a directive – amending act
Article 1 – point 7

Directive 2001/83/EC
Article 21 – paragraph 4 – subparagraph 1

4. The national competent authorities shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical and pre-clinical tests, the clinical trials and the risk management system and the pharmacovigilance system of the medicinal product concerned. The assessment report shall detail the natural development of the disease, existing treatments for the indication requested, where appropriate, and whether the medicinal product produces tangible therapeutic progress in comparison with existing treatments (‘added value’ or ‘improvement in the medical service provided’). The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the medicinal product concerned.

Amendment 121 #

Proposal for a directive – amending act
Article 1 – point 7

Directive 2001/83/EC
Article 21 – paragraph 4 – subparagraph 1

4. The national competent authorities shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical and pre-clinical tests, the clinical trials and the risk management system and the pharmacovigilance system of the medicinal product concerned. The assessment report shall detail the natural development of the disease, existing treatments for the indication requested, where appropriate, and whether the medicinal product produces tangible therapeutic progress in comparison to existing treatments (‘added value’ or ‘improvement in the medical service provided’). The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the medicinal product concerned.

Amendment 122 #

Proposal for a directive – amending act
Article 1 – point 7

Directive 2001/83/EC
Article 21 – paragraph 4 – subparagraph 2

The national competent authorities shall make publicly accessible without delay the final assessment report, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature. The justification shall be provided separately for each indication applied for.

Amendment 123 #

Proposal for a directive – amending act
Article 1 – point 8

Directive 2001/83/EC
Article 21a - introduction

AIf the medicinal product responds to unmet medical needs and if its risk- benefit balance is favourable, a marketing authorisation may be granted subject to one or more of the following conditions:

Amendment 124 #

Proposal for a directive – amending act
Article 1 – point 8

Directive 2001/83/EC
Article 21a - introductory words

AIf the medicinal product responds to unmet medical needs and if its risk- benefit balance may be considered favourable, a marketing authorisation may be granted subject to one or more of the following conditions:

Amendment 125 #

Proposal for a directive – amending act
Article 1 – paragraph 8

Directive 2001/83/EC
Article 21a - introductory words

Amendment 126 #

Proposal for a directive – amending act
Article 1 – point 8

Directive 2001/83/EC
Article 21a - introduction

AIn addition to the provisions laid down in Article 19, a marketing authorisation may be granted subject to one or more of the following conditions:

Amendment 127 #

Proposal for a directive – amending act
Article 1 – point 8

Directive 2001/83/EC
Article 21a - introduction

AIf the medicinal product responds to unmet medical and public health needs, and if the benefit/risk balance is favourable, a marketing authorisation may be granted subject to one or more of the following conditions:

Amendment 128 #

Proposal for a directive – amending act
Article 1 – point 8

Directive 2001/83/EC
Article 21a - introduction

Amendment 129 #

Proposal for a directive – amending act
Article 1 – point 8

Directive 2001/83/EC
Article 21a – paragraph 2

The marketing authorisation shall lay down deadlines for the fulfilment of the conditions where necessary. If the conditions included in the marketing authorisation are not fulfilled by the relevant deadline, the competent authorities shall have the power and appropriate resources to immediately suspend or revoke the marketing authorisation.

Amendment 130 #

Proposal for a directive – amending act
Article 1 – point 8

Directive 2001/83/EC
Article 21a – paragraph 2

Amendment 131 #

Proposal for a directive – amending act
Article 1 – paragraph 8

Directive 2001/83/EC
Article 21a – point 4 – subparagraph 2

The marketing authorisation shall lay down deadlines for the fulfilment of the conditions ~~where necessary~~.

Amendment 132 #

Proposal for a directive – amending act
Article 1 – paragraph 8

Directive 2001/83/EC
Article 21a – point 4 – subparagraph 2

The marketing authorisation shall lay down deadlines for the fulfilment of the conditions where necessary and stipulate that continuation of the authorisation shall be linked to timely compliance with the conditions laid down.

Amendment 133 #

Proposal for a directive – amending act
Article 1 – point 8

Directive 2001/83/EC
Article 21a – point 4 – subparagraph 2

Amendment 134 #

Proposal for a directive – amending act
Article 1 – point 9

Directive 2001/83/EC
Article 22

In exceptional circumstances and following consultation with the applicant, the authorisation may be granted subject to a requirement for the applicant to ~~meet certain condition~~introduce specific procedures, in particular concerning the safety of the medicinal product, notification to the ~~national~~ competent authorities of any incident relating to its use, and action to be taken. This authorisation may be granted ~~only when the applicant can show that he is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use,~~ for objective, verifiable reasons and must be based on one of the grounds set out in Annex I to Directive 2001/83/EC. Continuation of the authorisation shall be linked to the annual reassessment of these conditions.”

Amendment 135 #

Proposal for a directive – amending act
Article 1 – point 10

Directive 2001/83/EC
Article 22a – paragraph 1

Amendment 136 #

Pilar AYUSO, Françoise GROSSETÊTE, Antonyia PARVANOVA

Proposal for a directive – amending act
Article 1 – point 11

Directive 2001/83/EC
Article 23– paragraph 4 – subparagraph 1

4. In order that the risk-benefit balance may be continuously assessed, the national competent authority may at any time ask the holder of the marketing authorisation to forward ~~data demonstrating that~~, through its pharmacovigilance system, the data necessary for a reassessment of the risk- benefit balance ~~remains favourable~~.

Amendment 137 #

Proposal for a directive – amending act
Article 1 – point 12 – point b

Directive 2001/83/EC
Article 24– paragraph 3

3. Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the ~~national~~ competent authority decides, on justified grounds relating to pharmacovigilance ~~or to insufficient exposure to the product~~, to proceed with one additional five-year renewal in accordance with paragraph 2.”

Amendment 138 #

Proposal for a directive – amending act
Article 1 – point 14 – point a

Directive 2001/83/EC
Article 27– paragraph 1

1. ATwo coordination groups shall be set up: (a) A coordination group for mutual recognition and decentralised procedures shall be responsible for the following ~~purposes:~~ tasks: (ai) the examination of any question relating to a marketing authorisation of a medicinal product in two or more Member States in accordance with the procedures laid down in Chapter 4; (bii) the examination of questions related to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1), with the exception of all questions relating to pharmacovigilance. For the fulfilment of its tasks, the coordination group for mutual recognition and decentralised procedures shall be assisted by the Committee for Medicinal Products for Human Use referred to in Article 5(1) of Regulation (EC) No 726/2004. (b) A coordination group for pharmacovigilance risk assessment shall be responsible for the following tasks: (i) the examination of questions relating to the pharmacovigilance of medicinal products authorised by the Member States, in accordance with Articles 107c, 107e, 107g, 107l and 107r; (cii) the examination of questions relateding to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1)~~. The Agency shall provide the secretariat of this coordination group~~, for all questions relating to pharmacovigilance. For the fulfilment of its pharmacovigilance tasks, the coordination group for pharmacovigilance risk assessment shall be assisted by the Pharmacovigilance ~~Risk Assessment Advisory~~ Committee referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004. The Agency shall provide the secretariat for these coordination groups.

Amendment 139 #

Proposal for a directive – amending act
Article 1 – point 14 – point a

Directive 2001/83/EC
Article 27 – paragraph 1

1. ATwo coordination groups shall be set up: (a) a coordination group for mutual recognition and decentralised procedures shall be responsible for the following ~~purposes: (a~~tasks: (i) the examination of any question relating to a marketing authorisation of a medicinal product in two or more Member States in accordance with the procedures laid down in Chapter 4; (bii) the examination of questions related to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1), with the exception of all questions relating to pharmacovigilance. For the fulfilment of its tasks, the coordination group for mutual recognition and decentralised procedures shall be assisted by the Committee for Medicinal Products for Human Use referred to in Article 5(1) of Regulation (EC) No 726/2004. (b) A coordination group for pharmacovigilance risk assessment shall be responsible for the following tasks: (i) the examination of questions relating to the pharmacovigilance of medicinal products authorised by the Member States, in accordance with Articles 107c, 107e, 107g, 107l and 107r; (cii) the examination of questions relateding to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1)~~. The Agency shall provide the secretariat of this coordination group~~, for all questions relating to pharmacovigilance. For the fulfilment of its pharmacovigilance tasks, the coordination group for pharmacovigilance risk assessment shall be assisted by the European Pharmacovigilance ~~Risk Assessment Advisory~~ Committee referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004. The Agency shall provide the secretariat for these coordination groups.

Amendment 140 #

Proposal for a directive – amending act
Article 1 – point 14 – point a

Directive 2001/83/EC
Article 27– paragraph 1 – subparagraph 3

For the fulfilment of its pharmacovigilance tasks, the coordination group shall be assisted by the Pharmacovigilance Risk- Benefit Assessment Advisory Committee referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Amendment 141 #

Proposal for a directive – amending act
Article 1 – point 14 – point a

Directive 2001/83/EC
Article 27– paragraph 1 – subparagraph 3

For the fulfilment of its pharmacovigilance tasks, the coordination group shall be assisted by the Pharmacovigilance ~~Risk Assessment Advisory~~ Committee referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004.

Amendment 142 #

Proposal for a directive – amending act
Article 1 – point 14 – point b

Directive 2001/83/EC
Article 27– paragraph 2 – subparagraphs 1a and 1b

Members of the coordination groups for mutual recognition and decentralised procedures and for pharmacovigilance risk assessment and experts shall, for the fulfilment of their tasks, rely on the scientific and regulatory resources available to the national ~~marketing authorisation bodies~~bodies responsible for, respectively, issuing marketing authorisations and pharmacovigilance. Each national competent authority shall monitor the level of expertise of the evaluations carried out and facilitate the activities of nominated coordination group members and experts. Article 63 of Regulation (EC) No 726/2004 shall apply to the coordination groups as regards the transparency and independence of ~~its members.~~ their members. A member of one coordination group may not simultaneously be a member of the other group. The members of the coordination group for pharmacovigilance risk assessment shall be hierarchically independent of the national marketing authorisation bodies.

Amendment 143 #

Proposal for a directive – amending act
Article 1 – point 14 – point c

Directive 2001/83/EC
Article 27– paragraphs 4, 5 and 6

4. The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all meetings of the coordination groups. 5. The members of the coordination groups for mutual recognition and decentralised procedures and for pharmacovigilance risk assessment shall ensure that there is appropriate coordination between the tasks of thateir respective group and the work of national competent authorities, including, respectively, the consultative bodies concerned with the marketing authorisation and those concerned with the surveillance of medicinal products. 6. Save where otherwise provided for in this Directive, the coordination groups shall use ~~its~~their best endeavours to take decisions by consensus. If such a consensus cannot be reached, the position of the majority of members shall prevail.

Amendment 144 #

Proposal for a directive – amending act
Article 1 – point 14 – point c

Directive 2001/83/EC
Article 27– paragraph 6 a (new)

6a. A detailed agenda of coordination group meetings shall be made public on the day before the meeting at the latest. Detailed minutes of coordination group meetings, containing, in particular, details of votes and explanations of votes, including minority opinions, shall be made public in the month following the meeting.

Amendment 145 #

Proposal for a directive – amending act
Article 1 – point 18

Directive 2001/83/EC
Article 59 – paragraph 1

18. Article 59(1) is amended as follows: (a) the following point (aa) is inserted: “(aa) a summary of the essential information necessary to use the medicine safely and effectively;” (b) the following second and third subparagraphs are added: “The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. Any new or amended text shall for a period of 1-year be presented in bold text and preceded by the following symbol  and text “New information”. For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included “This medicinal product is under intensive monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>.”deleted

Amendment 146 #

Proposal for a directive – amending act
Article 1 – point 18 – point a

Directive 2001/83/EC
Article 59 – paragraph 1 – point aa

~~(a) the following point (aa) is inserted: “(aa) a summary of the essential information necessary to use the medicine safely and effectively;”~~deleted

Amendment 147 #

Proposal for a directive – amending act
Article 1 – point 18 – point a

Directive 2001/83/EC
Article 59 – paragraph 1 – point aa

~~(aa) a summary of the essential information necessary to use the medicine safely and effectively;~~Deleted

Amendment 148 #

Proposal for a directive – amending act
Article 1 – point 18 – point a

Directive 2001/83/EC
Article 59 – paragraph 1 – point aa

“(aa) a summary of the essential information necessary to use the medicine safely and effectively; except for the medicinal products referred to in Articles 10, 10a and 10c, 14, 16 and 16a.”

Amendment 149 #

Proposal for a directive – amending act
Article 1 – point 18 – point a

Directive 2001/83/EC
Article 59 – paragraph 1 – point aa

“(aa) a ~~summary of the essential information necessary to use the medicine~~brief description of the main characteristics of the medicinal product enabling the patient to understand its benefits and possible adverse effects and to use it safely and effectively;”

Amendment 150 #

Proposal for a directive – amending act
Article 1 – point 18 – point a

Directive 2001/83/EC
Article 59 – paragraph 1 – point aa

Amendment 151 #

Proposal for a directive – amending act
Article 1 – point 18 – point a

Directive 2001/83/EC
Article 59 – paragraph 1 – point aa

~~(aa) a summary of the essential information necessary to use the medicine safely and effectively;~~deleted

Amendment 152 #

Antonyia PARVANOVA, Françoise GROSSETÊTE

Proposal for a directive – amending act
Article 1 – point 18 – point a

Directive 2001/83/EC
Article 59 – paragraph 1 – point aa

(aa) a ~~summary of the essential information necessary to use~~reference to the existence of a free- phone number provided by the competent authorities and/or the marketing authorisation holder or a website which, for each medicinal product, includes a section with concise essential information about the medicine ~~saf~~, as welyl a~~nd effectively~~s advice on how to maximise its benefits whilst minimising any risks associated with its use;

Amendment 153 #

Proposal for a directive – amending act
Article 1 – point 18

Directive 2001/83/EC
Article 59 – paragraph 1

“(aa) a summary of the essential information necessary to use the medicine safely and effectively;” (b) the following second and third subparagraphs are added: “The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. Any new or amended text shall for a period of 1-year be presented in bold text and preceded by the following symbol  and text “New information”. For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included “This medicinal product is under intensiveFor medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, a summary including the following statement: ‘This medicinal product is subject to post- authorisation safety monitoring. All suspected adverse reactions should be reported to your doctor, pharmacist or <name and web-address of the national competent authority>”’.”

Amendment 154 #

Peter LIESE, Thomas ULMER, Anja WEISGERBER

Proposal for a directive – amending act
Article 1 – point 18 – point b

Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraphs 2 and 3

(ba) the following second and third subparagraphs are added: “The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. Any new or amended text shall for a period of 1-year be presented in bold text and preceded by the following symbol  and text “New information”. For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included “This medicinal product is under intensivepoint (a b) is inserted: “(ab) For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, summary including the following statement: ‘This medicinal product is subject to post- authorisation detailed safety monitoring. All suspected adverse reactions should be reported to your doctor, pharmacist or <name and web-address of the national competent authority>”’.” ~~(The third subpara of the Commission text largely corresponds to the second subpara of the~~Or. en amendment)

Amendment 155 #

Proposal for a directive – amending act
Article 1 – point 18 – point b

Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraph 2

“The information referred to in point (aa) of the first subparagraph shall be presented in a ~~box surrounded by a black border~~form that is clearly legible, prominent and clearly distinguishable from the rest of the text. Any new or amended text shall for a period of 1-year be presented in bold text and preceded by the following symbol and text “New information”.

Amendment 156 #

Proposal for a directive – amending act
Article 1 – point 18 – point b

Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraphs 2 and 3

“~~The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. Any new or amended text~~New important safety warnings shall for a period of 1-year be presented in bold text and preceded by the following symbol  and t~~ext “New information~~he following text “New important safety warnings”. For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included “‘This newly authorised medicinal product is under intensive monitoring in order to increase knowledge of its adverse effects. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>”’. The statement shall be accompanied by an inverted black triangle, which shall also appear on the outer packaging.”

Amendment 157 #

Proposal for a directive – amending act
Article 1 – point 18 b

Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraphs 2 and 3

“~~The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. Any new or amended text~~New important safety warnings shall for a period of 1-year be presented in bold text and preceded by the ~~following symbol  and~~ text “‘New i~~nformation”~~mportant safety warnings’. For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included ~~“This medicinal product~~, preceded by the symbol ▼ : ‘This medicinal product has been new on the market for less then 3 years or is under intensive monitoring. All suspected adverse reactions should be reported to your doctor, pharmacist, or <name ~~and~~, web-address, postal address and/or telephone number of the national competent authority>”’.”

Amendment 158 #

Proposal for a directive – amending act
Article 1 – point 18 – point b

Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraphs 2 and 3

“~~The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. Any new or amended text~~New important safety warnings shall for a period of 1-year be presented in bold text and preceded by the ~~following symbol  and text “New information”~~text “New important safety warnings “. For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included ~~“This medicinal product~~, preceded by the symbol : ‘This medicinal product has been new on the market for less then 3 years or is under intensive monitoring. All suspected adverse reactions should be reported to your doctor, pharmacist, or <name ~~and~~, web-address, postal address and/or telephone number of the national competent authority>”’.”

Amendment 159 #

Proposal for a directive – amending act
Article 1 – point 18 – point b

Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraphs 2 and 3

(b) the following ~~second and third~~ subparagraph~~s are~~ is added: “The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. Any new or amended text shall for a period of 1-year be presented in bold text and preceded by the following symbol  and text “New information”. For medicinal products includeWithin 24 months from the publication of this Directive in the Official Journal of the European Union, the Commission shall undertake to submit a report to the European Parliament and the Council on the relevance of the summary of product characteristics and onf the ~~list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included “This medicinal product is under intensive monitoring. All suspected adv~~package leaflet in relation to the needs of patients and health care professionals. On this basis, the Commission shall, wherse ~~reactions should be reported to <name and web-address of the national competent authority>“~~necessary, make recommendations and/or legislative proposals to improve these two documents.”

Amendment 160 #

Proposal for a directive – amending act
Article 1 – point 18 – point b

Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraphs 2 and 3

“The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. Any new ~~or amended text~~important safety warnings shall for a period of 1-year be presented in bold text and preceded by the ~~following symbol  and~~ text “‘New i~~nformation”~~mportant safety warnings’. For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included ~~“This medicinal product~~, preceded by the symbol : ‘This medicinal product is new and has been on the market for less than 3 years or is under intensive monitoring. All suspected adverse reactions should be reported to your doctor, pharmacist, or <name ~~and~~, web- address, postal address, fax and/or telephone number of the national competent authority>“.’.”

Amendment 161 #

Proposal for a directive – amending act
Article 1 – point 18 – point b

Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraph 3

For medicinal products included on the list referred to in Article 23 of Regulation (EC) No. 726/2004, the following additional statement shall be included “‘This medicinal product ~~is under intensive~~has been proven to be of benefit to patients with your condition. As with all medicines, it is subject to safety monitoring.. All suspected adverse reactions should be reported to your healthcare professional or to <name and web-address of the national competent authority >”’.”

Amendment 162 #

Proposal for a directive – amending act
Article 1 – point 20

Directive 2001/83/EC
Article 65 – point g

Amendment 163 #

Proposal for a directive – amending act
Article 1 – point 20

Directive 2001/83/EC
Article 65 – point g

Amendment 164 #

Proposal for a directive – amending act
Article 1 – point 20

Directive 2001/83/EC
Article 65 – point g

Amendment 165 #

Antonyia PARVANOVA, Pilar AYUSO

Proposal for a directive – amending act
Article 1 – point 20

Directive 2001/83/EC
Article 65 – point g

Amendment 166 #

Proposal for a directive – amending act
Article 1 – point 20 a (new)

Directive 2001/83/EC
Article 65 – point g a (new)

20a. In Article 65, the following point is added: “(ga) the Community procedure defining a procedural timeline, a clear structure and defined roles for all the stakeholders involved, including for the conduct of public hearings.”

Amendment 167 #

Proposal for a directive – amending act
Article 1 – point 20 a (new)

Directive 2001/83/EC
Article 86 – paragraph 2

20a. The first indent of Article 86(2) is amended as follows: “– the labelling and the accompanying package leaflets, which are subject to the provisions of Title V, and the summary of the product characteristics, insofar as they are made available to the public independently of the delivery of the medicinal product in unchanged wording and without additional promotional elements,”

Amendment 168 #

Andrés PERELLÓ RODRÍGUEZ

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 101 – paragraph 2

2. Member States shall by means of the pharmacovigilance system referred to in paragraph 1 evaluate all information scientifically, consider options for risk minimisation and prevention and take regulatory action as necessary. To that end they shall also obtain the relevant information concerning use of the medication so as to assess the impact of the risks on public health. They shall perform a regular audit of their pharmacovigilance system and report the results to the Commission on [insert concrete date - two-years after the date of transposition referred to in Article 3(1)] at the latest and then every two years thereafter.

Amendment 169 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 101 – paragraph 3

3. Each Member State shall designate aone or more competent authorityies for the conduct of pharmacovigilance tasks.

Amendment 170 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 1

(1) take all appropriate measures to encourage ~~doctor~~patients, doctors, hospitals, pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority ~~or the marketing authorisation holder~~;

Amendment 171 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 1

(1) take all appropriate measures to encourage patients, doctors, pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority ~~or the marketing author~~. Those measures shall include training for health professionals and for patients and a public information campaign for patients. Patients’ organisation s shoulder be involved in providing information and training to patients and in developing public information campaigns in cooperation with regulatory bodies.

Amendment 172 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 1

(1) take all appropriate measures to encourage doctors, pharmacists and other health-care professionals as well as patients to report suspected adverse reactions to the national competent authority or the marketing authorisation holder;

Amendment 173 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 1

(1) take all appropriate measures to encourage doctors, pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority orand the marketing authorisation holder;

Amendment 174 #

Elena Oana ANTONESCU

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 1

Amendment 175 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 1

Amendment 176 #

Oreste ROSSI

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 1

Amendment 177 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 1

Amendment 178 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – point 1

Amendment 179 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 1 a (new)

(1a) conduct public awareness campaigns on the importance of reporting adverse reactions;

Amendment 180 #

Elena Oana ANTONESCU

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – point 1 a (new)

(1a) facilitate direct patient reporting through the provision of alternative reporting formats (email, telephone, fax and letter) in addition to web-based formats;

Amendment 181 #

Oreste ROSSI

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – point 1 a (new)

(1a) take appropriate measures to ensure that spontaneous reports by patients are properly presented and guided efficiently by health-care professionals;

Amendment 182 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 1 a (new)

(1a) facilitate direct patient reporting through the provision of alternative reporting formats (email, telephone, fax and letter) in addition to web-based formats;

Amendment 183 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 3 a (new)

Reporting of suspected adverse reactions resulting from medication errors should be done anonymously and with due regard for medical confidentiality.

Amendment 184 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 1 a (new)

(1a) conduct public awareness campaigns on the importance of reporting adverse reactions;

Amendment 185 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 1 a (new)

(1a) conduct public awareness campaigns on the importance of reporting adverse reactions;

Amendment 186 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 2

(2) ensure that adverse reaction reports and the databases contain the highest quality information possible;

Amendment 187 #

Proposal for a directive – amending act
Article 1 – point 2

Directive 2001/83/EC
Article 102 – paragraph 1 – point 2

(2) ensure that adverse reaction reports and the databases contain the highest quality information possible;

Amendment 188 #

Pilar AYUSO, Françoise GROSSETÊTE

Proposal for a directive – amending act
Article 1 – paragraph 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 2

(2) ensure that adverse reaction reports and the databases contain the highest quality information possible;

Amendment 189 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 3

(3) ~~through the methods of collecting information and where necessary through the follow up of adverse reaction reports, ensure that any biological~~ensure that any biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of a report on a suspected adverse reaction is identifiable by, as far as available, the name of the MAH, the INN, the name of the medicinal product ~~prescri~~and the batch numbedr, ~~dispensed, or sold in their territory which is the subject of an adverse reaction report is identifiable;~~using the standard forms and procedures developed in accordance with Article 25(1) of the Regulation (EC) No 726/2004 and taking due account of the developments within the EudraVigilance system. For the purposes of point (1) and (3) of the first paragraph the Member States may impose specific requirements on doctors, pharmacists and other health-care professionals ~~in respect of the reporting of suspected serious or unexpected adverse reactions~~.

Amendment 190 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 3

(3) through the methods of collecting information and where necessary through the follow up of adverse reaction reports, ensure that any biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of an adverse reaction report is identifiable using the content format and procedure developed in accordance with Article 25(1) of Regulation (EC) No 726/2004 and implement the necessary measures to ensure the traceability of biological medicinal products dispensed to patients;

Amendment 191 #

Proposal for a directive – amending act
Article 1 – paragraph 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 3 a (new)

(3a) ensure that the public is given important information in good time on pharmacovigilance concerns relating to the use of a medicinal product and that the data is permanently accessible to the public;

Amendment 192 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 3 a (new)

Amendment 193 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 3 a (new)

Amendment 194 #

Oreste ROSSI

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 2 a (new)

The reporting of suspected adverse reactions due to medication errors should not be the subject of – nor give rise to – legal action against persons reporting them.

Amendment 195 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 103

A Member State may delegate any of the tasks entrusted to it under this Title to another Member State subject to a written agreement of the latter. The delegating Member State shall inform the Commission, the Agency and all other Member States of the delegation in writing. The delegating Member State and the Agency shall make that information public.deleted

Amendment 196 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 103

Amendment 197 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 104 – paragraph 2 – subparagraph 2

The marketing authorisation holder shall be required to perform a regular audit of his pharmacovigilance system. He shall ~~place a note concerning the main findings of the audit on the pharmacovigilance system master file and, based on the audit findings,~~ ensure that an appropriate corrective action plan is prepared and followed.

Amendment 198 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 104 – paragraph 2 – subparagraph 2

The marketing authorisation holder shall be required to perform a regular audit of his pharmacovigilance system. He shall place a note ~~concerning the main findings of the audit~~ on the pharmacovigilance system master file ~~and, based on the audit findings, ensure that~~concerning any modifications made following the audit in accordance with an appropriate corrective action plan ~~is prepared and followed~~.

Amendment 199 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 104 – paragraph 2 – subparagraph 2

The marketing authorisation holder shall be required to perform a ~~regular~~n annual audit of his pharmacovigilance system. He shall place a note concerning the main findings of the audit on the pharmacovigilance system master file and~~, based on the audit findings,~~ communicate them to the competent national authority before 31 December each year. Based on the audit findings, the marketing authorisation holder shall ensure that an appropriate corrective action plan is prepared and followed.

Amendment 200 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 104 – paragraph 3 – point d a (new)

(da) submit to the competent national authority a detailed description of the risk management system that he intends to establish;

Amendment 201 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 104 – paragraph 3 – point d b (new)

(db) incorporate the requirements of the competent national authority following this assessment;

Amendment 202 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 104a – paragraph 2 – subparagraph 2

The requirement shall be made in writing, provide a detailed justification, and include the timeframe for submission of the detailed description of the risk- management system. It shall be made public without delay.

Amendment 203 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 104a – paragraph 2 – subparagraph 2

The requirement shall be made in writing, provide a detailed scientific justification, and include the timeframe for submission of the detailed description of the risk- management system.

Amendment 204 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 105

~~The management of funds intended for a~~Activities connected with pharmacovigilance, the operation of communication networks and market surveillance shall receive adequate public funding commensurate with the tasks conferred. The management of funds intended for these activities shall be under the permanent control of the national competent authorities in order to guarantee their independence. The first paragraph shall not preclude ~~the~~indirect collection ~~of fees to be paid by marketing authorisation holder~~by the national authorities of further resources for ~~the~~ carrying out of those activities ~~by the national competent authorities~~, provided that their independence is strictly guaranteed.

Amendment 205 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 105

Activities connected with pharmacovigilance, the operation of communication networks and market surveillance should be financed primarily through either national or EU public funding. The management of funds intended for activities connected with pharmacovigilance, the operation of communication networks and market surveillance shall be under the permanent control of the national competent authorities in order to guarantee their independence. The first paragraph shall not preclude the collection ~~of fees to be paid by marketing authorisation holders for the carrying out of those activities by the national competent authorities~~by the Agency of further resources for carrying out those activities as fees to be paid by marketing authorisation holders, provided that its independence is strictly guaranteed.

Amendment 206 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 105 – paragraph 2

~~The first paragraph shall not preclude the collection of fees to be paid by marketing authorisation holders for the carrying out of those activities by the national competent authorities.~~deleted

Amendment 207 #

Proposal for a directive – amending act
Article – point 21

Directive 2001/83/EC
Article 105 – paragraph 2

~~The first paragraph shall not preclude the collection of fees to be paid by marketing authorisation holders for the carrying out of those activities by the national competent authorities.~~deleted

Amendment 208 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 - introductory words

Each Member State shall set up and maintain a national medicines web-portal, including a dedicated medicine safety web- p~~ortal~~age, which shall be linked to the European medicines safety web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004. By means of the national medicines ~~safety~~ web- portals, the Member States shall make public at least the following:

Amendment 209 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106

Each Member State shall set up and maintain a national medicines web-portal including a dedicated medicine safety web- p~~ortal~~age which shall be linked to the European medicines safety web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004. By means of the national medicines ~~safety~~ web-portals, the Member States shall make public at least the following: (1) the leaflets of the medicines available on the national market in the national language (and where applicable the link to the EMEA EudraPharm database), (2) the summary of the product characteristics and any conditions established in accordance with Articles 21a, 22 and 22a, together with any deadlines for their fulfilment, for each medicinal product which they have authorised, and (3) the assessment report. By means of the national medicines web- pages, the Member States shall make public at least the following: (1) risk management systems for medicinal products authorised in accordance with this Directive; (2) the list of medicinal products under intensive monitoring referred to in Article 23 of Regulation (EC) No 726/2004; (3) web-based structured forms for the reporting of suspected adverse reactions by healthcare professionals and patients based on the forms referred to in Article 25 of Regulation (EC) No 726/2004; (4) agendas for meetings of the pharmacovigilance committee and records of its meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions.

Amendment 210 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point -1 (new)

(-1) the leaflets for the medicines available on the national market in the national language (and where applicable the link to the EMEA EudraPharm database);

Amendment 211 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point -1 a (new)

(-1a) the summary of the product characteristics and any conditions established in accordance with Articles 21a, 22 and 22a, together with any deadlines for their fulfilment, for each medicinal product which they have authorised;

Amendment 212 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point -1 b (new)

(-1b) the assessment reports together with the periodic safety update reports submitted by marketing authorisation holders to the health authorities;

Amendment 213 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point 1

(1) a summary of risk management systems for medicinal products authorised in accordance with this Directive;

Amendment 214 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point - 1

(1) ~~risk management system~~detailed descriptions of risk management systems, and detailed protocols for post-authorisation studies for medicinal products authorised in accordance with this Directive;

Amendment 215 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106

(1) a summary of risk management systems for medicinal products authorised in accordance with this Directive; (2) the list of medicinal ~~products under intensive monitoring~~ referred to in Article 23 of Regulation (EC) No 726/2004 whose authorisation is subject to certain conditions or requirements; (3) web-based structured forms for the reporting of suspected adverse reactions by healthcare professionals and patients based on the forms referred to in Article 25 of Regulation (EC) No 726/2004. ; (4) the most up-to-date electronic version of the package leaflet and summary of product characteristics for all existing and new medicinal products; (5) a brief document history of changes made to the product information. All information on the safety web-portals, including all of the above, shall be presented in a manner that is comprehensible to the general public.

Amendment 216 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point 3

(3) web-based structured forms for the reporting of suspected adverse reactions by healthcare professionals, if applicable, and patients based on the forms referred to in Article 25 of Regulation (EC) No 726/2004.

Amendment 217 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point 3 a (new)

(3a) agendas for meetings of the Pharmacovigilance Committee and of the coordination group and records of their meetings, accompanied by the decisions taken and by details and explanations of the votes, including minority opinions;

Amendment 218 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point 3 b (new)

(3b) requests from the national competent authority to the marketing authorisation holder to operate a risk management system or to conduct a post-authorisation study, together with the explanations provided by the marketing authorisation holder to the national competent authority where necessary, and the final decision of the competent authority.

Amendment 219 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 – paragraph 1 – subparagraph 1

1. Marketing authorisation holders shall be required to record all suspected adverse reactions in the Community or in third countries which are brought to their attention and to specify whether they occurred at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function, as a result of a medication error or following off-label use, whether reported spontaneously by patients or healthcare professionals or occurring in the context of a post- authorisation safety study.

Amendment 220 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 – paragraphs 1 and 2

1. Marketing authorisation holders shall be required to record all suspected adverse reactions in the Community or in third countries which are brought to their attention, whether reported spontaneously by ~~patients or~~ healthcare professionals or occurring in the context of a post- authorisation safety study. Marketing authorisation holders shall be required to ensure that those reports are accessible at a single point within the Community. By way of derogation to the first subparagraph, suspected adverse reactions occurring in the context of a clinical trial shall be recorded and reported in accordance with Directive 2001/20/EC. 2. The marketing authorisation holder may not refuse reports of suspected adverse reactions received electronically from ~~patients and~~ health-care professionals.

Amendment 221 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107

1. Marketing authorisation holders shall be required to record all suspected adverse reactions in the Community ~~or in third countries~~ which are brought to their attention, whether reported spontaneously by patients or healthcare professionals or occurring in the context of a post- authorisation safety study. Marketing authorisation holders shall be required to ensure that those reports are accessible at a single point within the Community. By way of derogation to the first subparagraph, sclinical trial or a post-authorisation safety study. Suspected adverse reactions occurring in the context of a clinical trial shall also be recorded and reported in accordance with Directive 2001/20/EC. 2. The marketing authorisation holder ~~may not refuse~~shall forward to the national competent authorities any reports of suspected adverse reactions received ~~electronically~~ from patients and health-care professionals~~. 3. M~~ within 45 days of receiving the reports. The marketing authorisation holders shall be required to submit electronically to the database and data-processing network referred to in Article 24 of Regulation (EC) No 726/2004 (hereinafter referred to as ‘the Eudravigilance database’) information on all serious suspected adverse reactions that occur in the Community and in third countries within 15 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event. Marketing authorisation holders shall be required to submit electronically to the Eudravigilance database information on all non-serious suspected adverse reactions that occur in the Community, within 90 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event. For medicinal products containing the active substances referred to in the list of publications monitored by the Agency pursuant to Article 27 of Regulation (EC) No 726/2004, marketing authorisation holders shall not be required to report to the Eudravigilance database the suspected adverse reactions recorded in the listed medical literature, but they shall monitor all other medical literature and report any suspected adverse reactions. 4. Member States shall access reports on adverse reactions through the Eudravigilance database and shall assess the quality of the data received from marketing authorisation holders. They shall, as appropriate, involve patients and health-care professionals in the follow up of any reports they receive and request follow up of such reports to be conducted by the marketing authorisation holders. The marketing authorisation holders shall be required to report any follow up information received to the Eudravigilance databasinform the patient and healthcare professional that their report has been forwarded to the competent authorities who will be in charge of following it up. The national competent authorities may not refuse reports of suspected adverse reactions received by post, telephone, facsimile transmission or in electronic format from patients and healthcare professionals. 3. Marketing authorisation holders shall be required to submit electronically to the national competent authorities information on all serious suspected adverse reactions that occur in the Community and in third countries within 15 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event. Marketing authorisation holders shall be required to submit electronically to the national competent authorities information on all non-serious suspected adverse reactions that occur on the markets in which they operate, within 45 days following the receipt of the report. For medicinal products containing the active substances referred to in the list of publications monitored by the Agency pursuant to Article 27 of Regulation (EC) No 726/2004, marketing authorisation holders shall not be required to report the suspected adverse reactions recorded in the listed medical literature, but they shall monitor all other medical literature and report any suspected adverse reactions. 4. Member States shall assess the quality of the data received from marketing authorisation holders. They shall, as appropriate, involve patients and health- care professionals in the follow up of any reports they receive.

Amendment 222 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 – paragraph 2 a (new)

2a. Unless justifiable on grounds related to pharmacovigilance, individual Member States shall not impose any additional reporting requirements on marketing authorisation holders.

Amendment 223 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 – paragraphs 1 and 2

Amendment 224 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 – point 2

2. The marketing authorisation holders m~~ay not refuse~~ust forward to the national competent authorities any reports of suspected adverse reactions received from patients and health-care professionals within 7 days following the receipt of the report. The marketing authorisation holder must inform the patient and health-care professional that their report has been forwarded to the competent authorities who will be in charge of the follow up. Member States shall, as appropriate, involve patients and health-care professionals in the follow up of any reports they receive. The national competent authorities may not refuse any reports of suspected adverse reactions received via post, telephone, fax or in electronic~~ally~~ format from patients and health-care professionals.

Amendment 225 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 – paragraph 2

2. The marketing authorisation holder may not refuse reports of suspected adverse reactions received electronically or by any other appropriate means from patients and health-care professionals.

Amendment 226 #

Holger KRAHMER

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 – paragraph 3 – subparagraph 2

Marketing authorisation holders shall be required to submit electronically to the Eudravigilance database information on all non-serious suspected adverse reactions that occur in the Community, within 90 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event. Marketing authorisation holders of medicines authorised on the basis of Article 10a and holders of registrations for medicinal products referred to in Articles 14 to 16a shall be exempted from the above requirement.

Amendment 227 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 – paragraph 3 – subparagraphs 1 and 2

3. Marketing authorisation holders shall be required to submit electronically to the database and data-processing network referred to in Article 24 of Regulation (EC) No 726/2004 (hereinafter referred to as ‘the Eudravigilance database’) information on all serious suspected adverse reactions that occur in the ~~Community and in third countries~~Union and in third countries, specifying whether they have occurred at the doses normally used in humans for the prevention, diagnosis or treatment of an illness or in order to restore, correct or alter a physiological function, following a medication error or following use not in accordance with the authorised summary of product characteristics, within 15 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event. Marketing authorisation holders shall be required to submit electronically to the Eudravigilance database information on all non-serious suspected adverse reactions that occur in the ~~Community~~Union, specifying whether they have occurred at the doses normally used in humans for the prevention, diagnosis or treatment of an illness or in order to restore, correct or alter a physiological function, following a medication error or following use not in accordance with the authorised summary of product characteristics,, within 90 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event.

Amendment 228 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 – paragraph 3 – subparagraph 1 and 2

3. Marketing authorisation holders shall be required to submit electronically to the ~~database and data-processing network referred to in Article 24 of Regulation (EC) No 726/2004 (hereinafter referred to as ‘the Eudravigilance database’)~~national competent authorities information on all serious suspected adverse reactions that occur in the Community and in third countries within 15 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event. Marketing authorisation holders shall be required to submit electronically to the ~~Eudravigilance database~~national competent authorities information on all non-serious suspected adverse reactions that occur ion the ~~Community~~markets in which they operate, within 9045 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event.

Amendment 229 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 – paragraph 4

4. Member States shall ~~access reports on adverse reactions through the Eudravigilance database and shall~~ assess the quality of the data received from marketing authorisation holders. They shall, as appropriate, involve patients and health- care professionals in the follow up of any reports they receive and request follow up of such reports to be conducted by the marketing authorisation holders. The marketing authorisation holders shall be required to report any follow up information received to the Eudravigilance database.

Amendment 230 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 – paragraph 4

Member States shall access reports on adverse reactions through the Eudravigilance database and shall assess the quality of the data received from marketing authorisation holders. They shall, as appropriate, involve patients and health-care professionals in the follow up of any reports they receive and request follow up of such reports to be conducted by the marketing authorisation holders. The marketing authorisation holders shall be required to report any follow up information received to the Eudravigilance database.

Amendment 231 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107a – paragraph 1 – subparagraph 1

The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention from healthcare professionals ~~and patient~~. Concerning suspected adverse reactions reported by patients, Member States may decide whether those are reported directly or via health care professionals.

Amendment 232 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 a – paragraph 1 – subparagraph 1

1. The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention from healthcare professionals and patients, specifying whether they have occurred at the doses normally used in humans for the prevention, diagnosis or treatment of an illness or in order to restore, correct or alter a physiological function, following a medication error or following use not in accordance with the authorised summary of product characteristics.

Amendment 233 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 a – paragraph 1 – subparagraph 2

Member States shall ensure that reports of such reactions are submitted by means of the national medicines safety web-portals, or by any other appropriate means.

Amendment 234 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 a – paragraph 1 – subparagraph 2

Member States shall ensure that reports of such reactions arcan be submitted by means of the national medicines safety web- portals.

Amendment 235 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107a – paragraph 1 – subparagraph 2

Member States shall ensure that reports of such reactions arcan be submitted by means of the national medicines safety web- portals.

Amendment 236 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 a – paragraph 3

3. The Member States shall ensure that reports of medication errors, or of adverse reactions derived from uses outside the authorised summary of the product characteristics, brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the Eudravigilance database and to any authorities responsible for patient safety within that Member State. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that Member State.

Amendment 237 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 a – paragraph 2 – subparagraph 1

2. Member States shall, within 15 days following the receipt of the reports referred to in paragraph 1, submit the reports electronically to the Eudravigilance database, specifying whether they have occurred at the doses normally used in humans for the prevention, diagnosis or treatment of an illness or in order to restore, correct or alter a physiological function, following a medication error or following use not in accordance with the authorised summary of product characteristics.

Amendment 238 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 a – paragraph 3

Amendment 239 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107a

1. The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention ~~from~~by healthcare professionals ~~and patient~~, patients, marketing authorisation holders and programmes for the reporting and prevention of medication errors. Member States shall ensure that reports of such reactions arcan be submitted by means of the national medicines safety web- portals, as well as by mail, telephone and fax. 2. Member States shall, within 15 days following the receipt of the reports referred to in paragraph 1, submit the reports electronically to the Eudravigilance database. Marketing authorisation holders, healthcare professionals and the public shall access those reports through the Eudravigilance database, which must be made permanently accessible without delay. 3. The Member States shall ensure that reports of medication errors brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the Eudravigilance database ~~and~~, to any authorities responsible for patient safety within that Member State and to independent programmes for the reporting and prevention of medication errors. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that Member State.

Amendment 240 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107a

1. The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention ~~from~~by healthcare professionals ~~and patient~~, patients, marketing authorisation holders and programmes for the reporting and prevention of medication errors. Member States shall ensure that reports of such reactions arcan be submitted by means of the national medicines safety web- portals, as well as by mail, telephone and fax. 2. Member States shall, within 1530 days following the receipt of the reports referred to in paragraph 1, submit ~~the reports electronically to the Eudravigilance database. Marketing authorisation holders~~electronically to the database and data-processing network referred to in Article 24 of Regulation (EC) No 726/2004 (hereinafter referred to as ‘the Eudravigilance database’) information on all adverse reactions that occur within their territory Marketing authorisation holders, healthcare professionals and the public shall access those reports through the Eudravigilance database, which must be made permanently accessible without delay. 3. The Member States shall ensure that reports of medication errors brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the Eudravigilance database ~~and~~, to any authorities responsible for patient safety within that Member State. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that Member State.

Amendment 241 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107a

1. The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention ~~from~~by healthcare professionals ~~and patient~~, patients, marketing authorisation holders and programmes for the reporting and prevention of medication errors. Member States shall ensure that reports of such reactions arcan be submitted by means of the national medicines safety web- portals, as well as by mail, telephone and fax. 2. Member States shall, within 15 days following the receipt of the reports referred to in paragraph 1, submit ~~the reports electronically to the Eudravigilance database. Marketing authorisation holders~~electronically to the database and data-processing network referred to in Article 24 of Regulation (EC) No 726/2004 (hereinafter referred to as ‘the Eudravigilance database’) information on all adverse reactions that occur within their territory within 15 days following the receipt of the report or, in the absence of a report, following the day on which the competent authority gained knowledge of the event. Marketing authorisation holders, healthcare professionals and the public shall access those reports through the Eudravigilance database, which must be made permanently accessible without delay. 3. The Member States shall ensure that reports of medication errors brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the Eudravigilance database ~~and~~, to any authorities responsible for patient safety within that Member State and to independent programmes for the reporting and prevention of medication errors. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that Member State.

Amendment 242 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 b

1. Marketing authorisation holders shall be required to submit to the Agency periodic safety update reports ~~containing: (a) summaries of data relevant to the benefits and risks of the medicinal product; (b) a scientific evaluation of the risk- benefit bala~~in the following cases: (a) where such obligation has been laid down as a condition in the marketing authorisation in accordance with Article 21a or Article 22; or (b) where a Community reference date and the corresponding frequencey of ~~the medicinal product; The evaluation referred to in point (b) shall be bas~~submission of periodic safety update reports have been determined oin a~~ll available data, including data from clinical trials in unauthorised i~~ccordance with paragraphs 3 and 4 of Article 107c, subject to the condications ~~and populations. The p~~laid down in Article 107c(5). 2. Periodic safety update reports shall ~~be submitted electronically. 2. The Agency shall distribute the reports referred to in paragraph 1 to the Pharmacovigilance Risk Assessment Committee, the Committee for M~~contain: (a) a scientific evaluation of the risk- benefit balance of the medicinal product; (b) all data relating to the volume of sales of the medicinal Pproducts for Human Use and the coordination group. 3. By way of derogation from paragraph 1 of this Article, holders of marketing authorisations for medicinal products referred to in Articles 10, 10a or 10c, and holders of registrations for medicinal products referred to in Articles 14 or 16a, shall be required to submit periodic safety update reports for such products only in the following cases: (a) where such obligation has been laid down as a condition in the marketing authorisation in accordance with Article 21a or Article 22; or (b) where a Community reference date and the corresponding frequency of submission of periodic safety update reports have been determined in accordance with paragraphs 3 and 4 of Article 107c, subject to the conditions laid down in Article 107c(5) and any data in possession of the marketing authorisation holder relating to the volume of prescriptions. The evaluation referred to in point (b) shall be based on all available data, including data from clinical trials in unauthorised indications and populations. The periodic safety update reports shall be submitted electronically.

Amendment 243 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 b – paragraph 3 – introduction

Amendment 244 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107b – paragraph 3 - introductory words

By way of derogation from paragraph 1 of this Article, holders of marketing authorisations for medicinal products referred to in Articles 10, 10a or, 10c, and 16 and holders of registrations for medicinal products referred to in Articles 14 or 16a, shall be required to submit periodic safety update reports for such products only in the following cases: –

Amendment 245 #

Holger KRAHMER

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 b – paragraph 3 – introduction

3. ~~By way of derogation from paragraph 1 of this Article, h~~Holders of marketing authorisations for medicinal products referred to in Articles 10, 10a or 10c, and holders of registrations for medicinal products referred to in Articles 14 tor 16a, shall not be required to submit periodic safety update reports for such products ~~only~~. By way of derogation, holders of marketing authorisations for medicinal products shall be required to submit periodic safety update reports in the following cases:

Amendment 246 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107b – paragraph 3 – introduction

3. By way of derogation from paragraph 1 of this Article, holders of marketing authorisations for medicinal products referred to in Articles 10, 10a or 10c and 16, and holders of registrations for medicinal products referred to in Article~~s 14 or~~ 16a, shall be required to submit periodic safety update reports for such products only in the following cases:

Amendment 247 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107b – paragraph 3 – introduction

3. By way of derogation from paragraph 1 of this Article, holders of marketing authorisations for medicinal products referred to in Articles 10, 10a or 10c, and holders of marketing authorisations for products containing active substances fulfilling the criteria of the concept of well-established medicinal use mentioned in Annex I, Part II, Point 1 (a) of this Directive, and holders of registrations for medicinal products referred to in Articles 146 or 16a, shall be required to submit periodic safety update reports for such products only in the following cases:

Amendment 248 #

Pilar AYUSO, Françoise GROSSETÊTE

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107c – paragraph 2 – subparagraph 1

2. Holders of marketing authorisations which were granted before [insert concrete date - date set out in the second subparagraph of Article 3(1)], and for which the frequency and dates of submission of the periodic safety update reports are not laid down as a condition to the marketing authorisation, shall submit the periodic safety update reports in accordance with the second subparagraph of this paragraph until another frequency or other dates of submission of the reports are laid down in the marketing authorisation or determined in accordance with paragraphs 3, 4, 5 or 6. This obligation does not cover products referred to in Art. 107b(3) unless the conditions set out in points (a) and (b) of Article 107b(3) apply.

Amendment 249 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 g – paragraphs 1, 2 and 3

1. In the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with Article 107e(1) which does not include any marketing authorisation granted in accordance with Regulation (EC) No 726/2004, the coordination group shall, within 30 days of receipt of the report of the Pharmacovigilance Risk Assessment Advisory Committee, consider the report and adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisations concerned, including a timetable for the implementation of the opinion. Before adopting such a decision, the coordination group must enable the marketing authorisation holders concerned to submit written or verbal explanations within the required time- limits, which must be specified. 2. If the opinion of the coordination group is adopted by consensus, the chairman shall record the agreement and inform the marketing authorisation holder accordingly. The Member States shall maintain, vary, suspend or revoke the marketing authorisations concerned as necessary to comply with the opinion within the determined time table for implementation, and they shall inform the Commission and the coordination group. If an opinion by consensus cannot be adopted, the majority opinion shall be forwarded to the Commission which shall apply the procedure laid down in Articles 33 and 34. However, by way of derogation from Article 34(1), the procedure referred to in Article 121(2) shall apply. The stages of the procedure described in Article 32(4) of Directive 2004/83/EC may apply. 3. In the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with Article 107e(1) which includes at least one marketing authorisation granted in accordance with the procedure of Regulation (EC) No 726/2004, the Committee for Medicinal Products for Human Use shall, within 30 days of receipt of the report of the Pharmacovigilance Risk Assessment Advisory Committee, consider the report and adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisations concerned. The stages of the procedure described in Article 9(2) of Regulation (EC) No 726/2004 may apply.

Amendment 250 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107g – paragraph 1

Amendment 251 #

Pilar AYUSO, Françoise GROSSETÊTE

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107g – point 3

3. In the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with Article 107e(1) which includes at least one marketing authorisation granted in accordance with the procedure of Regulation (EC) No 726/2004, the Committee for Medicinal Products for Human Use shall, within 30 days of receipt of the report of the Pharmacovigilance Risk Assessment Advisory Committee, consider the report and adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisations concerned. The opinion shall be published immediately, indicating any minority views.

Amendment 252 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 i

1. A Member State shall initiate the procedure under this section, by informing the other Member States, the Agency ~~and~~, the Commission~~, in any of the following cases: (a) it considers~~ and the marketing authorisation holders potentially affected, in any of the following cases: (a) it considers, in the light of the outcome of the assessment of pharmacovigilance data, one of the following regulatory measures: – suspending or revoking of a marketing authorisation; ~~(b) it considers~~– prohibiting the supply of a medicinal product; ~~(c) it considers~~– refusing the renewal of a marketing authorisation; (db) it is informed by the marketing authorisation holder that, on the basis of safety concerns, he has interrupted the placing on the market of a medicinal product or withdrawn a marketing authorisation, or that he intends to do so; (~~e) it considers that new contraindications, a reduction in the recommended dose, or a restriction to the indications is necessary; (f~~c) it has conducted a pharmacovigilance inspection and found serious deficiencies.

Amendment 253 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 k – paragraph 2

2. The Pharmacovigilance Risk/Benefit Assessment Advisory Committee shall assess the matter which has been submitted. For the purposes of that assessment, it may hold a public hearing as part of a risk/benefit analysis. Public hearings shall be announced by means of the European medicines safety web-portal. The announcement shall include information on how marketing authorisation holders and the public can participate. The Agency shall provide the opportunity, to all those who request it, to participate in the hearing either in person or through the use of web-based technology. Where a marketing authorisation holder or another person intending to submit information has commercially confidential data relevant to the issue of the procedure, he may request to present those data to the Pharmacovigilance Risk Assessment Advisory Committee in a non-public hearing. Where a public hearing is organised, a preliminary report shall be published at its conclusion.

Amendment 254 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 k – paragraph 2 – subparagraph 1

2. The Pharmacovigilance Risk Assessment ~~Advisory~~ Committee shall assess the matter which has been submitted. For the purposes of that assessment, it may hold a public hearing, if objective criteria are met on the basis of scientific data, taking account of the effectiveness and benefits of the product concerned and of earlier risk/benefit assessments conducted by the Committee for Medicinal Products for Human Use or the coordination group in accordance with the procedure for granting marketing authorisations described in Article 107l, which must involve the rapporteur of the Committee for Medicinal Products for Human Use on the product in question, or the rapporteur of the coordination group. The Agency, in consultation with the parties concerned, shall draw up guidelines on the organisation and conduct of public hearings.

Amendment 255 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 k – paragraph 3 – introduction

3. Within 60 days of the information submitted, the Pharmacovigilance Risk Assessment Advisory Committee shall make a recommendation, stating the reasons on which it is based, and also taking account of the benefits of the medicinal product as assessed by the Committee for Medicinal Products for Human Use or the coordination group in accordance with the procedure for granting marketing authorisations described in Article 107l. The recommendation shall be any or a combination of the following:

Amendment 256 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107m

The Agency shall make public the final conclusions (recommendations, opinions and final decisions) referred to in Articles 107b to 107l by means of the European medicines safety web-portal.

Amendment 257 #

Andrés PERELLÓ RODRÍGUEZ

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107 n – paragraph 1

1. Th~~is Chapte~~e procedures laid down in Articles 107o to 107r shall apply to non- interventional post-authorisation safety studies which are initiated, managed or financed by the marketing authorisation holder, voluntarily or following a requirement in accordance with Articles 21a or 22a, and which involve the collection of data from patients or health- care professionals.

Amendment 258 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 108 – point 3

(3) the use of internationally agreed terminologies, formats and standards for the conduct of pharmacovigilance allowing the clinical significance of reported case to be preserved;

Amendment 259 #

Linda McAVAN

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 108 – paragraph 1 – point 5

(5) the format of electronic reporting of adverse reactions by Member states and marketing authorization holders, including the presentation of the collected information. The collected information must distinguish adverse reactions due to overdose, misuse, abuse, medication errors, and those occurring in the course of studies with the medicinal product or after occupational exposure;

Amendment 260 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 108 – point 5

(5) the format of electronic reporting of adverse reactions by Member states and marketing authorization holders, including the presentation of the collected information. The collected information must be presented, with the purpose of an appropriate evaluation and follow-up, in a way that makes it possible to distinguish the different adverse reactions, including overdose, misuse, abuse, medication errors, and those occurring in the course of studies with the medicinal product or after occupational exposure;

Amendment 261 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 108 – paragraph 2

Those guidelines shall be based on patient needs from a scientific perspective, shall take account of international harmonisation work carried out in the field of pharmacovigilance and shall where necessary be revised to take account of technical and scientific progress.

Amendment 262 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 108 – paragraph 2

Those guidelines shall take account of international harmonisation work carried out in the field of pharmacovigilance and shall where necessary be revised to take account of technical and scientific progress. For the purposes of this Article and Article 102(3), the Commission, in cooperation with the Agency, Member States, and stakeholders, shall prepare detailed guidelines on good record- keeping practices for pharmacies and others that dispense or administer medicinal products, to ensure retention of records that would be needed in the event of needing to file a pharmacovigilance report or to provide information needed by a marketing authorisation holder conducting an evaluation of an adverse event and to facilitate follow-up investigations by the marketing authorisation holder and national competent authorities.

Amendment 263 #

Proposal for a directive – amending act
Article 1 – point 23

Directive 2001/83/EC
Article 116 – paragraph 1

The competent authorities shall suspend, revoke, withdraw or vary a marketing authorisation if the view is taken that the product is harmful or that it lacks therapeutic efficacy, or that the risk-benefit balance is not positive, or that its qualitative and quantitative composition is not as declared. Therapeutic efficacy shall be considered to be lacking when it ~~is concluded~~cannot be shown that therapeutic results can~~not~~ be obtained from the medicinal product.

Amendment 264 #

Proposal for a directive – amending act
Article 1 – point 24 a (new)

Directive 2001/83/EC
Article 119 a (new)

24a. The following Article is inserted: “Article 119a Environmental supervision and protection Member States shall appoint one or several national authorities to monitor adverse environmental effects of medicinal products on public health or the environment. If one of these authorities identifies an environmental risk that is higher than that indicated in the evaluation pursuant to Article 8(3)(ca), or if it finds new adverse environmental effects, it shall forthwith transmit all findings to the European Medicines Evaluation Agency and to the competent authority. The Agency shall, upon receiving such information, assess whether the risk-benefit balance remains favourable when taking into account the new findings. This must not lead to the withdrawal of the authorisation for drugs necessary for treating life-threatening or serious diseases.”

Amendment 265 #

Proposal for a directive – amending act
Article 1 – point 24 a (new)

Directive 2001/83/EC
Article 119 a (new)

24a. The following Article is inserted: “Article 119a Environmental monitoring Member States shall appoint one or several authorities to monitor adverse environmental effects of medicinal products. If one of these authorities identifies an environmental risk that is higher than that indicated in the evaluation pursuant to Article 8(3)(ca), or if it finds new adverse environmental effects, it shall forthwith transmit all findings to the competent authority. The competent authority shall, upon receiving such information, assess whether the risk- benefit balance remains favourable when taking into account the new findings.”

Amendment 266 #

Proposal for a directive – amending act
Article 2 – paragraph 1

1. With regard to the requirement for the inclusion of a summary of the essential information necessary to use the medicine safely and effectively in the summary of the product characteristics and the package leaflet provided for in point 3a of Article 11 and in point (aa) of Article 59(1) of Directive 2001/83/EC as amended by this Directivto state, where necessary, in the summary of the product characteristics and the package leaflet that the medicine is under intensive monitoring, and to indicate any new information concerning the medicine, the Member States shall ensure that the requirement applies to a marketing authorisation granted before the date set out in the second subparagraph of Article 3(1) of this Directive from renewal of that authorisation or from the expiry of a period of three years starting from that date, whichever is the earliest.

Amendment 267 #

Proposal for a directive – amending act
Article 1 – point 28

Directive 2001/83/EC
Article 2 – paragraph 1

Amendment 268 #

Proposal for a directive – amending act
Article 1 – point 28

Directive 2001/83/EC
Article 2 – paragraph 1

Amendment 269 #

Proposal for a directive – amending act
Article 2 – paragraph 1

1. With regard to the requirement for the inclusion of a ~~summary of the essential information necessary to use the medicine safely and effectively~~medicinal product’s adverse reaction profile in the summary of the product characteristics and the package leaflet provided for in point 3a of Article 11 and in point (aa) of Article 59(1) of Directive 2001/83/EC as amended by this Directive, the Member States shall ensure that the requirement applies to a marketing authorisation granted before the date set out in the second subparagraph of Article 3(1) of this Directive from renewal of that authorisation or from the expiry of a period of three years starting from that date, whichever is the earliest.

Amendment 270 #

Andrés PERELLÓ RODRÍGUEZ

Proposal for a directive – amending act
Article 1 – point 28

Directive 2001/83/EC
Article 2 a (new)

Article 2a Transitional provision 1. With regard to the requirement for the marketing authorisation holder to submit information on adverse reactions electronically to the Eudravigilance database, laid down in Article 107(3) of the present Directive, Member States shall ensure that the said requirement is applied once the functionalities of the database make it possible to provide information on adverse reactions that is complete and of proper quality and includes essential health data, codified data on the medicinal products, proper differentiation of follow-up reports and the elimination of duplicate cases. 2. The Agency’s Management Board shall confirm, on the basis of an independent inquiry, that the functionalities referred to in paragraph 1 are operational.

source: PE-438.412

2010/08/02 ITRE 35 amendments...

Amendment 33 #

Werner LANGEN

Proposal for a directive – amending act
Recital 5

(5) For the sake of clarity, the definition of adverse reaction should be amended to ensure that it not only covers noxious and unintended effects derived from the authorised use of a medicinal product at the normal doses, but also noxious and unintended effects derived from medication errors and uses outside the authorised summary of the product characteristics, including the misuse and abuse of the product.

Amendment 34 #

Proposal for a directive – amending act
Recital 8

(8) In order to ensure the collection of any necessary additional data about the safety of authorised medicinal products, competent authorities should be empowered to require post-authorisation safety studies at the time of the granting of the marketing authorisation or later, and this requirement should be included as a condition of the marketing authorisation. If the conditions included in the marketing authorisation are not met within the deadline set, the competent authorities should have the power and appropriate resources to immediately suspend or revoke the marketing authorisation.

Amendment 35 #

Proposal for a directive – amending act
Recital 9

(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. Steps must be taken to ensure that tightening up the pharmacovigilance system does not result in marketing authorisations being issued prematurely. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).

Amendment 36 #

Werner LANGEN

Proposal for a directive – amending act
Recital 9

(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. In that connection, it is essential that improving the pharmacovigilance system does not result in marketing authorisations for medicinal products being issued prematurely. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).

Amendment 37 #

Proposal for a directive – amending act
Recital 10

(10) In order to make it possible for the healthcare professionals and patients to identify easily the most relevant information about the medicines they use, the summary of the product characteristics and the package leaflet should include a concise section o~~n the key information about the medicinal product and information how to minimize its risks and maximize its benefits~~utlining the benefits and potentially noxious effects of the medicinal product and giving further indications with a view to its safe and effective use.

Amendment 38 #

Patrizia TOIA

Proposal for a directive – amending act
Recital 10 a (new)

(10a) The Commission should, without delay, and in collaboration with EMEA, following consultations with patient and consumer organisations, medical and pharmacist organisations, social health insurance organisations, Member States and other interested parties, present to the European Parliament and the Council an assessment report regarding the readability of the summaries of product characteristics and the packaging leaflets and their value to the general public and to healthcare professionals. Following an analysis of the above data, the Commission should, if appropriate, put forward proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and for healthcare professionals.

Amendment 39 #

Proposal for a directive – amending act
Article 1 – point 1 – point a

Directive 2001/83/EC
Article 1 – point 11

(11) Adverse drug reaction: A response to a medicinal product which is noxious and unintended.

Amendment 40 #

Proposal for a directive – amending act
Article 1 – point 1 – point b

Directive 2001/83/EC
Article 1 – point 14

(14) Suspected adverse drug reaction: An ~~adverse reaction~~unintended event in respect of which a causal relationship between the event and the medicinal product cannot be excluded.

Amendment 41 #

Proposal for a directive – amending act
Article 1 – point 1 – point d

Directive 2001/83/EC
Article 1 – point 28b

(28b) Risk management system: a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks already detected, and risks identified subsequently, relating to a medicinal product, including the assessment of the effectiveness of those interventions.

Amendment 42 #

Proposal for a directive – amending act
Article 1 – point 3 – point b

Directive 2001/83/EC
Article 11 - subparagraph 3

For ~~the purposes of point (3a) of the first subparagraph, for~~ medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the following statements: ~~“This~~(a) "This newly authorised medicinal product is under intensive monitoring in order to increase knowledge on its adverse reactions. All suspected adverse reactions should be reported to <name ~~and~~, web-address ~~of the national competent authority>~~, postal address and telephone number of the national competent authority>, or reported directly to the pharmacy"; (b) An exclamation mark surrounded by a red triangle. This symbol shall also appear on the outer packaging, accompanied by an indication that it is advisable to read the package leaflet before taking the medicinal product.

Amendment 43 #

Patrizia TOIA

Proposal for a directive – amending act
Article 1 – point 12 – point a

Directive 2001/83/EC
Article 24 – paragraph 2 – subparagraph 2

To this end, the marketing authorisation holder shall provide the national competent authority with a consolidated version of the file in respect of quality, safety ~~and~~, efficacy, and added value, such as reduced toxicity. This version shall includ~~ing~~e the evaluation of data contained in adverse reactions reports and periodic safety update reports submitted in accordance with Title IX, and all variations introduced since the marketing authorisation was granted, at least nine months before the marketing authorisation ceases to be valid in accordance with paragraph 1.

Amendment 44 #

Patrizia TOIA

Proposal for a directive – amending act
Article 1 – point 14 – point b

Directive 2001/83/EC
Article 27 – paragraph 2 – subparagraph 3

Article 63 of Regulation (EC) No 726/2004 shall apply to the coordination group as regards the transparency and independence of its members from both the Agency and marketing authorisation holders.

Amendment 45 #

Proposal for a directive – amending act
Article 1 – point 18 – point a

Directive 2001/83/EC
Article 59 – paragraph 1 – point aa

(aa) a ~~summary~~brief description of the essential ~~information necessary to use the medicine~~features of the medicine enabling the patient to understand its benefits and potentially noxious effects and to use it safely and effectively.

Amendment 46 #

Proposal for a directive – amending act
Article 1 – point 18 – point a a (new)

Directive 2001/83/EC
Article 59 – paragraph 1 – point h a (new)

(aa) the following point (ha) is inserted: “(ha) a detachable portion of the leaflet that the patient can tear off, including the following statement: “suspected adverse reactions should be reported to your doctor, pharmacist, or to <name, web- address, postal address and/or telephone and fax number of the national competent authority>";”

Amendment 47 #

Proposal for a directive – amending act
Article 1 – point 18 – point b

Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraph 2 and 3

The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. Any new or amended text shall for a period of 1-year be presented in bold text and preceded by the following symbol  and text "New information". For medicinal products included on the list referred to in Article 23 of Regulation (EC)No 726/2004, the following additional statement shall be included “This medicinal product is ~~under intensive~~subject to post- authorisation safety monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>".

Amendment 48 #

Proposal for a directive – amending act
Article 1 – point 18 – point b

Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraph 3

For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statements shall be included: (a) “This newly authorised medicinal product is under intensive monitoring in order to increase knowledge on its adverse reactions. All suspected adverse reactions should be reported to <name ~~and~~, web-address ~~of the national competent authority>~~, postal address and telephone number of the national competent authority>,or reported directly to the pharmacy"; (b) An exclamation mark surrounded by a red triangle. This symbol shall also appear on the outer packaging, accompanied by an indication that it is advisable to read the package leaflet before taking the medicinal product.

Amendment 49 #

Proposal for a directive – amending act
Article 1 – point 20 a (new)

Directive 2001/83/EC
Article 86 - paragraph 2 – indent 1

20a. The first indent of Article 86(2) is replaced by the following: ‘- the labelling and the accompanying package leaflets, which are subject to the provisions of Title V, and the summary of the medicinal product’s features, even if they are made available to the public independently of the medicinal product, in unchanged form and with no additional promotional material,’

Amendment 50 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 1

(1) take all appropriate measures to encourage patients, doctors, pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority ~~or the marketing author~~. Those measures shall include training for healthcare professionals and for patients, and a public information campaign for patients. Patient organisation s shoulder be involved in providing information and training to patients;

Amendment 51 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 1 a (new)

(1a) facilitate direct patient reporting, in addition to web-based formats, through the provision on the patient information leaflet of a detachable portion that can be reported to the doctors, pharmacists or the national competent authority;

Amendment 52 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 1 a (new)

(1a) conduct public awareness campaigns on the importance of reporting adverse reactions and possible ways of doing so;

Amendment 53 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 3

(3) ~~through the methods of collecting information and where necessary through the follow up of adverse reaction reports, ensure that any biological~~ensure that any biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of a suspected adverse reaction report is identifiable by, as far as available, the name of the marketing authorisation holder, the International Non-proprietary Name (INN), the name of the medicinal product ~~prescri~~and the batch numbedr, ~~dispensed, or sold in their territory which is the subject of an adverse reaction report is identifiable~~using the standard forms and procedures developed in accordance with Article 25 of Regulation (EC) No 726/2004 and taking due account of the developments within the EudraVigilance system;

Amendment 54 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 3

(3) through the methods of collecting information and where necessary through the follow up of adverse reaction reports, ensure that any biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of an adverse reaction report is identifiable using the content format and procedure developed in accordance with Article 25 of Regulation (EC) No 726/2004 and shall implement the necessary measures to ensure the traceability of biological medicinal products dispensed to patients;

Amendment 55 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 102 – paragraph 1 – point 3 a (new)

(3a) take the necessary steps to enable the public to report adverse reactions, in particular by ensuring that appropriate forms are available at pharmacies, drawn up in line with technical criteria and complying with the principles of simplified language and structure, accessible to the general public; these forms shall be sent by the pharmacists to the competent authorities;

Amendment 56 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 103 – paragraph 2 a (new)

The Member States shall cooperate with each other in order to develop the appropriate skills and capacities to supervise the pharmacovigilance system on their territory.

Amendment 57 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 105 – paragraph 2

The first paragraph shall not preclude the collection of fees to be paid by marketing authorisation holders ~~for~~as a contribution to the carrying out of those activities by the national competent authorities.

Amendment 58 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 106 – point 3 a (new)

(3a) A summary of the periodic safety update reports showing the assessment made by the competent authorities, including the analysis of the risk-benefit balance of the medicinal product.

Amendment 59 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107a – paragraph 1 – subparagraph 2

Member States shall ensure that reports of such reactions armay be submitted by means of the national medicines safety web- portals.

Amendment 60 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107a – paragraph 3

3. The Member States shall ensure that reports of medication errors, or of the unintended effects of medicinal products used contrary to the indications covered by the authorisation, brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the Eudravigilance database and to any authorities responsible for patient safety within that Member State. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that Member State.

Amendment 61 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107a – paragraph 3 a (new)

3a. The Member States shall ensure that marketing authorisation holders may electronically transmit information on unintended effects of medicinal products to national databases so that country- specific safety problems can be identified more effectively and more promptly.

Amendment 62 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107i – paragraph 1 – points a, b, c

(a) it considers, as a result of the evaluation of pharmacovigilance data: - suspending or revoking of a marketing authorisation; ~~(b) it considers~~- prohibiting the supply of a medicinal product; ~~(c) it considers~~- refusing the renewal of a marketing authorisation;

Amendment 63 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107k – paragraph 1 - subparagraph 1

1. Following the information referred to in Article 107i(1), the Agency shall notify the concerned marketing authorisation holders and publicly announce the initiation of the procedure by means of the European medicines safety web-portal.

Amendment 64 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107k – paragraph 2 - subparagraph 1

2. The Pharmacovigilance Risk Assessment Advisory Committee shall assess the matter which has been submitted. For the purposes of that assessment, it may hold a public hearing together with representatives from the Committee for Medicinal Products for Human Use or the coordination group, depending on the procedure for granting the marketing authorisation of the medicinal product as described in Article 107l. The Agency, in consultation with stakeholders, shall develop guidelines for the organisation and conduct of public hearings. The hearing shall ensure a fair balance between the assessment of risks and benefits of the product and shall in this regard also take into account previous risk-benefit assessments by the Committee for Medicinal Products for Human use or the coordination group, depending on the procedure for granting the marketing authorisation of the medicinal product as described in Article 107l.

Amendment 65 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 107k – paragraph 3 - subparagraph 1 - introductory part

3. Within 60 days of the information submitted, the Pharmacovigilance Risk Assessment Advisory Committee shall make a recommendation, stating the reasons on which it is based. The recommendation, which shall not pre-empt the assessment of the risk-benefit balance by the Committee for Medicinal Products for Human use or the Coordination group before those bodies adopt their opinion in accordance with Article 107l, shall be any or a combination of the following:

Amendment 66 #

Proposal for a directive – amending act
Article 1 – point 21

Directive 2001/83/EC
Article 108 – paragraph 2 a (new)

For purposes of Article 102(3) and this Article, the Commission, in cooperation with the Agency, Member States, and stakeholders, shall prepare detailed guidelines on good record-keeping practices for pharmacies and others that dispense or administer medicinal products, to ensure retention of records required in the event of needing to file a pharmacovigilance report or to provide information required by a marketing authorisation holder conducting an evaluation of an adverse event, and to facilitate follow-up investigations by the marketing authorisation holder and national competent authorities.

Amendment 67 #