Parltrack

Activites

• 2004/04/30 Final act published in Official Journal
  • Directive 2004/27
  • OJ L 136 30.04.2004, p. 0034-0057
• 2004/03/31 Final act signed
• 2004/03/31 End of procedure in Parliament
• 2004/03/11 Act approved by Council, 2nd reading
• #2570
• 2004/03/11 Council Meeting
• 2004/02/17 Commission opinion on Parliament's position at 2nd reading
  • COM(2004)0124 summary

    The Commission can accept in full the 32 amendments to the Council's common position adopted by Parliament on the proposal for a regulation, the 30 amendments to the Council's common position adopted by Parliament on the proposal for a directive on medicinal products for human use and the 22 amendments to the Council's common position adopted by Parliament on the proposal for a directive on veterinary medicinal products. The Commission notes the convergence of views between the three institutions on the general approach and on the most important issues regarding the compulsory field of application of the centralised procedure, the administrative structure of the agency, the period of data protection, definitions, information for patients and the assessment of the environmental impact. The amendments adopted by Parliament mainly concern the issues of the compulsory field of application of the centralised procedure, the period of data protection and the administrative structure of the agency as far as the regulation is concerned, and the definitions, period of data protection, information for patients and assessment of the environmental impact as regards the two directives on medicinal products for human use and veterinary use.

  • DG Enterprise and Industry,
• 2003/12/17 Text adopted by Parliament, 2nd reading
  • T5-0577/2003 summary

    The European Parliament adopted a resolution drafted by Francoise GROSSETETE EPP-ED, France) making some amendments to the Council's common position. The amendments adopted by Parliament were agreed in advance with the Council for both human and veterinary products: - in order to take account both of the emergence of new therapies and of the growing number of so-called "borderline" products between the medicinal product sector and other sectors, the definition of "medicinal product" should be modified so as to avoid any doubt as to the applicable legislation when a product, whilst fully falling within the definition of a medicinal product, may also fall within the definition of other regulated products; - biological medicinal products similar to a reference medicinal product do not usually meet all the conditions to be considered as a generic medicinal product mainly due to manufacturing process characteristics, raw materials used, molecular characteristics and therapeutic modes of action. When a biological medicinal product does not meet all the conditions to be considered as a generic medicinal product, the results of appropriate tests should be provided in order to fulfil the requirements related to safety (pre-clinical tests) or to efficacy (clinical tests) or to both; - environmental impact must be assessed and, on a case-by-case basis, specific arrangements to limit it must be envisaged. In any event this impact should not constitute a criterion for refusal of a marketing authorisation; - if, during the first eight years of ten years given for marketing protection, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies, the protection can be extended to a maximum of eleven years; - Member States should also take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 210 days of the submission of a valid application; - within three years the Commission will, following consultations with patients' and consumers' organisations, doctors' and pharmacists' organisations, Member States and other interested parties, present to the European Parliament and the Council a report on current practice with regard to information provision - particularly on the Internet - and its risks and benefits for patients. Following analysis of the above data, the Commission shall, if appropriate, put forward proposals setting out an information strategy to ensure good- quality, objective, reliable and non-promotional information on medicinal products and other treatments and shall address the question of the information source's liability; - appropriate collection systems must be in place for medicinal products that are unused or have expired; - Member States must ensure that members of staff of the competent authority responsible for issuing authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no financial or other interests in the pharmaceutical industry which could affecttheir impartiality; - the name of the medicinal product must also be expressed in Braille format on the packaging. The marketing authorisation holder should ensure that the package information leaflet is made available on request from patients' organisations in formats appropriate for the blind and partially-sighted. Member States should ensure that appropriate collection systems are in place for medicinal products that are unused or have expired.

  • OJ C 091 15.04.2004, p. 0133-0298 E
• 2003/12/16 Debate in Parliament
• 2003/11/27 Committee recommendation tabled for plenary, 2nd reading
  • A5-0446/2003
  • ENVI ENVI/5/16947 GROSSETÊTE Françoise PPE-DE
• 2003/10/17 Committee draft report
  • PE337.033
• 2003/10/09 Committee referral announced in Parliament, 2nd reading
  • ENVI ENVI/5/16947 GROSSETÊTE Françoise PPE-DE
• #2528
• 2003/09/29 Council Meeting
  • 10950/3/2003 summary

    The Council's common position incorporates 20 amendments adopted by the European Parliament, which had been taken up unchanged in the Commission's amended proposal. In addition, the Council has accepted in part or in principle 42 amendments adopted by the European Parliament, which have been endorsed at least partially or in principle in the Commission's amended proposal. The Council has agreed on a number of changes, including editorial ones, to clarify the provisions of the text, to update terminology or to align the text with the proposal for a Regulation and the proposal for a Directive on medicinal products for veterinary use. The more substantial changes are described below: - deletion of the possibility to extend the data protection period to 11 years when a new therapeutic use is found for a new product; - deletion of the proposal to harmonise of the legal status of a medicinal product; - the Council has changed the provision on the choice of Committee procedure in relation to decisions to be taken by the Commission following an opinion from the scientific committee. The Council does not consider it consistent with Decision 1999/468/EC to have two different procedures for decisions having the same object and believes that the management procedure is the appropriate procedure to apply for these decisions; - the Council has provided for the possibility of adoption of amendments to the arrangements concerning the periodic safety update reports through a Committee procedure in the light of experience gained; - to improve availability of medicines - particularly in smaller markets - a new article 126a has been introduced that will allow a Member State for public health reasons and under certain circumstances to grant an authorisation for a medicinal product authorised in another Member State; - Article 32 (5) of the Directive allows for the scientific committee to give recommendations for conditions and restrictions in respect of nationally authorised products. The new Article 127a provides for adoption through comitology of decisions requiring Member States to implement such conditions and restrictions in relation to the safe and effective use of centrally authorised products, including vis-à-vis third parties. Other changes include: - adjusting some time limits in relation to the evaluation procedure; - strengthening the supervision powers of the competent authorities by providing them with the explicit right to request the submission of data from the marketing authorisation holder at any time (Article 23); - a new Article 23a has been inserted that requires the marketing authorisation holder to inform the competent authorities of the date of marketing of the medicinal product and any withdrawal from the market of the product; - extending the requirements on good manufacturing practice to certain excipients; - extending the duty of the marketing authorisation holder to report adverse reactions occurring in the territory of a third country; - extending the scope of the provision in Article 111 on inspections.

  • OJ C 297 09.12.2003, p. 0041-0071 E
• #2512
• 2003/06/02 Council Meeting
• 2003/04/03 Modified legislative proposal
  • COM(2003)0163 summary

    The Commission accepted 30 amendments proposed by the European Parliament. These include: - any authorisation, which is not followed within three years by the actual placing on the market of the authorised product, will cease to be valid; - the possibility of unannounced inspections by the competent authorities; - Member States may temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected spread of a pathogen which could cause harm; - clarification that the data protection period of 11 years constitutes the maximum time; - the documents to be submitted by the applicant on the constituents of the medicinal product include the reference to its international non-proprietary name recognised by the WHO; - an applicant has to submit documents to prove that he will be able to meet certain pharmacovigilance obligations; - homeopathic products authorised before December 1993 do not need to be updated according to the new legislation; - the rules of procedure of the coordination group are to be made public; - the committee must specify the time limit for explanations by the applicant; - the Commission must prepare a draft decision in 15 and not 30 days; - the Rules of Procedure of the Standing Committee must be made public. The Commission accepted 48 amendments in part or in principle. These include: - the change in the period of validity foe the marketing authorisation. The latter for new medicinal products must initially be limited to five years' validity. After the first renewal, the marketing authorisation shall be considered to be valid indefinitely; - further clarification on the definition of a medicinal product. A reformulation is required to refer, in addition to pharmacological action, to immunological and metabolic action; - the deletion of certain parts of the definition of a homeopathic medicinal product. There is a rewording to reintroduce the reference to homeopathic stocks, which are an important step in the production of a homeopathic medicinal product; - the introduction of a definition of the risk/benefit balance; - the situation that a given product could fulfil the definition of different regulatory regimes. This excludes food, food supplements, medical devices and cosmetics from the scope of the Directive; reinforcement of the arbitration procedures. The option to refer to the Agency will be made into an obligation in the cases of referral where a Community interest is involved. A requirement for the marketing authorisation holder, and, within the limits of their responsibilities, the distributors, to provide suitable supplies; it is compulsory for Member States to take measures to require doctors and other healthcare professionals to report adverse reactions The Commission rejected 79 amendments proposed by the Parliament. These include: - the requirement for generic medicinal products authorised bythe Member States to be identified with the same denomination; - amendments which introduce the possibility of conducting the tests and trials needed for authorisation, submitting the application for authorisation, and authorising generic medicinal products during the ten year period of data protection; - amendments which require the competent authorities to set up a website containing information on the medicinal product and to include its address on the packaging; - including patients as a source of information adverse reactions that is forwarded directly to the holder of marketing authorisations; the proposal that a new category of medicinal product "herbal health product" be introduced.

  • DG Enterprise and Industry,
• #2470
• 2002/12/02 Council Meeting
• 2002/10/23 Text adopted by Parliament, 1st reading/single reading
  • T5-0505/2002 summary

    The European Parliament adopted, by 504 to 30 with 16 abstentions, the report by Mrs Françoise GROSSETETE (EPP-ED, F) which aims to update an EU code relating to pharmaceutical products, together with a number of amendments. The Parliament voted for a ban on direct advertising such products, thus rejecting the Commission's proposal for a pilot project to allow information to be provided on new drugs to treat diseases such as AIDS, asthma and diabetes. With regard to patent protection, MEPs voted for a period of 10 years, which could be extended to 11 in certain circumstances, with protection for the results of clinical tests during this period. MEPs take the view that this is a sufficient time period to guarantee the viability of new products before allowing generics on the market. Parliament proposes that Member States shall take all appropriate measures to ensure that the procedure for granting an authorisation to place a medicinal product on the market is completed within 150 days of a valid application, including 80 days for scientific data analysis and preparation of the report by the rapporteur. Parliament also wants to see the new rules applying to candidate countries.

  • OJ C 300 11.12.2003, p. 0166-0352 E
• 2002/10/22 Debate in Parliament
• 2002/10/02 Committee report tabled for plenary, 1st reading/single reading
  • A5-0340/2002
  • AGRI STURDY Robert PPE-DE
  • BUDG KUCKELKORN Wilfried PSE
  • CONT MULDER Jan ELDR
  • ENVI ENVI/5/16947 GROSSETÊTE Françoise PPE-DE
  • ITRE READ Imelda Mary PSE
  • JURI
• #2440
• 2002/06/26 Council Meeting
• 2002/05/21 Committee draft report
  • PE290.143
• 2001/12/13 Committee referral announced in Parliament, 1st reading/single reading
  • AGRI STURDY Robert PPE-DE
  • BUDG KUCKELKORN Wilfried PSE
  • CONT MULDER Jan ELDR
  • ENVI ENVI/5/16947 GROSSETÊTE Françoise PPE-DE
  • ITRE READ Imelda Mary PSE
  • JURI
• 2001/11/26 Legislative proposal
  • COM(2001)0404 summary

    PURPOSE : to amend Directive 2001/83/EC on the community code relating to medicinal products for human use. CONTENT : In general terms the pharmaceutical legislation needs to be revised (see COD010252), in view of lessons learnt as well as scientific and technical progress. The main amendments are as follows: -the definition of medicinal product is adapted to take account of new therapies and their particular mode of administration. -since the possible duality of certain "borderline" products (medical devices, cosmetics, biocides etc.) has led to differences of opinion as to the applicable legislation, it is proposed that when a product fully meets the definition of a medicinal product, but may also meet the definition of other regulated products, the pharmaceutical legislation should apply. -adaptations are proposed to certain provisions relating to the marketing authorisation application file. -in the case of abridged marketing authorisation procedures, the concept of "essentially similar" medicinal products is abandoned since it actually refers to generic medicinal products, a definition of which is inserted, together with a definition of reference medicinal product. -the administrative protection period for data on the reference medicinal product is harmonised at ten years. -any medicinal product not compulsorily subject to the centralised procedure will be covered by the decentralised or mutual recognition procedure, on condition that it is intended for the market of more than one Member State. These procedures are thus still optional for other medicinal products which represent a therapeutic innovation and will be the procedure of choice for generic medicinal products. -the mutual recognition procedure has been criticised because of difficulties encountered in practice. Added to the general principles of mutual recognition is a new decentralised procedure for medicinal products not yet authorised in the Community, where Member States would cooperate before a decision is taken by one of them. -the establishment of the co-ordination group to whom disagreements are referred under the new decentralised procedures. -the obligation to renew marketing authorisation every five years is removed. (see COD010252) -the referral procedure is amended, and the overall length is reduced from 90 days to 60 days. -Commission decision-making is to be subject to a consultation procedure and a management procedure, depending on the case. -on inspection and surveillance matters, it is proposed that the regulation be extended to cover active substances used as starting materials in the manufacture of medicinal products. Provision is made for issuing certificates of good manufacturing practice attesting compliance with the relevant requirements. -there are provisions to ensure a greater emphasis on a preventive approach with regard to pharmacovigilance. -the proposal introduces a limited mutual recognition procedure for homeopathy. Invented names may be used. The blanket prohibition on advertising is removed.

  • DG Enterprise and Industry,

Documents

• Legislative proposal published: COM(2001)0404
• Committee draft report: PE290.143
• Committee report tabled for plenary, 1st reading/single reading: A5-0340/2002
• Decision by Parliament, 1st reading/single reading: T5-0505/2002
• Text adopted by Parliament, 1st reading/single reading: OJ C 300 11.12.2003, p. 0166-0352 E
• Modified legislative proposal published: COM(2003)0163
• Council position published: 10950/3/2003
• Council position: OJ C 297 09.12.2003, p. 0041-0071 E
• Committee draft report: PE337.033
• Committee recommendation tabled for plenary, 2nd reading: A5-0446/2003
• Decision by Parliament, 2nd reading: T5-0577/2003
• Text adopted by Parliament, 2nd reading: OJ C 091 15.04.2004, p. 0133-0298 E
• Commission opinion on Parliament's position at 2nd reading: COM(2004)0124
• : Directive 2004/27
• : OJ L 136 30.04.2004, p. 0034-0057

History

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