BETA

20 Amendments of Carl SCHLYTER related to 2008/0225(COD)

Amendment 3 #
Proposal for a regulation – amending act
The European Parliament rejects the Commission proposal.
2010/05/04
Committee: ENVI
Amendment 6 #
Proposal for a regulation – amending act
Article 1 – point -1 a (new)
Regulation (EC) No 726/2004
Article 9 – paragraph 4 – point a
(-1a) In Article 9(4), point (a) is replaced by the following: "(a) a draft of the summary of product characteristics, as referred to in Article 11 of Directive 2001/83/EC. It shall list other therapeutic options available and indicate whether the new medicinal product brings about a therapeutic advance. It shall also mention the voting results within the Agency’s scientific committees, notably the number of votes approving the medicine;"
2010/05/04
Committee: ENVI
Amendment 8 #
Proposal for a regulation – amending act
Article 1 – point -1 b (new)
Regulation (EC) No 726/2004
Article 9 – paragraph 4 – point e
(-1b) In Article 9(4), point (e) is replaced by the following: "(e) the assessment report, which shall include as an annex the preliminary report on the medicinal product prepared by the rapporteurs as well as the marketing authorisation holder’s comments";
2010/05/04
Committee: ENVI
Amendment 10 #
Proposal for a regulation – amending act
Article 1 – point -1 c (new) Regulation (EC) No 726/2004

Article 9 – paragraph 4 – point e a (new)
(-1c) In Article 9(4), the following point is added: "(ea) the public summary of the assessment report referred to in Article 13(3)".
2010/05/04
Committee: ENVI
Amendment 12 #
Proposal for a regulation – amending act
Article 1 – point -1 d (new)
Regulation (EC) No 726/2004
Article 10 – paragraph 6
(-1d) Article 10(6) is replaced by the following: "6. The Agency shall disseminate and make publicly available the documents referred to in Articles 9(4)(a), (b), (c), (d), (e) and (ea)."
2010/05/04
Committee: ENVI
Amendment 13 #
Proposal for a regulation – amending act
Article 1 – point -1 e (new)
(-1e) In Article 13(3), the second subparagraph is replaced by the following: "The European Public Assessment Report (EPAR) shall include a summary written in a manner that is understandable to the public. The summary shall contain [...]a section relating to the conditions of use of the medicinal product as well as a section listing other therapeutic options available and indicating whether the new medicinal product brings about a therapeutic advance."
2010/05/04
Committee: ENVI
Amendment 16 #
Proposal for a regulation – amending act
Article 1 – point 1
Regulation (EC) No 726/2004
Article 20b – paragraph 3
3. The Agency may object to the information submitted or parts thereof on grounds related to non-compliance with the provisions of Title VIIIa of Directive 2001/83/EC within 6120 days after receipt of the notification. If the Agency does not object within 6120 days, the information shall be deemed accepted and may be published. The marketing authorisation holder remains fully liable and responsible for the information provided in all cases.
2010/05/04
Committee: ENVI
Amendment 18 #
Proposal for a regulation – amending act
Article 1 – point 1
Regulation (EC) No 726/2004
Article 20b – paragraph 3 a (new)
3a. If the Agency has to make comments or objections to the documents submitted by the marketing authorisation holder, the Agency shall charge the marketing authorisation holder double the fee referred to in paragraph 4.
2010/05/04
Committee: ENVI
Amendment 19 #
Proposal for a regulation – amending act
Article 1 – point - 1 a (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 1 – point d
(-1a) In Article 57(1), point (d) is replaced by the following: "d. ensuring the dissemination of information on adverse reactions to medicinal products authorised in the Union, by means of a database permanently accessible to all Member States, health-care professionals, marketing authorisation holders and the public, [...] with personal data protection being guaranteed;"
2010/05/04
Committee: ENVI
Amendment 21 #
Proposal for a regulation – amending act
Article 1 – point 2 a (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 1 – point u a (new)
(2a) In Article 57(1), the following point is added: “(ua) promoting existing sources of independent reliable health information.”
2010/05/04
Committee: ENVI
Amendment 22 #
Proposal for a regulation – amending act
Article 1 – point 2 b (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 2
(2b) In Article 57, paragraph 2 shall be replaced by the following: "2. The database provided for in paragraph 1(l) shall include the most recent version of: - the summaries of product characteristics, - the patient or user package leaflet, - the information shown on the labelling, which shall always at least specify the International Non-proprietary Name, - the mock-ups of the secondary and primary packaging as well as of any other devices included in the package, - the conditions for authorisations granted subject to specific obligations as referred to in Articles 14(7) and 14(8), together with the deadline for their fulfilment and where appropriate a link to the results of the post-authorisation studies or risk management plans, once completed; - the European Public Assessment Reports (EPARs), including their summaries written in user-friendly language for the public, as referred to in Article 13(3); - for updates of European public assessment reports (EPARs) (variations or ‘steps taken after authorisation’) related to safety issues, the complete reports from the Committee for Medicinal Products for Human Use (CHMP); - the Public Assessment Reports (PARs) and, where available, summaries of them written in user-friendly language for the public; - the periodic safety update reports (PSURs), assessment reports and, where available, summaries of them written in user-friendly language to the public. It shall also include the date on which the marketing authorisation was awarded, and the procedure through which it was granted (centralised, decentralised or by mutual recognition). The database shall be developed in a stepwise way, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC and of Directive 2001/82/EC respectively. The database shall subsequently be extended to include all the medicinal products authorised into the market within the European Union. This shall be achieved by ... *. This database shall be actively promoted to European citizens. To this end, each webpage from a marketing authorisation holder that refers to a medicinal product subject to medical prescription shall include a prominent link to the corresponding webpage of the Eudrapharm database. The database shall also include references to data on clinical trials being carried out, and those abandoned, or already completed, as contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC (hereinafter the ‘EudraCT database’)." * OJ: Please insert the date 5 years after the entry into force of this Regulation.
2010/05/04
Committee: ENVI
Amendment 23 #
Proposal for a regulation – amending act
Article 1 – point 2 c (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 2 a (new)
(2c) In Article 57, the following paragraph is added: "2a. The EudraCT database shall make publicly available: - the study protocols and subsequent variations of the study protocols; - a model of the informed consent form distributed to the patients; - a statement to the effect that clinical trials carried out outside the European Union meet the ethical requirements of Directive 2001/20/EC referred to in Article 6(1); - deadlines for the study completion; - detailed study results, to be made available not later than one year after the end of the study."
2010/05/04
Committee: ENVI
Amendment 24 #
Proposal for a regulation – amending act
Article 1 – point 2 d (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 2 b (new)
(2d) In Article 57, the following paragraph is added: "2b. All clinical trials run by a marketing authorisation holder based in Europe or by a third party acting on its behalf shall be registered in the EudraCT database regardless of whether the clinical trials take place in Europe or in third countries."
2010/05/04
Committee: ENVI
Amendment 25 #
Proposal for a regulation – amending act
Article 1 – point 2 e (new)
Regulation (EC) No 726/2004
Article 59 – paragraph 4
(2e) In Article 59, paragraph 4 is replaced by the following: "4. Save as otherwise provided in this Regulation, in Directive 2001/83/EC or in Directive 2001/82/EC, where there is a fundamental conflict over scientific recommendations and decisions and the body concerned is a Member State institution, the Agency and the national body concerned shall work together to resolve the conflict, or to prepare a joint document duly clarifying the scientific points of conflict. This document shall be published and made publicly available immediately after its adoption."
2010/05/04
Committee: ENVI
Amendment 26 #
Proposal for a regulation – amending act
Article 1 – point 2 f (new)
Regulation (EC) No 726/2004
Article 62 – paragraph 2 – subparagraph 1
(2f) In Article 62(2), the first subparagraph is replaced by the following: "2. Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products who would be available to serve on working parties or scientific advisory groups of the Committee for Medicinal Products for Human Use, the Committee on Herbal Medicinal Products or the Committee for Medicinal Products for Veterinary Use, together with an indication of their qualifications, specific areas of expertise and declaration of interests."
2010/05/04
Committee: ENVI
Amendment 27 #
Proposal for a regulation – amending act
Article 1 – point 2 g (new)
Regulation (EC) No 726/2004
Article 62 – paragraph 2 a (new)
(2g) In Article 62, the following paragraph is inserted: "2a. Marketing authorisation holders shall provide the Agency and national competent authorities with a comprehensive list of payments and sponsorships to any patients' organisation, consumer organisation, healthcare professionals' organisation, learned society, individual health professional, political party and opinion leader in excess of 10 EUR. This list shall be made publicly available."
2010/05/04
Committee: ENVI
Amendment 28 #
Proposal for a regulation – amending act
Article 1 – point 2 h (new)
Regulation (EC) No 726/2004
Article 63 – paragraph 2
(2h) In Article 63, paragraph 2 is replaced by the following: "Members of the Management Board, members of the committees, rapporteurs and experts shall not have financial or other interests in the pharmaceutical industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests. All indirect interests which could relate to this industry shall be entered in a register held by the Agency which is accessible to the public on its website."
2010/05/04
Committee: ENVI
Amendment 29 #
Proposal for a regulation – amending act
Article 1 – point 2 i (new)
Regulation (EC) No 726/2004
Article 63 – paragraph 2 a (new)
(2i) In Article 63, the following paragraph is added: "2a. The Agency shall make publicly accessible: - the detailed agendas for the meetings of its committees and working parties, at the latest by the day before the meetings take place, - the records of these meetings, including the list of all experts attending and of experts not allowed to participate due to conflicts of interests, as well as a description of decisions taken, details of votes and explanations of votes, including minority opinions."
2010/05/04
Committee: ENVI
Amendment 30 #
Proposal for a regulation – amending act
Article 1 – point 2 j (new)
Regulation (EC) No 726/2004
Article 63 – paragraph 2 b (new)
(2j) In Article 63, the following paragraph is added: "2b. The Agency’s committees shall meet in public. Meetings shall be announced through the European Medicines Agency's website. The announcement shall include information on how the public can participate. Access to background documents shall be granted to all participants in the meeting."
2010/05/04
Committee: ENVI
Amendment 31 #
Proposal for a regulation – amending act
Article 1 – point 2 k (new)
Regulation (EC) No 726/2004
Article 80 – paragraph 2 a (new)
(2k) In Article 80, the following paragraph is added: "Commercial confidentiality may only be granted if it has been clearly shown by the applicant that the disclosure of the information would cause an unreasonable degree of prejudice to the commercial interests of the marketing authorisation holder. Commercial confidentiality may not be applied to an entire document or certain type of documents, but shall be restricted to the removal of specific elements of data, provided that there is no overriding public interest in disclosure."
2010/05/04
Committee: ENVI