Procedure lapsed or withdrawn
2008/0225(COD) Visas: third countries whose nationals are subject to or exempt from a visa requirement. Codification
Lead committee dossier: JURI/8/00029
Legal Basis TFEU 077-p2
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | JURI |
Legal Basis TFEU 077-p2
Activites
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2015/03/07
Proposal withdrawn by Commission
- DG {'url': 'http://ec.europa.eu/dgs/legal_service/', 'title': 'Legal Service'}, BARROSO José Manuel
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2009/12/02
Additional information
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2009/10/19
Committee referral announced in Parliament, 1st reading/single reading
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2009/03/09
Committee referral announced in Parliament, 1st reading/single reading
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2008/11/28
Legislative proposal published
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COM(2008)0761
summary
PURPOSE: to list the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (codification).PROPOSED ACT: Council Regulation.CONTENT: the purpose of this proposal is to undertake a codification of Council Regulation (EC) No 539/2001 of 15 March 2001 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement. The new Regulation will supersede the various acts incorporated in it. This proposal fully preserves the content of the acts being codified and hence does no more than bringing them together with only such formal amendments as are required by the codification exercise itself.
- DG {'url': 'http://ec.europa.eu/dgs/legal_service/', 'title': 'Legal Service'}, BARROSO José Manuel
-
COM(2008)0761
summary
Documents
- Legislative proposal published: COM(2008)0761
| Amendments | Dossier |
| 29 |
2008/0225(COD)
2010/05/04
ENVI
29 amendments...
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)".
Amendment 11 #
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) 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)."
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."
Amendment 14 #
Proposal for a regulation – amending act Article 1 – point -1 e (new) Regulation (EC) No 726/2004 Article 13 – paragraph 3 – subparagraph 2 (-1e) In Article 13(3), the second subparagraph shall be 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."
Amendment 15 #
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
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
Amendment 17 #
Proposal for a regulation Article 1 – point 1 3a. If the Agency asks for changes to a document submitted by the marketing authorisation holder, and if the latter resubmits an improved proposal within 30 working days, the marketing authorisation holder should have the opportunity to benefit from an accelerated procedure. The Agency shall communicate its response to the new proposal within 60 working days. The Agency shall charge the marketing authorisation holder a new fee for this assessment.
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.
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;"
Amendment 20 #
Proposal for a regulation – amending act Article 1 – point 2 a (new) (2a) In Article 57(1), the following point is added: "(ua) promoting existing sources of independent reliable health information."
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.”
Amendment 22 #
Proposal for a regulation – amending act Article 1 – point 2 b (new) Regulation (EC) No 726/2004 Article 57 – paragraph 2 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."
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."
Amendment 25 #
Proposal for a regulation – amending act Article 1 – point 2 e (new) Regulation (EC) No 726/2004 Article 59 – paragraph 4 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."
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."
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."
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."
Amendment 3 #
Proposal for a regulation – amending act – The European Parliament rejects the Commission proposal.
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."
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."
Amendment 4 #
Proposal for a regulation – amending act – The European Parliament rejects the Commission proposal.
Amendment 5 #
Proposal for a regulation – amending act Recital 5 (5) To ensure the adequate funding of these activities related to
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;"
Amendment 7 #
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) shall be 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;"
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";
Amendment 9 #
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) shall be 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;"
source: PE-441.030
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History
(these mark the time of scraping, not the official date of the change)
2015-11-04Show (4) Changes | Timetravel
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