2008/0225(COD) | [ParlTrack]

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2008/0225(COD) Visas: third countries whose nationals are subject to or exempt from a visa requirement

Role	Committee	Rapporteur	Shadows
Lead	JURI

Lead committee dossier: JURI/8/00029
Legal Basis TFEU 077-p2

Subjects

7.10.04 External borders crossing and controls, visas

Links

Activites

2015/03/07 Proposal withdrawn by Commission
- DG {'url': 'http://ec.europa.eu/dgs/legal_service/', 'title': 'Legal Service'}, BARROSO José Manuel
2009/12/02 Additional information
2009/10/19 Committee referral announced in Parliament, 1st reading/single reading
2009/03/09 Committee referral announced in Parliament, 1st reading/single reading
2008/11/28 Legislative proposal published
- 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

Documents

Legislative proposal published: COM(2008)0761

Amendments	Dossier
29	2008/0225(COD) 2010/05/04 ENVI 29 amendments... Amendment 10 # Carl SCHLYTER 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 # Thomas ULMER 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 12 # Carl SCHLYTER 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 # Carl SCHLYTER 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 # Thomas ULMER 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 # Jiří MAŠTÁLKA 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. Amendment 16 # Carl SCHLYTER 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. 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 # Carl SCHLYTER 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 # Carl SCHLYTER 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 # Thomas ULMER 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 # Carl SCHLYTER 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 # Carl SCHLYTER 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. Amendment 23 # Carl SCHLYTER 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 # Carl SCHLYTER 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 # Carl SCHLYTER 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." Amendment 26 # Carl SCHLYTER 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 # Carl SCHLYTER 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 # Carl SCHLYTER 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 # Carl SCHLYTER 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 # Carl SCHLYTER Proposal for a regulation – amending act – The European Parliament rejects the Commission proposal. Amendment 30 # Carl SCHLYTER 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 # Carl SCHLYTER 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 # Gilles PARGNEAUX Proposal for a regulation – amending act – The European Parliament rejects the Commission proposal. Amendment 5 # Thomas ULMER Proposal for a regulation – amending act Recital 5 (5) To ensure the adequate funding of these activities related to ~~information~~the monitoring of the marketing authorisation holder's communications to the public, provision should be made for the collection of fees charged to marketing authorisation holders by the Agency. Amendment 6 # Carl SCHLYTER 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 # Thomas ULMER 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 # Carl SCHLYTER 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 # Thomas ULMER 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

Amendments

Dossier

2008/0225(COD)

2010/05/04 ENVI 29 amendments...

Amendment 10 #

Carl SCHLYTER

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 #

Thomas ULMER

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 12 #

Carl SCHLYTER

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 #

Carl SCHLYTER

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 #

Thomas ULMER

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 #

Jiří MAŠTÁLKA

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.

Amendment 16 #

Carl SCHLYTER

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

Regulation (EC) No 726/2004
Article 20b – paragraph 3

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 #

Carl SCHLYTER

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 #

Carl SCHLYTER

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 #

Thomas ULMER

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 #

Carl SCHLYTER

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 #

Carl SCHLYTER

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.

Amendment 23 #

Carl SCHLYTER

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 #

Carl SCHLYTER

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 #

Carl SCHLYTER

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."

Amendment 26 #

Carl SCHLYTER

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 #

Carl SCHLYTER

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 #

Carl SCHLYTER

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 #

Carl SCHLYTER

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 #

Carl SCHLYTER

Proposal for a regulation – amending act
–

The European Parliament rejects the Commission proposal.

Amendment 30 #

Carl SCHLYTER

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 #

Carl SCHLYTER

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 #

Gilles PARGNEAUX

Proposal for a regulation – amending act
–

The European Parliament rejects the Commission proposal.

Amendment 5 #

Thomas ULMER

Proposal for a regulation – amending act
Recital 5

(5) To ensure the adequate funding of these activities related to ~~information~~the monitoring of the marketing authorisation holder's communications to the public, provision should be made for the collection of fees charged to marketing authorisation holders by the Agency.

Amendment 6 #

Carl SCHLYTER

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 #

Thomas ULMER

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 #

Carl SCHLYTER

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 #

Thomas ULMER

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

History

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

2019-07-06Show (12) Changes | Timetravel

activities	date: 2008-11-28T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2008/0761/COM_COM(2008)0761_EN.pdf title: COM(2008)0761 type: Legislative proposal published celexid: CELEX:52008PC0761:EN body: EC commission: DG: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service Commissioner: BARROSO José Manuel type: Legislative proposal published date: 2009-03-09T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: True committee_full: Legal Affairs committee: JURI date: 2009-10-19T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: True committee_full: Legal Affairs committee: JURI date: 2009-12-02T00:00:00 body: all type: Additional information date: 2015-03-07T00:00:00 body: EC type: Proposal withdrawn by Commission commission: DG: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service Commissioner: BARROSO José Manuel
commission	body: EC dg: Legal Service commissioner: BARROSO José Manuel
committees/0/associated	False
committees/0/date
committees/0/responsible	True
committees/0/type	Responsible Committee
committees/1	type Former Responsible Committee body EP associated False committee_full Legal Affairs committee JURI date
committees/2	type Former Responsible Committee body EP associated False committee_full Legal Affairs committee JURI date
events	date: 2008-11-28T00:00:00 type: Legislative proposal published body: EC docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2008/0761/COM_COM(2008)0761_EN.pdf title: COM(2008)0761 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2008&nu_doc=761 title: EUR-Lex 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. date: 2009-03-09T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP date: 2009-10-19T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP date: 2009-12-02T00:00:00 type: Additional information body: all summary: The Lisbon Treaty, which entered into force on 1 December 2009, amended the EU's two core treaties, the Treaty on European Union (TEU) and the Treaty establishing the European Community (EC Treaty). The latter was renamed the Treaty on the Functioning of the European Union (TFEU). These changes had various consequences for many ongoing procedures. First of all, the articles of the TEU and of the old EC Treaty that constitute the legal basis of all the proposals founded on those Treaties were renumbered in accordance with the table of equivalences mentioned in Article 5 of the Lisbon Treaty. In addition, some proposals underwent a change to their legal basis going beyond a mere change to their numbering, and this resulted in changes to the type of procedure . The Lisbon Treaty also introduced new concepts of decision-making procedure . The old "codecision procedure" was extended to new areas and renamed the "ordinary legislative procedure". A new "consent procedure" replaced the old "assent procedure". New interinstitutional procedures were also set up for the adoption of certain non-legislative acts, for example the conclusion of some international agreements. The ongoing proposals concerned by these changes were formally modified by the Commission in a Communication published on 2 December 2009 ( COM(2009)0665 ). In the case of the proposal for a Council Regulation 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 entry into force of the Lisbon Treaty had the following impacts : · the old legal basis - Treaty/EC/Art.62(2)(b) and (i) – became Art. 77 (2)(a) of the TFEU. Please note that the numbering of the old legal basis corresponds to the consolidated version of the Treaty that was applicable immediately before the entry into force of the Lisbon Treaty, and may differ from the references in the original Commission proposal ; · the proposal, which had previously fallen under the old consultation procedure (CNS), was classified as an ordinary legislative procedure (COD). date: 2015-03-07T00:00:00 type: Proposal withdrawn by Commission body: EC
other	body: EC dg: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service commissioner: BARROSO José Manuel
procedure/dossier_of_the_committee	Old JURI/8/00029 New JURI/8/00029
procedure/subject	Old 7.10.04 External borders crossing and controls, visas New 7.10.04 External borders crossing and controls, visas

2015-11-04Show (4) Changes | Timetravel

activities/0/docs/0/url	Old http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2008/0761/COM_COM(2008)0761_EN.pdf New http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2008/0761/COM_COM(2008)0761_EN.pdf
links/European Commission/title	Old PreLex New EUR-Lex
procedure/summary	Repealing Regulation (EC) No 539/2001
procedure/title	Old Visas: third countries whose nationals are subject to or exempt from a visa requirement. Codification New Visas: third countries whose nationals are subject to or exempt from a visa requirement

2015-03-12Show (2) Changes | Timetravel

activities/4	date 2015-03-07T00:00:00 body EC type Proposal withdrawn by Commission commission DG: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service Commissioner: BARROSO José Manuel
procedure/stage_reached	Old Awaiting committee decision New Procedure lapsed or withdrawn

2014-11-10Show (5) Changes

activities	date: 2008-11-28T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2008/0761/COM_COM(2008)0761_EN.pdf title: COM(2008)0761 type: Legislative proposal published celexid: CELEX:52008PC0761:EN body: EC type: Legislative proposal published commission: DG: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service Commissioner: BARROSO José Manuel date: 2009-03-09T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: True committee_full: Legal Affairs committee: JURI date: 2009-10-19T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: True committee_full: Legal Affairs committee: JURI date: 2009-12-02T00:00:00 body: all type: Additional information
committees	body: EP responsible: True committee_full: Legal Affairs committee: JURI
links	National parliaments url: http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=COD&year=2008&number=0225&appLng=EN title: IPEX European Commission url: http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=COD&DocYear=2008&DocNum=0225 title: PreLex
other	body: EC dg: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service commissioner: BARROSO José Manuel
procedure	dossier_of_the_committee JURI/8/00029 reference 2008/0225(COD) subtype Codification legal_basis Treaty on the Functioning of the EU TFEU 077-p2 stage_reached Awaiting committee decision summary Repealing Regulation (EC) No 539/2001 instrument Regulation title Visas: third countries whose nationals are subject to or exempt from a visa requirement. Codification type COD - Ordinary legislative procedure (ex-codecision procedure) subject 7.10.04 External borders crossing and controls, visas

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