Activities of Bernadette VERGNAUD related to 2008/0257(COD)
Plenary speeches (1)
Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate)
Shadow opinions (1)
OPINION Proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Amendments (16)
Amendment 9 #
Proposal for a regulation – amending act
Recital 7
Recital 7
(7) In order to ensure the availability of the necessary expertise and resources for pharmacovigilance assessments at Community level, it is appropriate to create a new scientific committee within the Agency, the Pharmacovigilance Risk Assessment Advisory Committee. That committee should be composed of independent scientific experts with competence in the safety of medicines including the detection, assessment, minimisation and communication of risk, and the design of post-authorisation safety studies and pharmacovigilance audit.
Amendment 10 #
Proposal for a regulation – amending act
Recital 9
Recital 9
Amendment 13 #
Proposal for a regulation – amending act
Article 1 — point 1
Article 1 — point 1
Regulation (EC) No 726/2004
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 15 #
Proposal for a regulation – amending act
Article 1 — point 11
Article 1 — point 11
Regulation (EC) No 726/2004
Article 25
Article 25
The Agency, in collaboration with the Member States, shall develop standard web-based structured forms for the reporting of suspected adverse reactions by health-care professionals and patients. All citizens of the Member States of the Union shall have the option of submitting online declarations in their mother tongue. The Agency shall also make available to the public any other means for patients to report undesirable effects, such as a dedicated telephone number or special email address.
Amendment 26 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 28 – paragraph 3
Article 28 – paragraph 3
3. The European Pharmacovigilance Risk Assessment Advisory Committee shall assess the periodic safety update reports. It shall prepare an assessment reporCommittee shall assess scientifically the risk-benefit balance of the medicinal product on the basis of all the information available, including periodic safety update reports and data entered in the Eudravigilance database. It shall prepare a scientific report on the risk-benefit balance of the medicinal product within 90 days of receipt of the periodic safety update report and send it to the marketing authorisation holder and the pharmacovigilance risk assessment coordination group. Within 30 days of receipt of the assessment report, the marketing authorisation holder may submit comments to the Agencyand the pharmacovigilance risk assessment coordination group may submit comments to the European Pharmacovigilance Committee. At its next meeting following the end of the period for comments by the marketing authorisation holder, and the Ppharmacovigilance Rrisk Aassessment Advisorycoordination group, the European Pharmacovigilance Committee shall adopt the assessment report with or without changes, taking into account any comments submitted by the marketing authorisation holder. With effect from [indicate precise date, namely 18 months after the date referred to in Article 3], the assessment report shall be published immediately on the European medicines safety web-portal.
Amendment 27 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 28 – paragraph 4 – subparagraph 1
Article 28 – paragraph 4 – subparagraph 1
4. Within 30 days of receiptadoption of the report by, the European Pharmacovigilance Risk Assessment Advisory Committee, the Committee for Medicinal Products for Human Use shall consider the report andCommittee shall adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisation concerned.
Amendment 28 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 28 – paragraph 6
Article 28 – paragraph 6
6. The assessment reports, opinions and decisions referred to in paragraphs 3 to 5 of this Article shall be made public by means of the European medicines safety web- portal referred to in Article 26.
Amendment 29 #
Proposal for a regulation – amending act
Article 1 — point 12
Article 1 — point 12
Regulation (EC) No 726/2004
Article 56 – paragraph 1 – point aa
Article 56 – paragraph 1 – point aa
“(aa) the Pharmacovigilance Risk Assessment Advisory Committee, which shall be responsible for providing advice to the Committee for Mthe pharmacovigilance assessment, after marketing authorisation has been granted, of medicinal Pproducts for Human Use and the coordination group on any question relating to the pharmacovigilance of medicinal products for human usplaced on the market in accordance with the centralised procedure;”
Amendment 30 #
Proposal for a regulation – amending act
Article 1 – point 14
Article 1 – point 14
Regulation (EC) No 726/2004
Article 61a – paragraph 1
Article 61a – paragraph 1
1. The Pharmacovigilance Risk Assessment Advisory Committee shall be composed of the following: a) twenty-seven members and twenty-seven alternates appointed by the Management Board, on the basis of proposals by the national competent authorities; b) five members and five alternates appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament. The alternates shall represent and vote for the members in their absence. The Commission may adapt the nincluding at least one healthcare professional representative, at least one patient representative and at least one consumber of members and alternates in the light of technical and scientific needs. Those measurepresentative, on the basis of a public call for expressions of interest, designed to amend non- essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a)after consulting the European Parliament. The alternates shall represent and vote for the members in their absence.
Amendment 31 #
Proposal for a regulation – amending act
Article 1 — point 14
Article 1 — point 14
Regulation (EC) No 726/2004
Article 61a – paragraph 2
Article 61a – paragraph 2
2. The members and alternates of the Pharmacovigilance Risk Assessment Advisory Committee shall be appointed on the basis of their relevant expertise in pharmacovigilance and risk assessment of medicinal products for human use, in such a way as to guarantee the highest levels of specialist qualifications and a broad spectrum of relevant expertise. They shall not be subject to the authority of national marketing authorisation bodies and of the Committee for Medicinal Products for Human Use. For this purpose, the Executive Director of the Agency shall assist the Management Board and the Commission in order to ensure that the final composition of the Committee covers the scientific areas relevant to its tasks.
Amendment 32 #
Proposal for a regulation – amending act
Article 1 — point 14
Article 1 — point 14
Regulation (EC) No 726/2004
Article 61a – paragraph 3
Article 61a – paragraph 3
3. The members and alternates of the Pharmacovigilance Risk Assessment Advisory Committee shall be appointed for a term of three years, which may be prolonged once. The Committee shall elect its Chairman among its members for a term of three years, which may be prolonged once.
Amendment 33 #
Proposal for a regulation – amending act
Article 1 — point 14
Article 1 — point 14
Regulation (EC) No 726/2004
Article 61a – paragraph 4
Article 61a – paragraph 4
4. Paragraphs (3), (4), (7)3, 4, 7 and (8)8 of Article 61 shall apply to the Pharmacovigilance Risk Assessment Advisory Committee.
Amendment 34 #
Proposal for a regulation – amending act
Article 1 – point 14
Article 1 – point 14
Regulation (EC) No 726/2004
Article 61a – paragraph 5
Article 61a – paragraph 5
5. Members and alternates of the Pharmacovigilance Risk Assessment Advisory Committee may not seek or take instructions from any national competent authority, organisation or person. They shall carry out the duties assigned to them objectively and impartially.
Amendment 35 #
Proposal for a regulation – amending act
Article 1 – point 14
Article 1 – point 14
Regulation (EC) No 726/2004
Article 61a – paragraph 6
Article 61a – paragraph 6
Amendment 36 #
Proposal for a regulation – amending act
Article 1 – point 18 – subpoint b
Article 1 – point 18 – subpoint b
Regulation (EC) No 726/2004
Article 67 – paragraph 4
Article 67 – paragraph 4
“4. Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall be under the permanent control of the Management Board in order to guarantee the independence of the Agency, and receive public funding commensurate with the scale of the tasks assigned. This shall not preclude the indirect collection of fees to be paid by marketing authorisation holders for theadditional funding to enable the Agency to carrying out of theose activities by the Agency, provided that its independence is strictly guaranteed.”
Amendment 81 #
Proposal for a regulation – amending act
Article 1 – point 18 – point b
Article 1 – point 18 – point b
Regulation EC/726/2004
Article 67 – paragraph 4
Article 67 – paragraph 4
4. Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall be under the permanent control of the Management Board in order to guarantee the independence of the Agency and shall receive public financing commensurate with the tasks set. This shall not preclude the indirect collection of fees to be paid by marketing authorisation holderadditional resources for the carrying out of these activities by the Agency, on condition that its independence is strictly guaranteed.