Activities of Oreste ROSSI related to 2008/0257(COD)
Plenary speeches (4)
Explanations of vote
Explanations of vote
Explanations of vote
Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate)
Amendments (2)
Amendment 24 #
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 withone member per Member State and seven members appointed by the Commission, among whom one should represent health professionals and one should represent patients. These members should possess 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 73 #
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) tenone members and tenone alternates appointed by the Management Board, on the basis of proposals by the national competent authorities for each Member State, appointed by the competent national authority in agreement with the Management Board; (b) fiseven members and fiseven alternates appointed by the Commission, among whom one should represent health professionals and one should represent patients, 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 number of members and alternates in the light of technical and scientific needs. Those measures, 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).