4 Amendments of Dagmar ROTH-BEHRENDT related to 2008/0257(COD)
Amendment 34 #
Proposal for a regulation – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Regulation EC/726/2004
Article 3 – paragraph 2 – point b
Article 3 – paragraph 2 – point b
In paragraph 2 of Article 3, point b is replaced by the following: (b) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interests of patients, or could result in better availability of a medicinal product for patients or animal health at EU level.
Amendment 70 #
Proposal for a regulation – amending act
Article 1 – point 12 – point b a (new)
Article 1 – point 12 – point b a (new)
Regulation EC/726/2004
Article 56 – paragraph 1 – point g
Article 56 – paragraph 1 – point g
(ba) point (g) is replaced by the following: "(g) an Executive Director General, who shall exercise the responsibilities set out in Article 64;"
Amendment 72 #
Proposal for a regulation – amending act
Article 1 – point 14
Article 1 – point 14
Regulation EC/726/2004
Article 61a – paragraph 1
Article 61a – paragraph 1
1. The Pharmacovigilance Risk Assessment Advisory Committee shall be composed of the following: (a) ten members and ten 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 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)following consultation with the national competent authorities and on the basis of their relevant expertise in pharmacovigilance and the risk assessment of medicinal products for human use, as laid down in paragraph 2; (b) seven additional members and five alternates appointed by the Commission, including at least one healthcare professional representative, and at least one patient representative, on the basis of a public call for expressions of interest, after consulting the European Parliament. A Member State may request another Member State to represent it in the committee. The alternates shall represent and vote for the members in their absence.
Amendment 77 #
Proposal for a regulation – amending act
Article 1 – point 14
Article 1 – point 14
Regulation EC/726/2004
Article 61a – paragraph 6
Article 61a – paragraph 6
6. Representatives of the national competent authorities shall be entitled to attend all meetings of the Pharmacovigilance Risk Assessment Advisory Committee and to participate in discussions in order to facilitate appropriate coordination between the tasks of the Agency and the work of national competent authorities. They may provide clarification or information if invited to do so but shall not seek to influence discussions.”