9 Amendments of Jean-François JALKH related to 2014/0256(COD)
Amendment 27 #
Proposal for a regulation
Article 1 – point 7
Article 1 – point 7
Regulation (EC) No 726/2004
Article 10b– paragraph 1
Article 10b– paragraph 1
The Commission shall be empowered to adopt measures, by means of delegated acts in accordance with Article 87b,propose acts to Parliament and the Council to determine the situations in which post- authorisation efficacy studies may be required under point (cc) of Article 9(4) and point (b) of Article 10a(1).
Amendment 28 #
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EC) No 726/2004
Article 14 – paragraph 7 – subparagraph 3
Article 14 – paragraph 7 – subparagraph 3
The Commission shall be empowered to adopt delegated acts in accordance with Article 87bpropose acts to Parliament and the Council in order to lay down provisions and requirements for granting such marketing authorisation and for its renewal.
Amendment 35 #
Proposal for a regulation
Article 1 – point 13
Article 1 – point 13
Regulation (EC) No 726/2004
Article 61– paragraph 1 – subparagraph 1
Article 61– paragraph 1 – subparagraph 1
Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human Use. Full and alternate members may be dismissed ad nutum by the appointing Member State and dismissed where there is a conflict of interest.
Amendment 40 #
Proposal for a regulation
Article 1 – point 15
Article 1 – point 15
Regulation (EC) No 726/2004
Article 67 – paragraph 3 – subparagraph 1
Article 67 – paragraph 3 – subparagraph 1
The Agency’s revenue shall consist of a contribution from the Union, fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for other services provided by the Agency, or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC and charges for other services provided by the Agencyme from the general budget of the Union.
Amendment 47 #
Proposal for a regulation
Article 1 – point 16
Article 1 – point 16
Regulation (EC) No 726/2004
Article 70 – paragraph 1 – subparagraph 1 – introductory wording
Article 70 – paragraph 1 – subparagraph 1 – introductory wording
The Commission shall propose to Parliament and the Council, on the basis of the principles set out in paragraph 2, adopt implementing acts in accordance with the procedure laid down in Article 87(2)cts specifying:
Amendment 48 #
Proposal for a regulation
Article 1 – point 16
Article 1 – point 16
Regulation (EC) No 726/2004
Article 70 – paragraph 1 – subparagraph 2
Article 70 – paragraph 1 – subparagraph 2
The fees shall be set at such a level as to avoid a deficit or a significant accumulation of surplus in the budget of the Agency and be revised when this is not the casein the budget of the Agency. They shall be collected by the Agency, which shall pay them back in their entirety into the general budget of the Union.
Amendment 49 #
Proposal for a regulation
Article 1 – point 16
Article 1 – point 16
Regulation (EC) No 726/2004
Article 70 – paragraph 2 – point a
Article 70 – paragraph 2 – point a
(a) fees shall be set at such a level as to ensure that the revenue derived from them is, in principle, sufficient to cover the costs of the services delivered and shall not exceed what is necessary to cover the costs;
Amendment 50 #
Proposal for a regulation
Article 1 – point 16
Article 1 – point 16
Regulation (EC) No 726/2004
Article 70 – paragraph 2 – point b
Article 70 – paragraph 2 – point b
(b) the level of the fees shall take into account the results of a transparent and objective evaluation of the costs of the Agency and the costs of the tasks carried out by the national competent authorities. It shall take account of the economic prospects of the market sought by the applicant and of the place where the medicinal product was manufactured so as to promote production within the Union;
Amendment 51 #
Proposal for a regulation
Article 1 – point 17
Article 1 – point 17
Regulation (EC) 726/2004
Article 84 – paragraph 3 – subparagraph 1
Article 84 – paragraph 3 – subparagraph 1
The Commission may impose financial penalties on the holders of marketing authorisations granted under this Regulation if they fail to observe obligations laid down in connection with the marketing authorisations granted in accordance with this Regulation. Member States may suspend authorisations on their territory for the same reasons.