BETA

8 Amendments of Matthias GROOTE related to 2014/0256(COD)

Amendment 33 #
Proposal for a regulation
Article 1 – point 10 a (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 1 – subparagraph 2 – point t a (new)
(10a) In subparagraph 2 of Article 57(1), the following point is added: "(ta) cooperating with health technology assessment bodies and other national authorities involved in market access, in particular to facilitate their assessment."
2015/06/17
Committee: ENVI
Amendment 36 #
Proposal for a regulation
Article 1 – point 13 a (new)
Regulation (EC) No 726/2004
Article 62 – paragraph 2
(13a) Article 62(2) is amended as follows: "2. Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products for human use who, taking into account Article 63(2), would be available to serve on working parties or scientific advisory groups of any of the Committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise. The Agency shall keep an up-to-date list of accredited experts. The list shall include the experts referred to in the first subparagraph and any other experts appointed directly by the Agency or the Commission. The list shall be updated."
2015/06/17
Committee: ENVI
Amendment 37 #
Proposal for a regulation
Article 1 – point 14
Regulation (EC) No 726/2004
Article 62 – paragraph 3 – subparagraph 2
(14) in Article 62(3), the second subparagraph is deleted;
2015/06/17
Committee: ENVI
Amendment 38 #
Proposal for a regulation
Article 1 – point 14 a (new)
Regulation (EC) No 726/2004
Article 64 – paragraph 1
(14a) Article 64(1) is amended as follows: "1. The Executive Director shall be appointed by the Management Board, on a proposal from the Commission, for a period of five years on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and elsewhere. Before appointment, the candidate nominated by the Management Board shall be invited forthwith to make a statement to the European Parliament and to answer any questions put by its Members. His mandate may be renewed once by the Management Board, in consultation with the Commission. The Management Board may, upon a proposal from the Commission, remove the Executive Director from his post."
2015/06/17
Committee: ENVI
Amendment 41 #
Proposal for a regulation
Article 1 – point 15 a (new)
Regulation (EC) No 726/2004
Article 67 – paragraph 3 – subparagraph 1 a (new)
It is necessary to ensure that the Agency can deliver the services required by the legislation. A reserve fund could help to deal with potential unpredicted shortfalls in fee revenue.(15a) In Article 67(3), the following subparagraph is inserted after subparagraph 1: "In order to safeguard fluctuations in fee revenue, any positive budget outturn of a financial year (N) shall be set aside as assigned revenue and serve as a reserve should actual fee revenue be below budgeted appropriations. The total amount of such safeguard fund shall not exceed the Agency's appropriations for the fee revenue of the past year." Or. en Justification
2015/06/17
Committee: ENVI
Amendment 42 #
Proposal for a regulation
Article 1 – point 15 b (new)
Regulation (EC) No 726/2005
Article 67 – paragraph 6 – subparagraph 1 a (new)
(15b) In Article 67(6), the following subparagraph is added: "The draft establishment plan shall contain the number of staff required by the Agency to provide the services financed through fees and the number of staff financed by the Union budget."
2015/06/17
Committee: ENVI
Amendment 43 #
Proposal for a regulation
Article 1 – point 15 c (new)
Regulation (EC) No 726/2004
Article 67 – paragraph 8
(15c) Article 67(8) is amended as follows: "8. On the basis of the estimate, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan concerning the staff financed by the Union budget and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty."
2015/06/17
Committee: ENVI
Amendment 44 #
Proposal for a regulation
Article 1 – point 15 d (new)
Regulation (EC) No 726/2004
Article 67 – paragraph 9 – subparagraph 2
(15d) In Article 67(9), subparagraph 2 is amended as follows: "The budgetary authority shall adopt the establishment plan for the staff financed by the EU budget for the Agency."
2015/06/17
Committee: ENVI