Activities of Pilar AYUSO related to 2013/0222(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use PDF (277 KB) DOC (355 KB)
Amendments (10)
Amendment 18 #
Proposal for a regulation
Recital 7
Recital 7
(7) Fees referred to in this Regulation should be transparent, fair and proportionate to the work carried out. Information on these fees should be publicly available.
Amendment 35 #
Proposal for a regulation
Article 1 – paragraph 4 a (new)
Article 1 – paragraph 4 a (new)
4a. Member States may not impose fees for pharmacovigilance tasks that are already covered by this Regulation.
Amendment 39 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Where a fee is levied by the Agency in accordance with paragraph 1(a), the Agency shall remunerate the rapporteur and the co-rapporteur in the Pharmacovigilance Risk Assessment Committee appointed by the Member State or the Member State who act as the rapporteur in the coordination group (hereinafter ‘the rapporteur’) for the work they carry out for the Agency or the coordination group. This remuneration shall be paid to the Member State appointing or acting as the rapporteur or co-rapporteur in accordance with Article 9.
Amendment 48 #
Proposal for a regulation
Article 4 – paragraph 6 a (new)
Article 4 – paragraph 6 a (new)
6a. Marketing authorisation holders who are charged the fee under this Article shall be exempted from any other fee charged by a competent authority for the assessment referred to in paragraph 1, including, but not limited to, fees for variations submitted in accordance with Articles 107g(2) and (4) of Directive 2001/83/EC.
Amendment 51 #
Proposal for a regulation
Article 5 – paragraph 6
Article 5 – paragraph 6
6. Marketing authorisation holders who are charged the fee under this Article shall be exempted from any other fee charged by a competent authority for the submission of studies referred to in paragraph 1, including, but not limited to, fees for variations submitted in accordance with Articles 107p(2) and 107q(2) of Directive 2001/83/EC.
Amendment 54 #
Proposal for a regulation
Article 6 – paragraph 6 a (new)
Article 6 – paragraph 6 a (new)
6a. Marketing authorisation holders who are charged the fee under this Article shall be exempted from any other fee charged by a competent authority for the assessment referred to in paragraph 1, including, but not limited to, fees for variations submitted in accordance with Article 34(3) and Article 35 of Directive 2001/83/EC.
Amendment 62 #
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. Any marketing authorisation holder claiming to be entitled to a reduced annual flat fee under Article 7(5) shall make a declaration to that effect to the Agency; the Commission shall publish guidelines on how this declaration is to be formulated by the marketing authorisation holder. The Agency shall apply the reduction on the basis of that declaration where the required conditions are met,. Where the declaration is made by the marketing authorisation holder after the receipt of the invoice from the Agency, the declaration shall be done within 30 calendars days from the receipt of that invoice.
Amendment 80 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The Executive Director of the Agency shall provide the Commission and the Management Board annuallyin the annual report delivered to the European Parliament, the Council, the Commission, the European Economic and Social Committee, the Court of Auditors and the Member States according to Article 65 paragraph 10 of Regulation (EC) No 726/2004 with information on the components that may have a bearing on the costs to be covered by the fees provided for in this Regulation. This information shall include a cost breakdown related to the previous year and a forecast for the following year. The Agency shall also publish this overview in its public annual report. The Executive Director of the Agency shall also provide the Commission and the Management Board once per year with the performance information set out in Part V of the Annex based on the performance indicators referred to in paragraph 3.
Amendment 85 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. Any amendments to the amounts shall be based on an transparent evaluation of the costs of the Agency and the costs of the assessments provided by the rapporteurs as laid down in Article 9 or on the monitoring of the inflation rate referred to in Article 15(4).
Amendment 99 #
Proposal for a regulation
Annex – part III – paragraph 1
Annex – part III – paragraph 1
1. The fee for the assessment of the procedure referred to in Article 6(1) is EUR 168 600. The corresponding remuneration of the rapporteur is EUR 45 100[...] when one or two active substances are involved. This fee is increased with EUR [...] for every additional active substance involved in the procedure. The corresponding remuneration of the rapporteur and co-rapporteur is 50% of the total fee collected.