5 Amendments of Alda SOUSA related to 2013/0222(COD)
Amendment 23 #
Proposal for a regulation
Recital 12
Recital 12
(12) The work carried out at Union level in respect of the assessment of non- interventional post- authorisation safety studies imposed by an authority and of which the protocol has been endorsed by the Pharmacovigilance Risk Assessment Committee, involves the supervision of these studies, starting from the assessment of the draft protocol, and is not limited to the assessment of the final study reports. Therefore, the fee levied for this procedure in respect of studies that have been finalised should cover all the work relating to the study. In order to avoid double charging, marketing authorisation holders who are charged the fee for the assessment of non-interventional post-authorisation safety studies imposed by an authority, should be exempted from any other fee charged by a competent authority for the submission of those studies.
Amendment 34 #
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This Regulation determines the pharmacovigilance activities performed at Union level for which fees are due, the amounts and the rules of payment of those fees and the level of remuneration of the Agency, the rapporteurs and the co- rapporteurs.
Amendment 61 #
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 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. For the purpose of this paragraph, the Commission shall publish guidelines on how this declaration is to be formulated by the marketing authorisation holder.
Amendment 79 #
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 84 #
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).