7 Amendments of Thomas ULMER related to 2013/0222(COD)
Amendment 15 #
Proposal for a regulation
Recital 2
Recital 2
(2) The provisions on pharmacovigilance relating to medicinal products of human use laid down in Regulation (EC) No 726/2004 and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use12 were amended by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use13 , Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products14 , Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance15 and Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance16 . Those amendments only cover medicinal products for human use. Those amendments provide for new pharmacovigilance tasks for the Agency including Union-wide pharmacovigilance procedures, the monitoring of literature cases, the improved information technology tools and the provision of more information to the general public. Furthermore, the pharmacovigilance legislation stipulates that the Agency should be enabled to fund those activities from fees charged to marketing authorisation holders. New categories of fees should therefore be created to cover the new and specific tasks of the Agency. __________________ 12 13 14 15 16However, taking into account the benefit for society as a whole, due respect should be given to pharmacovigilance as a sovereign task. Therefore, the percentage share of EU funding in the financing of the EMA budget should be kept, at least, at the status quo before the implementation of this Regulation. The contribution should be used to reduce the costs for financing the routine tasks and hence the annual flat fee. New categories of fees should therefore be created to cover the new and specific tasks of the Agency. __________________ 12 OJ L 311, 28.11.2001, p. 67. OJ L 311, 28.11.2001, p. 67. 13 OJ L 348, 31.12.2010, p.74. OJ L 348, 31.12.2010, p.74. 14 OJ L 348, 31.12.2010, p.1. OJ L 348, 31.12.2010, p.1. 15 OJ L 299, 27.10.2012, p.1. OJ L 299, 27.10.2012, p.1. 16 OJ L 316, 14.11.2012, p.38. OJ L 316, 14.11.2012, p.38.
Amendment 40 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Agency shall levy a fee for the assessment of periodic safety update reports referred to in 107e and 107g of Directive 2001/83/EC and in Article 28 of Regulation (EC) No 726/2004 with assessment criteria according to Annex I of Directive 2001/83/EC.
Amendment 44 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. The amount of the fee is laid down in Part I of the Annex. The Agency shall define 3 clusters of PSUR assessments reflecting the workload.
Amendment 45 #
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Where only one marketing authorisation holder is subject to the obligation to submit a periodic safety update report in the context of the procedures referred to in paragraph 1, the Agency shall levy the total amount of the applicable fee on that marketing authorisation holder. However, in hardship cases, e.g. for economic reasons related to the concerned product, a maximum upper limit of the fee shall apply.
Amendment 89 #
Proposal for a regulation
Annex – part I – paragraph 1 a (new)
Annex – part I – paragraph 1 a (new)
1a. In application of Article 4(2), the following fees apply: (i) category 1: 100 % of the applicable amount; (ii) category 2: 50 % of the applicable amount; (iii) category 3: 10 % of the applicable amount.
Amendment 92 #
Proposal for a regulation
Annex – part I – paragraph 2 a (new)
Annex – part I – paragraph 2 a (new)
2a. In application of Article 4(3), in hardship cases, the concerned marketing authorisation holder shall pay a maximum fee of 40 % of the applicable amount.
Amendment 109 #
Proposal for a regulation
Annex – part IV – paragraph 3
Annex – part IV – paragraph 3
3. Holders of marketing authorisations for medicinal products (other than authorised homeopathic medicinal products) referred to in Article 7(5) shall pay 80 % of the amount applicable to the chargeable units corresponding to those products. Holders of marketing authorisations for homeopathic medicinal products shall pay the percentage equivalent to the ICT services applicable to the chargeable unit corresponding to those products.