5 Amendments of Spyros DANELLIS related to 2013/0222(COD)
Amendment 16 #
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 and a contribution from the Union. New categories of fees should therefore be created to cover the new and specific tasks of the Agency. __________________ 12 13 14 15 16The European Parliament and the Council should examine the level of the Union contribution on the basis of an evaluation of needs and taking account of the level of fees. The level of the fees charged to marketing authorisation holders will take into account the current financial situation and entrepreneurial environment of Member States. __________________ 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 29 #
Proposal for a regulation
Recital 15
Recital 15
(15) In line with the policy of the Union to support small and medium-sized enterprises, reduced fees, deferral of payment of fees and administrative assistance should apply to small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium- sized enterprises18 . Consistent with this policy, micro enterprises within the meaning of that Recommendation should be exempted from all fees under this Regulation. __________________ 18 OJ L 124, 20.5.2003, p.36. OJ L 124, 20.5.2003, p.36.
Amendment 46 #
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. The Agency, in exceptional circumstances, may allow for a settlement to be negotiated in order to assist the single marketing authorisation holder in paying the applicable fee.
Amendment 49 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The Agency shall levy a fee for post- authorisation safety studies referred to in Article 21 a(b) or Article 22a(1)(a) of Directive 2001/83/EC and Article 9(4)(cb) or Article 10a(1)(a) of Regulation (EC) No 726/2004 that have been conducted in more than one Member States for the assessment thereof carried out under Articles 107n to 107q of Directive 2001/83/EC and Article 28b of Regulation (EC) No 726/2004.
Amendment 55 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. For its pharmacovigilance activities relating to information technology systems under Article 24, Article 25a, Article 26, Article 57(1)(l) of Regulation (EC) No 726/2004, monitoring of selected medical literature under Article 27 thereof and signal detection under Article 28a thereof, the Agency shall levy once per year a flat fee as laid down in Part IV of the Annex.