12 Amendments of Peter LIESE related to 2013/0222(COD)
Amendment 27 #
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) If marketing authorisation holders demonstrate that the revenue for a medicinal product is lower than or as high as the costs of the product, and that the medicinal product is of great diagnostic or therapeutic value, involves new substances or new indications for existing substances, or that it concerns serious disease patterns without any existing test or therapy methods, or if the target group is small, fees should be subject to a reduction.
Amendment 43 #
Proposal for a regulation
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
1a. A reduced fee, as laid down in Part I of the Annex, shall apply in respect of homeopathic medicinal products as defined in Article 1(5) of Directive 2001/83/EC and herbal medicinal products as defined in Article 1(30) of Directive 2001/83/EC.
Amendment 47 #
Proposal for a regulation
Article 4 – paragraph 5 a (new)
Article 4 – paragraph 5 a (new)
5a. If the marketing authorisation holder cannot expect an economic benefit in relation to the fee and if: (a) there is public interest in the marketing of the product due to the therapeutic indication or (b) the target group of the product is small, the amount payable shall be reduced upon application by the marketing authorisation holder as laid down in Part I paragraph 2 subparagraph 2 of the Annex.
Amendment 50 #
Proposal for a regulation
Article 5 – paragraph 4 a (new)
Article 5 – paragraph 4 a (new)
Amendment 53 #
Proposal for a regulation
Article 6 – paragraph 5 a (new)
Article 6 – paragraph 5 a (new)
5 a. If the marketing authorisation holder cannot expect an economic benefit in relation to the fee and if: (a) there is public interest in the marketing of the product due to the therapeutic indication or (b) the target group of the product is small, the amount payable shall be reduced upon application by the marketing authorisation holder as laid down in Part III paragraph 2 subparagraph 2 of the Annex.
Amendment 56 #
Proposal for a regulation
Article 7 – paragraph 4 a (new)
Article 7 – paragraph 4 a (new)
4a. If the marketing authorisation holder cannot expect an economic benefit in relation to the fee and if: (a) there is public interest in the marketing of the product due to the therapeutic indication or (b) the target group of the product is small, the amount payable shall be reduced upon application by the marketing authorisation holder as laid down in Part IV paragraph 2 subparagraph 2 of the Annex.
Amendment 57 #
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. A reduced annual flat fee, as laid down in Part IV of the Annex, shall apply in respect of medicinal products referred to in Article 10(1) and Article 10a of Directive 2001/83/EC and in respect of authorised homeopathicerbal medicinal products, ands defined in Article 1(30) of Directive 2001/83/EC. For authorised herbalomeopathic medicinal products, as defined respectively in Article 1(5) and Article 1(30) of Directive 2001/83/EC, no flat fee shall apply.
Amendment 90 #
Proposal for a regulation
Annex – part I – paragraph 1 a (new)
Annex – part I – paragraph 1 a (new)
1a. Holders of marketing authorizations or registrations of homeopathic or herbal medicinal products referred to in Article 4(1a) shall pay 10 % of the amount laid down in paragraph 1.
Amendment 91 #
Proposal for a regulation
Annex – part I – paragraph 2
Annex – part I – paragraph 2
2. In application of the first subparagraph of Article 4(5), small and medium-sized enterprises shall pay 60 % of the applicable amount. In application of the second subparagraph of Article 4(5), marketing authorisation holders shall pay up to 60 % of the applicable amount.
Amendment 96 #
Proposal for a regulation
Annex – part II – paragraph 2
Annex – part II – paragraph 2
2. In application of the first subparagraph of Article 5(4), small and medium-sized enterprises shall pay 60 % of the applicable amount. In application of the second subparagraph of Article 5(4), marketing authorisation holders shall pay up to 60 % of the applicable amount.
Amendment 103 #
Proposal for a regulation
Annex – part III – paragraph 2
Annex – part III – paragraph 2
2. In application of the first subparagraph of Article 6(5), small and medium-sized enterprises shall pay 60 % of the applicable amount. In application of the second subparagraph of Article 6(5), marketing authorisation holders shall pay up to 60 % of the applicable amount.
Amendment 108 #
Proposal for a regulation
Annex – part IV – paragraph 2
Annex – part IV – paragraph 2
2. In application of the first subparagraph of Article 7(4), small and medium-sized enterprises shall pay 60 % of the applicable amount. In application of the second subparagraph of Article 7(4), marketing authorisation holders shall pay up to 60 % of the applicable amount.