Activities of Elisabetta GARDINI related to 2014/0256(COD)
Plenary speeches (2)
Authorisation and supervision of veterinary medicinal products (A8-0035/2016 - Claudiu Ciprian Tănăsescu) IT
Veterinary medicinal products - Authorisation and supervision of veterinary medicinal products (debate) IT
Amendments (8)
Amendment 21 #
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) In the interest of public health, authorisation decisions under the centralised procedure should be taken on the basis of the objective scientific criteria of quality, safety and efficacy, and taking into consideration cost-effectiveness of the medicinal product concerned.
Amendment 22 #
Proposal for a regulation
Recital 7 b (new)
Recital 7 b (new)
(7b) Provision should be made for the quality, safety and efficacy criteria in Directives 2001/83/EC and 2001/82/EC to apply to medicinal products authorised by the Community and it should be possible to assess both the risk-benefit balance and the cost-effectiveness of all medicinal products when they are placed on the market, at the time of the renewal of the authorisation and at any other time the competent authority deems appropriate.
Amendment 23 #
Proposal for a regulation
Recital 7 c (new)
Recital 7 c (new)
Amendment 24 #
Proposal for a regulation
Article 1 – point 2 a (new)
Article 1 – point 2 a (new)
Regulation (EC) No 726/2004
Article 1 – paragraph 2
Article 1 – paragraph 2
(2a) In Article 1, the second paragraph is replaced by the following: "The provisions of this Regulation shall not affect the powers of Member States' authorities as regards setting the prices of medicinal products or their inclusion in the scope of the national health system or social security schemes on the basis of health, economic and social conditions, provided that Member States take in due consideration the reference comparative efficacy and reference cost-effective evaluation of medicinal product as per the provisions stated in Article 9(4). In particular, Member States shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indications and pack sizes which will be covered by their social security bodies."
Amendment 26 #
Proposal for a regulation
Article 1 – point 5 a (new)
Article 1 – point 5 a (new)
Regulation (EC) No 726/2004
Article 9 – paragraph 1 – point d a (new)
Article 9 – paragraph 1 – point d a (new)
Amendment 29 #
Proposal for a regulation
Article 1 – point 10 a (new)
Article 1 – point 10 a (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 1 – subparagraph 1
Article 57 – paragraph 1 – subparagraph 1
(10a) In Article 57(1), subparagraph 1 is replaced by the following: "1. The Agency shall provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy, efficacy and cost effectiveness of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Community legislation relating to medicinal products."
Amendment 30 #
Proposal for a regulation
Article 1 – point 10 b (new)
Article 1 – point 10 b (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 1 – subparagraph 2 – point i a (new)
Article 57 – paragraph 1 – subparagraph 2 – point i a (new)
Amendment 53 #
Proposal for a regulation
Article 1 – point 20
Article 1 – point 20
Regulation (EC) No 726/2004
Article 87b – paragraph 2
Article 87b – paragraph 2
2. The delegation of power referred to in Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) shall be conferred on the Commission for an indeterminate period of timeten years from the date of entry into force of this Regulation.