Activities of Norbert ERDŐS related to 2014/0257(COD)
Plenary speeches (1)
Veterinary medicinal products (A8-0046/2016 - Françoise Grossetête) HU
Amendments (8)
Amendment 75 #
Proposal for a regulation
Recital 58
Recital 58
(58) When examining the compatibility with Union law of the conditions for the supply of medicinal products, the Court of Justice of the European Union has recognised, in the context on medicinal products for human use, the very particular nature of medicinal products whose therapeutic effects distinguish them substantially from other goods. The Court of Justice has also held that health and life of humans rank foremost among the assets and interests protected by the Treaty and that it is for Member States to determine the level of protection which they wish to afford to public health and the way in which that level has to be achieved. Since that level may vary from one Member State to another, Member States must be allowed some discretion as regards the conditions for the supply on their territory of medicinal products to the public. Therefore Member States should be able to subject the supply of medicinal products offered for sale at a distance by means of information society services to conditionto stricter conditions than required by this regulation to the extent that this is justified by the protection of public health. Such conditions should not unduly restrict the functioning of the internal market.
Amendment 242 #
Proposal for a regulation
Article 38 – paragraph 2 – point e
Article 38 – paragraph 2 – point e
Amendment 248 #
Proposal for a regulation
Article 46 – paragraph 1
Article 46 – paragraph 1
(1) Applications for decentralised marketing authorisation shall be submitted to the Member State chosen by the applicant (‘reference Member State’). It shall also forward the applications to all Member States for information.
Amendment 250 #
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
(1) Applications for mutual recognition of marketing authorisations shall be submitted to the Member State that granted the first national marketing authorisation ( " "reference Member State " )"). It shall also forward the applications to all Member States for information.
Amendment 262 #
Proposal for a regulation
Article 51 – paragraph 4
Article 51 – paragraph 4
Amendment 263 #
Proposal for a regulation
Article 51 – paragraph 6
Article 51 – paragraph 6
Amendment 279 #
Proposal for a regulation
Article 56
Article 56
Amendment 365 #
Proposal for a regulation
Article 108 – paragraph 1
Article 108 – paragraph 1
(1) PThe Member States may authorise persons permitted to supply veterinary medicinal products requiring accordance with Article 107(1) may veterinary prescription to offer veterinary medicinal products by means of information society services in the meaning of Directive 98/34/EC of the European Parliament and of the Council28 to natural or legal persons established in the Union under the condition that those medicinal products comply with the legislation of the destination Member State. __________________ 28Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37).to natural or legal persons established in the Union