Code de l’Union relatif aux médicaments à usage humain, et abrogation de la directive 2001/83/CE et de la directive 2009/35/CE

Texte tel que publié par le PE, en anglais.

1. Amendement 339Rejeté

   Recital 11

   Déposé par Aurélia Beigneux, Anders Vistisen · ID

   … enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular Supprimé: SMEs. Ajouté: SMEs or other marketing authorisation holders producing on the EU territory regardless of their size. In this respect a balanced system of incentives is proposed that rewards … medical need and innovation that reaches patients and improves access across the Supprimé: Union. Ajouté: Union and its Outermost regions. To make the regulatory system more efficient and innovation-friendly the Directive also …

2. Amendement 343Rejeté

   Article 63 – paragraph 3

   Déposé par Annalisa Tardino, Anders Vistisen, Aurélia Beigneux · ID

   3. Supprimé: Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, Ajouté: By default, a package leaflet in paper format shall be included in the packaging of a medicinal product. Supprimé: If Ajouté: Member States may decide that the package leaflet Supprimé: is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge Ajouté: shall be made available electronically as well, and it should be ensured that the information in digital format is …

3. Amendement 345Rejeté

   Article 81 – paragraph 1

   Déposé par Aurélia Beigneux, Annalisa Tardino, Anders Vistisen · ID

   1. The regulatory data protection period shall be Supprimé: six Ajouté: eight years from the date when the marketing authorisation for that medicinal product …

4. Amendement 346Rejeté

   Article 82 – paragraph 1 – subparagraph 1

   Déposé par Aurélia Beigneux, Anders Vistisen · ID

   … point (a), shall only be granted to medicinal products if they are Supprimé: released and continuously Ajouté: continuously produced and supplied into the supply chain Ajouté: by marketing authorisation holders regardless of their size in a sufficient quantity and in the presentations necessary to cover the …