Codice dell'Unione relativo ai medicinali per uso umano e abrogazione delle direttive 2001/83/CE e 2009/35/CE

Testo come pubblicato dal PE, in inglese.

1. Emendamento 339Respinta

   Recital 11

   Presentato da Aurélia Beigneux, Anders Vistisen · ID

   … enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular Rimosso: SMEs. Aggiunto: 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 Rimosso: Union. Aggiunto: Union and its Outermost regions. To make the regulatory system more efficient and innovation-friendly the Directive also …

2. Emendamento 343Respinta

   Article 63 – paragraph 3

   Presentato da Annalisa Tardino, Anders Vistisen, Aurélia Beigneux · ID

   3. Rimosso: 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, Aggiunto: By default, a package leaflet in paper format shall be included in the packaging of a medicinal product. Rimosso: If Aggiunto: Member States may decide that the package leaflet Rimosso: 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 Aggiunto: shall be made available electronically as well, and it should be ensured that the information in digital format is …

3. Emendamento 345Respinta

   Article 81 – paragraph 1

   Presentato da Aurélia Beigneux, Annalisa Tardino, Anders Vistisen · ID

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

4. Emendamento 346Respinta

   Article 82 – paragraph 1 – subparagraph 1

   Presentato da Aurélia Beigneux, Anders Vistisen · ID

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