Código de la Unión sobre medicamentos para uso humano y derogación de la Directiva 2001/83/CE y la Directiva 2009/35/CE

Texto tal como lo publica el PE, en inglés.

1. Enmienda 339Rechazada

   Recital 11

   Presentada por Aurélia Beigneux, Anders Vistisen · ID

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

2. Enmienda 343Rechazada

   Article 63 – paragraph 3

   Presentada por Annalisa Tardino, Anders Vistisen, Aurélia Beigneux · ID

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

3. Enmienda 345Rechazada

   Article 81 – paragraph 1

   Presentada por Aurélia Beigneux, Annalisa Tardino, Anders Vistisen · ID

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

4. Enmienda 346Rechazada

   Article 82 – paragraph 1 – subparagraph 1

   Presentada por Aurélia Beigneux, Anders Vistisen · ID

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