Schaffung eines Unionskodexes für Humanarzneimittel und Aufhebung der Richtlinie 2001/83/EG und der Richtlinie 2009/35/EG

Wortlaut wie vom EP veröffentlicht, auf Englisch.

1. Änderungsantrag 339Abgelehnt

   Recital 11

   Eingereicht von Aurélia Beigneux, Anders Vistisen · ID

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

2. Änderungsantrag 343Abgelehnt

   Article 63 – paragraph 3

   Eingereicht von Annalisa Tardino, Anders Vistisen, Aurélia Beigneux · ID

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

3. Änderungsantrag 345Abgelehnt

   Article 81 – paragraph 1

   Eingereicht von Aurélia Beigneux, Annalisa Tardino, Anders Vistisen · ID

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

4. Änderungsantrag 346Abgelehnt

   Article 82 – paragraph 1 – subparagraph 1

   Eingereicht von Aurélia Beigneux, Anders Vistisen · ID

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