Activities of Dagmar ROTH-BEHRENDT related to 2008/0045(COD)
Plenary speeches (2)
Variations to the terms of marketing authorisations for medicinal products - Counterfeiting of medicinal products (debate)
Variations to the terms of marketing authorisations for medicinal products - Counterfeiting of medicinal products (debate)
Amendments (3)
Amendment 4 #
Proposal for a directive – amending act
Recital 6
Recital 6
(6) For reasons of public health, legal consistency and predictability for economic operators, variations to all types of marketing authorisations, with the exception of purely national ones based on Article 10a of Directive 2001/83/EC, should be subject to harmonised rules.
Amendment 17 #
Proposal for a directive – amending act
Article 2 – point 1
Article 2 – point 1
Directive 2001/83/EC
Article 23 b – paragraph 1
Article 23 b – paragraph 1
The Commission shall adopt appropriate arrangements for the examination of variations to the terms of marketing authorisations granted in accordance with this Directive. Variations of purely national marketing authorisations based on Article 10a of this Directive may continue to follow existing national procedures provided that the products concerned are not part of the decentralised or mutual recognition authorisation procedure.
Amendment 26 #
Proposal for a directive – amending act
Article 3 – paragraph 1 – subparagraph 1
Article 3 – paragraph 1 – subparagraph 1
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [124 months after entry into force] at the latest. They shall forthwith communicate to the Commission the text of those provisions and a table showing the correlation table between those provisions and this Directive.