Activities of Thomas ULMER related to 2008/0045(COD)
Plenary speeches (1)
Variations to the terms of marketing authorisations for medicinal products - Counterfeiting of medicinal products (debate)
Amendments (2)
Amendment 5 #
Proposal for a directive – amending act
Recital 6 a (new)
Recital 6 a (new)
(6a) For reasons of proportionality and in the case of marketing authorisations not resulting from a centralised marketing authorisation procedure, a mutual recognition procedure or a decentralised procedure (so-called purely national marketing authorisations), the harmonised rules for post-authorisation amendments to the terms of marketing authorisations of medicinal products should only apply to those medicinal products that are authorised after the date this Directive has to be transposed into the national law of the Member States. This is necessary to preserve pharmaceutical companies with a high number of purely national marketing authorisations, a lot of them SMEs, from additional expense and a further regulatory burden resulting from the change from the established national regulatory framework in the Member State concerned to the European framework. However, this Directive should not prevent a Member State from extending the harmonised rules for post- authorisation amendments to the terms of marketing authorisations of medicinal products to medicinal products having a purely national marketing authorisation and having been authorised before the date this Directive has to be transposed into the national law of the Member States on a voluntary basis.
Amendment 18 #
Proposal for a directive – amending act
Article 2 – point 1
Article 2 – point 1
Directive 2001/83/EC
Article 23 b – paragraph 2 a (new)
Article 23 b – paragraph 2 a (new)