1 Amendments of Heide RÜHLE related to 2008/0142(COD)
Amendment 309 #
Proposal for a directive – amending act
Article 9 – paragraph 3
Article 9 – paragraph 3
3. Member States shall specify in advance and in a transparent way the criteria for refusal of the prior authorisation referred to in Article 8(3). These criteria shall be made available to patients at a local or regional level so that patients are fully informed in advance of an application.