1 Amendments of Sylvana RAPTI related to 2008/0260(COD)
Amendment 74 #
Proposal for a directive – amending act
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2a. Until the Agency can ensure the functionalities of the Eudravigilance database, all the periodic safety update reports should also be submitted to the National Competent Authorities where the product is authorised.