1 Amendments of Isabelle THOMAS related to 2012/0267(COD)
Amendment 282 #
Proposal for a regulation
Article 49 – paragraph 2 – subparagraph 1 a (new)
Article 49 – paragraph 2 – subparagraph 1 a (new)
In case of more than one Member State concerned, where there is a disagreement on whether the clinical performance study should be approved, the member states concerned shall make an attempt to agree on a conclusion. If no conclusion is found, the European Commission takes a decision after hearing the member states concerned, and if appropriate taking advice from EMA.