CRED Managing Variations Effectively

 Outlined in Article 19 of Regulation 1234/2008  Extension Applications follow the same procedure and timelines as for granting new MAA  Guideline on the Categorisation Of Extension Applications (EA) versus Variations Applications (V) OCTOBER 2003 ● Provides clarification on the classification of extension applications (e.g. defining pharmaceutical form and strength) ● See EDQM Guidance: Standard terms Extensions – Points to Consider