CRED Managing Variations Effectively

Important references • Notice to Applicants, Volume 2A, Chapter 5 Variations / Chapter 7

• CMD(h) Best Practice Guides (BPG) for the Submission and Processing of Variations in the Mutual Recognition Procedure (also applies to national only procedures; April 2013 and subsequent chapter updates) • European Medicines Agency post-authorisation procedural advice for users of the centralised procedure • Guideline on the Categorisation of Extension Applications vs. variation applications F2/AW D(2002) - October 2003 • EMEA Procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 EMEA/588416/2008