EMA
- Regulatory and procedural guideline: European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 (updated)
CMDh
- UPDATE - CMDh Best Practice Guide on the processing of renewals in the MRP/DCP [Track version]
- UPDATE - Cover letter template for renewals
- UPDATE - Position paper common grounds seen for invalidation/delaying day 0 for variations [Track version]