In order to view some of the documents on this website you need Acrobat Reader 
(click here to download)

 

• Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure
  • Chapter 1: CMDh BPG for the allocation of the mutual recognition variation number for Type I Notifications, Type II Variations, Grouping and Worksharing (January 2020) [Track version]
  • Chapter 2: Procedure for automatic validation of Mutual Recognition Procedures for Variations (December 2022) [Track version]
  • Chapter 3: CMDh BPG for the processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure (December 2022) [Track version]
  • Chapter 4 : CMDh BPG for the processing of Type IB Minor Variations (Notifications) in the Mutual Recognition Procedure (July 2023) [Track version]
  • Chapter 5: CMDh BPG for the handling of Type II Variations in the Mutual Recognition Procedure (July 2023) [Track version]
  • Chapter 6: CMDh BPG for the processing of Grouped Applications in the Mutual Recognition Procedure (December 2023) [Track version]
  • Chapter 7: CMDh BPG on Worksharing (December 2023) [Track version]
  • Chapter 8: CMDh BPG on CMDh Recommendations on Unforeseen Variations (February 2022) [Track version]
  • Chapter 9: CMDh BPG on fast track procedure for annual update of Human Influenza Vaccines (July 2023) [Track version]

• EMA/CMDh explanatory notes on Variation Application Form - Human medicinal products only (July 2022) [Track version]

• Examples for acceptable and not acceptable groupings for MRP/DCP products (May 2022) [Track version]

• Position paper on common grounds seen for invalidation/delaying day 0 for Variations (February 2023) [Track version]

• Data requested for Variations and/or Renewal Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines / Recommendation papers (December 2023 - correction of the document published on November 2023) [Track version]

• Mock-ups, Specimens and Samples for variations (May 2024) [Track version]

• Languages to be used for Marketing Authorisation Application (MAA), Variations and Renewals - Please see Application for MA

• Requirements on submissions for Variations and Renewals within MRP and National Procedures

Questions & Answers on variations

• Questions and answers

• Templates Type II variation ´Preliminary Variation Assessment Report´ and ´Type II variation Final Variation Assessment Report´

• Cover letter for Variation Applications in the Mutual Recognition Procedure