Variation Procedure

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• Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure (April 2013) [Track version]
  (Please note: for purely national Marketing Authorisations these Best Practise Guides will apply from 4 August 2013)
  
• Chapter 1: CMDh BPG for the allocation of the mutual recognition variation number for Type I Notifications, Type II Variations, Grouping and Worksharing (February 2013)
• Chapter 2: Procedure for automatic validation of Mutual Recognition Procedures for Variations (July 2014) [Track version]
• Chapter 3: CMDh BPG for the processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure (September 2014) [Track version]
• Chapter 4: CMDh BPG for the processing of Type IB Minor Variations (Notifications) in the Mutual Recognition Procedure (July 2016) [Track version]
• Chapter 5: CMDh BPG for the handling of Type II Variations in the Mutual Recognition Procedure (July 2016) [Track version]
• Chapter 6: CMDh BPG for the processing of Grouped Applications in the Mutual Recognition Procedure (February 2016) [Track version]
• Chapter 7: CMDh BPG on Worksharing (April 2016) [Track version]
• Chapter 8: CMDh BPG on CMDh Recommendations on Unforeseen Variations (December 2016) [Track version]
• Chapter 9: CMDh BPG on fast track procedure for annual update of Human Influenza Vaccines (March 2017) [Track version]

• EMA/CMDh explanatory notes on Variation Application Form - Human medicinal products only (December 2014) [Track version]

• Examples for acceptable and not acceptable groupings for MRP/DCP products (June 2017) [Track version]

• Position paper on common grounds seen for invalidation/delaying day 0 for Variations (December 2010) [Track version]

• Data requested for Variations and/or Renewal Applications in the MRP/DCP (June 2017)

• Mock-ups, Specimens and Samples for variations and renewals (September 2013) [Track version]

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

• Requirements on submissions (number and format) variations and renewals within MRP or National procedures 

Questions & Answers on variations

• Questions and answers

Templates on variations

• 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