Variation Procedure

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  • Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure
    (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]
  • Languages to be used for Marketing Authorisation Application (MAA), Variations and Renewals - Please see Application for MA

Questions & Answers on variations