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Variation Procedure

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Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure (Revision 15, November 2011) [Track version]

EMA/CMDh explanatory notes on Variation Application Form - Human medicinal products only (September 2011) [Track version]

Examples for acceptable and not acceptable groupings for MRP/DCP products (June 2011) [Track version]

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

Cover letter for Variation Applications in the Mutual Recognition Procedure (December 2009)

Questions & Answers - List for the Submission of Variations according to Commission Regulation (EC) 1234/2008 (July 2011) [Track version]

Questions and Answers on variations to an existing pharmacovigilance system as described in the DDPS (March 2011)

Implementation of Variation Regulation No 1234/2008 in each Member State for Medicinal Products authorised by purely national procedures (February 2011)

Data requested for Variations and/or Renewal Applications in the MRP/DCP (December 2010)

For the templates Type II variation ´Preliminary Variation Assessment Report´ and ´Type II variation Final Variation Assessment Report´, please refer to Assessment Report

Requirements on electronic submissions and paper documentation for Renewals & Variations within MRP, DCP or National procedures