EU Commission finally issues Guidance on new Variations Rules

The European Commission has published the "Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products" (2009/C 323/04) in the Official Journal of the European Union C323 on 31 December 2009.

Article 4(1)(b) of the variations regulation charges the Commission with the task of drawing up guidelines on the operation of the procedures laid down in Chapters II, III and IV of that regulation as well as on the documentation to be submitted pursuant to these procedures.
Consequently, this guideline provides details on the operation of those procedures and covers the steps to follow from the submission of an application concerning the examination of variations to the terms of a marketing authorisation to the final outcome of the procedure on the application and the timeframe and procedure for competent authorities to amend, where necessary due to an approved variation, the terms of the marketing authorisation. The guideline is thus facilitating the interpretation and application of the variations regulation.

For each of the following categories, guidance is provided on the submission of the variations, grouping of variations and handling of the variations.

  • Minor variations of Type IA
  • Minor variations of Type IB
  • Major variations of Type II
  • Extensions
  • Urgent safety restriction

Given the fact companies are expected to use the new procedures from the beginning of 2010, the guidance was published rather late and it might now be a challenge to align internal processes in time.

The European Medicines Agency (EMA) and the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMD(h)) have published explanatory notes on Variation Application Form for human medicinal products. This document is intended to provide more clarification on how the new Variation Application Form should be completed. It will be regularly updated as more experience is gained once Commission Regulation (EC) No 1234/2008 has come into force.

Please note that the ECA will conduct a Conference on "The new EU Variations Regulation and supporting Guidelines" on 8 - 9 June 2010 in Heidelberg, Germany. Take advantage of this opportunity to discuss the current issues and to exchange experiences on the various aspects of the new regulation.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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