HMA: Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure

The Co-Ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has produced a compilation of the following Best Practice Guides regarding the submission and processing of variation applications within the Mutual Recognition Procedure: Commission Regulation (EC) No. 1234/2008 is effective 1 January 2010 and replaces 1084/2003/EC. It concerns variations in the Mutual Recognition procedure and Centralised procedure. Since the implementation of Article 28(3) of Directive 2001/83/EC (as amended) applicants have been able to apply for a Marketing Authorisation through the Decentralised procedure. Irrespective of whether the MA was approved via the Mutual Recognition or Decentralised procedure, Regulation 1234/2008/EC and Mutual Recognition Variation procedures will apply to subsequent changes to the MA. Separate guidance is available for Centralised variations.

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