Revised classification guideline for variation applications - Swedish Medical Products Agency

Revised classification guideline for variation applications

Thursday, July 18, 2013

The European Commission’s guideline for classification of variation applications has been revised and the new classifications apply from 4 August 2013. The purpose of the revision is to reflect changes in the legislation and experience acquired in the application of variation classifications since 2010. Some new classifications have been added and others have been adjusted in content.

Variation applications submitted to the MPA after 4 August 2013 shall use the new variation application form (dated 2013) and variations before this date should be submitted in the old application form (dated 2009) since the content in some of the classifications have changed.

 

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