PL EN

EMA: New EMA Draft Guideline on Stability Data regarding Applications for Variations to a Marketing Authorisation.

09.08.2011
This guideline addresses the requirements in terms of stability testing data which drug manufacturers have to provide when applying variations to a marketing authorisation. Due to the extensive changes in the new Variations Regulation EC 1234/2008 from 1st January 2010, the revision of the guideline was necessary.

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