Regulatory information - EMA clarifies interpretation of new variation classification categories

News 10/02/2014

The European Medicines Agency has clarified, in agreement with the European Commission, a number of points related to the new categories of variations to the terms of marketing authorisations that were introduced in August 2013. The related PDF icon question and answer document has been updated to reflect these adjustments.

The Commission guidelines on variations to marketing authorisations of medicinal products were amended in 2013. The revision of the variations guidelines was principally triggered by the implementation of the pharmacovigilance legislation.

In the light of experience accumulated with the application of the new guidelines, it is appropriate to make the following clarifications:

These adjustments will be applied retrospectively by the Agency from 1 January 2014. They concern centrally authorised products only.

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