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EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.
The European Medicines Agency (EMA), in agreement with the European Commission, has released an updated question and answer document clarifying a number of issues related to the new categories of variations to the terms of marketing authorizations that were introduced by the agency in August 2013. The Commission guidelines on variations to marketing authorizations of medicinal products were amended in 2013. The revision of the variations guidelines was initiated by the pharmacovigilance legislation.
The following clarifications were made to the Q&A document:
EMA will apply the changes, which concern centrally authorized products only, retrospectively from Jan. 1, 2014.
Source: European Medicines Agency