Press Release: Regulatory information – EMA clarifies interpretation of new variation classification categories

Author (Corporate)
Series Title
Series Details 10.02.14
Publication Date 10/02/2014
Content Type

The European Medicines Agency clarified in February 2014, 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 question and answer document has been updated to reflect these adjustments.
Source Link Link to Main Source http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/02/news_detail_002020.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: Question and answer document, 06.02.14: Practical questions and answers to support the implementation of the variations guidelines in the centralised procedure http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2013/07/WC500146564.pdf
ESO: Background information: Press Release: Regulatory information – EMA introduces product numbers to track medicines through pre-authorisation procedures http://www.europeansources.info/record/press-release-regulatory-information-ema-introduces-product-numbers-to-track-medicines-through-pre-authorisation-procedures/
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