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EMA is advising marketing authorization holders to submit any transfer of marketing authorization applications or type IA variations for 2015 by the end of November to enable the agency to acknowledge the validity of the submissions before its closure between December 24, 2015 and January 3, 2016. Marketing authorization holders are also advised to submit any type IB variations or groupings of type IBs and type IAs by December 1, 2015. For submissions received after that date, the assessment may not begin until January 2016.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
