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EMEA: eCTD Plasma Master File guidance

18.08.2009
It is the intention that the eCTD format supports all marketing applications sent to EMEA, and related procedures. By analogy this is applicable also to submission of the Plasma Master File, meaning that it is in January 2010 that this guidance comes into force (although the eCTD format can, of course, be used for PMF submissions before this point and is indeed recommended).