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Dear colleagues,

In connection to the transition to eCTD format from 01.01.2010 we inform you that from the beginning of 2010 the documentation for renewal or variation to MA (marketing authorization) of medicinal products can be submitted in åCTD format or in the previous format (on paper or NeeS). When using eCTD it is preferable (if possible) to submit the whole file, in order to continue to maintain the electronic file during the whole life cycle of the medicinal product.