From 1st of January 2018 the eCTD format will become mandatory for variations of human medicines via the Mutual Recognition Procedure (MRP).
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Reporting the commercialisation of medicinal products to the FAMHP
Notice to pharmaceutical companies concerning the reporting of the commercialisation of medicinal products to the FAMHP.
Pilot project for new Clinical Trial Regulation
In October 2018 the new clinical trial regulation 536/2014 (CTR) is foreseen to enter into force. This important change in legislation targets administrative simplification and harmonization in Europe.