EU-FMD Delegated Act: The wait is nearly over

29 April 2015

The European Commission has published the notes from the 74th meeting of the Pharmaceutical Committee, held on 17th March 2015, that confirm that DG Sanco stands by the timeline that has been set out before. It is expected that the delegated act will be adopted – together with the relative impact assessment – by Q2 2015 and published in Q4 2015.
These dates are key as the adoption will finalise the details of what compliance with the EU-FMD requirement means and will therefore remove all lingering doubts as to what all participants in the European medicines supply chain – in particular pharmaceutical manufacturers – need to implement (3C Integrity, 2 April 2015).
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