EMA’s consultation on draft Q&As on remote certification of batches by QP
by Giuliana Miglierini The last two years saw the implementation of a high degree of regulatory flexibility as…
The new Annex 21 to GMPs
by Giuliana Miglierini The new Annex 21 to GMPs (C(2022) 843 final) that EIPG gave a significant contribution…
EMA’s OMS has turned mandatory for centrally authorised products
by Giuliana Miglierini Since November 1st, 2021, the use of the Organisation Management Service (OMS) became mandatory for…