medicines-medical devices-regulatory affairs
The following commission implementing decisions on the harmonised standards for medical devices drafted in support of the Medical Devices Regulation (EU) 2017/745 (MDR) of the European Parliament and of the Council have been published thus far: Commission Implementing Decision (EU)…
The EU Commission has published a public consultation on the revision of the EU’s pharmaceutical legislation. This is part of its work to create a future-proof and crisis-resilient regulatory framework for the pharmaceutical sector and the latest step towards an…
The European Commission (EC) has issued a notice on the handling of duplicate marketing authorisation applications (MAAs) of pharmaceutical products under Article 82(1) of Regulation (EC) No 726 Basically, this means duplicate MAAs for products authorised via the centralised procedure.…