medicines-medical devices-regulatory affairs
The European Parliament has adopted a report calling for increased use of off-patent medicines in Europe to improve patient access, highlighting lessons learned during the Covid-19 pandemic and urging the European institutions to address them directly in future healthcare policy…
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 Medicines Agency (EMA) is consulting the public on draft common EU standards for electronic Product Information (ePI). You can read more about ePI here. About the draft common standard for ePI The draft EU common standard for ePI…
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.…