Medicines assessed under the ‘EU-M4all’ procedure
The European Medicines Agency (EMA), in cooperation with the World Health Organization (WHO), can provide scientific opinions on high priority human medicines, including vaccines, that are intended for markets outside of the European Union (EU).
The procedure is called EU-Medicines for all or 'EU-M4all'. It was previously known as the Article 58 procedure, as the legal basis is Article 58 of Regulation (EC) No 726/2004. It has been in place since 2004.
It is also possible to apply in parallel for an opinion under EU-M4all for a medicine to be used outside the EU and an EU marketing authorisation under the centralised procedure.
Regulatory information on medicines assessed under the EU-M4all procedure is contained in the human regulatory section. Please refer to:
- Medicines for use outside the European Union
- Obtaining and maintaining a scientific opinion on a medicine for use outside the European Union
For the opinions on medicines assessed under the EU-M4all procedure, see:
A review of the public health impact of the procedure is available in the following article published in the Expert Review of Clinical Pharmacology in 2020:
- Expert Review of Clinical Pharmacology: The European Medicines Agency facilitates access to medicines in Low and Middle Income Countries
EMA's Head of International Affairs, Martin Harvey, describes the EU-M4all's procedure in the video below: