The EMA provides guidance on obtaining and maintaining a scientific opinion under the 'EU-M4all' procedure (previously known as Article 58) on high priority human medicines intended for markets outside of the EU.
The pre-submission requirements and evaluation procedure for the EU-M4all procedure are similar to the centralized marketing authorization procedure. Applicants may apply in parallel for an EU marketing authorization under the centralized procedure and an opinion under EU-M4all for their medicine to be used outside the EU.
EU-M4all (EU-Medicines for all) medicines can be evaluated in parallel with a centralized procedure, which will result in independent outcomes of EU-M4all opinion and centralized marketing authorization, and get facilitated worldwide access after approval.
The eligibility criteria are:
