EMA Updated Guidance on Obtaining and Maintaining a Scientific Opinion on a Medicine for Use Outside the EU

On 14 January 2021 the EMA updated the guidance on promoting parallel application for EU-M4all opinion and centralized marketing authorization procedure.

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:

  • Active substances must be identical and indications comparable
  • Medicines may have different formulations, forms or routes of administration
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