EMA has published today a draft public guidance on parallel application for EU-M4all (Article 58) opinion and the centralised marketing authorisation procedure for a public consultation
New: Applicants may apply in parallel for an EU marketing authorisation under the centralised procedure and an opinion under EU-M4all for their medicine to be used outside the EU.
The same CHMP and PRAC rapporteurs evaluate the applications in parallel, although the timetables may differ.
For a medicine to be eligible for a parallel evaluation, the active substance(s) must be identical in both applications, with comparable indications.
However, the formulation, pharmaceutical form and route of administration may be different in the two applications.
Draft guidance on applying for the two procedures in parallel is available for public consultation:
Guidance – Parallel application for EU-M4all (Article 58) opinion and centralised marketing authorisation procedure (PDF/127.19 KB) (new)
Submission of comments on ‘Public Guidance on Parallel application for EU-M4all (Article 58) opinion and Centralised Marketing Authorisation procedure’ (DOC/232.5 KB) (new)