Guidance on applying in parallel with an EU marketing authorisation application

As you are aware 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.
 
In this context, please note that the final guidance on applying for the two procedures in parallel, together with the outcome of a public consultation, is available in link below:
 
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/medicines-use-outside-european-union#applying-in-parallel-with-an-eu-marketing-authorisation-application-section