CRED ERP 25

It is advisable to review available European Product Assessment Reports (EPARs) to determine whether a precedent has been set with another medicinal product in relation to an issue.

If ‘conditional approval’ or approval under ‘exceptional circumstances’ is requested, this should be justified in a pre-authorisation or pre-submission meeting request form and discussed at the meeting.

Further reading: Guidance on pre-submission meetings and Q&A available at: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance