Europe – EMA : pre-authorisation procedural advice for users of the centralised procedure

This integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the pre-submission guidance for access to the hyperlinked information.
Questions and answers are being updated continuously and will be marked by “NEW” or “Rev.” with the relevant date upon publication.
This guidance document addresses a number of questions which users of the centralised procedure may have. It provides an overview of the European Medicines Agency’s position on issues, which aretypically addressed during the course of pre-submission meetings…