Europe – European Medicines Agency 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 are typically addressed during the course of pre-submission meetings.

It will be updated regularly to reflect new developments, to include guidance on further preauthorisation procedures and to reflect the implementation of the new European legislation. Revised topics will be marked by “New” or “Rev” upon publication.

The EMA emphasises the importance of pre-submission meetings between applicants and the EMA/(Co-) Rapporteur. Pre-submission meetings (which should take place approximately 7 months prior to the anticipated date of submission of the application) are a vital opportunity for applicants to obtain procedural, regulatory and legal advice from the EMA. The product team is available to address any questions MAHs may have regarding their pre-authorisation application.

This guidance information and fruitful pre-submission meetings should enable applicants to submit applications, which are in conformity with the legal and regulatory requirements and which can be validated speedily. Pre-submission meetings will also enable applicants to establish contact with the EMA staff closely involved with the application as it proceeds…