Human post-authorisation Q&A: Introduction

These questions and answers provide an overview of the European Medicine Agency’s position on issues which are typically addressed in discussions or meetings with Marketing Authorisation Holders in the Post-Authorisation phase.  It is updated regularly to reflect new developments, to include guidance on further post-authorisation procedures and to reflect the implementation of the new European legislation. 

• Post-authorisation advice for generic/hybird applications is available separately

New or revised questions are marked with "New" or "Rev" together with the relevant date.

The Post-Authorisation questions address the following topics, click on a link to go to the page:

In case your question is not answered here please contact the Agency in advance of your planned submission. Agency staff is available to address any questions Marketing Authorisation Holders may have regarding a particular upcoming post-authorisation application. Where appropriate, a pre-submission meeting could be organised at the Agency in order to obtain further procedural and regulatory/legal advice.

In addition, Marketing Authorisation Holders are strongly recommended to inform the Agency and (Co-) Rapporteur of all upcoming Post-Authorisation submissions for the following 6-12 months, in order to allow optimal planning, identification of procedural issues and handling of overlapping applications.

Notes

• It should be highlighted that these questions and answers have been produced for guidance only and should be read in conjunction with The Rules governing Medicinal Products in the European Union, Volume 2, Notice to Applicants.
• Marketing Authorisation Holders must in all cases comply with the requirements of Community Legislation. Provisions, which extend to Iceland, Liechtenstein and Norway by virtue of the EEA agreement, are outlined in the relevant sections of the text.