Veterinary post-authorisation Q&A: Introduction
This guidance addresses a number of questions marketing-authorisation holders may have on post-authorisation procedures. It provides an overview of the 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. New or Revised topics will be marked by “New” or “Rev” upon publication.
Where appropriate, a pre-submission meeting can be organised at the Agency in order to obtain further procedural and regulatory advice.
The aim of the guidance and dialogue with the marketing-authorisation holder is to enable marketing-authorisation holders to submit applications which are in conformity with the legal and regulatory requirements and which can be validated and processed promptly.
For post-authorisation submissions, marketing-authorisation holders should carefully consider the relevant dossier requirements and recommended submission dates which are included in the following documents:
- Centralised procedures - Recommended submission dates
- Dossier requirements for submission of marketing authorisation and maximum residue limit applications
In addition, marketing-authorisation holders are strongly advised to inform the Agency 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.
As of 1 January 2017 it is mandatory for applicants to use the eSubmission Gateway / Web Client for all veterinary procedural submissions to the Agency. For more information, including links to guidance on registration with the system, see:
- Procedural announcement on mandatory use of eSubmission Gateway for veterinary submissions as of 1 January 2017
- Veterinary eSubmission website
- eSubmission Gateway and Web Client information website
Note: This question-and-answer section has been produced for guidance only and should be read in conjunction with "The Rules governing Medicinal Products in the European Union, Volume 6, Notice to Applicants".
To enter the list of questions, please click on the topics below: