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.
New or revised topics will be identified as such for individual Q&As. In case of major review of all Q&As for a particular topic, the date of overall last review will be included at the beginning of the document.
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 any pre-submission dialogue with the MAH is to enable applications to be submitted in conformity with the legal and regulatory requirements, and which can be validated and processed promptly.
MAHs are strongly advised to inform the Agency of all upcoming post-authorisation submissions according to the notice period specified for individual types of procedures within the respective Q&As in order to allow optimal planning, identification of procedural issues and handling of overlapping applications. Applicants should 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 the Veterinary eSubmission website.
This guidance 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: