Parallel distribution: Regulatory and procedural guidance
This content applies to human and veterinary medicines.
The procedure described here is intended to provide guidance and assist parallel distributors to fulfil their obligations, without prejudice to the interpretation of Community Directives and Regulatons by the European Commission and/or European Court of Justice.
List of centrally authorised products requiring a notification of a change for update of annexes (PDF/299.7 KB) (updated)Adopted
First published: 19/09/2016
Last updated: 17/02/2021
Checklist for initial notifications for parallel distribution: guidance for industry (PDF/232.34 KB)
First published: 19/05/2020
Checklist for annual updates for parallel distribution: guidance for industry (PDF/188.99 KB)
First published: 08/10/2020
IRIS guide to registration (PDF/1.47 MB)
First published: 19/06/2018
Last updated: 21/09/2020
IRIS guide for parallel distribution applicants (PDF/226.58 KB)
First published: 11/02/2019
Last updated: 16/11/2020