Parallel distribution: Regulatory and procedural guidance
Table of contents
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.
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Frequently asked questions about parallel distribution (PDF/539.74 KB)
First published: 09/06/2021
Last updated: 31/05/2022
EMA/297155/2021 Rev. 2 -
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List of centrally authorised products requiring a notification of a change for update of annexes (PDF/318.99 KB) (updated)
Adopted
First published: 19/09/2016
Last updated: 26/05/2023
EMA/238038/2023 -
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Checklist for initial notifications for parallel distribution: guidance for industry (PDF/248.45 KB)
First published: 19/05/2020
Last updated: 02/08/2021
EMA/267299/2020 Rev. 3 -
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Checklist for annual updates for parallel distribution: guidance for industry (PDF/339.78 KB)
First published: 08/10/2020
Last updated: 22/06/2022
EMA/405782/2020 Rev. 3 -
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IRIS guide to registration and RPIs (PDF/1.32 MB) (updated)
First published: 19/06/2018
Last updated: 25/05/2023
Version 2.15 -
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IRIS guide for parallel distribution applicants (PDF/310.39 KB)
First published: 11/02/2019
Last updated: 13/12/2022
EMA/805961/2018
Webinar on submissions of parallel distribution notifications for centrally authorised products (CAPs)