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.

Guidance documents

Frequently asked questions about parallel distribution

Reference Number: EMA/297155/2021 Rev. 4

List of centrally authorised products requiring a notification of a change for update of annexes

AdoptedReference Number: EMA/169204/2024

Checklist for initial notifications for parallel distribution: guidance for industry

Reference Number: EMA/267299/2020 Rev. 4

Checklist for annual updates for parallel distribution: guidance for industry

Reference Number: EMA/405782/2020 Rev. 4

IRIS guide to registration and RPIs

Reference Number: Version 2.15Summary:

Preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration.

IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants

Reference Number: EMA/444925/2018

Webinar on submissions of parallel distribution notifications for centrally authorised products (CAPs)

Templates

Parallel distribution user admin affiliation template letter