EMA Checklist for annual updates for parallel distribution - Draft Guidance

June 23, 2022

EMA flags in front of buildings.

22/06/2022
EMA/405782/2020 Rev. 3
Human Medicines Division

The European Medicines Agency (hereinafter 'the Agency') asks its applicants to use this checklist in advance of submission of an annual update for parallel distribution. You should be able to answer “Yes” to every item listed below unless a specific point is not applicable (“n/a”) to the application in question. In order to improve the quality of submissions, it is recommended to include the checklist with your submission.

Points 6 – 12 refer to the creation of scopes of change within an annual update. In case you are only updating the package leaflet and labelling and are not creating any additional scopes of change, please refer to points 1 – 5 only.

Upon receipt of an annual update for parallel distribution, the procedure manager proceeds to validate the documentation submitted in accordance with the checklist included below.

Updates to the information included in the IRIS form after submission of any notification for parallel distribution are only possible in exceptional cases, so the applicants should review the information included in the form carefully before submitting. Changes impacting fees would not be possible after submission. Only changes requested by the assessor would be possible and only by exception when properly justified.

Reference documents for further information

  • Parallel distribution regulatory and procedural guidance:

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/parallel-distribution/

  • Frequently asked questions (FAQs) about parallel distribution:

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/parallel-distribution/frequently-asked-questions-about-parallel-distribution

  • Public register of parallel distribution notices:

https://iris.ema.europa.eu/registerpd/

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