The CRS applies regulatory reliance as an efficient mechanism for review, to ensure products are good quality, safe and effective.
* See CRS guidance for details, including policies formatting, and timelines for responses.
Download a Quick Reference Guide for the requirements for medicines approved by a trusted reference authority.
1. Requirements for Verification Review of Medicines and Vaccines – November 2020 (document)
2. Submission of Biotherapeutic Product Applications for Verification Review – May 2020 (document)
3. CRS Requirements for COVID-19 EUA Product Review November 2021 (document)
4. CRS User Fee Schedule 08.2023 (document)
5. CRS Guidance for Post-approval Changes and Additional Documents 11.2023 (document)
6. CRS Guidance for Periodic Review 01.2021 (document)
7. CRS Gateway Guide for Applicants 07.2023 (document)
For more information or submission of queries
CRSRegistration@carpha.org
Copyright 2022 by The Caribbean Public Health Agency