In brief
The Autonomous Service of Health Control (SACS) of the Ministry of People’s Power for Health issued Circular No. DGSACS/0002/2025 (“Circular”) on 28 October 2025, which establishes a new system for procedures and authorizations granted by SACS.
The Circular mandates the use of the new automated system through which procedures and authorizations will be executed jointly with the Foreign Trade Committee (COMEX). The Circular became effective on 28 October 2025.
In detail
Below are the most relevant aspects of the resolution.
COMEX competence
The Circular establishes COMEX’s competence to process requests under Legal Regime 3, Legal Regime 8, and Legal Regime 12, related to the permit from the Ministry of People’s Power with competence in health matters, the import license administered by the Ministry of People’s Power with competence in food matters, and the certificate of sanitary registration issued by the Ministry of People’s Power with competence in health matters, respectively, pursuant to Decree No. 5,165 dated 30 September 2025.
Name changes
The Circular notifies the name change of Legal Regime 12 established in Decree No. 4,944 dated 24 April 2024:
- It is modified from ‘Sanitary Registration issued by the Ministry of People’s Power with competence in health matters’ to ‘Certificate of Sanitary Registration issued by the Ministry of People’s Power with competence in health matters.’
This requirement will be enforced at all customs offices nationwide. SACS will review and approve all documentation to obtain the permits and registrations requested through the COMEX platform.
Affected procedures
As of the Circular’s effective date, the following procedures must be carried out through the COMEX platform:
- All procedures addressed to the Directorate of Food and Beverage Safety
- All procedures addressed to the Directorate of Regulation and Control of Materials, Equipment, and Health Establishments
- All procedures addressed to the Directorate of Regulation and Control of Drugs, Medicines, and Cosmetics
Click here to learn about the specific procedures for each directorate.
We remain at your disposal should you require further details or clarification on the general aspects highlighted in this alert, and for any related inquiries.
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Click here to read the Spanish version.