Pharmaceutical Products Registration

To import, distribute and commercialize a medicine or pharmaceutical product in Panama, it is strictly necessary to request its previous registration at the National Directorate of Pharmacies and Drugs of the Ministry of Health. Once the sanitary registration is approved, the introduction of the product into Panama can be authorized, thus complying with the sanitary regulations in force.

It is important to mention that if the application for the Sanitary Registration of Medicines is made through the regular procedure before the Ministry of Health of Panama (MINSA), a chemical analysis will be performed by the Specialized Institute of Analysis (I.E.A.), to analyze, before its trade, that the products comply with the quality standards established in the sanitary provisions in force. If the application for the Sanitary Registration of Medicines is filed through the abbreviated procedure, as long as the product applies and complies with the requirements, this analysis does not have to be performed.

In both cases, the sanitary registration must be endorsed by a pharmacist regent and by the National Bar of Pharmacists.

The requirements for the Sanitary Registration of Medicines are regulated under Executive Decree 13 of March 1, 2023, which regulates Law 1 of January 10, 2001, on Medicines and other products for Human Health.

All documentation filed to obtain the Health Registration must be in Spanish or duly translated by an authorized public translator. As for clinical studies, they will be accepted in English and their summary must be submitted in Spanish.

The validity of the Sanitary Registration for Medicines is 5 years.

Our law firm has a team of professionals specialized in the matter to provide you with the support and advice required during the whole sanitary registration process.

For more information about our pharmaceutical registration services please contact us at info@jquijano.com