Panama and Nicaragua publish Central American regulations on the production and sanitary registration of medicines
11 agosto 2021


On July 28, Panama’s Ministry of Commerce published, through the Official Gazette, Resolution 446-2021 approved by the Council of Ministers of Economic Integration (COMIECO in Spanish). The regulation updates the Central American Technical Regulation on Pharmaceutical Products and Medicines for Human Use (RTCA in Spanish) and the Procedure for the Mutual Recognition of Sanitary Registration for Human Use. The update will become effective on January 3, 2022. It also published Resolution 444-2021, approved by COMIECO, which modifies the aforementioned RTCA regarding the execution of contracts with third parties. The same publications took place in Nicaragua on August 5 when both resolutions were published by the Ministry of Commerce in the Official Gazette.

The Central American regulation on requirements for the sanitary registration of medicines keeps in force the provision that establishes that the legislation of each State party will be applied to medicines and radiopharmaceuticals. On the other hand, it establishes that the regulatory authority of each country may authorize the exception of the sanitary registration for the importation and use of medicines negotiated through the Council of Ministers of Health of Central America (COMISCA in Spanish). For Panama, with regard to the information contained in the product monograph, precautions regarding excipients published by the current European Medicines Agency (EMA) Guidelines must be included.

Regarding the update of the Mutual Recognition Procedure on Sanitary Registrations of Medicines for Human Use, it is indicated that in the case of Panama, the regulatory authority will have 30 working days to resolve the request for mutual recognition or modification by the interested party. It also indicates which are the documents to be submitted for the renewal of the recognition of the registration. The update recognizes as causes for cancellation that falsehood is demonstrated in the data and information contained in the dossier and that the product turns out to be harmful or unsafe, among others. In the section on general provisions, it is clarified that this Procedure applies to drugs that have been registered under the harmonized regulations in force.

Finally, Resolution 444 focuses on changes regarding the conclusion of agreements between a laboratory and a third party when a commercial relationship of production and analysis is established through a contract. Thus, a specific change is included in paragraph 15.1.5. of the RTCA on the minimum requirements of the agreements between the parties. As of January 2022, contracts will no longer be required to include permission for the contractor to enter the contractor’s facilities. This regulation has already entered into force in Nicaragua, while in Panama it will come into force as of January 3, 2022.