GUATEMALA

On August 26, Guatemala’s Ministry of Economy published in the Official Gazette a series of ministerial agreements containing resolutions approved by the Council of Ministers of Central American Economic Integration (COMIECO in Spanish). Among them is resolution 446-2021, which includes the new version of the Central American Technical Regulation (RTCA in Spanish) on Pharmaceutical Products, Medicines for Human Use and Sanitary Registration Requirements. It also includes the update of the Procedure for the Mutual Recognition of Sanitary Registration of Medicines for Human Use. All types of drugs are covered, including oncological drugs. The regulations cover any type of medicine. The resolution will enter into force on January 3, 2022.

Regarding the Central American Regulation, the update indicates that the regulatory authority may authorize the exception of the sanitary registration for the importation and use of drugs negotiated through the Council of Ministers of Health of Central America (COMISCA in Spanish). It also states that the renewal of the sanitary registration may be processed at any time before the expiration date of such registration, without losing its corresponding number.

In the case of the Mutual Recognition Procedure, it applies to any medicine produced in a Central American country member of the Secretariat of Economic Integration of Central America (SIECA in Spanish). Unlike the current document, the new Procedure specifies how its contents will be applicable in Panama. It should be recalled that Panama was not a member of SIECA when the previous procedure was agreed.