CENTRAL AMERICA

On April 28, the Council of Ministers of Economic Integration (COMIECO, in Spanish) approved a new version of the Central American Technical Regulations on Medicines for Human Use and their Sanitary Registration Requirements. The new text exempts medicines imported via the joint purchases of the Council of Ministers of Health of Central America (COMISCA, in Spansih) from registration. COMIECO also approved an updated text of the Procedure for Mutual Recognition of Sanitary Registration of Medicines for Human Use. Both regulations, which apply to any type of medicine, will enter into force on December 28, 2021.

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 medicines negotiated through the Council of Ministers of Health of Central America (COMISCA, in Spanish), except in the case of Honduras. 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.

Since the meeting through which the ATCM was approved took place virtually, the agreed resolution, which includes both updated documents, does not yet have the signatures of the ministers of each State party. Over the next few weeks, the official document will be sent via courier to each COMIECO representative in order to include their signature and then returned to COMIECO headquarters, where the document will be certified and published online. Despite the delay that this mechanism could generate, the deadline for entry into force will not be modified and the text will enter into force on December 28, 2021 in all SIECA member states (Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua and Panama).