COSTA RICA

On January 28, the Ministry of Health of Costa Rica published in the Official Gazette the resolution detailing the procedure for the importation and use of medicines against COVID-19. Among the requirements is the certified copy of the Emergency Use Authorization or the Certificate of Sale Authorization (Certificate of Free Sale or Certificate of Pharmaceutical Product) issued by a Strict Regulatory Authority or recommendation of the World Health Organization (WHO). The text is already in force.

 For the authorization of such medicines, the interested parties must send a series of requirements to the Directorate of Regulation of Products of Health Interest through the e-mail [email protected]. Among the documents to be gathered, the dossier with the quality, safety and efficacy information submitted and approved by the Strict Regulatory Authority or by the WHO, and the labels of the primary and secondary container/packaging, among others, stand out. The authorization is a prerequisite prior to the importation of the drug in question.  

The text mentions that the authorization will be in force until six months after the state of national emergency is lifted, unless violations in the elaboration, trade, use or demonstrative experiences that the product is unsafe or ineffective, make its cancellation appropriate. Once the complete application for authorization has been submitted, the Directorate of Regulation of Products of Health Interest of the Ministry of Health will have a term of 15 calendar days to resolve the matter.