Executive Branch publishes technical norm on requirements for sanitary registrations, including Trastuzumab
4 noviembre 2021


On November 4, the Department of Regulation and Control of Pharmaceutical and Related Products of the Ministry of Public Health (MSPAS in Spanish) of Guatemala published technical regulation 83-2021, which establishes the extraordinary and temporary guidelines for the presentation of the requirements requested in the issuance of sanitary licenses and sanitary registrations. It also includes a list of essential drugs, among which trastuzumab and remdesivir are mentioned. The regulation is already in force.

Regarding the presentation of documents coming from abroad, the document establishes that for the processing of sanitary registrations, sanitary registration, mutual recognition and homologation procedures, simple photocopies of the documents issued by the regulatory authority and that require apostille may be presented. The regulation also establishes that applications for sanitary registration, inscription and renewals of products of foreign origin that enter during the term of validity of this technical regulation must present all the documentation established in the Central American technical regulations and other technical regulations in force. Otherwise, the sanitary registration or sanitary inscription will be considered cancelled, without prior or subsequent notification.

The document states that products called essential medicines will be subject to sampling and analysis in the market for reasons of national interest. In addition, it indicates that they will have priority in their evaluation in order to ensure the supply of the national network. In its Annex A, the regulation establishes the list of drugs considered essential, among which are trastuzumab and remdesivir.