Por: Andrea Castillo y Olga Torres
On August 29 of this year, COMMUNICATION DGRVCS-04-2022 was published, informing us about the socialization and clarification of the projects of the General Directorate of Health Regulation, Surveillance and Control and the Department of Regulation and Control of Pharmaceutical and Related Products, which are being worked on with the support of the Technical Vice-Minister of the Ministry of Public Health and Social Assistance.
The advances correspond to:
- Continuity is given to the accreditation process of the Department of Regulation and Control of Pharmaceutical and Related Products as National Regulatory Authority according to the criteria established by the Pan American Health Organization (PAHO).
- In July 2022, the Ministry of Public Health and Social Assistance joined the Mechanism for Joint Evaluation of Health Registration Dossiers for Pharmaceutical Products through the PRAIS platform of the Pan American Health Organization (PAHO), in order to integrate the processes and criteria for the evaluation of dossiers for the Central American market.
- The Superintendencia de Administración Tributaria (SAT) and the Departamento de Regulación y Control de Productos Farmacéuticos y Afines are working on an information exchange agreement and the development of a digital platform for the sanitary authorization of imports and exports.
- The Department of Regulation and Control of Pharmaceutical and Related Products and the National Health Laboratory have been provided with online payment of tariffs and other computer tools for the management of sanitary authorizations.
- IICA has assisted in the revision of regulations to adapt international requirements to current standards.
- The special window for people with different capacities, senior citizens and Pharmaceutical Chemists professionals has been enabled since August 2020; from October 2021, the sample reception window of the National Health Laboratory in zone 8 of Guatemala City.
-The purchase of computer equipment and office furniture has been managed in order to strengthen the work team; the purchase of vehicles for the General Directorate of Health Regulation, Surveillance and Control and equipment to automate processes at the National Health Laboratory was managed. We are also promoting ongoing staff training with the support of international entities.”
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