Guatemalan legislators exhort the Department for Regulation and Control of Pharmaceutical and Related Products to regularize its status
Guatemala
6 diciembre 2017

On November 27th, members of the congressional Health Committee, which is chaired by opposition party deputy Karla Martínez (Alianza Ciudadana), questioned the delay by the Department for Regulation and Control of Pharmaceutical and Related Products in processing files, which started in January as the result of a fire at its installations. During the meeting, Martínez indicated that there was already a plan in place to move forward with the thousands of files which are pending review at the agency.


Opposition party congressional member Estuardo Galdámez (Movimiento Reformador) indicated that the National Health Laboratory’s delay could lead to the expiration of many health registrations for pharmaceutical products, with the attendant risk of causing supply shortages. Deputy member Martínez affirmed that she is willing to file the corresponding complaints in the event of such an occurrence.


“Some months ago, a routing sheet was established, where the Chamber of Commerce had offered to enter into an agreement and assist the General Directorate for Health Regulation, Surveillance and Control,” recalled Martínez. The chair of the work group considers that the action has been extremely inefficient, as evidenced by the thousands of pending health files. Deputy Julio Lainfiesta, member of opposition party Unión del Cambio Nacional, agreed that a significant period of time has elapsed and that the Ministry of Public Health and Social Welfare (Ministerio de Salud Pública y Asistencia Social or MSPAS) should have already reestablished its activities and normalized the situation, yet the regulatory agency continues working under precarious conditions.


The meeting included the participation of the Technical Vice Minister of Public Health, José Roberto Molina, as well as Karla Chávez, from the General Directorate for Health Regulation, Surveillance and Control, which is part of MSPAS, and representatives from the Office of the Human Rights Ombudsman. Lawmakers asked the authorities to submit reports to the Health Committee to monitor the agency’s situation.

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