By: Ruth Olivares
On January 30, 2024, the JEF Communiqué was published by the Department of Regulation and Control of Pharmaceutical and Related Products, of the Ministry of Health of Guatemala. DRCPFA-02-2024, Identification of Homologation Files of the Health Registry Based on Technical Standard 77 Version 8-2023, with Health Authorization from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
It tells us that as of February 15, 2024, the records of medicines and vaccines submitted to the Ministry of Health, under Technical Standard 77 (Homologation of Health Registry), and that come from the Food and Drug Administration Agency of the United States (FDA) or the European Medicines Agency of the European Union (EMA) must be identified on its cover with the acronym “EMA” or “FDA”, as appropriate.
Likewise, it is indicated that a simple copy of the certificate issued by EMA or FDA must also be attached to the registration dossier that is entered into the National Health Laboratory.
The above aims to comply with section 6.18 of the aforementioned Standard, which establishes that applications that have a Pharmaceutical Product Certificate (CPP), issued by the FDA or EMA and that meet the established requirements, will be assigned Health Registration number and the respective Certification will be issued within 10 business days.