On May 6, 2021, it was published the new Technical Norm 77-2021, Version 4, issued by the Department of Regulation and Control of Pharmaceutical and Related Products of the Ministry of Health, regarding the procedure for the Registration Approval in Guatemala, called “Sanitary Registration of Medicines Approved by Regulatory Agencies level IV recognized by the Pan American Health Organization (PAHO); as well as those approved by Strict Regulatory Authorities defined by the World Health Organization (WHO), as a basis for processing the registration approval in Guatemala”.
Among the most relevant changes in relation to the previous version, we have:
- Article 6 is added, which states:
- Renewals and updates will be evaluated according to the RTCA Pharmaceutical Products, Medicines for Human Use. Sanitary Registration Requirements, and in the case of Vaccines according to the Technical Standard 67 Sanitary Registration for Biological Products.
- When the Certificate of Pharmaceutical Product (CPP) or Certificate of Free Sale (CLV) submitted differs from what is stated in the application, the following may be submitted:
– Product Name: Submit a document issued by the Legal Representative in Guatemala, consigning the name under which the product will be marketed in the country.
– Presentations: If not all presentations are indicated, they may be included as long as they are supported by the therapeutic scheme or the need for a medical sample.
– Lifespan: If a different lifespan is indicated, the corresponding stability studies must be submitted.
– Quali-Quantitative Formula: If the formula is not included, it may be submitted signed and stamped by the Responsible Professional.
- Another change was in the registration procedure, indicating that an extension of 20 working days may be requested to respond, counted from the date stated in the password, eliminating what was established with respect to the notification of approval.