Sanitary Registration Form Update – Guatemala

By: Adriana Pérez, Ruth Olivares y Olga Torres

On September 21, 2021, the Ministry of Health of Guatemala published Version 19 of the Application Form for the Sanitary Registration of Reference of Pharmaceutical Products, which presents several changes to the previous version. These changes are described below:

1. Within the form, in the Administrative Identity section, it will be necessary to place:

• Data of the Laboratory Manufacturer of the finished product
• Data of the Laboratory Manufacturer of the active ingredient.

1. The requirements listed in this form are updated according to the Central American Technical Regulation RTCA 11.03.59:11, called Pharmaceutical Products. Medicines For Human Use Sanitary Registration Requirements, the Technical Norms 09 Sanitary Registration of Industrially Manufactured Official Pharmaceutical Products, 67-2020 Reference Sanitary Registration for Biological and Biotechnological Products and the Communiqué issued by the Department of Regulation and Control of Pharmaceutical Products regarding the Decree 5-2021 Law for the Simplification of Requirements and Administrative Procedures, in its current versions, in the sense that the following requirements must be entered only in digital format (PDF) in a storage device (CD, DVD, USB):

• Analytical methodology
• Clinical safety and efficacy studies
• Quality studies of the active ingredient and finished product
• Clinical studies of reactogenicity and immunogenicity (Vaccines)
• Manufacturing method, analytical controls, and biosimilarity exercise.

1. The Quali-Quantitative Formula of the composition described in the form F-AS-d-01, signed and stamped by the responsible professional in Guatemala, will also be required for the entry.
2. Likewise, it is indicated that the Finished Product Specifications (organoleptic, physical, chemical, biological, and microbiological) must be signed and sealed by the responsible professional.
3. Based on Technical Standard 67-2020, the requirements for Biological and Biotechnological Drugs are the same as before, however, both biological and biotechnological drugs are now in the same box within the application form, being the most significant change for these products, the original and valid Certificate of the Pharmaceutical Product, issued by a competent authority of the country of origin (WHO type) and/or issued by a Strict Authority according to Annex A of said standard, will now be required.
4. According to Decree 5-2021 Law for the Simplification of Requirements and Administrative Procedures, in the case of Guatemalan establishments, the following documents are no longer mandatory, since the Ministry of Health has them, however, it is suggested to always attach them in simple copy:

• Certificate of Good Manufacturing Practices of the finished product and the conditioner.
• Pharmacovigilance Plan
• Sanitary License
  This form came into force on October 1, 2021, however, it is being evaluated together with the College of Pharmaceutical Chemists if it is extended to a later date, due to the lack of knowledge of users on the subject.