By: Cindy Carreto
Aspects to consider for obtaining sanitary registration under Technical Standard 77 version 7-2023, Homologation of the sanitary registration of drugs and vaccines
On March 16, 2023, the Ministry of Health in Guatemala published the Release UAS 04-2023, detailing aspects to consider for the entry of dossiers under the Technical Norm Standard 77 version 7-2023, on homologated registrations.
Generalities
- It is clarified that the response period for comments is 45 working days from the date of notification, with no possibility of extension.
- It is emphasized that the documentation in digital format, as applicable, must be submitted in PDF format, only in USB devices.
List of High Maturity and High Performance Regulatory Authorities
- The list of Regulatory Authorities of high maturity and performance is available for download on the official website of the Department of Regulation and Control of Pharmaceutical and Related Products.
- This list is continuously updated, based on the publications made by the World Health Organization (WHO).
- Each of the Regulatory Authorities of high maturity and performance has a scope in terms of products (vaccines, drugs, vaccines and drugs). It must be verified that the product to be registered is within the scope of the corresponding Regulatory Authority.
Certificate of Pharmaceutical Product (CPP) Information
- It is clarified that the CPP submitted must be issued by a Regulatory Authority of high maturity and performance, it must indicate that the product is registered and is being marketed. This may or may not be the country of origin, holder or source.
Post-registration modifications
- It is reminded that in cases where an update affects the quality, safety and efficacy of the product, and this is not included in the Certificate of Pharmaceutical Product, an additional document issued by a Regulatory Authority of high maturity and performance that approves the modification must be submitted. As an example, changes that could affect the quality, safety and efficacy of a vaccine are listed below:
o Change in strains
o Change in finished product specifications
o Change in analytical methodology
o Change in the manufacturing method
Patent protection
It is clarified the patent rights documents to be submitted, depending on the case of the product to be registered:
- Innovator: if it has patents in force or pending approval in Guatemala, it must submit an Affidavit on the existence of patents and a Report of antecedents in the state.
- Non-innovative: if it is a second product of its category to be registered in Guatemala, an Affidavit on the absence of patents and a Report of antecedents in the state must be submitted.
- Multi Origin: it is clarified that it is not necessary to present an Affidavit or a Report of antecedents in the state.