By: Andrea Castillo
On February 2023, the Guatemalan Ministry of Health published Technical Norm 67 version 5-2023 on the Sanitary Registration of Biological and Biotechnological Products, which becomes effective on March 24, 2023. Among the updates, the following can be mentioned:
- Application Scope is expanded, where biological products include vaccines and blood products; and biotechnological products include innovators and biosimilar’s.
- Some definitions are included in point 4, for the correct interpretation of the Technical Standard.
- Article 6 clarifies the extra documentation to be submitted in case the information issued in the Certificate of Pharmaceutical Product (CPP) is different from that stated in the application form, as the case may be:
- Primary/secondary conditioner
- Product name
- Presentations
- Product not marketed in the issuing country
- Holder Shelf life
- In point 6.19, the term of the pending dossier 1 year of validity is modified to that indicated in the current legislation. According to Technical Standard 80 version 4-2022, the maximum period is 6 months from the notification of the note of observations, otherwise it will be sent to the inactive file.
- In numeral 7.5 the Authority that issues the Certificate of Pharmaceutical Product (CPP) must appear in the list of Regulatory Authorities of High Maturity and Performance, published by the Ministry of Health.
- The type of product stated in the Certificate must match the WHO-defined scope of the issuing Regulatory Authority (drug/vaccine).
- Article 7.6 requires the submission of an Affidavit indicating whether or not there are patents covering the product or its uses. In addition, submit the background search report issued by the Intellectual Property Registry.
- Item 7.14 requests the Certificate of Good Manufacturing Practices of all the establishments involved in the manufacture of the product.
- Item 7.18 expands on what is requested for the manufacturing methods, also indicating that these must be submitted on USB. It must contain, among others, the following:
- Master formula, including batch size.
- Methods for exclusion of adventitious agents.
- Process control specifications
- Reprocessing criteria for each step
- Clarification on analytical controls in point 7.19, they must be submitted in digital format on USB memory.
- Article 8 details the requirements that must be submitted on USB memory, as appropriate for the following:
- Blood products
- Vaccines (Biological and Biotechnological)
- Combined Vaccines (Biological or Biotechnological)
- Item 9 establishes the specific requirements for Biologicals Innovative, which does not apply to biotechnology vaccines. Article 9.3, which indicated the consideration of the exception to present Phase III studies in cases of early development of the biotechnological drug, is eliminated.
- Point 10 clarifies the Biosimilar sanitary registration, where the information will be submitted on USB memory. In addition, it is reiterated that the biotechnological product of reference must be authorized in Guatemala and must have been marketed for at least 5 years.
- Article 11 refers to post-registration modifications, where will be evaluated according to the current version of the RTCA for Pharmaceutical Products.
- In case the change affects the quality and this is not reflected in the CPP, an additional document issued by the High Maturity and Performance Regulatory Authority accepting the changes must be submitted.
- Article 12 mentions that it is the responsibility of the Legal Representative of the product to notify about the arrival of the first import lot.
- Article 13 clarifies that the products are subject to post-commercialization analysis for surveillance, if the result of the National Health Laboratory does not comply, the Sanitary Registration is canceled.
- Article 14 expands on the Renewal process, indicating that the products that have been registered without complying with everything requested in the 4-2023 version, must comply with the new requirements when carrying out the renewal with or without changes”.
Additionally, I leave you a link to the document published by the Ministry of Health, due to space issues it is not possible to attach it:
https://drive.google.com/file/d/1cFsrEX_pJTGvMwiwp2RY2MW985UpYQKz/view?usp=sharing