“On June 2, the new technical standard 77-2022, version 5, Approval of the sanitary registration of medicines and vaccines, was published, which aims to establish the conditions and requirements for the approval of the registration health of pharmaceutical products approved by regulatory authorities High Maturity and Performance Authorities defined by the World Health Organization (WHO), both for chemically synthesized pharmaceutical specialties and for vaccines, including biological and biotechnological vaccines.
It replaces technical standard 77-2021, version 4, and among the most substantial changes, it is worth highlighting:
- The term “High Maturity and Performance Regulatory Authorities” is used, instead of Strict Regulatory Authorities or High Supervisory Regulatory Authorities.
- A range of definitions are given for regulators, such as: Maturity Level 3 Regulator (ML3, Maturity Level 3). Maturity Level 4 Regulator (ML4, Maturity Level 4 ).WHO Transitional Regulatory Authority (tWLA, Transitional Who Listed Authority).WHO Listed Regulatory Authority (WLA, Who Listed Authority).
- It defines health registration endorsement as the formal recognition of health registration granted by regulatory authorities qualified by WHO as high maturity and performance regulatory authorities, through which the quality, safety and efficacy of pharmaceutical products are guaranteed.
- The following points are confirmed: – The health registration will have a duration of 5 years, the Regulatory Authority reserving the right to cancel or suspend it for justified reasons. – If the product is manufactured by different subsidiaries or country, one record must be processed for each laboratory. It does not admit the figure of the alternative manufacturer.– All documents must be submitted in Spanish, or with their respective sworn translation, in accordance with the Law of Judicial Power in Guatemala.– The name of the drug must coincide in all the documentation presented, otherwise an explanatory note must be added. – The medicinal product may use a trade name or an international nonproprietary name (INN), provided that it does not lead to error or confusion.
- The following solutions are proposed in the event that the Certificate of Pharmaceutical Product (CPP) or the Certificate of Free Sale differs from what is indicated in the registration application:
Product Name : Submit a document signed by the legal representative in Guatemala, with the name that will be marketed in the country.
Presentations: Justify according to the therapeutic support scheme or the need to use medical samples.
The duration of the conversation : Attach the corresponding stability studies.
Product not marketed in the country issuing the Certificate: Also attach the CPP or CLV issued by the High Maturity and Performance Authority of the country where the product is marketed.
Incumbent: Submit a document showing the relationship between the subsidiaries or the parent company, the assignment or the manufacturing contract, as applicable.
6. The requirements established by the National Health Laboratory for the procedure must also be followed.
7. The Department of Regulation and Control of Pharmaceutical Products of Guatemala will publish a list of regulatory authorities of high maturity and performance, which will include the type of product (drug or vaccine) to which the registration is applicable, with the scope indicated by WHO.
8. If the evaluation is favourable, the Pharmaceutical Products Department will have thirty (30) working days to decide after the submission of the application in order to issue the Certificate.
9. If the review of the documentation reveals observations, the Department of Pharmaceutical Products will have twenty (20) working days to notify them, and the responsible professional in Guatemala will have forty-five (45) working days after the notification to answer. . This deadline is not extendable, therefore, if no response is made or if it is made without complying with what has been requested, the procedure will be canceled.
10. Among the changes for the Proprietary Pharmaceutical (Chemical Synthesis) requirements that we need to mention are:
Qualitative-quantitative formula, which must include:
- Composition of the release system, for modified release products.
- Qualitative composition of empty capsules and number of capsules used.
- Qualitative composition of the printing ink of capsules, coated tablets and coated tablets.
- All components of the medicinal product should be described with their internationally accepted nonproprietary names, without abbreviations or acronyms.
- In the case of active ingredients in the form of salts, esters or others, the equivalent quantity of the molecule must be indicated.
- The pigments and dyes used must have the code CI (Color Index), FD & C (Food, Drug and Cosmetic), or equivalent.
- Excess active ingredients used in manufacturing.
- Pharmaceutical Product Certificate or Free Sale Certificate: The regulatory authority issuing the certificate must be on the list published by the Department of Regulation and Control of Pharmaceutical Products, Guatemala, as well as the product type and scope defined by WHO.
- Affidavit for patent rights: Whether there is a patent in force or pending approval in Guatemala or abroad indicating that it covers the product or its uses.
- New Pharmaceutical Forms, New Indications or New Dosages: Also include full clinical studies for safety and efficacy.
Structured and comprehensive procedures (if applicable) must be attached:
- Environmental management of waste from national manufacturer and distributors in Guatemala.
- Cold Chain Management, from the national or foreign manufacturer, and distributors in Guatemala.
11. For vaccines, in addition to the requirements indicated for pharmaceutical specialties of chemical synthesis, they must refer to the legislation in force in the country, referring at this time to the requirements required by Technical Standard 67, Health Registration of benchmark for organic products. and biotech products.
12. The entry of the first batch of the product to be marketed in Guatemala must be notified, so that the National Health Laboratory can verify its quality.
13. The product will also be subject to sampling and analysis in the market, after the issuance of the sanitary registration. In cases where the analysis carried out by the National Health Laboratory shows that the product is not compliant, the Sanitary Registration will be cancelled.
The new technical standard will come into effect on July 2, 2022.