Por: Ruth Olivares
New Technical Norm 77, version 7, 2023, Approval of the Sanitary Registration of Drugs and Vaccines, which will come into force on March 3, 2023, has a series of changes, among which we can mention:
- It extends the application scope, in the sense of including pharmaceutical specialties of chemical synthesis and vaccines (biological and biotechnological).
- It establishes that the Standard will apply to Sanitary Registrations issued by Regulatory Authorities of High Maturity and Performance, defined by the WHO, and published in the list issued by the Department of Pharmaceutical Products.
- Ratifies concepts related to the Regulatory Authority:
- WHO Catalogued Regulatory Authority (ACO) (WLA, Who-Listed Authority).
- Maturity Level 3 (ML3, Maturity Level 3) Regulatory Authority.
- Regulatory Authority with Maturity Level 4 (ML3, Maturity Level 4)
- OMS Transitional Listed Regulatory Authority (tWLA, transitional Who Listed Authority)
- Within its general provisions, it reminds us of the following:
- The Sanitary Registration shall be valid for a renewable of 5 years period.
- If a product is manufactured by different subsidiaries or countries, separate sanitary registrations must be processed.
- Any certificate or document must be valid at the time of its presentation. If it is not valid, it will be valid for 2 years from the date of issuance.
- All documents must be presented in Spanish, or with its respective sworn translation in Guatemala.
- Legal documents must be presented in original or authenticated photocopy.
- The name of the drug or vaccine must coincide with all the documentation submitted, otherwise, an original clarifying note must be submitted.
- In post-registration modifications cases that affect the quality and efficacy of the product and whose change is not reflected in the CPP/CLV, a document issued by the High Maturity and Performance Regulatory Authority (Autoridad Reguladora de Alta Madurez y Desempeño) must also be submitted stating the change.
- It is important to remember that in Guatemala all documents issued abroad must be sent in original and legalized by Apostille.
- If the CPP/CLV differs from the application form in terms of conditioner, product name, presentations or is not marketed in the issuing country, it will be required:
- Conditioner: If it is not in the CPP or CLV submit:
- Manufacturing Contract
- Good Manufacturing Practices of the Conditioner, complying with local legislation.
- Product Name: Letter of clarification from the holder or Legal Representative.
- Presentations: If the CPP/CLV does not include all the presentations to be registered, it must be supported with the therapeutic scheme.
- Product not marketed in the Issuing Country: Attach a document issued by the High Maturity and Performance Regulatory Authority of the country where the product is being marketed. This applies as long as it is the same manufacturer stated in the CPP/CLV.
- Holder: If the holder does not correspond in the CPP/CLV to the one requested, the following must be submitted:
- Letter issued only by the Head Office, where the relationship between this and the Subsidiaries is clarified, and who will be the holder of the product, or.
- Letter issued by the Legal Representative in the country, indicating who will be the owner of the product. For this purpose, a Power of Attorney must be submitted stating that the Legal Representative has express powers to clarify ownership, for which the Authority will verify these powers.
- Shelf Life: Stability Studies must be submitted to obtain the applicable information.
- Regarding the Sanitary Registration procedure, the following modifications were made:
- The deadline for the Department of Pharmaceutical Products to assign the Sanitary Registration Number was extended to 45 working days.
- The 20-day term for the National Health Laboratory to analyze the Analytical Methodology was eliminated.
- It establishes a term of 20 working days for the Department of Pharmaceutical Products to evaluate the procedure and issue notifications.
- If there are observations, the interested party will be notified and a period of 45 working days from the notification will be granted to respond. This period cannot be extended.
- It is ratified that in case there is no response, or the response does not comply with what is required the file will be terminated.
- Other considerations:
– All distributors must have a Pharmacovigilance Plan registered in the National Pharmacovigilance Program.
– For the Renewal procedure, the Periodic Safety Report must be registered in the National Pharmacovigilance Program.
– The Quali-Quantitative Formula must also state:
- Composition of the release system.
- Qualitative composition of empty capsules and the number of capsules used.
- Qualitative composition of the printing ink.
- The components must be described in their international nonproprietary name, and not presented in acronyms or abbreviations.
- For active ingredients in the form of salts, esters or others, declare the equivalent quantity of the molecule to the therapeutic dose.
- Pigments and colorants used should include the C.I. (Color Index) code.
- Excesses of active ingredients used in the manufacture.
– The Monograph must be based on official literature or on the International Technical Data Sheet published by the High Maturity and Performance Regulatory Authority.
– The Analytical Methodology and Validations must be attached in digital format, only in USB memory.
– Present Good Manufacturing Practices Certificates from each of the establishments involved in the product manufacturing process.
– Distributors must have a structured and complete procedure for environmental waste.
– Both manufacturer and distributors must have procedure structure cold chain management.
- Patent Rights:
- Affidavit must be submitted that there are one or more patents in force or in the process of approval in Guatemala and include in the same the patent data and expiration date.
- If there are no patents, an Affidavit must be submitted stating that there are no patents in force in Guatemala covering the product.
- In both cases, a patent background search report issued by the Intellectual Property Registry of Guatemala must be attached.
- In the case of Vaccines:
- If the CPP/CLV is issued by a Regulatory Authority that is not High Maturity and Performance or the product category of the Regulatory Authority does not include vaccines, a WHO Prequalification document must be submitted.
- Biological and biotechnological vaccines must comply with current legislation (Technical Standard 67-2020, Version 4, Reference Sanitary Registration for Biological and Biotechnological Products).
- It is reconfirmed that the products will be subject in this case to sampling and analysis in the market, after the issuance of the Sanitary Registration (Post Commercialization Analysis). If the result of the analysis is unfavorable, the Sanitary Registration will be cancelled.