By: Adríana Pérez, Ruth Olivares, y Olga Torres
On November 5, 2021, the new Technical Norm 83-2021, version 2, called “Extraordinary and Temporary Provisions of the Department of Regulation and Control of Pharmaceutical and Related Products for the presentation of the requirements in the issuance of Sanitary Licenses, Licenses of Precursors and Chemical Substances, Certifications, Sanitary Registrations, Sanitary Inscriptions and Surveillance, Monitoring and Control, by COVID-19”, repealing with it the Technical Norm 83-2020, came into force in Guatemala.
In summary, it is similar to the previous Norm, and eliminates the presentation of the Sworn Statement for official documents coming from abroad, when these have not been legalized by Apostille, and replaces it with a Letter of Pronouncement, which will contain:
- Capacity with which the applicant acts.
- Indication that the accompanying documents are true and exact copies of the originals.
- The user will be obliged to deliver during the term of validity of the Technical Standard, to the Department of Regulation and Control of Pharmaceutical Products, through the Application for Modification of Sanitary Registration, the totality of the described documents, with their respective passes of law or Apostille. The name of the documents must be indicated in the letter of pronouncement as well as in the corresponding application.
- Indication of the electronic address or link where the existence of the document issued by the corresponding Regulatory Authority or Competent Authority can be verified.
- In case of non-compliance, the Legal Representative undertakes to abide by the sanctions following the Health Code and Applicable Standards.
- It must be signed by the Holder or the Legal Representative in the country.
The following must also be taken into account for the registration, renewal or modification of products coming from abroad:
- The totality of documents established in the Central American Technical Regulations and Technical Norms according to the category of the product must always be presented.
- New molecules used for the treatment of COVID 19 that have not yet been on the market for 5 years must submit Safety and Efficacy Studies, according to RTCA.
- Documents obtained from Regulatory Authorities worldwide, which have information of the Sanitary Registration of the product, are accepted, as long as such documents can be consulted online through their databases. If the documents are not verifiable electronically in the link or electronic address indicated in the letter of pronouncement, a rejection note will be issued.
- For registration modification requests submitted before this Technical Standard and that have obtained a review note for official documents coming from abroad, a one-time extension may be requested, attaching the respective justification.