by: Ruth Olivares and Olga Torres
On September 8, 2021, the Ministry of Public Health and Social Assistance of Guatemala issued a new notice regarding Decree 05-2021, Law for the Simplification of Administrative Requirements and Procedures, leaving without effect the previous notice issued on September 1, 2021.
It states the following:
- These guidelines will apply only to files submitted to the Directorate of Regulation and Control of Pharmaceutical and Related Products as of September 1, 2021, onwards.
- The user shall submit legalized documents only if such requirements are established in Legislative Decrees, Governmental Agreements, and Central American Technical Regulations, otherwise a simple copy may be submitted.
- The presentation of Affidavits shall only be required if so established in Legislative Decrees, Governmental Agreements, and Central American Technical Regulations.
- The documents issued by the Directorate of Regulation and Control of Pharmaceutical and Related Products, of the Ministry of Health of Guatemala, such as Sanitary Licenses, Certifications of Good Manufacturing Practices, Pharmacovigilance Certificates or similar, which are requirements for diverse application procedures, shall not be of obligatory presentation for the user.
- The user is exempted from the presentation of legalized documents, in case of documents issued by Public Authorities (this being understood as Public Authorities of Guatemala).
- The documents issued abroad, must comply with the current legislation, exempting only the presentation of the translation of the Apostille SEAL.
- Any type of Rulings (Legal Representative, Responsible Pharmaceutical Chemist, Manufacturing Contracts, Good Manufacturing Practices) will be without effect, the previous rulings will be obsolete, and the document must be attached according to the national legislation required.
- The Directorate of Regulation and Control of Pharmaceutical and Related Products will verify in the FIRST REVIEW NOTE the totality of the requirements of substance and form of the dossier, avoiding partial reviews. If it identifies that there are missing or errors, it will issue 03 review notes.
After issuing 3 review notes and the user does not satisfy the requirements, the user must submit the application again, paying the fee.
If the missing items are attributable to the evaluator, this circumstance will not affect the user. - Applications for renewal of all sanitary authorizations issued by the Directorate of Regulation and Control of Pharmaceutical and Related Products, such as Sanitary Registration, Sanitary Inscriptions, Sanitary Licenses, Certificates, and Certifications, will be understood to be extended as long as such Directorate has not issued a final decision or opinion.
This means that the Sanitary Registration will be in force until the Department of Regulation and Control of Pharmaceutical and Related Products notifies that the file has been canceled, in case the non-conformities indicated in the review notes have not been solved or if the Technical Norm 80, current version, is not complied with (files with more than 6 months of inactivity).
This provision applies only to renewal applications submitted on, or after September 1, 2021.