by: Ruth Olivares and Olga Torres
A notice was issued by the Department of Regulation and Control of Pharmaceutical and Related Products, of the Ministry of Health, regarding the entry into force of Decree 05-2021 Law for the Simplification of Administrative Requirements and Procedures, which will be in force as of September 1st, and which establishes, among others, the following:
- The user must submit legalized documents only if such requirement is established in Legislative Decrees, Governmental Agreements, Ministerial Agreements, or Technical Regulations, otherwise a simple copy may be submitted.
- The user must comply with the presentation of Affidavits if such a requirement is included in the aforementioned regulations.
- Documents issued by the Directorate of Regulation and Control of Pharmaceutical and Related Products, such as Sanitary Licenses, Good Manufacturing Practices Certifications, Various Certifications, Pharmacovigilance Certifications, or other similar ones, shall not be mandatory for the user to submit.
- The user is exempted from presenting legalized documents if they have been issued by Public Authorities.
- Concerning documents issued abroad, these must comply with the national legislation in force. Only the presentation of the translation of the Apostille stamp is exempted.
- As of this date, the issuance of any type of Rulings (Legal Representative, Responsible Pharmaceutical Chemists, Manufacturing Contracts) is void. The Rulings issued with previous dates become obsolete, so the user must attach the documents according to the legislation in force.
- The Department of Regulation and Control of Pharmaceutical and Related Products will issue a REVIEW NOTE during the authorization process of all the requests of this Department, which must be solved in its entirety by the user, otherwise, the file will be definitively canceled. If the user wishes to re-enter the file, a new process must be initiated.
- In the case of requests for renewal of authorizations, such as Sanitary Registrations, Sanitary Registrations, Sanitary Licenses, Certificates, and Certifications, they will be understood to be extended as long as a decision on the merits or final ruling has not been issued. This provision will apply only to applications filed as of September 1, 2021.
- The user will be considered as notified when the status is updated in the SIAD (Integrated Document Management System), in case the service does not have SIAD, the user will be notified through the e-mail indicated in the form.
- All forms will be updated gradually. However, the evaluation of application submitted as of September 1st will be evaluated under the Law for the Simplification of Administrative Requirements and Procedures.