Executive summary

Ministerial Decree No. 23 of 1 October 2025 sets out the requisite elements to include in application files requesting the licensing of pharmaceutical establishments responsible for making marketing authorization decisions for pharmaceutical products and approval decisions for medical devices. Further, the Decree provides the procedures for processing the file and the list of modifications considered "substantial."

Key provisions

Competent authorities

The competent services of the Ministry of the Pharmaceutical Industry will deliver the decision on the application, constituting an agreement with the applicant if approved. This authorization is delivered for a period of two years.

The Technical Director Pharmacist also receives a two-year renewable authorization to practice.

Renewal and withdrawal

Renewal applications must be submitted four months before the authorization expires. If a pharmaceutical establishment voluntarily ceases operations, the establishment must notify the Ministry electronically, which will then proceed with license withdrawal.

Modifications

Substantial modifications require prior authorization and must be declared within 15 days. Non-substantial modifications (e.g., change of name, legal form, manager or pharmacist) must also be declared within 15 days.

Moreover, the addition or removal of represented laboratories and updates to technical agreements must be reported.

Implications

Entities must be compliant with their request and the provisions adopted by the decree to be in a position to obtain an authorization from the Ministry.