A Decree was published on June 22, 2021. Said decree amended the so-called Equivalence Decree published back on January 28, 2020 in the Federal Official Gazette by the Ministry of Health (For further reference please see our newsletter No. 91/FEB 2020).
The Decree of January 2020 established the equivalent requirements to recognize the approval process of certain foreign regulatory agencies to allow the importation of drugs with or without marketing authorization in México in case of "necessity" with the aim to expedite the granting of marketing authorizations of health supplies (i.e. drugs, vaccines) in Mexico, by establishing an authorization equivalence mechanism for products that had met the corresponding requirements and procedures before a foreign regulatory agency recognized in the Decree.
The Decree includes the following amendments:
- The inclusion of medical devices as health supplies that can be imported without marketing authorization.
- New Regulatory Agencies for medical devices have been added.
- Contrary to the decree of January 2020, the current Decree expressly mentions biosimilar drugs and health supplies that can be imported without marketing authorization.
- In compliance with the recent amendments to the Health Law Regulation, (For further reference please see our newsletter No. 177/JUN 2021) the Decree allows the submission of documentation in English without the need for its translation into Spanish.
- The deadline to comply with the requirement to request the corresponding Marketing Authorization after importation was extended from 5 to 10 days.
- The deadline for COFEPRIS to respond to an Approval Application has been reduced from 60 to 45 days.
- The requirements, such as the quality data (chemical, pharmaceutical and biological) and the non-clinical and clinical data to be submitted as part of the eventual Marketing Authorization application, have been reduced.
- "Section IV" of the Technical Annex is the one with more changes and inclusions, including details on the process that were not entirely described in the first Decree dated on 2020. Said section mainly states the following:
- The Ministry of Health shall coordinate with Health Institutions of the Public Sector for the importation of necessary drugs.
- The health supplies subject to importation without Marketing Authorization must satisfy the "necessity" aspect to comply with access and distribution requirements in public and social security institutions. However, the term "necessity" is not clearly defined.3.
- COFEPRIS should issue the corresponding approvals and conduct pharmacovigilance, along with the importers and Health Institutions involved in the use of the imported goods.
- The requirements to import drugs and medical supplies under this regime are listed.
- The deadlines provided by the Health Law Regulation for the Authority to respond to importation permit applications, under this process, will be reduced to a one third, when applicable.
- No IP provision was included.
At OLIVARES, we will continue monitoring and studying the impact of this decree to guide our clients and the industry with best practice strategies.
Originally published 30 June 2021.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.