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Volume XI, Number 267

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Mexico. Amendments to the Equivalence Decree to Import Health Supplies Without Marketing Authorization.

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:

  1.  The Ministry of Health shall coordinate with Health Institutions of the Public Sector for the importation of necessary drugs.

  2. 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.

  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.

  4. The requirements to import drugs and medical supplies under this regime are listed.

  5. 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.

  6. No IP provision was included.

© 2005-2021 OLIVARES Y COMPAÑIA S.C.National Law Review, Volume XI, Number 182
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About this Author

Partner

Alejandro Luna has been alternately dubbed “an extraordinary litigator, active at every level,” “responsive and insightful,” and “a knowledgeable IP practitioner offering creative and cost-effective advice” by his peers, according to IAM Patent 1000, while World Trademark Review’s WTR 1000 called him “a reliable ally for any party in a dispute”. Since joining OLIVARES in 1996 and being made partner in 2005, he has been instrumental to the firm’s IP Litigation, Regulatory, and Administrative Litigation practices. He co-chairs the Life Sciences & Pharmaceutical...

+52 (55) 5322 3000
Gustavo Alcocer Attorney OLIVARES Corporate Commercial Law
Partner

Gustavo Alcocer manages the Corporate and Commercial Law Group at OLIVARES, advising domestic and foreign businesses and the owners of those businesses on Mexican and cross-border corporate and commercial transactions. He serves as outside general counsel in Mexico to many of his domestic and foreign clients, and also represents emerging and middle-market companies, including closely-held businesses from Mexico, the United States, Canada and Latin America. Mr. Alcocer’s significant experience on domestic and cross-border transactions allows for extensive connections with...

+52 (55) 5322 3000
Armando Arenas Intellectual Property and Litigation Attorney Olivares Law Firm Mexico City
Partner

Armando Arenas joined OLIVARES in 2000 and became a partner in January 2017. He has experience working on a range of IP matters, including consulting and litigation on trademark, patent, unfair competition, trade dress protection, and misleading advertising cases before the Mexican Institute of Industrial Property (IMPI), Federal Court of Tax and Administrative Affairs (FCTA), Federal Circuit Courts (FCC) and the Supreme Court of Justice (SCJ) Regulatory Affairs and Public Acquisitions. Mr. Arenas is especially adept in patent litigation and protection under Mexico’s patent linkage system...

+52 (55) 5322 3000 Ext. 3906
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