June 14, 2021

Volume XI, Number 165

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June 11, 2021

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New Guidelines for temporary authorizations for health supplies that contribute to the eradication and mitigation of the SARS virus CoV2 (COVID-19) in Mexico.

These guidelines were published recently in the Official Gazette. The Mexican Federal Commission for the Protection against Sanitary Risks (COFEPRIS) will follow the extraordinary measures in the processes of submission, evaluation and authorization of health supplies and health care establishments, including the temporary certification of good manufacturing practices for establishments that contribute to the eradication and mitigation of the COVID-19.

These guidelines are also focused on the conditions for those establishments interested in the production of medicinal gases (oxygen) or those which would carry out primary conditioning such as filling oxygen tanks (of medical grade) and those applicants to obtain temporary production and / or import authorization and marketing of invasive ventilators, diagnostic tests, concentrators of oxygen, antibacterial gel, sterile masks (mouth covers), thermometers and oximeters.

It is worth highlighting that among the extraordinary measures within this guideline is that COFEPRIS would be able to review of good manufacturing practices for establishments through video conference calls. For the authorization of products (i.e., medicines or devices) a letter indicating the request for authorization of emergency use is required.

COFEPRIS shall respond any application under these guidelines in a term 10 (ten) working days counted from the time of submission of an application.

The authorizations issued under these Guidelines are of a temporary nature. In other words, if the holder of the authorization intends to continue conducting the activities, a further application should be filed within a period that does not exceed 24 months after the submission date of the emergency authorization.

In conclusion, these guidelines seek to streamline requirements and facilitate the eventual approval of products or authorizations for establishments that will contribute to the eradication and mitigation of the COVID-19. Also, the timeline is being reduced in order to expedite the granting of the corresponding authorization.

© 2005-2021 OLIVARES Y COMPAÑIA S.C.National Law Review, Volume XI, Number 117
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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...

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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...

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Armando Arenas Intellectual Property and Litigation Attorney Olivares Law Firm Mexico City
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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...

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