September 28, 2021

Volume XI, Number 271

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September 27, 2021

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Mexico Amends the Health Law Regulations with Impact in the Approval of Medicines

Last May 31, 2021, the Ministry of Health issued a decree in the Official Gazette, amending several articles of the Health Law Regulations. The most relevant points of this decree were the following:

  • COFEPRIS allows the submission of documentation in English, without translation into Spanish within sanitary approval applications. In the case of documents issued by a foreign Authority, they must be legalized.

  • The labels of products destined for the public sector must now be differentiated from those of the private.

  • For the approval of biocomparable medicines, the participation of the Subcommittee for the Evaluation of Biotechnological Products was eliminated, now it is sufficient the New Molecules Committee opinion.

  • Clinical studies in the country of origin of biocomparable medicines can be submitted as evidence for the Marketing Authorization application. When applying for a renewal of the Marketing Authorization, clinical studies in Mexico must be submitted.

  • The first extension must be requested 5 years after the approval and must be resolved within 120 days.

  • To obtain the first Marketing Authorization renewal, all products will be monitored by the regulatory agency, taking into account the effects of the product during its first years in the market.

  • For further renewals must be requested/ informed to COFEPRIS every five years, and no later than 150 calendar days before the expiration of the Marketing Authorization.

  • The statutory terms regarding applications to modify the Marketing Authorization have changed, the regulatory agency shall issue a response within 45 days for technical modifications and 20 days for administrative modifications.

  • If the modification of the Marketing Authorization is authorized, the holder will have a period up to 240 calendar days to eliminate the stock of the product.

These amendments to the Health Law Regulation, in general, are focused on improving the analysis and resolution of various processes.

© 2005-2021 OLIVARES Y COMPAÑIA S.C.National Law Review, Volume XI, Number 159
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About this Author

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
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...

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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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