Mexico starts the New Year with new guidelines to apply for drugs and medical devices marketing authorizations.
January 10, 2024
The Federal Commission for Protection against Health Risks (COFEPRIS) announced the elaboration of two guidelines on prior requirements to the submission of marketing authorizations, one guide for medical device applications and the other for drug applications.
These guidelines are expected to facilitate, standardize and keep updated the criteria for the integration of information into the dossier of these health supplies, to make their content much clearer, and to speed up processes and response and approval times for these applications by the regulatory authority. OLIVARES is updated on the regulatory improvements for health products in our country and in compliance with the needs of our customers we follow up on the implementation of these guidelines.
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Alejandro Luna F.
Alejandro Luna joined 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 Law industry group and coordinates the Litigation Department.
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.
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.