Mexico issues new NOM for good manufacturing practices (GMP) regarding cosmetic products.
July 13, 2022
The new NOM for good manufacturing practices (GMP) regarding cosmetic products was published in the Official Federal Gazette on July 5th, 2022. The NOM establishes several requirements that companies must meet when it comes to production and importation of cosmetic products, to guarantee the product´s quality, safety, as well as efficacy.
Firstly, the NOM provides the hygiene requirements relating to the working staff, the sanitary conditions of the facilities, equipment usage, inspection, and reception of raw- and packaging materials, as well as for production operations, transportation, and quality control. The standard furthermore establishes that companies are required to record and document the compliance of the NOM, which must be made available to the health authorities when requested.
Also, the NOM requires companies to have a procedure for dealing with complaints and returns. Such inquires must be investigated, similarly to pharmacovigilance or technovigilance actions, especially those related to toxic or allergenic aspects of the product, for the company to provide the appropriate follow-up.
The NOM itself enters into force on September 2nd, 2022, however, the requirement to document compliance enters into force December 31st, 2022, and the requirements relating to the adequacy of facilities enters into force from March 1st, 2023.
The Secretary of Health and the federal entities oversees the compliance with the standard. We at OLIVARES will be attentive to the entering into force an eventual application of this new regulation to advice our clients.
FOR FURTHER INFORMATION ON THE CONTENT OF THIS NEWSLETTER, PLEASE CONTACT:
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.
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.