On August 21, 2026, the Ministry of Health published a new Agreement that replaces the regulatory framework in place since 2012 and will enter into force on November 17, 2026.
Key changes include a new procedure for authorizing unlisted uses, clearer rules for updating the annexes, new maximum contaminant limits, and transitional rules with staggered timelines to bring formulations into compliance. The new framework also strengthens COFEPRIS’s role as an evaluating authority and establishes additional requirements for the industry.
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