On April 24th, 2026, the Decree was published in the Official Gazette of the Federation, amending Articles 10 and 23 Bis 4 and adding Section XXXII Bis to Article 2 and a new Article 13 Bis to the Regulations governing pesticides, plant nutrients, and toxic or hazardous substances. The amendments introduce test data protection for new agricultural chemical products, update documentary requirements for COFEPRIS registrations, and extend the term of registration renewals.
Key Points of the Decree
New “New Agricultural Chemical Product” Definition.
Section XXXII Bis is added to Article 2, defining a new agricultural chemical product as any pesticide or plant nutrient whose active ingredient has not been previously registered before COFEPRIS. This definition serves as the gateway to the data protection regime established under Article 13 Bis.
10-Year Test Data Protection.
New Article 13 Bis establishes that the safety and efficacy data of a new agricultural chemical product is protected for 10 years from the date of first registration in Mexico. No third party may obtain a registration based on such data without the express consent of the data holder, even where the application relies in part on a foreign marketing authorization. This provision introduces a mechanism analogous to pharmaceutical reference data protection, with direct implications for generic agricultural product market access.
Updated Documentary Requirements for Registration.
The amendment to Article 10 introduces two new requirements for COFEPRIS filings: (i) express consent from the holder of safety and efficacy data when the applicant intends to rely on data from a new agricultural chemical product registered within the past 10 years; and (ii) proof of ownership of a patent in force in Mexico, or evidence of an exploitation license recorded before IMPI. Both requirements directly affect the structuring of registration applications for generic or me-too products.
COFEPRIS Registry Transparency.
COFEPRIS is required to publish and update —at minimum every 30 days— databases of granted registrations and pending applications on its website. This increases market visibility for competitors and facilitates regulatory monitoring by existing registration holders.
Registration Renewal: 10-Year Term.
The amendment to Article 23 Bis 4 sets a fixed 10-year term for registration renewals, preserving COFEPRIS’s authority to review them at any time under the General Health Law.
Transitional Provisions.
The Decree takes effect the day after publication. The Ministry of Health has 180 calendar days to implement the necessary regulatory and administrative adjustments. During that period, prior provisions remain applicable to the extent they do not conflict with the Decree.
