Administrative or technical?
The Mexican pesticide registration regulation splits the cases. Adding a supplier, or changing its name or address, with no change in the manufacturing site or process of the active ingredient or in the formulation site, is an administrative amendment (article 16, section II). Adding a manufacturer, formulator or supplier that does involve a change in site or process is a technical amendment (article 19, section IV). Adding a toll manufacturer is also technical (section V).
Since the simplification notice of 22 October 2025, the technical route is a single procedure: “Modification of registration of pesticides and plant nutrients by addition of manufacturer and/or toll manufacturer and/or formulator and/or supplier” (procedure code COFEPRIS-06-017).
What you supply as manufacturer
Every technical-route case needs an original supplier's letter, signed, stating the trade and common name of the product, its percentage composition, the supplier's name and address, and the name and address of the buyer, who must be the applicant. It must be issued within the six months before filing and, if not in Spanish, come with a Spanish translation (article 22, section I).
The rest depends on what changes (article 22, section IV):
- 01New manufacturer of the technical: the technical data required by article 12, either the full package (section I) or the equivalence package (section XI).
- 02New site of the same manufacturer or its affiliates: identity, specification table, five-batch analysis and manufacturing route summary (items b.1 to b.4 of section XI) for both the registered site and the new one. COFEPRIS compares one against the other.
- 03New formulator, same active ingredient manufacturer: a sworn letter that the active ingredient manufacturer is the same, plus a certificate of analysis with the active ingredient content and at least one physical property, provided the existing file complies; otherwise, the physical property studies.
- 04New active ingredient manufacturer, same formulator: a letter from the formulated-product supplier stating the change, the identity and composition of the formulation and its draft label, plus the technical data.
- 05Toll manufacturer: a document from the registrant naming the toll manufacturer, the process it will carry out and for how long, a confirming document from the toll manufacturer, and its health licence or licence number.
The 2025 notice removed the obligation to file paper copies of, among others, the health notice or licence, the registration being amended and the toll manufacturer's licence: that information goes into the application form (article first). It lists the same blocks for new manufacturing sites: identity and composition, specification table, final analysis report of the active ingredient and its impurities, manufacturing route summary and, for toxicological equivalence, acute toxicity where applicable. With a letter of access and use of information, toxicological, ecotoxicological, environmental fate, physicochemical and physical property studies are exempt. See the letter of access guide.
The chemistry is the same work as an equivalence dossier: five-batch analysis and technical equivalence.
Timeline
The 2025 notice cut the maximum resolution time for COFEPRIS-06-017 from 90 to 50 business days, effective once the electronic platforms are running (fifth transitory article). Until that reduction is confirmed, plan with the longer figure.
Why your customer cares about timing
If the registration has a single supplier and that supplier stops supplying, the holder must obtain the technical amendment adding a supplier (article 23).
Renewals add pressure. A renewal must be filed no later than 33 business days before the registration expires (article 23 Bis 2), and it is inadmissible if it includes administrative or technical changes not previously authorised (article 23 Bis 1). The eighth transitory article of the 2025 notice allows updating manufacturer, formulator, toll manufacturer or supplier through any amendment or renewal with supporting information; until COFEPRIS clarifies how that fits with article 23 Bis 1, adding the source first is the safer route.
If you would rather hold the registration yourself than supply someone else's, read how registration holding works.
A source that is missing from the registration is a problem your customer usually discovers while preparing the renewal, which must be filed at least 33 business days before expiry. Send us the product list and the registration you want to supply; we reply in writing with the route and what is missing.
Frequently asked questions
Is adding a new supplier always a technical amendment in Mexico?
No. If the manufacturing site and process of the active ingredient and the formulation site do not change, it is an administrative amendment (article 16, section II). If they change, it is technical (article 19, section IV).
How recent must the supplier's letter be?
Issued within the six months before the application, original and signed, with a Spanish translation if written in another language (article 22, section I).
How long does COFEPRIS take to add a manufacturer?
The 2025 simplification notice sets a maximum of 50 business days (previously 90) for COFEPRIS-06-017, once the electronic platforms are running.
Sources
- Mexican Pesticide Registration Regulation (Reglamento en Materia de Registros, Autorizaciones de Importación y Exportación y Certificados de Exportación de Plaguicidas, Nutrientes Vegetales y Sustancias y Materiales Tóxicos o Peligrosos), as amended in the DOF, 13 February 2014: articles 12 (sections I and XI), 16, 19, 22, 23, 23 Bis 1 and 23 Bis 2.
- Simplification notice for COFEPRIS procedures (Acuerdo por el que se establecen acciones de simplificación…), DOF 22 October 2025, articles first, second, third and sixth; fifth and eighth transitory articles.
Informational guide based on public regulations in force on the date shown. It does not replace a review of your dossier.
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