Regulatory Framework
Mexico regulates standard cosmetics through a sanitary notice model under COFEPRIS, supported by the General Health Law, health product regulations, and applicable labelling standards. Standard cosmetics typically use the Aviso Sanitario pathway, while products with medicinal positioning or treatment claims may move into a different registration route.
Cosmetic Definition
A cosmetic is generally a substance or preparation for external use on the body, teeth, or oral mucosa, intended to cleanse, beautify, modify appearance, protect, or help control body odour without delivering a pharmacological, immunological, or metabolic action.
Responsible Person Requirements
A foreign brand needs a Mexico-based legal representative or local responsible entity to operate the filing path, hold the local account, manage authority interaction, and support post-market obligations. The local representative should have a valid Mexican legal identity and documentary evidence of its address and authorization.
Compliance Process
- Local Setup
- Confirm the Mexico-based legal representative and prepare core contact and authorization materials.
- Set up the working access needed for the relevant filing environment.
- Operating Notice and Business Readiness
- Prepare the operating notice package, address evidence, authorization letter, and corporate documents for the local filing party.
- Confirm the business scope and local responsibility structure before the product filing begins.
- Aviso Sanitario Filing
- Prepare the formula, artwork, free-sale support, GMP evidence where needed, and the brand authorization package.
- Submit the sanitary notice and retain the filing evidence for customs, distribution, and inspections.
- Market Follow-up
- Track label readiness, import documentation consistency, and any updates needed after filing.
- Maintain a contact point for COFEPRIS follow-up or adverse event communication.
Products that cross into therapeutic or medicinal positioning may require a different route and should be screened before the cosmetic filing starts.
Deliverables
- Mexico market route screening and product boundary review
- Formula and Spanish artwork compliance review
- Aviso Sanitario dossier preparation and filing support
- Authorization letter and free-sale evidence checklist
- Local representative coordination service
- Post-filing document control for customs and inspections
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