COFEPRIS and dietary supplements in Mexico
Start with the product formula, claims, and intended use. MexInc Consultants helps you organize the product and importer information needed to review the COFEPRIS path for bringing dietary supplements into Mexico.
What to consider
What to review before importing supplements
Product classification
Review the formula, dosage form, intended use, and marketing claims. The category used in another market may differ from the category that applies in Mexico.
Spanish labeling
Gather the ingredient list, directions, warnings, and current label artwork. Check the proposed Spanish label alongside the formula and claims.
Importer and filings
Confirm who will import and commercialize the product. Review whether the operation needs an Aviso de Funcionamiento and what applies to the prior sanitary import permit (PSPI).
Planning steps
Prepare the product and shipment files
Collect the product details
Start with product names, the full formula, manufacturer details, and existing packaging for each product you intend to import.
Screen the formula and claims
Identify classification and labeling questions before printing packaging or planning inventory.
Define the filing scope
Confirm the responsible entity, the applicable COFEPRIS procedure, and any supporting documents or lot information needed for the intended shipment.
Coordinate import planning
Align the label and filing review with the importer, customs broker, and shipment plan before dispatch.
Common questions
Is an operations notice the same as a sanitary import permit?
An Aviso de Funcionamiento concerns the establishment or activity. A prior sanitary import permit concerns the import itself. Review both separately for the product and operation.
Can I start with my current label?
Yes. Bring the current label and formula for review together, including any claims that appear online or on the packaging.
Next step
Review your supplement import plan
Bring your formula, current label, origin, and intended use in Mexico. Those details help narrow the classification and filing questions.