COFEPRIS Prior Sanitary Import Permit for Food Supplements in Mexico

Introducing food supplements into the Mexican market requires adherence to health legislation and regulatory processes. The country has the Federal Commission for Protection against Sanitary Risks (COFEPRIS) to oversee them. Food supplements that are manufactured overseas and are to be imported into Mexico require a Prior Sanitary Import Permit (Permiso Sanitario Previo de Importación, or PSPI). It is mandatory. It is a critical step prior to commercialization and distribution of foreign food supplements in Mexico.

Here’s a comprehensive guide to the documents required and the steps involved in securing this permit.

Documents Required for the COFEPRIS Prior Sanitary Import Permit for Food Supplements

Before submitting the application for a sanitary import permit for food supplements to COFEPRIS, the following documents should be prepared:

• Format of Authorizations, Certificates, and Visits: A duly completed application form is required for the process. For COFEPRIS-01-002-A, the 2025 simplification measures eliminated the obligation to physically submit the FF-COFEPRIS-01 form; the required information must still be provided through the applicable online or physical process.
• Proof of Payment of Rights: Payment of fees, as per the Federal Law of Rights, should be submitted. For the applicable submission method, the payment receipt should be provided as required by COFEPRIS.
• Sanitary Certificate or Health Certificate: An original and copy of the Constancia Sanitaria or Certificado Sanitario, where applicable, are required for comparison and return of the original.
• Certificate of Free Sale: Where the import permit application is supported by a Certificate of Free Sale, the applicable original and copy should be provided for comparison and return of the original. The physicochemical and microbiological analyses required for this route must also be provided.
• Physicochemical and Microbiological Analysis: Must be provided for each lot. (where required under the import-permit route that applies).
• Additional Analyses or Certificates: COFEPRIS may require these depending on the nature and origin of the product. The requirements include specific cases involving heavy metals, Vibrio cholerae, peroxide index, and radioactive contamination. These are product-specific requirements.
• Product Labeling: Mexican requirements need to be followed for such products. COFEPRIS reviews it along with the ingredients of food supplements as part of the import-permit process. The 2025 simplification measures eliminated the obligation to physically submit the original label of origin for COFEPRIS-01-002-A.

Who Can Apply for the COFEPRIS Prior Sanitary Import Permit?

The COFEPRIS-01-002 procedure covers two applicant categories:

• Interested party: The person or entity that takes interest in importing the particular food, food supplement, or non-alcoholic beverage.
• Legal representative: An authorized legal representative may also submit the application on behalf of the relevant company or applicant.

For companies importing food supplements commercially, the online procedure also requires registration of the legal representative with the SAT as part of the electronic application process.

COFEPRIS Import Permit Submission Process for Dietary Supplements

The COFEPRIS-01-002 procedure is available online through the Ventanilla Única portal. Applicants must complete the required steps and submit the application electronically with an e.firma.

The online application process involves the following steps:

1. Obtain an e.firma (electronic signature).
2. Register as the company’s legal representative with the SAT, where applicable.
3. Generate the applicable payment assistance form through the COFEPRIS electronic payment system and make the required payment.
4. Convert the required supporting documents and proof of payment into electronic files.
5. Enter the Ventanilla Única portal.
6. Log in as the applicant and select the applicable procedure and modality.
7. Enter the required product and application information and attach the supporting documents.
8. Sign the application electronically using the e.firma and submit it to COFEPRIS

COFEPRIS Validity & Response Time for Food Supplement Sanitary Import Permit

The response time provided by COFEPRIS for food supplement sanitary import permit is 4 business days. Its validity is 30 calendar days.

COFEPRIS Fees for Sanitary Import Permit for Food Supplements

The cost of the sanitary import permit procedure for food supplements is $470-$7041 MXN. The initial amount of $470 MXN = import applications for donations, personal consumption, scientific research, laboratory testing, and exhibition. The applicable $7041 MXN amount = food products, non-alcoholic beverages, and dietary supplements.

How, When, and Where to Pay the COFEPRIS Import Permit Fee?

The applicable fee must be paid before starting the application procedure. COFEPRIS instructs applicants to first obtain the “Help for Generating the Fee Payment Form” through a specific website link and then make the payment at the bank of their choice.

For food supplements, applicants should select the payment reference applicable specifically to dietary supplements, because COFEPRIS uses different payment references for supplements and other products. The current COFEPRIS-01-002 page lists the following:

The references shown by COFEPRIS are valid during the applicable fiscal year, so applicants should verify the current reference when preparing the payment.

Where is the payment made?

The payment can be made at the applicant’s preferred bank, using the payment assistance form generated through the COFEPRIS electronic payment system.

When should the payment be made?

COFEPRIS states that payment must be made before the application procedure is initiated.

Additional Information About the COFEPRIS Import Permit

First, the reference numbers for food supplements and general items differ. So, take care of that during payment. Next, consider the document requirements in Article Two of the agreement. It specifies the characteristics of the required supporting documents for import permit and notification applications.

Conclusion

Getting an import health permit for food supplements allows companies to bring their products into the national territory. They can comply with the current health legislation of the country to commercialize, distribute, and undertake production here. Such compliant products can be used for donation, personal consumption, scientific research, laboratory tests, and exhibitions in the country.

For assistance with food supplement import requirements and COFEPRIS compliance in Mexico, explore Artixio’s nutrition regulatory affairs services in Mexico or contact us at info@artixio.com.

FAQs

Do food supplements require a Prior Sanitary Import Permit in Mexico?

Yes. Food supplements imported into Mexico are subject to a Prior Sanitary Import Permit (PSPI) from COFEPRIS when imported under the applicable commercial import route. COFEPRIS reviews the product’s ingredients and labeling as part of the process.

How long does the COFEPRIS Prior Sanitary Import Permit process take?

The current COFEPRIS-01-002 procedure indicates a response time of 4 business days. The permit, once issued, has a 30-calendar-day validity period, according to the procedure.

Who can apply for a COFEPRIS Prior Sanitary Import Permit?

The application may be submitted by the interested party or their legal representative. For online processing, the applicable electronic-signature and legal-representative requirements must also be fulfilled.