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COFEPRIS Prior Sanitary Import Permit for Food Supplements in Mexico

COFEPRIS Import Permit Food Supplements Mexico
COFEPRIS Import Permit Food Supplements Mexico

Introducing food supplements into the Mexican market requires adherence to health legislation and regulatory processes overseen by the Federal Commission for Protection against Sanitary Risks (COFEPRIS). For the food supplements manufactured oversees and are to be imported into Mexico, obtaining Prior Sanitary Import Permit 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 COFEPRIS Submission:

  • Format of Authorizations, Certificates, and Visits: A duly completed application form is essential for initiating the process- Original

  • Proof of Payment of Rights: Payment of fees, as per the Federal Law of Rights, should be submitted along with the application – Original and 2 copies

  • Health Certificate: This certificate, along with its copy, serves as evidence of compliance with health legislation – Original and copy

  • Certificate of Free Sale: A copy of the certificate, along with its original, is required for comparison purposes – Original and copy

  • Physicochemical and Microbiological Analysis: Submission of original and copy of analysis reports for each batch of food supplements is necessary. Original and copy

  • Additional Specific Analysis: Depending on the nature of the product, specific analyses may be required, such as heavy metal determination, Vibrio cholerae analysis, or peroxide index determination.

  • Label of Origin: The original label indicating the product's origin must be provided.

  • Label in Spanish: The label with which the product will be marketed in Mexico should be submitted in its original form.

COFEPRIS Import Permit Submission Process:

Once all required documents are compiled, there are several options for submitting the application to COFEPRIS:

  • Online Submission: Applications can be submitted online through the designated portal. However, electronic signatures are mandatory for online submissions.

  • Face-to-Face Submission: Applicants can schedule an appointment to submit their application in person at the COFEPRIS office in Mexico City. Appointments can be made online or via the COFEPRIS Call Center.

  • Integral Service Centers: For assistance with form filling or clarification of requirements, applicants can visit the Integral Service Center or contact the COFEPRIS Call Center.

  • Courier Service: Alternatively, applications can be sent via courier to the COFEPRIS Comprehensive Service Center. A prepaid courier guide should be attached for sending the response.

COFEPRIS Operating Hours and Contact Information:

COFEPRIS operates from Monday to Friday, with specific hours for different procedures. For queries or assistance, applicants can contact the COFEPRIS Call Center at 01 800 033 5050.

COFEPRIS Fees for Sanitary Import Permit:

The fee for obtaining a prior Sanitary Import Permit for food supplements is $5,770.79 MXN.



Prior Sanitary Permit for the Import of Food supplements

$5,770.79 MXN

Navigating the process of obtaining advertising permission for food supplements in Mexico requires meticulous attention to detail and adherence to regulatory requirements. By understanding the necessary documents and submission procedures outlined by COFEPRIS, applicants can ensure a smooth and compliant process, facilitating the introduction of their products into the Mexican market. For further assistance or inquiries, applicants can reach out to COFEPRIS or seek guidance from regulatory experts like Artixio.

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