To import dietary supplements into Mexico, it is essential to understand the applicable regulations, particularly the requirement for a prior sanitary import permit.
This permit, issued by COFEPRIS, authorizes the entry of food products, dietary supplements, and non-alcoholic beverages that comply with Mexico’s current sanitary regulations, allowing their commercialization and distribution in the country.
Obtaining this document in place from the early stages of planning is crucial to avoid delays and ensure regulatory compliance.
Information included in the Prior Sanitary Import Permit:
Authorization number
Name and address of the importer (fiscal and operational)
Description of the goods (product name and brand)
Country of origin
Country of provenance
Permit Modalities
Depending on the purpose and/or type of products, this permit may have different modalities, requirements, and even government fee amounts. The three available modalities are:
COFEPRIS-01-002-A – Importation of products: Applies to products intended for commercialization in Mexico.
COFEPRIS-01-002-B – Importation of samples or personal use: Applies to products intended for personal consumption, donations, laboratory testing, scientific research, or exhibition.
COFEPRIS-01-002-C – Importation by return: Allows the entry of products that were previously exported and are being returned to national territory.
The documentation required by COFEPRIS varies depending on the type of product and its intended use. Among the documents that must be submitted under certain modalities are sanitary certificates, certificates of free sale, batch laboratory test results, and product labels, along with other documents that demonstrate the product’s safety, quality, and origin.
Compliance with current agreements and applicable updates regarding food additives—such as colorants, flavorings, preservatives, sweeteners, and enzymes—must also be verified. It is recommended to request a product classification consultation from COFEPRIS as a technical opinion to confirm the applicable regulatory pathway before initiating the import process. For more information about this type of product and its regulation, you may consult the published articles on the regulatory framework for dietary supplements and COFEPRIS´s role in health surveillance.
Once the application is submitted, COFEPRIS evaluates the documentation and issues a resolution. By law, the review period is 5 business days. In the event of a request for modification or extension, the response time is 2 business days. The permit is valid for up to 30 calendar days and may be extended once for the same period, provided that the conditions under which it was originally granted remain unchanged.
Complying with sanitary regulations is essential for the importation of dietary supplements into Mexico. Timely and proper management of the import permit not only ensures regulatory compliance but also minimizes the risk of logistical delays and helps maintain product availability in the market.
Given the possibility of specific requirements based on the type of dietary supplement, it is essential to be well-informed and to follow the process correctly to ensure a smooth importation experience.
Written By:
Dulce Ángel
about ips
Navigating the import of dietary supplements into Mexico can be complex due to specific regulations, particularly the prior sanitary import permit issued by COFEPRIS. Our team is dedicated to providing comprehensive guidance on these key aspects—both nationally and internationally—and their potential regulatory, commercial, and operational implications for your business.
Don't hesitate to contact us at info@insumosparasalud.com if you need assistance in ensuring a smooth and compliant importation process.