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Case Study : Ensuring COFEPRIS Regulatory Compliance for Health Supplements in Mexico

COFEPRIS Health Supplements Mexico

Client Background:

The client, an US based health supplement brand, is seeking to expand its market presence into Mexico. With a commitment to upholding the highest standards of compliance and quality, the client recognizes the importance of ensuring that their products meet all necessary regulatory requirements as required by COFEPRIS before launching on prominent e-commerce platforms in Mexico.

Problem Statement:

The client's primary objective is to translate and adapt their U.S. specification health supplement label to comply with the COFEPRIS regulations in Mexico. They require expert assistance to navigate the complex regulatory landscape and ensure prompt compliance to facilitate the launch of their products in the Mexican ecommerce marketplaces.

Artixio Solution:

Artixio, a reputable organization specializing in regulatory compliance for health supplements, was engaged to assist the client in achieving full compliance with Mexican regulations. The following steps were taken to address the client's needs:

  • Initial Assessment: Artixio carried out a comprehensive assessment of the client's U.S. specification health supplement label to identify areas requiring adaptation to comply with Mexican COFEPRIS regulatory requirements. Artixio has reviewed the Formula, intended use and label of the health supplement for COFEPRIS compliance.

  • Comprehensive Regulatory Support: Artixio has provided comprehensive regulatory assistance to the client, covering all necessary regulatory activities for the launch of health supplements in Mexico. This support includes:

    • Acquiring the Official Classification letter from COFEPRIS

    • Document review, application submission, and preparation of necessary documents for obtaining the Prior Sanitary Import Permit

    • Thorough assessment of marketing materials and submission of applications for the Advertisement Permit from COFEPRIS

  • Seamless Coordination: Throughout the entire process, Artixio has served as a seamless liaison between the client and COFEPRIS, ensuring efficient communication and coordination.

  • Translation Services: Professional translation services were employed to accurately translate the label content from English to Spanish, ensuring linguistic clarity and compliance with local language regulations.

  • Regulatory Compliance Review: Artixio conducted a thorough review of the translated label content to ensure alignment with the regulatory requirements stipulated by the Ministry of Health in Mexico. This included verifying ingredient lists, nutritional information, and labeling format.

  • Documentation Preparation: Artixio assisted the client in preparing all necessary documentation for submission of multiple applications and approvals to the COFEPRIS in Mexico, including translated label content, product specifications, and any additional regulatory documentation required.


  • Regulatory Expertise: Artixio's regulatory experts provided invaluable guidance and support in navigating the complex regulatory landscape in Mexico, ensuring that the client's products met all necessary compliance requirements.

  • Timely Compliance: Artixio facilitated the timely submission of applications for Sanitary Import Permit and Advertising Permission along with necessary documents, ensuring adherence to specified deadlines and expediting the compliance process.

  • Market Expansion: With regulatory compliance secured, the client successfully expanded their market presence into Mexico, launching their products on prominent e-commerce platforms and reaching a wider audience of consumers.

By partnering with Artixio, the client achieved their goal of ensuring regulatory compliance for their health supplements in Mexico, paving the way for successful market expansion and continued brand growth in the region.

Contact Artixio Today !

Ready to ensure regulatory compliance for your health supplements in Mexico? Contact Artixio now to discuss your compliance needs and receive expert assistance tailored to your requirements.


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