Mexico’s COFEPRIS
Global Regulatory Partners Mexico: Your Trusted Partner for Market Entry and Compliance
Since 2019, Global Regulatory Partners Mexico—a subsidiary of the GRP Group—has been assisting manufacturers in entering Mexico’s pharmaceutical and consumer markets. GRP provides regulatory support for the market entry of health products regulated by the Mexican Health Authority (COFEPRIS).
GRP-Mexico is based in Mexico City and is COFEPRIS-licensed Local Representative specializing in regulatory compliance, product registration, approval, and commercialization. With deep expertise in navigating regulatory frameworks, we ensure a smooth and efficient market entry process. Our comprehensive regulatory services support a wide range of health products, including pharmaceuticals, biologics, medical devices, cosmetics, and food supplements.
Why Choose GRP-Mexico?
- Local Representation – GRP-Mexico is licensed by COFEPRIS to act as your Local Representative.
- Expert Bilingual Team – Local Based Mexico City team of Regulatory specialists ensure COFEPRIS compliance.
- Licensed Warehousing – GRP’s Authorized GMP COFEPRIS facility for Health Products ( Biologics,Medical Devices, Food Supplements and Cosmetics)
- Authorized Importer – Legally import and distribute products in Mexico.
- Customs & Market Entry Support – Avoid delays and ensure smooth legal access.
- Full Regulatory & Business Support – End-to-end assistance from lawyers and accountants.
The Mexican Health Authority (COFEPRIS) mandates that foreign pharmaceutical and biologic companies without a local presence appoint a Mexican Registration Holder before registering or selling products in Mexico.
Comprehensive Services Provided by GRP-Mexico :
Pre-Market Services:
- Regulatory Strategy & Intelligence tailored for the Mexican market
- COFEPRIS Liaison & Communication, including:
- Consultation meetings for new drugs and biosimilars (NMC meetings)
- Dossier preparation and product registration
- Handling COFEPRIS queries and responses
Post-Market Services:
- Adverse Event Reporting
- Product Release Procedures (QA)
- Importation & Customs Clearance
- Pharmaceutical Warehousing
- Distribution & Market Access
- Product Life-Cycle Maintenance
Additional Services:
- Analytical Transfers (QA)
- Product Release Testing (QA)
- Supplier Audits (GMP)
- Support for Commercial Activities
- Pharmaceutical Trademark Registration
- IMP Importation ( clinical studies)
GRP-Mexico provides expert guidance and full-service support to ensure a smooth and efficient approval process for your medical devices.
Pre-Market Services:
- Local Representation – GRP-Mexico is licensed by COFEPRIS to act as your Local Representative.
- Regulatory Classification & Grouping – Determine the correct classification and grouping for your medical device.
- Medical Device Registration – Prepare and submit COFEPRIS-compliant
- COFEPRIS Consultation & Inspection Support – Organize meetings and assist with regulatory inspections.
Post-Market Services:
- Technovigilance & Adverse Effect Reporting – Ensure post-market surveillance compliance.
- Importation – Manage customs clearance
- Warehousing & Distribution – licensed storage for Medical Devices.
- Product Release – QA Release to the Market.
- Recall & Incident Management – Full support for product recalls and incident reporting.
Expanding into Mexico’s food supplement market requires compliance with COFEPRIS regulations.
Regulatory Requirements in Mexico:
✔ Marketing Authorization or Positive Opinion– Required for herbal, homeopathic, and vitamin medicines manufactured outside Mexico.
✔ Clave Alfanumérica – Mandatory approval for herbal remedies.
✔ COFEPRIS Classification Consultation – Determines if food supplements meet regulatory standards.
✔ Label & Ingredient Compliance – Strict adherence to Article 215 of the General Health Act.
✔ Non-Compliance Risks – Improper classification may lead to customs holds or legal issues.
GRP-Mexico Regulatory Services
- Authorized Local Representative
- Ingredient & Label Compliance Review
- Regulatory Affairs & COFEPRIS Registration
- Advertising Materials Review and Permit Applications
- Importation & Customs Clearance
- Licensed Warehouse for Food Supplements
GRP-Mexico Services Cosmetics
- Authorized Local Representative
- Ingredient Compliance Review
- Label Compliance & Development
- Regulatory Affairs & Product
- Registration with COFEPRIS
- Importation & Customs Clearance
- Warehousing