Celebrating 10 years of innovative, global,
Regulatory solutions & services for Life Sciences industry

Medicinal Products Regulatory Support in Mexico

Overview

The “Comisión Federal para la Protección Contra Riesgos Sanitarios” (COFEPRIS) is the key Drug Regulatory Authority in Mexico. Drug department of the COFEPRIS is responsible for handling and licensing of the manufacture, import, export, distribution, promotion, advertising, and pharmaceutical product registration. COFEPRIS is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and for monitoring the quality & safety of marketed medicinal products.

Classification of Medicinal Products

Medicinal products are classified into following categories. 

  • Chemical Synthesis Drugs (New Drug/ New Chemical Entityand Generic Drug)
  • Biological(New Entity and Generic Drug)
  • Biotechnological (New entity and biosimilar)
  • Herbal Medicines

Medicinal Product Registration

Pharmaceutical Product registration is carried out in following steps

Note- For a foreign manufacturer, it is mandatory to have an authorized representative for Mexico Pharma Regulatory services

A) Marketing Authorization

Steps:

  • Submission of the application for ‘’Operation Notice’’ to Centro Integral de Servicios” (CIS)
  • Submission of the Marketing Authorization Application and pharmaceutical dossier preparation
  • Validation, Assessment, Testing and Evaluation by relevant departments of COFEPRIS
  • Review of the product pricing by the Pricing department
  • Review of the approval request by the registration committee to grant Product Licence

B) Verification and Abridged Procedure

This process will be applicable if the product has been approved and marketed by any of the following entities: Health Canada, US FDA, EMA, the Pharmaceutical and Food Safety Bureau (PFSB) of Japan, the Australian Therapeutic Goods Administration or another entity recognized by COFEPRIS. 

C) Waiver of Onsite GMP Inspection

Onsite GMP inspection can be waived if the manufacturing facility is approved by a COFEPRIS recognized entity: Health Canada, US FDA, EMA, the Pharmaceutical and Food Safety Bureau (PFSB) of Japan, the Australian Therapeutic Goods Administration or another entity recognized by COFEPRIS.  

COFEPRIS allows importation of non-registered products for the cases mentioned below:  

  • Essential drugs 
  • Security extraordinary cases

However, before importation, the local agent must obtain an import permit for each shipment from the COFEPRIS for the pharmaceutical product registration.

Product Maintenance & Compliance

Sr. No

Application

Validity

01

Validity for Registration Certificate

05 years from the date of registration

02

Renewal of Registration certificate

The renewal application should be submitted 6 months before expiration of the existing registration certificate

03

Post Approval Changes (Variations)

Any change of registered medicine should be sent to the COFEPRIS with relevant documents, case-by-case basis.

Freyr Expertise

  • Regulatory Affairs consulting and Pharma market access
  • End-to-end Pharmaceutical Product registration 
  • Authorized Local Agent support
  • Pharma GMP compliance support
  • Dossier Gap Analysis as per the COFEPRIS Regulatory requirements
  • Preparation of Gap Analysis report and remediation plan
  • Pharmaceutical Dossier preparation and submission to the COFEPRIS
  • Query Support Management Until Approval
  • Pharmaceutical Life Cycle Management support
  • Pharmaceutical artwork management
  • Ad-hoc Mexico Regulatory consultation

Location

Calle Jose Bernardo Couto 87, Colonia Mexico, Nezahualcoyotl, Estado de Mexico – CP. 57620

CLICK HERE TO VIEW IN MAPS

Quick Inquiry
x