Authorized Third Parties by Mexican Secretariat of Health


26. February 2021

By Marco Antonio García Euroza. Senior Patent Consultant.

An authorized third party by the Mexican Secretariat of Health comprises a natural or legal person authorized to issue opinions on the fulfillment of requirements established by applicable law, carry out equivalence studies or perform specific tests according to the official Mexican standards.

Authorized third parties are classified according to the activities they perform:

Equivalence entities

These perform clinical or analytical equivalence tests for pharmaceuticals or biocompatibility tests for biologics.

Testing Laboratories

These perform analysis of common use products or different health supplies. The laboratories are approved to perform tests in accordance with the official Mexican standards.

Verification entities

They issue favorable or unfavorable opinions over the adherence of applicable law for healthcare establishments, marketing authorization applications for pharmaceuticals, medical devices, agrochemicals, or advertising activities for several products.

Although the above classification comprises a summary of the activities these authorized third parties may perform, these can be highly specific; for example, a testing laboratory for performing the official Mexican standard No. NOM-092-SSA1-1994, related to the plate count method of aerobic bacteria.

Once an applicant has a favorable opinion from one of these authorized third parties the Mexican Secretariat of Health is required by law to issue the corresponding permit or authorization or license in a short time.

The objective of these authorized third parties is to ease the administrative burden for the Mexican Secretariat of Health and expedite healthcare-related procedures which may otherwise take a long time.

A list of these authorized third parties is publicly available and updated continuously.

Sources: 

Comisión Federal para la Protección de Riesgos Sanitarios, Información General del proceso de Terceros Autorizados, 25/04/2019

Comisión Federal para la Protección de Riesgos Sanitarios, Relación de Terceros Autorizados, 20/01/2021.

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