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Mexico – Regulatory Affairs

Mexico is the second-largest pharmaceutical market in Latin America and one of the strongest economies in Latin America. Market access is not too difficult, but you might need a good network. Mexico has relatively high pharmacy prices in a number of market segments.


Click on the segment to read more

Pharma/Prescription Drugs

Consumer Healthcare Drugs/OTC Drugs

Medical Devices

Food Supplements/Nutraceuticals

Cosmetics & Derma


Our Services & experience
We have more than 20 years of experience in Mexico & Latin America, we would gladly guide you through the maze of the regulatory affairs with our local network. We will also make sure that the whole registration process of your product in Mexico is very clear to you.

We do not have a standard approach to regulatory affairs, but rather tailor our services to the expectations and needs of our clients.

Some examples: 
1. A very detailed yet easy to understand flow chart with the pharma/prescription drug registration process in Mexico
2. A full overview of Medical Devices registration timeline and costs in Mexico

1. Mexico Registration Process – Tips & Tricks
2. Mexico Registration Process – Fast Track Time & Cost

Ministry of Health in Mexico

The regulatory body in Mexico responsible for the registrations is called COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios). Click here to go to the official website of COFEPRIS

Contact us to get answers to all your individual product and situation questions!


Pharma/Prescription Drugs

Overview

An official definition of Pharma/Prescription Drugs in Mexico differs slightly from other countries. In addition to that, Mexico offers more flexibility in the registration process and the pharma/prescription drug registration process can be complex and easy at the same time depending on the experience and network with COFEPRIS and other local experts.

Below we have listed the questions that our clients usually have with regards to Pharma drug registrations in Mexico:

  • Will my existing BE studies and expected in Mexico?
  • What are the important things to take understand with regards to
    trademarks by COFEPRIS in Mexico?
  • Can my home company act as a MAH in Mexico?
  • What is the difference in a climate zone for stability studies in Mexico vs. Europe and Asia?
  • Is the fast track registration process possible for my products in Mexico and what to be aware of?
  • What are the pharma/prescription drug registration costs and time in Mexico? 

Contact us about your questions on your Pharma and medicine registration in Mexico!


Consumer Healthcare Drugs/OTC

Overview

The Consumer Healthcare and OTC drugs registration process in Mexico does vary from registration processes in Europe, Asia as well as from neighbor countries in Latin America. With our long-term experience and network with COFEPRIS in Mexico, we can offer a relatively fast registration process for Consumer Healthcare & OTC drugs in Mexico.
Different registration categories may be considered for OTC medicine in Mexico such as Herbal Remedies or Medical Devices. This could be a much faster process for registration with medical claims.

Please see below the questions that our clients usually have on the Consumer Healthcare & OTC drugs registration process in Mexico:

  • How many trademarks should be suggested to COFEPRIS and why?
  • Should I consider registering my OTC drug as a Herbal Remedy or Medical Devices?
  • How can my own company be MAH in Mexico for my products?
  • What are the Consumer Healthcare Drugs/OTC registration costs and time in Mexico? 
  • How to register Herbal and Phyto OTC drugs in Mexico via a fast track process and why to prepare the market entry strategy before?
  • What do I need to know about climate zone for stability studies in Mexico
  • Is a fast track registration process available in Mexico and what to make sure of?

Contact us to learn more about Consumer Healthcare Drug/OTC registration in Mexico!


Medical Devices

Overview

The official definition of Medical Devices in Mexico by COFEPRIS is “the substance, mixture of substances, material, apparatus or instrument (including the computer program necessary for its appropriate use or application), used alone or in combination for the diagnosis, monitoring or prevention of diseases in humans or in the treatment of the same and of the disability, as well as those used in the replacement, correction, restoration or modification of the anatomy or human…”
It is important to have an expert understanding of what are the differences in the Medical Device process and definition in Europe, the US, Asia, and throughout Latin America. In general, a Medical Devices registration process in Mexico is relatively fast and easy, if the one has a well-prepared market entry strategy.

The questions that our clients usually ask about Medical Device Registration in Mexico with COFEPRIS

  • What is the difference between Medical Device Registration and definition in Mexico vs. Europe, US, Asia, and throughout Latin America?
  • Is my product a Medical Device by the laws of COFEPRIS in Mexico?
  • What are the important differences in trademark registration in Mexico with regards to COFEPRIS for Medical Devices?
  • Are local clinical trials necessary in Mexico?
  • Can my company act as a MAH in Mexico?
  • Climate zone for stability studies in Mexico?
  • Is a fast track registration process available in Mexico and what to be aware of?
  • How difficult is the registration of Medical Devices in Mexico?
  • What are the Medical Devices registration costs and time in Mexico? 
  • To which class of Medical Devices does my product belong?

Contact us to learn more about Medical Devices registration in Mexico!


Food Supplements/Nutraceuticals

Overview

COFEPRIS has an official definition of Food Supplements/Nutraceuticals in Mexico:  “herbal products, plant extracts, traditional foods, dehydrated or concentrated fruit added or not, vitamins or minerals that may arise in a pharmaceutical form and intended use is to increase total dietary intake, supplement it or replace some component of one’s diet.”

In general, a Food Supplements/Nutraceuticals registration process in Mexico is relatively fast and easy. You may want to consider registering some Consumer Health / OTC drugs in the Food Supplement category. This might be possible under special considerations.

The questions that our clients usually ask about the Food Supplement registration with COFEPRIS in Mexico:

  • How to register claims on the pack for Food Supplement in Mexico with COFEPRIS?
  • Why trademark registration in Mexico can be a very difficult task with COFEPRIS?
  • Can my company act as a MAH in Mexico for Food Supplement?
  • What Climate zone for stability studies do I need for Food Supplement in Mexico?
  • How difficult is the registration of Food Supplements/Nutraceuticals in Mexico?
  • What are the Food Supplements/Nutraceuticals registration costs and time in Mexico? 

Contact us to learn more about Food Supplements/Nutraceuticals registration in Mexico!


Cosmetics & Derma

Overview

The official definition of Cosmetics in Mexico by COFEPRIS is very board:
“Cosmetics in Mexico are products intended to be brought into contact with the parts of the human body to clean, perfume, help and with the principal purpose of cleaning, perfuming, helping to modify their appearance, protecting, keeping in good condition, correcting body odors or reducing alterations in the functioning of healthy skin.“

It might be beneficial to consider registering derma drug products via a cosmetic registration in Mexico. In general, Cosmetic product registration in Mexico is relatively fast and easy.

The questions that our clients usually ask us about cosmetic and derma registrations in Mexico with COFEPRIS are the following:

  • How to register claims in Mexico for Cosmetics with COFEPRIS?
  • Why is the trademark registration for Cosmetics and derma products a big topic in Mexico?
  • Can my company act as a MAH in Mexico or do I need a local partner for registration?
  • What are the important topics about climate zone for stability studies in Mexico?
  • Is a fast track registration process available in Mexico and what to be aware of?
  • How difficult is the registration of Cosmetics in Mexico?
  • What are the Cosmetics registration costs and time in Mexico? 

Contact us to learn more about Cosmetics registration in Mexico!