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.
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.
Regulatory Body - COFEPRIS
The regulatory body in Mexico responsible for the registrations is called COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios).
Pharma Prescription Drugs
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.
Consumer Healthcare Drugs/OTC
The Consumer Healthcare and OTC drugs registration process in Mexico does vary from registration processes in Europe, Asia as well as from neighbour 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.
Medical Devices
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.
Food Supplements/Nutraceuticals
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.
Cosmetics and Derma
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 odours 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.
Photo by Robbie Herrera on Unsplash
Frequently Asked Questions from clients – Regulatory Affairs
- FAQ - Prescription Products
- FAQ - OTC Products
- FAQ - Medical Devices
- FAQ - FS and Neutraceuticals
- FAQ - Cosmetics and Derma
- 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?
- 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?
- 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?
- 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?
- 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?