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Brazil – Regulatory Affairs

Brazil is the 5th largest OTC & Pharma market in the world and the biggest one in Latin America. Market access is not too difficult, but you might need a good network. With a reduction of more than 36% on the average time, Brazil’s regulatory agency has been optimizing and updating the pre-market registration in order to speed up the process.

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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 Brazil & 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 Brazil 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 Brazil 2. A full overview of Medical Devices registration timeline and costs in Brazil
1. Brazil Registration Process – Tips & Tricks
2. Brazil Registration Process – Time & Cost

Ministry of Health in Brazil

The regulatory body in Brazil responsible for the registrations is called ANVISA (Agência Nacional de Vigilância Sanitária). Click here to go to the official website of ANVISA 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 Brazil differs from other countries. Having several different categories of drugs, Pharma regulatory in Brazil might seem a bit overwhelming at first. The pharma/prescription drug registration process can be complex and easy at the same time depending on the experience and network with ANVISA and other local experts. Below we have listed the questions that our clients usually have with regards to Pharma drug registrations in Brazil:
  • Will my existing BE studies be accepted in Brazil?
  • What are the important things to take understand with regards to trademarks by ANVISA in Brazil?
  • Can my home company act as a MAH in Brazil?
  • What is the difference in a climate zone for stability studies in Brazil vs. Europe and Asia?
  • Is the fast track registration process possible for my products in Brazil and what to be aware of?
  • What are the pharma/prescription drug registration costs and time in Brazil?
Contact us about your questions on your Pharma and medicine registration in Brazil!

Consumer Healthcare Drugs/OTC

Overview The Consumer Healthcare and OTC drugs registration process in Brazil varies from registration processes in Europe, Asia as well as from neighbor countries in Latin America. The regulatory requirements will depend on the category of the drug. Those that offer low risk to the consumers and are included on ANVISA’s list are exempt from registration and only need to comply with the procedure of notification, a process that requires the submission of fewer documents and is much faster. With our long-term experience and network with ANVISA in Brazil, we can offer a relatively fast registration process for Consumer Healthcare drugs in Brazil. Please see below the questions that our clients usually have on the Consumer Healthcare & OTC drugs registration process in Brazil:
  • How many trademarks should be suggested to ANVISA and why?
  • How can my own company be MAH in Brazil for my products?
  • What are the Consumer Healthcare Drugs/OTC registration costs and time in Brazil?
  • How to register Herbal and Phyto OTC drugs in Brazil via 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 Brazil?
  • Is a fast track registration process available in Brazil and what to make sure of?
Contact us to learn more about Consumer Healthcare Drug/OTC registration in Brazil!

Medical Devices

Overview The official definition of Medical Devices in Brazil by ANVISA is: “Healthcare product, such as equipment, devices, materials, articles, or systems for medical, odontological, or laboratory use or application, intended for prevention, diagnosis, treatment, rehabilitation, or anti-conception and that does not use pharmacological, immunological, or metabolic means to fulfill its main function in human beings, but can have its functions assisted by such means.” It is important to have an expert understanding of the differences in the Medical Device process and definitions in Europe, the US, Asia, and throughout Latin America. In general, a Medical Device registration process in Brazil 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 Brazil with ANVISA:
  • What is the difference between Medical Device registration and definition in Brazil vs. Europe, US, Asia and throughout Latin America?
  • Is my product considered a Medical Device by the laws of ANVISA in Brazil?
  • What are the important differences in trademark registration in Brazil with regards to ANVISA for Medical Devices?
  • Are local clinical trials necessary in Brazil?
  • Can my company act as a MAH in Brazil?
  • Climate zone for stability studies in Brazil
  • Is a fast track registration process available in Brazil and what to be aware of?
  • How difficult is the registration of Medical Devices in Brazil?
  • What are the Medical Devices registration costs and time in Brazil?
  • To which class of Medical Devices does my product belong?
Contact us to learn more about Medical Devices registration in Brazil!

Food Supplements/Nutraceuticals

Overview ANVISA has an official definition of Food Supplements/Nutraceuticals in Brazil:  “Food supplements are products for oral ingestion, presented in pharmaceutical forms, intended to supplement the diet of healthy individuals with nutrients, bioactive substances, enzymes or probiotics, alone or in combination.” In general, a Food Supplements/Nutraceuticals registration process in Brazil is relatively fast and easy. ANVISA has a list of ingredients that are allowed in the products, along with their minimum and maximum quantities. Depending on these ingredients, the product might be exempt from registration. The questions that our clients usually ask about the Food Supplement registration with ANVISA in Brazil:
  • How to register claims on the pack for Food Supplement in Brazil with ANVISA?
  • Why trademark registration in Brazil can be a very difficult task with ANVISA?
  • Can my company act as a MAH in Brazil for Food Supplement?
  • What Climate zone for stability studies do I need for Food Supplement in Brazil?
  • How difficult is the registration of Food Supplements/Nutraceuticals in Brazil?
  • What are the Food Supplements/Nutraceuticals registration costs and time in Brazil?
Contact us to learn more about Food Supplements/Nutraceuticals registration in Brazil!

Cosmetics & Derma

Overview The ANVISA’s official definition of Cosmetics in Brazil is: “Personal hygiene products, cosmetics and fragrances are preparations made from natural or synthetic substances, for external use in various parts of the human body, skin, hair, nails, lips, external genitals, teeth and mucous membranes of the oral cavity, with the sole or principal purpose of cleaning, perfuming, altering and correcting bodily odors and/or protecting or keeping them in good condition.” Cosmetic product registration in Brazil is relatively fast and easy. Most products are considered exempt from pre-market approval, meaning you can commercialize them before receiving the certificate by ANVISA. The questions that our clients usually ask us about cosmetic and derma registrations in Brazil with ANVISA are the following:
  • How to register claims in Brazil for Cosmetics with ANVISA?
  • Why is the trademark registration for Cosmetics and Derma products a big topic in Brazil?
  • Can my company act as a MAH in Brazil or do I need a local partner for registration?
  • What are the important topics about climate zone for stability studies in Brazil?
  • Is a fast track registration process available in Brazil and what to be aware of?
  • How difficult is the registration of Cosmetics in Brazil?
  • What are the Cosmetics registration costs and time in Brazil?
Contact us to learn more about Cosmetics registration in Brazil!