This blog gives you step by step to register nutraceuticals in Brazil.
ANVISA, the National Health Surveillance Agency, is the body responsible for regulating various products that are present in our daily lives. The process is fraught with bureaucracy, which can take time and attention.
Despite the difficulty, registering your company and product is a guarantee of success! Recently there was a great increase in the demand for information on how to register nutraceuticals at ANVISA, due to the prominence that this product has been gaining.
Stone Okamont, thinking of helping its customers, created an article that will help you understand the regulatory process! Keep reading and learn more.
What are nutraceuticals?
Nutraceuticals are dietary supplements that contain bioactives with the function of improving a person's health. They have, in isolation, the concentrated form of a compound from a certain food, exceeding the dose that is found in nature.
A good example is omega 3: a compound found in foods, such as fish, and sold in capsule form.
But what does it take to register nutraceuticals at ANVISA? Check out how Stone Okamont can help you!
Operating License to register nutraceuticals with ANVISA in Brazil
Before you can start the nutraceutical registration process with ANVISA, your company must be properly regularized. The first step is to obtain the Operating License!
This document comes from an inspection carried out by the Local Health Surveillance (VISA) at the establishment.
At this moment, the technical and operational conditions required by ANVISA in the manufacture of nutraceuticals are evaluated.
After obtaining the Operating License, it is possible to start the process for obtaining the Company Operating Authorization.
Authorization for the Operation of a Company to register nutraceuticals with ANVISA
The AFE, Authorization for the Operation of a Company, is essential for it to be possible to register nutraceuticals with ANVISA.
In this step, ANVISA analyzes the survey report. If there are no divergences with the legislation, the authorization is published in the Official Gazette.
This documentation is an indication that the company is able to operate and is authorized to start its manufacturing processes.
Register nutraceuticals at ANVISA in Brazil
To register nutraceuticals at ANVISA, it is necessary to prepare a technical dossier containing various information and data about the product.
At this stage, it is important to know the rules of the legislation so that your process is not dismissed.
Did you know, for example, that there are substances that are not allowed? Check out some rules:
I - substances considered as doping by the World Anti-Doping Agency;
II - substances subject to special control,
III - partially hydrogenated oils and fats.
Although there are many details when registering nutraceuticals at ANVISA, please be aware that Stone Okamont professionals are in line with all relevant legislation.
Our job is to deliver your regulatory process with Zero Bureaucracy!
Are there labeling rules for registering nutraceuticals with ANVISA?
Your product labeling must also follow the rules imposed by law.
Some examples of information that should be included:
I - the recommendation for use,
II - the conservation instructions, even after opening the packaging,
III - the identification of the species of each strain, according to the most current binomial nomenclature.
If all recommendations are not followed, your process may not be approved.
Therefore, registering nutraceuticals at ANVISA requires the knowledge and attention that Stone Okamont can offer!
How to obtain nutraceuticals registration with agility and economy?
Stone Okamont is the most comprehensive advisory and consultancy company in regulatory matters in Brazil! We have a personalized service, identifying the needs of each client and proposing the best solutions.
Our professionals are highly qualified to register nutraceuticals at ANVISA! Our Zero Bureaucracy system guarantees ease and savings for our customers.
Want to know more? Contact us and request a budget. Start your process to register nutraceuticals at ANVISA today!
