How to register natural products?

How to register natural products?

In today's blog, we're going to talk more about how the process of registering natural products at ANVISA works, and what requirements are required.


What you will find in this blog:

The categories of natural products:

Food supplements:

A food supplement is a product that complements regular food and is intended to provide additional nutrients, such as vitamins, minerals, amino acids, fatty acids, or fiber, which may be lacking or consumed in insufficient amounts in a person's diet. They are designed to provide a concentrated boost of specific nutrients to fill gaps in daily nutrition. They are not considered medications and are not intended to treat, cure, or prevent diseases. Instead, they are meant to complement a healthy and balanced diet.

Herbal Medicines:

Herbal medicines are products obtained from active substances of plant origin, such as medicinal plants, their parts, or preparations, which are used for therapeutic purposes. They are used to treat, alleviate, or prevent different health conditions, and their effects are based on the medicinal properties of the plants used. They can be found in the form of tablets, capsules, syrups, liquid extracts, creams, among others.

How does the registration process work?

Herbal Medicines: For their registration, it is necessary to present scientific studies and evidence that prove the efficacy, safety, and quality of the product, in addition to complying with the specific regulations of each country.

Food Supplements: The requirements for notifying food supplements are generally less stringent compared to herbal medicines. It is common to ask for information about the composition of the product, how to use it, nutritional information, and safety guarantees.

The registration process for natural products may vary depending on the specific regulations in each country. Here are a few examples:

Research and development: Conduct scientific studies and research that prove the effectiveness, safety, and quality of the natural remedy.

Company registration: The company manufacturing the natural remedy must be registered with ANVISA as a drug-producing company and comply with good manufacturing practices.

Document analysis: ANVISA will carry out an analysis of the documentation presented to verify that all information and requirements have been met.

Approval and registration: After completing the previous steps, ANVISA will issue the registration decision if the natural remedy meets all the requirements. A registration number will be issued that will allow the product to be legally marketed.

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