How to register formulas for enteral nutrition?

It is a therapeutic option for feeding people who cannot or will not be able to ingest enough food orally to maintain their health.

Enteral nutrition is given to patients through a thin, flexible tube that carries the liquid diet directly to the  stomach or intestines.

It can be inserted through the nose or mouth, or it can be implanted through a surgical procedure performed in the stomach.

To register enteral nutrition formulas with the National Health Surveillance Agency (ANVISA), it is necessary to follow the required requirements, be aware of the agency's specific criteria, and correctly fill out the electronic petition form. With these measures, it is possible to ensure a fast and efficient registration, allowing the commercialization of the formula with safety and reliability.

After filling out the form, it is necessary to wait for ANVISA’s analysis. If the formula meets all the required requirements, the registration will be granted and the formula can be marketed.

To register enteral nutrition formulas with the National Health Surveillance Agency (ANVISA), the following steps should  be followed:

- The labeling statements must be correct;
- A copy of the health permit or  equivalent valid document must be available;
- Stability tests of the formula under specific storage conditions are required;
- The Technical Dossier, must contain information about the formula, such as composition, physical-chemical characteristics, stability test results, safety and efficacy data, among others.

All the requirements for registering the formula with ANVISA must be met.

Stone Okamont has expertise in regulatory procedures with the National Health Surveillance Agency (ANVISA) and other regulatory agencies. With expert consultants and with years of experience in regulatory affairs, we can help your company avoid wasting time registering enteral nutrition formulas with ANVISA.