How to register hormone replacement drugs?

How to register hormone replacement drugs?

Registering hormone replacement drugs can seem a difficult and confusing process, mainly because it is a product that is related to people's health.

To register medication for hormone replacement, it will be necessary to go through all the procedures and steps required by ANVISA. And following all the requirements imposed by the National Health Surveillance Agency (ANVISA), your company and your product will act in safety compliance for end consumers.

If you find it difficult to adapt your company or product to current laws, seek advice. Stone Okamont is here to assist you in the medication registration process at Anvisa in a quick, safe and economical way.


Hormone replacement is a commonly used treatment in menopause to relieve symptoms such as hot flashes, mood swings, among others. It is also used to prevent bone loss.

See what are the necessary steps to register hormone replacement drugs at ANVISA.


1st step: Operating License

Before filing the application to register hormone replacement drugs, the first step is to obtain the Operating License for your facility. It is acquired from an inspection carried out by VISA, that is, the Local Sanitary Surveillance.

The Operating License is an approval document from the local Health Surveillance, approving the technical and operational conditions of your establishment to carry out its activity and taking you to the next step, which is the Company Operating Authorization.


2nd step: Operation Authorization

The Operation Authorization (AFE) is a document issued by ANVISA, published in the Official Gazette (DOU). This document enables your company to carry out its activity for which it was petitioned at the Agency. Obtaining the AFE means that the company operates in accordance with Brazilian legislation and is able to operate throughout the national territory.

The AFE is necessary and indispensable for the next step, which is the application for the CBPF, that is, a certificate of good manufacturing practices.


3rd step: Certificate of Good Manufacturing Practices

To register drugs for hormone replacement, it is necessary to have the Certificate of Good Manufacturing Practices.

The CBPF is the document that certifies compliance with the guidelines of current legislation for the manufacture of a given product. It is one of the most improved parameters in the world, attesting that the establishment complies with Good Manufacturing Practices.

It is issued to prove that the company was instructed and inspected during the manufacturing process. Obtaining it is necessary for the manufacture of medicines and, consequently, for its registration.

In order to register hormone replacement drugs, the Good Practices certificate is required by ANVISA.


4th step: Registration of hormone replacement drugs

Product Registration is the document issued by ANVISA legalizing its sale. From that moment on, the Agency will analyze the petition in the most appropriate way, verifying the documentation presented to certify that the company complies with current legislation and is able to carry out its activities.

In this final step, information about the product is presented, such as: composition material, instructions for use, instructions for disposal, among others. In this way, the petition process must be respected, the mandatory documentation must be attached and the petition must be filed with ANVISA.

All companies that offer products that may be harmful to health, such as medicines, pesticides and cosmetics, need to be up to date with all the regularizations with ANVISA.

How can we help?

To register hormone replacement drugs, Stone Okamont has specialists in regulatory affairs to advise you at all stages and ensure that each process is carried out as quickly as possible at the lowest cost.

Company and product regularization processes are very complicated and bureaucratic, without the necessary knowledge in the area it is practically impossible to complete them without having to redo it several times, thus wasting a lot of time and money.

Contact us! Fill out the form below, talk to one of our professionals and get all your questions answered about how to register hormone replacement medication.

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