How to register radiopharmaceuticals?

How to register radiopharmaceuticals?

The radiopharmaceutical is the radiation-reaching substances used for diagnostic imaging examination and also for cancer treatment through radiotherapy. Radiopharmaceuticals are formed by radionuclides or radioisotopes.

The registration of this type of product is provided for through Collegiate Board Resolution (RDC) No. 451, of December 16, 2020. Currently there is a list of radiopharmaceuticals that can be notified, however, most of them need a registration at the brazilian National Health Surveillance Agency (ANVISA). 

If the radiopharmaceutical to be registered contains any biological product in its formulation, it will be necessary to obtain the registration number of the biological product according to current legislation. 

This product is a primary radionuclide with marked compounds. To register radiopharmaceuticals will be necessary to obtain the following documents: Operating License and Company Operation Authorization.

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To register radiopharmaceuticals, it’s essential to present tests and reports that prove the safety and efficacy of the product in order to ensure that it will perform perfectly its function without causing any harm to the final consumer.

How to register radiopharmaceuticals?

All companies subjected to sanitary inspection, with products that may offer health risks, such as medicines, pesticides, cosmetics, etc. need to be up to date with all regularizations of ANVISA.

After the company's regularization it’s possible to register radiopharmaceuticals at ANVISA. For this it’s essential to present tests and reports that prove the safety and efficacy of the product, in addition to specific information about the product, such as: accessories, instruction manual, material composition and others.

Operating License to register radiopharmaceuticals

This is the first regularization stage of the company to register radiopharmaceuticals at ANVISA, this part is made with the brazilian Local Sanitary Surveillance (VISA) of your municipality or state.

The Operating License is the first document issued by the Sanitary Surveillance (VISA), regularizing the operation of your company’s activities and ensuring that it respects all the standards established by the corresponding resolution to the activity performed. It's the most important step of the whole process.

This process requires that the establishment adapt its physical structure to receive the inspection of a VISA’s supervisory agent to evaluate the local technical and operational conditions.

Company Operation Authorization to register radiopharmaceuticals

The Company Operation Authorization (AFE) is one of the most important regulatory steps for the success of your business, and for this reason, it’s necessary to count on specialized technical support.

"AFE" is a permission of ANVISA for the company to carry out its activities. The document, which will be published in the brazilian Official Gazette (DOU), must be requested to start activities such as: manufacture, distribute, store, transport, import or export.

In this phase, occur petitions, changes in size, when necessary, collection of fees among others. Each type of product category requires specific documentation, it’s very important to look at the basic documents, because the lack of these can result in an instant rejection.

The next step will be to register radiopharmaceuticals at ANVISA. Obtaining AFE means that the company operates in accordance with brazilian legislation and is able to operate nationwide.

How to register radiopharmaceuticals?

The Product Registration is the document issued by ANVISA legalizing its commercialization. From that moment on, the agency will review the petition in the most appropriate way, verifying the documentation presented to certify that the company is in accordance with current legislation and able to develop its activities.

In this final step, product information such as: material composition, instructions for use, disposal instructions, and more are presented. In this way, the petitioning process must be respected, mandatory documentation must be attached and the petition must be filed at ANVISA.

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