How to register antineoplastic drugs at ANVISA?

How to register antineoplastic drugs at ANVISA?

Antineoplastic chemotherapy is carried out through the intervention of drugs for the treatment of cancer acting at the cellular level, however without specificity, in other words, the drugs do not only destroy tumor cells (BONASSA, 2012).

Follow this blog for more information on how to register antineoplastic drugs with ANVISA?


What you will see in this content:

  • How to register antineoplastics;
  • Operating License to register antineoplastics;
  • How to obtain the Company Operating Permit;
  • Obtaining the Good Manufacturing Practices Certification;
  • Registration of antineoplastic agents at ANVISA;
  • Clear your doubts.

Antineoplastic chemotherapy is widely used in the treatment of cancer. This treatment is used at doses as close as possible to the maximum individual tolerated doses and should be given as often as possible to discourage tumor regrowth.

How to register antineoplastics?

All companies subject to health inspection, which manufacture or sell products that may pose health risks, such as medicines, pesticides, cosmetics, etc., need to be up to date with all regulations with ANVISA.

Only after the company's regularization will it be possible to register its antineoplastics with ANVISA. For this, it is 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, composition material and others.

Operating license to register antineoplastics?

This is the first stage of regularization of the company to register antineoplastics in ANVISA, this part is done with the Visa (Local Sanitary Surveillance) of your municipality or state.

Company Operating Authorization (ANVISA)

The Company Operating Authorization (AFE) is granted by ANVISA (National Health Surveillance Agency) and is one of the most important regulatory steps for the success of your business, as without it it will not be possible to register your antineoplastic medication.

This authorization consists of a permission from ANVISA so that the company can carry out activities directly related to the activity/CNAE specified in the CNPJ, which, in this case, consists of the manufacture of medicines. The granted document, which will be published in the Federal Official Gazette (DOU), must be requested to start any type of activity such as: manufacturing, distributing, storing, transporting, importing or exporting.

At this stage, a petition process must be initiated, which includes document verification, fee collection, among others. Each type of category requires specific documentation and it is very important to pay attention to the base documents, as the lack of any of these documents can result in instant rejection.

Obtaining the AFE means that the company operates in accordance with Brazilian legislation, that is, that it is able to operate throughout the national territory.

Obtaining the Good Manufacturing Practices Certification (ANVISA)

The Certificate of Good Manufacturing Practices (CBPF) is the document that attests to compliance with the guidelines of current legislation for the manufacture of a given product. It is issued to prove that the company was instructed and inspected during the manufacturing process.

In order to register the antineoplastic agent with ANVISA, it is necessary to obtain the CBPF, as products classified as Risk III and IV require, obligatorily, the Certificate of Good Manufacturing Practices issued by ANVISA.

Registration of antineoplastics at ANVISA

The Medicine Registration is a document issued by ANVISA, legalizing the reception of the same. In order to acquire the registration, the Agency must evaluate the administrative and technical-scientific documents related to the quality, safety and efficacy of this medicine. After submitting these documents, in the form of a petition, the Agency will analyze and certify that the company complies with current legislation and is able to carry out its activities.

In this final stage, in addition to the concessions that make up the previous steps, other information about the product will also be presented, such as: composition, instructions for use, clinical studies, leaflet, label, among others. Therefore, in order to register an antineoplastic agent with ANVISA, all these steps must be met.

Don't waste unnecessary time on your way to success. Contact Stone Okamont and facilitate the regularization process for your company and product. Here you will find professionals specialized in this type of procedure. Count on us!

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