The National Health Surveillance Agency (ANVISA) is the body in charge of registering medicines in the national territory. And in this week's blog we will generally address the steps to obtain the registration of your medication.
What you will see in this blog:
Any pharmaceutical product obtained or technically developed and which has a diagnostic, therapeutic or palliative purpose is called a medicine. Thus, regardless of the nature of the product (vegetable, animal, mineral or synthetic), any product for which there are therapeutic claims must be considered a medicine and requires registration with ANVISA to be manufactured and marketed.
However, in order to register a medication with ANVISA, the company that will request the registration must first be regularized. This regularization consists of obtaining the Operating License (LF), followed by obtaining the Company Operating Authorization (AFE). After these steps, the regularization of the product will begin.
The Operating License is a document issued by the Sanitary Surveillance (VISA), which authorizes the operation of a company's activities, when its compliance with legal and regulatory requirements corresponding to the activity to be carried out is verified.
At this stage, the establishment must adapt its structure in accordance with the prerequisites established by law for the activity to be carried out, in order to subsequently request the inspection of a VISA inspection agent, who will assess whether these conditions have been met and request the issuance of the Operating License.
The Operating License is necessary and indispensable for the next step, which is the application for the Company Operating Authorization.
The Company Operating Authorization (AFE) 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 medication with ANVISA.
This authorization consists of permission from ANVISA for the company to carry out activities related to drugs or pharmaceutical supplies. The document, which will be published in the Federal Official Gazette (DOU), must be requested to start activities 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.
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.
Any medication fits the obligation to present the Certificate of Good Manufacturing Practices. This document will prove that the company meets the requirements established in Resolution RDC No. 658, of March 30, 2022
The Medicine Registration is a document issued by ANVISA, legalizing the commercialization of the same. In order to acquire the registration, it is necessary for the Agency to evaluate the administrative and technical-scientific documentation related to the quality, safety and efficacy of this medicine. After presenting this documentation, 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 be presented, such as: composition, instructions for use, clinical studies, leaflet, label, among others. Therefore, all of these must be met in order to register your medication with ANVISA.
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