How to register mannitol in ANVISA?

How to register mannitol in ANVISA?

The mannitol solution or also known as 20% mannitol is a drug recommended for stimulating the elimination of urine and preventing the failure of the kidneys that lose the ability to remove and balance fluids in the body, mainly during cardiovascular surgeries and/or after trauma, this medicine has other functions in addition to those mentioned, but the well-defined objective of this blog is to clarify how to register mannitol with ANVISA?

In order to register mannitol with ANVISA, it is first necessary to register with the company that will request the registration. This regularization consists of obtaining the Operating License, followed by obtaining the Company Operating Authorization (AFE). After these steps, the regularization of the product will begin.

To understand the steps to register mannitol with Anvisa, follow the blog, if you have any doubts, click on the button below and our commercial team will contact you, facilitating your process of registering mannitol with Anvisa.


1st Step: Operating License

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 essential for the next step, which is the application for the Company Operating Authorization.


2nd Step: 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 mannitol with ANVISA (National Health Surveillance Agency).

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.

Obtaining the Good Manufacturing Practices Certification

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.


Mannitol registration at ANVISA

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 be able to register mannitol with ANVISA.


Sounds complicated? Talk to those who understand registration at ANVISA! Sound complicated? Talk to those who understand ANVISA registration!

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