How to register inhalable insulin in Brazil

How to register inhalable insulin in Brazil

Inhalable insulin is a fast-acting medication developed for the control of diabetes. Due to its rapid action, the medication must be administered at the time of meals. The use of inhalable insulin does not exclude the use of long-term insulin (subcutaneous syringe).

The drug is not indicated for children under 18, smokers or people who have stopped smoking less than 6 months, people with lung problems such as bronchitis, asthma and others, also cannot use the drug. Its action takes place by aspirating the content to the lungs, resulting in rapid absorption into the bloodstream. In order to use inhalable insulin, it is essential to have the guidance of a doctor, to obtain the correct indication of the dosage in line with the long-term insulin.

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Inhalable insulin is registered by Anvisa (National Health Surveillance Agency) as a new product in the medication category. In order to register inhalable insulin in Brazil, as it is a medication according to its classification, it is mandatory to obtain the CBPF - Certificate of Good Manufacturing Practices. CBPF is mandatory for companies that work with medicines, products classified as risk III - high risk and IV - Maximum risk. These are standards and standard operating procedures that govern all processes through which the product goes. Learn more: Certification of Good Manufacturing Practices.

Anvisa is the Brazilian agency responsible for the regularization of: cosmetics, medicines, food, correlates products and others.

Do you know what it takes to register inhalable insulin in Brazil? Having knowledge of its category and classification is the first step to register inhalable insulin in Brazil. In this content we will briefly present all the regulatory steps necessary to register inhalable insulin in Brazil.

What is needed to register inhaled insulin in Brazil?

In order to register inhalable insulin in Brazil, it is necessary to present tests to Anvisa about safety and efficacy of the drug, in order to ensure that it will perform its function safely and within the expected action period. In addition, information such as: composition, package insert, labeling, form of disposal and other information will be requested. Product registration can be done directly by companies that already have the necessary regularization. See below how to get it!

Company regularization

To register inhalable insulin in Brazil, it is necessary the following steps:

Establishment of physical location: Establish physical location in Brazil following all the requirements imposed by Visa and Anvisa.

Operating License: Process carried out by the local or state VISA (Local Health Surveillance). It is under the responsibility of the company to adapt its establishment in accordance with the RDC (Resolution of the Collegiate Board) related to the activity performed. 

Operating Permits: Process protocoled in Brasília and analyzed by Anvisa. Compilation of documents, collection and fees and verification of petitions are one of the actions that occur at this point in the process. 

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Registering inhalable insulin in Brazil is a complex task that requires a lot of knowledge and experience in interpreting Brazilian legislation. Count on Stone Okamont to help you register inhalable insulin in Brazil.

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