16/09/2020

How to register antiasthmatics in Brazil

How to register antiasthmatics in Brazil How to register antiasthmatics in Brazil

Antiasthmatics are drugs to dilate the bronchi and improve control of shortness of breath, there are also some types used for the maintenance of those suffering from asthma or chronic bronchitis.

Anvisa (National Health Surveillance Agency) classifies antiasthmatics as medicines. Every drug has a high degree of risk, so to register antiasthmatics in Brazil it is mandatory to obtain the Certificate of Good Manufacturing Practices - CBPF. CBPF deals with standard procedures, rules and norms determined by Anvisa, in order to establish the quality control of the product development processes, until it reaches the final consumer. Learn more: Certificate of Good Manufacturing Practices.

Anvisa is the Brazilian agency that regulates products such as: sanitizing products, food, medicines, cosmetics and others.

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Do you know what it takes to register antiasthmatics in Brazil? Drug registration is by nature more complex and full of steps. In this content we will present the main points for registering antiasthmatics in Brazil. Check it out!

What do I need to register antiasthmatics in Brazil?

To register antiasthmatics in Brazil, it will be necessary initially to obtain the regularization of the company. It is subdivided into 3 parts: Establishment of physical location, Operating License and Operating Authorization. After completing this step, it will be possible to start the product registration process.

Part 1: Establishment of physical location:

The first step in regularizing a company to register antiasthmatics in Brazil is to establish a physical business location in Brazil following all the guidelines of VISA and Anvisa.

Part 2: Operating License:

The second step to register antiasthmatics in Brazil, begins with obtaining the Operating License. This license is requested from VISA (Local Health Surveillance) of your state or municipality. This step is very bureaucratic and says a lot about the location and physical structure of the company to develop the intended activity. It is the responsibility of the company to adapt its structure following the guidelines of the RDC (Resolution of the Collegiate Board) directly related to the type of product, in this case, medicine and the activity: Manufacturing, distribution, storage and etc. Learn more about: Operating License.

Part 3: Operating Permits:

Operating Permits is the last step to register antiasthmatics in Brazil. This process takes place in Brasília and is analyzed by Anvisa's technical staff. In this phase there are petitions, verification of documents, collection of fees, among others. Each type of category requires specific documentation, it is very important to pay attention to basic documents, as the lack of these can result in summary rejection. Learn more about: Operating Permits.

How to register antiasthmatics in Brazil

To register antiasthmatics in Brazil, it is necessary to have a series of documentation and studies about the product. Safety and effectiveness tests, for example, are required for any product category, thus ensuring that the product performs its function without causing harm to the final consumer. In addition, to register antiasthmatics in Brazil, specific tests and documents will be required, such as: stability tests, labeling, form of administration, adverse effects, overdosing effects and others. Learn more: product registration.

Do you need to register antiasthmatics in Brazil? Talk to those who understand!

Registering antiasthmatics in Brazil is a complex process that requires a lot of knowledge in legislation as well as high interpretive capacity. Count on Stone Okamont to register antiasthmatics in Brazil, a company specialized in regulatory affairs with professionals trained in several areas of expertise.

Don't waste any more time! Fill out the form below, talk to one of our professionals and ask all your questions about how to register antiasthmatics in Brazil.

Editor: Gabriela Batman Carvalho

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