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Information on Drug Access in the Brazilian and Latin American Market.

Aug,2022

Learn more about ANVISA:

Created by law nº 9,782 of January 26, 1999, the National Health Surveillance Agency (ANVISA) is an autarchy under a special regime, which has its headquarters and jurisdiction in the Federal District and is present throughout the Brazilian territory.

Designed to be an institution that promotes health, citizenship, and development, which acts agile, efficient, and transparently way, consolidating itself as a protagonist in the field of regulation and sanitary control nationally and internationally.

With approximately 29,799* medicines registered, ANVISA is the government entity responsible for the drug registration process in Brazil and the approval of products and services subject to sanitary surveillance.

Keep the national regulatory framework modern and up-to-date and ensure that the Brazilian context is part of the elaborate international references that will guide the regulation of products worldwide. ANVISA is also active in the economic sphere, monitoring drug prices and participating in the Medicines Chamber (CMED).

With approximatey 29,799* medicines registered, ANVISA is the government entity responsible for the drug registration process in Brazil and the approval of products and services subject to sanita

Keep the national regulatory framework modern and up-to-date and ensure that the Brazilian context is part of the elaborate international references that will guide the regulation of products worldwide. ANVISA is also active in the economic sphere, monitoring drug prices and participating in the Medicines Chamber (CMED).

When the subject is the release of an unregistered medication for a person with a rare disease, ANVISA may allow under exceptionalism the import of an international drug registered with another regulatory authority.

The Agency also informs that the requirements for drug registration in Brazil, in general, are similar and compatible with the international requirements of other agencies, such as Europe, the United States,
and Canada.

In addition, with the Ministry of Industry, Foreign Trade and Services, ANVISA controls ports, airports, and borders in matters related to health surveillance.

To support laboratories that wish to work or already work in Latin American countries, Multicare has developed a broad service platform, which ranges from dossier evaluation, pre-registration, and commercial promotion of products in the desired markets, in addition to having all the necessary licenses and capacity for drug registration in Brazil.

Multicare is a company focused on licensing, importing, selling, and distributing innovative medicines in Latin America for underserved patients and patients with rare and highly complex diseases.

ABOUT MULTICARE

We are the best option for access to medicines for the treatment of rare or highly complex diseases. We have been present in the pharmaceutical market for 37 years and have become a reference in the area of rare and highly complex diseases in the last decade.

Talk to us: bd@multicarepharma.com

Learn more: www.multicarepharma.com

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