This article will introduce you to Anvisa, the Brazilian institution in charge of coordinating and inspecting the health and sanitary conditions of products and services commercialized in Brazil.
The National Health Surveillance Agency was established in 1999 by president Fernando Henrique Cardoso. Linked to the Ministry of Health, the agency coordinates:
- The National Sanitary Surveillance System
- The National Program of Blood and Blood Products
- The National Program of Prevention and Control of Hospital Infections
Anvisa is responsible for monitoring drug prices and prices of medical devices; control and inspection of smoking products; technical support in granting of patents by the National Institute of Industrial Property.
The agency fosters protection of the health of the population by exercising sanitary control over production and marketing of products and services subject to sanitary surveillance, controlling ports, airports and borders and is also linked to the Brazilian Ministry of Foreign Affairs and foreign institutions over matters concerning international aspects of sanitary surveillance.
Its slogan is “to protect and promote health, ensuring hygiene and safety of products and services and taking part in developing access to it”.
Anvisa is responsible for the inspection and regulation of the following products:
- Medical drugs for human use, their active substances and other related inputs, processes and technologies;
- Foods, including drinks, bottled waters and their inputs, packaging, food or drink additives, levels of organic pollutants, residues of pesticides and veterinary drugs;
- Cosmetics, personal hygiene products and perfumes;
- Cleaning products for sanitation, disinfection or disinfestation in domestic, hospital and public premises;
- Kits, reagents and inputs to be used for diagnosis;
- Medical-hospital, odontological, hemotherapy, and laboratory and imaging equipment and materials;
- Immunobiologicals and their active substances, blood and blood products;
- Organs, human and animal tissue for use in transplants or reconstructions;
- Radioisotopes for in vivo diagnostic use, radiopharmaceuticals and radioactive products for use in diagnosis and therapy;
- Cigarettes, cigarillos, cigars and any other type of smoking product, derived or not from tobacco;
- Any products which involve the possibility of risk to health obtained as the result of genetic engineering, by any other procedure or submitted to sources of radiation.
All services involving routine or emergency, hospitalization, diagnostic and therapeutic support services, as well as those services which involve employment of new technology are subject to health inspection by Anvisa, as well as the physical installations, equipment, technologies, premises and procedures used in connection with every phase of the production of goods and products subject to health inspection and enforcement.
Anvisa is also responsible for the approval of products and services subjected to health surveillance for commercialization, implementation and production in the country. It also inspects the environment, procedures, inputs and technologies related to health.
How does it affects business?
Anvisa directly affects imports and exports, as each and every product has to meet its requirements. One example is related to the industry of drugs. Since 2010, every foreign company in the drug sector exporting to Brazil will have its plant evaluated by an Anvisa representative. Each visit costs BRL 37.00,00 and is paid by the Brazilian company who wishes to import. The average time for the procedure to be completed is of eight months at least.
Also, Anvisa provides an exports certificate for those exporting food. This certificate has become mandatory in several countries importing to Brazil. In order to issue this certificate, a declaration proving the commercial export transaction must be presented, among other documents.
The institution is also behind the granting of patents by the National Institute of Industrial Property.
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