Policy
The Ministry of Health published two policies which are the National Policy of Integrative and Complementary Practice (PNPIC) in the Unified Health System (SUS) – MS/GM 971/2006 (Ministério da Saúde/Gabinete do Ministro) and the National Policy of Medicinal Plants and Herbal Medicines (PNPMF, Decree 5813/2006), both of these documents stated the role of medicinal plants and herbal medicines in the Brazil Public Health System. These documents have been encouraging the research pertaining to medicinal plants and herbal medicine and also promoting the safe use of these plants and herbal medicines (mainly from the Brazilian biodiversity origin). This also resulted in the creation of a National Programme on Medicinal Plants and Herbal Medicines (Programa Nacional de Plantas Medicinais e Fitoterápicos, PNPMF). The inter-ministerial Regulation no. 2.960 under the Ordinance No. 1102 in 2010, which formally approved the PNPMF also facilitated the creation of a National Committee of Medicinal Plants and Herbal Medicines with government and non-government representatives to monitor and assess implementation of the programme and policy.
Contact
Ministério da Saúde
Esplanada dos Ministérios Bloco G
Brasilia-DF / CEP: 70058-900
Website: http://www.saude.gov.br/
Laws and Regulations
Registration and regulation of health supplements is provided by ANVISA, (the Brazilian Sanitary Surveillance Agency) established by the Ministry of Health in 1999. ANVISA is similar in many ways to the US FDA. ANVISA requires safety and efficacy verification of all products in the natural health sector before they are allowed to enter the commercial market. The registration process is difficult and expensive, particularly for formulations.
All products are considered drugs if they hold any therapeutic purpose. Certain disease claims (reduced risk) may be made on some nutritional products.
Botanicals have been regulated since 1967 with some of the regulations resembling the legislation for conventional drugs. Herbal products are segmented as herbal drugs, (prescription and over the counter), cosmetics, bioactives and functional foods. Claims may only be made if the product in question is registered as a drug. Presently over 1000 botanical medicines are registered. Herbal regulation has been introduced in 1998 but it differs from the conventional pharmaceuticals.
A post-marketing surveillance program monitors adverse events.
Contact
Ministry of Health
Website: https://www.gov.br/saude/pt-br
http://portal.saude.gov.br/saude/
Standards and Guidelines
Regulation of herbal medicine has existed in Brazil since 1967, and the fourth version of the regulations, RDC 48/2004, was put in place in 2004. It is partly the same as the legislation on conventional pharmaceuticals. Recently, the Ministry of Health published two policies regarding TM/CAM which also resulted in the creation of a National Programme on Medicinal Plants and Herbal Medicines (Programa Nacional de Plantas Medicinais e Fitoterápicos, PNPMF). The inter-ministerial Regulation no. 2.960 under the Ordinance No. 1102 in 2010, which formally approved the PNPMF also facilitated the creation of a National Committee of Medicinal Plants and Herbal Medicines with government and non-government representatives to monitor and assess implementation of the programme and policy.
The regulatory requirements for manufacturing include adherence to the information contained in pharmacopoeias and monographs, and the same rules of GMP as for conventional pharmaceuticals with special rules. GMP certification is encouraged and the implementation of these requirements is ensured through annual inspections.
There are more than 1000 herbal medicines registered in Brazil; none is included on the national essential drug list; however, a list of phytotherapeutic medicines is currently being prepared for inclusion.
Contact
Ministry of Health
Esplanade of Ministries Block G
Brasilia-DF/ CEP: 70058-900
Website: http://www.saude.gov.br/
