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Regulatory Focus™ > News Articles > Brazil Proposes New Traditional Herbal Products Classification

Brazil Proposes New Traditional Herbal Products Classification

Posted 01 August 2013 | By Louise Zornoza

The Board of Brazil's National Agency for Sanitary Surveillance (Anvisa) approved on 30 July 2013 the launch of a consultation on the creation of a new category of traditional herbal products whose effectiveness and safety could be established through reports of traditional use and literature references.  

Once finalized, the proposal would create two separate categories of products, herbal medicines and traditional herbal products.  

The traditional herbal products would not need to be prescribed. A second consultation will also be launched proposing Guidance for the Registration of Herbal Medicines and Notification of Traditional Herbal Products, which would assist companies in determining the appropriate classification for their products.


Anvisa: Consultation on Herbal Products

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