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Regulatory Focus™ > News Articles > Anvisa to Open Consultation on New Traditional Herbal Product Category

Anvisa to Open Consultation on New Traditional Herbal Product Category

Posted 08 August 2013 | By Louise Zornoza

Brazil's National Agency for Sanitary Surveillance (Anvisa) has announced the opening of a public consultation (34/2013) proposing a new category of traditional herbal (non-prescription) products. The proposal would update the rules for the registration of herbal medicines with a new traditional herbal product class, in which product effectiveness and safety could be established through reports of traditional use and literature references.

Under the proposal, the herbals that could qualify for the new classification are those listed in the Brazilian Herbal Pharmacopoeia and monographs in pharmacopoeias recognized by the agency such as Australia, Canada, Mexico and the European Union. Anvisa anticipates that many currently registered herbal medicines will fit into the new category.

The consultation will be open for comment for 60 days starting August 14, 2013.


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