Through its Coordination of Herbal Products (COFID), the Brazilian Health Surveillance Agency (ANVISA) has reiterated that the product reclassification as a Traditional Herbal Product (PTF) should be effected only upon the product’s first registration renewal. Article 63 of ANVISA’s Resolution 26/2014 states as follows:

“Art. 63. The products formerly classified as herbal medicines which did not undergo clinical and non-clinical safety and effectiveness tests, and now fall in the category of Traditional Herbal Products (PTF), shall be reclassified as such upon the first registration renewal after the publication of this Resolution, pursuant of art. 2 herein”.

Interested parties have filed label notices requesting said reclassification. This practice has not been accepted by ANVISA, since the correct procedure is to request the reclassification only upon the registration first renewal after the date when Resolution 26/2014 came into force.

Furthermore, label reclassification is not notifiable, in accordance with Resolutions 47/2009, 60/2012 and 38/2014.

COFID is currently examining notifications and identifying companies that filed for the product reclassification before registration renewal. Such notifications will be disregarded and the companies will be contacted by said Coordination.

Considering the first registration renewal after Resolution 26/2014 as the appropriate moment to request the product’s reclassification as a Traditional Herbal Product (PTF), ANVISA understands that companies who have proceeded otherwise should refrain from manufacturing or marketing drugs as a PTF.

In accordance with ANVISA, in case incorrectly labeled drugs have been commercialized, the responsible company must immediately collect all distributed products.

Source: ANVISA website (http://s.anvisa.gov.br/wps/s/r/dBzQ)

 

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