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Brazil Considers New Regulatory Framework for Traditional Medicine Products, Seeks to Streamline Various Administrative Procedures

The Brazilian Health Agency (ANVISA) has announced its intention to develop a specific regulatory framework for traditional health products subject to sanitary oversight. The goal of this process is to develop rules for complementary and alternative therapy products that currently are not subject to clearly defined health criteria. Traditional Chinese medicine products have been subject to more specific rules since 2014, when ANVISA established monitoring requirements for these products, although no specific registration and notification provisions were specified at the time.

ANVISA envisions the establishment of a working group that will have 120 days to present a regulatory proposal for traditional health products, including traditional Chinese medicine products, Bach flower remedies and certain other products. ANVISA believes the new regulatory framework for these products should include provisions related to product composition, labelling and manufacturing, so that these products can be marketed to the public without having to obtain prior registration or authorisation. In that way, the focus on the new regulation would be on the supervision and monitoring of the products available on the market.

Separately, ANVISA has updated through Resolution RDC 250/2018 the current regulatory requirements for regulated personal care and cosmetic products by allowing manufacturers to submit to the agency various labelling alternatives for the same product. Previously, every single change in labelling, including modifications to non-sanitary features such as promotional slogans and colours, had to be submitted to and approved by ANVISA. Moreover, it was not possible for a manufacturer to have more than one label for the same product. ANVISA believes the updated rules will increase the efficiency of the personal care and cosmetics sector and reduce overall costs.

Finally, ANVISA is conducting a public consultation process aimed at further simplifying administrative requirements and eliminating onerous provisions and practices. The agency has also issued guidelines to measure administrative burdens in the area of sanitary oversight based on principles put forward by the European Commission.

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