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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. 10 Directive 2004/24/EC introduced a registration scheme for traditional herbal medicines and requires herbal remedies sold over the counter in the UK to be registered. 2012/1916). 2012/1916).

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