Herbal Medicines

Herbal medicines use plant raw material —aside from isolated substances—for preventive, therapeutic, or palliative purposes, including herbal medicine and traditional herbal products.

The phytocomplex, also known as the IFAV (vegetable active pharmaceutical ingredient), is the set of all substances derived from primary and secondary metabolism, jointly responsible for the biological effects of a medicinal plant or its derivatives.

The Herbal Medicines standard refers to both Herbal Medicine (MF) and Traditional Herbal Medicine (PTF).

The main difference between these two classes is that MF proves its safety and efficacy through clinical studies, while PTF proves safety and effectiveness by demonstrating the time of use in the technical-scientific literature.

To be made available for consumption, both the MF and the PTF will have to present similar quality requirements, differing in the requirements for proof of safety and efficacy/effectiveness, package inserts/informative leaflet, packaging, restriction of use and Good Manufacturing Practices and Control (BPFC).

A phytotherapic can only contain IFAV; it is not one if it contains isolated or highly purified active ingredients, whether they are synthetic, semi-synthetic, or natural, or if they are combined with other extracts, including those from vegetable or other sources.

The quality of a herbal medicine must be ensured by controlling all stages of its production, including Good Agricultural Practices (BPA), Good Manufacturing and Control Practices (BPFC) and the manufacture of the herbal medicine.

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