A introduction history of Use of Traditional Herbal Medicines

3.3

Individual countries (Calixto, 2000)

3.3.1

France

The French Medicines Agency (Agence du Médicament) grants marketing autho-

rizations based on abridged dossiers by making reference to traditional use. The

shortened procedure requires limited or no pharmacological, toxicological and clinical

tests and is detailed in the Agency Instructions No. 3. The list of drugs with accepted

traditional uses was first published in 1985 by the Ministry of Health and has sub-

sequently been revised several times (Table 5). Traditional use of approximately 200

herbal drugs or preparations derived from these drugs has been recognized for minor

indications. Agency Instructions No. 3 includes rules for labelling and packaging of

herbal medicinal products. If the drug is not specifically included in the list, there is no

option to use an abridged procedure (AESGP, 1998). As of 1997, local medicinal plants

were on the A list of the French Pharmacopoeia (Castot et al., 1997) which groups the

454 herbs which benefit/risk ratio is considered as positive when traditionally used.

SOME TRADITIONAL HERBAL MEDICINES

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