Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGEMENTS
Afficher le documentFOREWORD
Ouvrir ce répertoire et afficher son contenuI. INTRODUCTION
Fermer ce répertoireII. REGULATORY SITUATION
Ouvrir ce répertoire et afficher son contenuAfrica
Ouvrir ce répertoire et afficher son contenuThe Americas
Ouvrir ce répertoire et afficher son contenuEastern Mediterranean
Fermer ce répertoireEurope
Afficher le documentGeneral aspects
Afficher le documentAttempts to Meet the Need for Harmonization
Afficher le documentAustria
Afficher le documentBelgium
Afficher le documentBulgaria
Afficher le documentDenmark
Afficher le documentEstonia
Afficher le documentFinland
Afficher le documentFrance
Afficher le documentGermany
Afficher le documentGreece
Afficher le documentHungary
Afficher le documentIceland
Afficher le documentIreland
Afficher le documentItaly
Afficher le documentNetherlands
Afficher le documentNorway
Afficher le documentPortugal
Afficher le documentSpain
Afficher le documentSweden
Afficher le documentSwitzerland
Afficher le documentTurkey
Afficher le documentUnited Kingdom
Ouvrir ce répertoire et afficher son contenuSouth East Asia
Ouvrir ce répertoire et afficher son contenuWestern Pacific
Afficher le documentIII. CONCLUSION
Afficher le documentIV. REFERENCES
 

France

Herbal medicines are defined as medicines the active ingredients of which are exclusively plants or plant extracts. In 1987, the Ministry of Health published the first "Avis aux fabricants" (advice to manufacturers) taking into account the fact that the directives of the EC which define pharmacotoxicological and clinical criteria required for a marketing authorization are not applicable for most herbal remedies, and the fact that frequently their efficacy cannot be demonstrated on the basis of bibliographical data. To give a better defined status to plant-based medicinal products, a list was drawn up of vegetable drugs which could be registered according to an abridged dossier. Their safety, with an optimum benefit-risk ratio, was taken into account as well as historical proof of their widespread traditional use and their well established use in self-medication. These guidelines were completed in 1990, and cover applications for marketing authorizations for new products and the validation of products already on the market [51].

This guideline includes a list of 174 plants and parts of plants with approved therapeutic indications, a list of 35 accepted therapeutic indications for minor ailments (17 for oral use, 9 for external use and 9 for both uses) with a low indication level which is introduced by "Traditionellement utilisé dans..." ("Traditionally used in ..."). Furthermore, a list of fixed combinations of plants is available and a special section on laxative herbs. The guideline is completed by a detailed description of the content of the dossier, a list of toxicological recommendations according to the preparations concerned (with special recommendations for laxatives), and rules for labelling and packaging of herbal medicines [51].

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Le Portail d'information - Médicaments essentiels et produits de santé a été conçu et est maintenu par l'ONG Human Info. Dernière mise à jour: le 1 décembre 2019