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
Ouvrir ce répertoire et afficher son contenuEurope
Ouvrir ce répertoire et afficher son contenuSouth East Asia
Fermer ce répertoireWestern Pacific
Afficher le documentAustralia
Afficher le documentChina
Afficher le documentHong Kong
Afficher le documentMacao
Afficher le documentFiji
Afficher le documentJapan
Afficher le documentMalaysia
Afficher le documentMongolia
Afficher le documentNew Zealand
Afficher le documentPhilippines
Afficher le documentRepublic of Korea
Afficher le documentSingapore
Afficher le documentViet Nam
Afficher le documentIII. CONCLUSION
Afficher le documentIV. REFERENCES


Legal Status

Therapeutic goods for human use which are imported or manufactured in Australia must be included in the Australian Register of Therapeutic Goods, in accordance with the Therapeutic Goods Act 1989. Traditional medicines also need registration. Alternative medicines are allowed to enter this register at a lower level than many other pharmaceuticals. In some cases, e.g., substances about which there are safety concerns, or products which are claimed to treat more serious medical conditions, a higher level of a pre-market registration will be required. The Traditional Medicines Evaluation Committee (TMEC) was established to provide expertise for the evaluation of non-prescription traditional medicines and to give advice to the authority on their registration. The TMEC is appointed by the Minister and consists of six to nine members who are experts in: the clinical practice or teaching of alternative medicine; pharmacy with expertise in pharmacognosy or plant toxicology; the manufacture of alternative medicines; or who are medical practitioners or who have qualifications and experience in clinical pharmacology [125].

According to general requirements for labels of medicines, herbs are included in the List of Australian Approved Names for Pharmaceutical Substances which is published by the Therapeutic Goods Administration in its edition "TGA Approved Terminology for Drugs" dated January 1993, with amendments. There are also special regulations on the expression of quantity or proportion of active ingredients in drug products, with special requirements for herbal ingredients [126].

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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