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


A new regulation for herbal medicines was published 1 April 1994 by the Ministry of Health [77], according to which, herbal medicines are medicines which contain as active ingredients only plants or preparations of plants. The regulation does not apply to plant products used in food or beverages and which are regulated as such, unless indication claims are made or they are advertised as medicines, in which case they are regarded as medicines and have to fulfil the requirements of the regulation.

The regulation contains a detailed description of the requirements of the dossier which comply with the European legislation. The dossier has to be submitted to the National Pharmaceutical Office (EOF) which will grant or reject the registration. Furthermore, there are detailed instructions for the content of the package leaflet and labelling [77].

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