Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentFOREWORD
Open this folder and view contentsI. INTRODUCTION
Open this folder and view contentsAfrica
Open this folder and view contentsThe Americas
Open this folder and view contentsEastern Mediterranean
Close this folderEurope
View the documentGeneral aspects
View the documentAttempts to Meet the Need for Harmonization
View the documentAustria
View the documentBelgium
View the documentBulgaria
View the documentDenmark
View the documentEstonia
View the documentFinland
View the documentFrance
View the documentGermany
View the documentGreece
View the documentHungary
View the documentIceland
View the documentIreland
View the documentItaly
View the documentNetherlands
View the documentNorway
View the documentPortugal
View the documentSpain
View the documentSweden
View the documentSwitzerland
View the documentTurkey
View the documentUnited Kingdom
Open this folder and view contentsSouth East Asia
Open this folder and view contentsWestern Pacific
View the documentIII. CONCLUSION
View the 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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