Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentACKNOWLEDGEMENTS
View the documentFOREWORD
Open this folder and view contentsI. INTRODUCTION
Close this folderII. REGULATORY SITUATION
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
 

Austria

The Austrian drug law does not distinguish between medicinal products made from chemical substances and those made from plants or natural substances. An abridged registration is possible for certain non-prescription medicines. This is laid down in section 17a of the Austrian Drug Law [40]. This means that with respect to quality and safety a detailed assessment is not performed. A list of active substances and excipients qualifying for the abridged procedure was published in 1989 [41] and was last modified in 1992 [42]. It lists some 500 substances and medicinal plants/parts of plants/essential oils etc., for which the simplified procedure according to section 17a can be used. The requirements for the documents that have to be submitted are listed in sections 15 and 17a of the Austrian Drug Law.

In principle, medicinal products can only be sold in pharmacies. An exemption is laid down in section 59, para 3 of the Austrian Drug Law stating that certain products which do not have any risk are allowed to be sold outside pharmacies, e.g., in drug stores. A list of these products of which many are medicinal plants has been published officially, and contains a description of the medicinal plant/part of plant, the wording for the indication and the dosage recommendation [43].

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