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
 

General aspects

The European Community has developed a comprehensive legislative network to facilitate the free movement of goods, capital, services and persons in the Community. According to Directives 65/65/EEC [30] and 75/318/EEC [31], pharmaceutical products require pre-marketing approval before gaining access to the market. Requirements for the documentation of quality, safety, and efficacy, the dossier and expert reports are laid down in Directive 91/507/EEC [32]. Article 39 para 2 of Directive 75/319/EEC [33] obliged Member States to check all products on the market at that time, with a deadline of 12 years, to determine whether they met the requirements of these directives. Countries have taken different approaches in reviewing phytomedicines.

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