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
 

Spain

The Ministerial Order of 3 October 1973 [89] established a special registration for medicinal plants. Products (1) consisting exclusively of whole, comminuted or powdered medicinal plants or parts thereof have to be registered. Preparations (2) containing a single species or parts thereof which are included in a special list as annex to this order, are exempted and do not need registration.

Medicinal plants with or without obligation for registration (1 and 2) can be controlled by the health authority. For registration of medicinal plants (1), pharmacological and analytical documentation has to be presented including indications, dosage, and the analytical methods. For plants which are not yet included in the list, it is possible to apply for their inclusion [89].

Preparations containing extracts, tinctures, distillates etc., and other galenical preparations, are regarded as medicines which have to fulfil all the requirements of the Spanish Drug Law [90].

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