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


The Medicinal Products Act [91] also applies to natural remedies. In November 1994, the Medicinal Products Agency issued a guideline "Information on application for authorization to market natural remedies" [92]. This guideline contains detailed requirements and regulations for obtaining a marketing authorization for natural remedies.

According to the Medical Products Agency's Order and guidelines on marketing authorizations for medicinal products, a natural remedy is defined as follows:

- A finished product intended for administration to human beings or animals for the prevention, diagnosis, relief or cure of diseases or symptoms of diseases.

- A natural remedy denotes a medicine in which the active ingredient or ingredients derive from natural sources such as plants or animals, or consist of a bacterial culture, mineral, salt or salt solution. The active ingredients however must not be processed too highly, e.g., constituents may not be chemically modified, produced by biotechnological methods or in a chemically defined isolated form.

A natural remedy must be suitable and intended for self-medication in accordance with tested national traditions or traditions of countries close to Sweden with respect to the drug use. Products for injection and homoeopathic preparations are not covered by the definition [48,92].

A marketing authorization is granted for five years by the Medical Products Agency and may be renewed. The general requirements for medicines of the Medicines Act of 1992 are also applicable to natural remedies. They must have a complete declaration of the contents, an acceptable name, and a clear label. Their manufacture has to follow Good Manufacturing Practice (GMP).

A simplified application procedure, according to Directive 65/65/EEC [30] which describes a bibliographic application, can usually be used. If the use of a preparation has become well established, full documentation of the results of pharmacological and toxicological investigations or clinical trials may be replaced by data from published scientific literature.

The guideline contains detailed requirements for the application dossier and the fees. The documentation should be in accordance with the European Notice to Applicants. The requirements for the documentation on quality take into consideration that natural remedies have special characteristics. For this reason, guidelines for the documentation on quality have been compiled as an annex to the main guideline.

With respect to safety, consideration should be given primarily to the experience of corresponding earlier use of the product or constituents, in which no harmful effects have arisen or been suspected. If satisfactory proof of safety is not provided, then it should be established by means of clinical trials and/or pharmacological and toxicological studies.

As natural remedies are normally intended to treat diseases or conditions suitable for self-medication, the indications depend on the documentation which supports the application. For well documented ingredients for which there is adequate experience, reliable bibliographical data may be sufficient for the efficacy assessment. If the product has not been used traditionally, the application has to be supplemented with a specific product-related documentation, and results of clinical trials and pharmacological studies presented.

Combination products containing several active ingredients need a special explanatory statement in the application. A fundamental precondition for the approval of combination products is that each active ingredient contributes to the overall effect. No restriction has been placed on the number of herbal drugs included in a remedy provided that the documentation is satisfactory with respect to quality, safety and efficacy.

The guideline also contains information on the processing of applications, possibilities of modifications and notifications thereof, and detailed requirements for product information such as labelling and the package leaflet [92].

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