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


In Switzerland medicinal products are classified as follows, depending on toxicity, indications and active ingredient:

List A - restricted prescription
List B - prescription-only
List C - sale limited to pharmacies, without prescription
List D - sale limited to pharmacies and drugstores, without prescription
List E - no restriction as to sales outlet.

The active substances are classified by the IKS (Interkantonale Kontrollstelle für Heilmittel) and published in a positive list (Lists A-E) [93,94]. Products containing these substances are classified by the IKS in the corresponding sales categories (A - E). Products in categories A, B, and C may be sold in pharmacies only, category D in pharmacies and drugstores, and category E in all shops.

For non-prescription medicines, the composition, mode of action, duration of treatment and method of application must be suitable for self-medication, with the possibility of obtaining specialist advice from the pharmacist or pharmacy staff. For these products, medical diagnosis is not required and their use does not need supervision.

Herbal products are considered as medicines and need a product licence. The national marketing authorization procedure for medicines is based on the Intercantonal Convention on the Control of Medicines of 3 June 1971 [95] and regulations implementing this convention and their amendments. According to the Regulations for the Implementation of the Intercantonal Convention on the Control of Medicines of 25 May 1972 (updated 23 November 1995), article 10, applications can only be submitted by a person or company with Swiss residence and with a cantonal licence for the trade of medicines [96].

Abridged applications for herbal medicines are in principle possible. For medicinal products with active substances which are not new chemical entities or which are already contained in registered products, it is not necessary to submit the complete documentation (no toxicological and only reduced clinical data required). Abridged registration for combination products is also possible if the products are comparable with an already registered combination product. Herbal remedies are defined as drugs that contain as declared components only plants, parts of plants or preparations of plants. Homoeopathic medicines or medicines containing isolated or synthetic active ingredients (even if prepared from raw material of plant origin) are not considered to be herbal remedies [97].

In 1992, the IKS published requirements for leaflets on phytomedicines in Lists C and D [98]. A specially adapted leaflet is required instead of the usual patient information. Product information for health care professionals is required only for herbal medicines in List B and for those containing anthraquinone laxatives. The leaflet is intended to guarantee the correct and safe use of the medicine and to give the relevant information to the consumer in an understandable manner. The leaflet should be in the three official languages (French, German, Italian) and must be approved by the IKS. Its language should be patient-friendly, avoid scientific and foreign words and be printed in minimum 8-point characters. Chapters should not be introduced by titles but by interrogative sentences such as "When should ... not be used or be used with caution?".

With respect to the therapeutic indications, the following standard sentences should be included in the leaflet if no clinical data on therapeutic efficacy are available:

- pharmacological properties: "(the following properties...) have traditionally been attributed to (the constituent plant(s))"

- instruction for use: "... is used in case of...".

If, on the other hand, efficacy has been clinically proven, the properties and use are described as follows: "The constituent plant(s) are effective in ..." and "the product is effective in ..." [98].

Regarding combination products, the Swiss regulations are rather restrictive. In 1990, the IKS issued recommendations for combination products which also partly apply to herbal medicines:

- Combination products should contain only few active ingredients in a suitable dose.

- Each ingredient must have a justification, i.e., it is only accepted if it contributes to the efficacy or improves the formula.

- After major modifications (deletion, reduction, exchange of active substances), a combination product should reapply for marketing authorization. Minor modifications (e.g., elimination of one active ingredient or reduction of its quantity, exchange of excipients) may be treated as a "reformulation" (not requiring a new marketing authorization) [99].

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