Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGEMENTS
Afficher le documentFOREWORD
Ouvrir ce répertoire et afficher son contenuI. INTRODUCTION
Fermer ce répertoireII. REGULATORY SITUATION
Ouvrir ce répertoire et afficher son contenuAfrica
Ouvrir ce répertoire et afficher son contenuThe Americas
Ouvrir ce répertoire et afficher son contenuEastern Mediterranean
Fermer ce répertoireEurope
Afficher le documentGeneral aspects
Afficher le documentAttempts to Meet the Need for Harmonization
Afficher le documentAustria
Afficher le documentBelgium
Afficher le documentBulgaria
Afficher le documentDenmark
Afficher le documentEstonia
Afficher le documentFinland
Afficher le documentFrance
Afficher le documentGermany
Afficher le documentGreece
Afficher le documentHungary
Afficher le documentIceland
Afficher le documentIreland
Afficher le documentItaly
Afficher le documentNetherlands
Afficher le documentNorway
Afficher le documentPortugal
Afficher le documentSpain
Afficher le documentSweden
Afficher le documentSwitzerland
Afficher le documentTurkey
Afficher le documentUnited Kingdom
Ouvrir ce répertoire et afficher son contenuSouth East Asia
Ouvrir ce répertoire et afficher son contenuWestern Pacific
Afficher le documentIII. CONCLUSION
Afficher le documentIV. REFERENCES
 

Switzerland

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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