Traditional Medicines and OTC Products
An intro to the legal situation for traditional medicines and OTC products in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
The distribution of alternative medicinal products such as traditional, herbal or complementary medicines requires a marketing authorisation. Such authorisation is always required for medicinal products, irrespective of whether it concerns prescription-only or over-the-counter products. Marketing authorisation for complementary and herbal medicines as well as other alternative medicines is governed by the TPA and the Ordinance on Simplified Marketing Authorisation of Complementary and Herbal Medicinal Products. In general, complementary and herbal medicines benefit from the simplified procedure as described in chapter 3 or an authorisation by way of notification. The choice of the right authorisation procedure depends on the composition of the medicinal product concerned and its intended use. Swissmedic provides guidelines, which assist in identifying the right procedure. The same applies to Asian medicinal products, for which Swissmedic also issued specific guidelines.
The TPA allows for certain medicinal product to be authorised by way of notification. This authorisation procedure is open for:
- complementary medicines without indications and with their active substances listed for specific therapy approaches.
- other medicinal products with a low risk potential, for which a simplified marketing authorisation would be disproportionate. In particular, individual teas, cough and throat lozenges and pastilles can be authorised in connection with a notification.
The regulation of medical devices in Switzerland follows the compliance assessment and certification based on bilateral agreements. Manufacturer and importer have to complete the applicable conformity assessment procedure before distributing the devices in the Swiss market.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Swiss law classifies medicinal products into two categories, i.e. prescription-only and over-the-counter products. Accordingly, the applicable advertising regulation de-pends on whether a complementary medicinal product requires a prescription or not. For prescription-only medicinal products advertising aimed at the general public is prohibited, whereas advertising for over-the-counter medicines is permitted. Irrespective of the category, the advertisement is not permitted for:
- medicinal products containing narcotic or psychotropic substances.
- medicinal products that may not be used without the intervention of a doctor for the necessary diagnosis, prescription or treatment.
- pharmaceuticals that are frequently misused or are likely to lead to addiction or dependence.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Advertising of complementary medicines aimed at healthcare professionals must be based on scientifically recognised specialist media or recognised monographs of complementary medicine. Advertising statements in this regard must contain a reference to the respective therapy direction.
For advertising aimed at the general public, the Ordinance on the Advertisement of Medicinal Products outlines, which claims may be made in connection with a certain medicinal product. These requirements are applicable to all medicinal products for which public advertising is permissible. The Ordinance requires all information in the public advertising to be in accordance with the product information approved by Swissmedic. In particular, only indications or possible applications approved by Swissmedic may be advertised. For medicinal products without package leaflets, the approved text on the packaging applies. The latter applies in particular to medicinal products that are authorised without specific indication or possible application. In this case, the approved text on the packaging limits at the same time the scope of the advertisement. It is prohibited to circumvent this restriction by enclosing flyers, brochures etc. which inform about possible applications.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
The distribution of over-the-counter medicinal products requires a marketing authorisation from Swissmedic. The applicable procedure depends on the composition of the concerned product. Compared to prescription-only products, over-the-counter products are subject to different regulations with regard to advertising (please refer to question 3) and dispensation (please refer to question 5).
5. Are there any limitations on locations or channels through which OTC products may be sold?
The following persons are entitled to distribute over-the-counter products:
- Everyone that is entitled to distribute prescription-only products, i.e. pharmacists and doctors.
- Druggist holding a federal diploma.
- All duly trained professionals within the limits of their right to dispense medicinal products provided that they are supervised either by a pharmacist, a doctor or a druggist. Persons, who hold an education in complementary medicine that is recognised by the Federal Government, may distribute certain over-the-counter products.
As described in chapter 3, the LTP prohibits, in principle, mail order delivery of medicinal products. This applies to all form of orders, which are made from distance (i.e. e-mail, internet or in writing). However, the cantons my grant on an exceptional basis authorisations to operate a mail delivery service of medicinal products.
6. What health, advertising, and marketing claims may be made for OTC products?
Please refer to question 3.
7. Can OTC products be marketed or advertised directly to the public?
Please refer to question 2.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
Medicinal products are categorised into the four categories A, B, D and E with A and B encompassing prescription-only products and D and E encompassing over-the-counter products. Swissmedic categorises the medicinal products during the authorisation process and reviews the categorisation periodically. The holder of the marketing authorisation can request a conversion of the categorisation. The procedure is governed by the Ordinance on Medicinal Products and the corresponding guidelines of Swissmedic. Request for conversion of the categorisation based on adaptions of the medicinal product must be notified in advance to Swissmedic in order to seek approval from Swissmedic.
9. What are the requirements for the importation of either traditional medicines or OTC products?
The importation of traditional medicines or over-the-counter products follows the general regulation for importation of medicinal products. Importation of medicinal products requires an import licence granted by Swissmedic. Medicinal products may be imported into Switzerland if a marketing authorisation has been obtained for such products. Imports of non-authorised medicinal products will be blocked by the Custom authorities. The Federal Council may permit the importing of non-authorised medicinal products if they have been prescribed by a health care professional and are imported in small quantities for private use. It may also allow the importing of small quantities of medicinal products for which no alternative and equivalent medicinal product has been authorised to be imported.