Medicinal products & medical devices

Thanks to research and technological progress, the number of new drugs and medical devices is increasing all the time. To ensure that the health of people and animals remains protected, the federal authorities regulate the use of therapeutic products.

The use of therapeutic products is regulated by the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA). It’s designed primarily to safeguard the health of humans and animals. Only high-quality, safe and effective therapeutic products can be put on the market in Switzerland. The law places particular emphasis on the following:

  • User safety: Therapeutic products must be used in moderation and in accordance with their intended purpose.
  • Product safety: Only high-quality, effective therapeutic products may be put on the market and used.
  • Security of supply: A reliable and well-organised supply of therapeutic products, together with the necessary technical information and advice, is to be available throughout the country.

Therapeutic products include medicinal products and medical devices

Therapeutic products are used in the diagnosis, prevention or treatment of diseases, injuries and handicaps. A distinction is to be made between medicinal products and medical devices:

Medicinal products are products of chemical or biological origin which are intended to have or are presented as having a medicinal effect on the human or animal organism.

Medical devices are products which are intended to have or are presented as having a medical use and whose principal effect is not obtained with a medicinal product. They include instruments, apparatuses, in vitro diagnostics medical devices, software and other goods or substances.

Handling of the Therapeutic Products Act

We supervise the Therapeutic Products Act and the corresponding Federal Council ordinances. In the interests of patients we create a legal framework allowing the best possible use of high-quality, safe and effective therapeutic products. Important considerations are product safety, appropriate and moderate use of therapeutic products, and their availability.

The Therapeutic Products Act (TPA), in force since 1 January 2002, has basically proven itself in practice. In the meantime the law has been revised in two stages, and the relevant implementing provisions (Therapeutic Products Ordinance Package IV) are currently being amended.

Sustainable and impact-oriented development of therapeutic products legislation

Therapeutic products legislation is to be developed on an interdisciplinary, sustainable and impact-oriented level. Changing values in society, developments in science and technology as well as economic dynamics are all taken into account.

Current topics:

Simplified supply of medicinal products subject to prescription

Elimination of the supply category C, and the supply of medicinal products subject to prescription in the absence of a prescription.

Medicinal products for paediatric use

A national register for recommended dosages of medicinal products used in paediatrics (www.swisspeddose.ch) has been available to health professionals since 1 April 2018.

Security in the supply of medicines

Overall, the security of supply with medicinal products in Switzerland is good. But according to a report by the federal government, we have to expect an increase of bottlenecks in supply.

Counterfeiting of medical products and illegal trade

Trade in counterfeit therapeutic products is increasing throughout the world. It constitutes a danger to health and calls for concerted action at international level.

Current therapeutic products legislation projects

The therapeutic products legislation is continually developed further in order to stay abreast of societal, technological, political and economic developments. Several legislative projects are in progress.

Fresh cell therapy

Concerns about Switzerland’s reputation as a centre for medical services drove the authorities to put a stop to illegal and shady offerings of this obsolete and high-risk treatment.

Veterinary medicinal products

Just like human medicinal products, veterinary medicinal products are governed by the Therapeutic Products Act (TPA) and its ordinances.

Legislation

Medicinal products and medical devices legislation

The legislation on therapeutic products comprises the Federal Act on Medicinal Products and Medical Devices (TPA) and the associated ordinances. It is regularly aligned to the state of scientific and technical knowledge.

Last modification 30.10.2018

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Contact

Federal Office of Public Health FOPH
Division of Biomedicine
Therapeutic Products Law Section
Schwarzenburgstrasse 157
3003 Berne
Switzerland
Tel. +41 58 463 51 54
E-mail

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