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 is 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. The modifications following the Ordinary Revision of the TPA (Stage 2) and its right of enforcement entered into force on 1 January 2019.

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

Abolition of Dispensing Category C, and the dispensing of prescription medicinal products without a prescription

Medical devices legislation

Switzerland has comprehensively revised its medical devices legislation in line with the EU Regulations on medical devices (MDR and IVDR), thereby increasing the safety and quality of medical devices.

Security in the supply of medicines

The supply of medicines in Switzerland can no longer be assured in all cases. The federal government is looking into additional measures and implementation proposals to assure a regular supply of medicinal products.

Medicinal products for paediatric use

A national register for recommended dosages of medicinal products used in paediatrics (SwissPedDose) has been available to health professionals since 2018.

The fight against counterfeit products

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

Veterinary medicinal products

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

Good Distribution Practice of Medicinal Products

The Federal Department of Home Affairs has adapted the Guidelines on Good Distribution Practice of Medicinal Products according to EU law. This move increases quality requirements for the distribution of medicinal products.

Therapeutic Products Act: Partial revision (2023)

The consultation on the third amendment to the Therapeutic Products Act was opened on 8 December 2023. You will find information and documents here.

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.