Amendment to the Therapeutic Products Act 3b (TPA 3b)
The Therapeutic Products Act (TPA) has been in force since 2002. It is currently undergoing its third revision. The consultation on TPA Revision 3b was opened on 19 June 2026. You can find out which topics are affected on this page.
Stage 3a of the revision of the TPA is already under way. In addition, Parliament and the Federal Council have identified a need for action in other areas. This necessitates a further revision of the Therapeutic Products Act: the present Stage 3b.
- The mail-order sale of medicinal products is being re-regulated. The focus is on patient safety.
- The supply of medicinal products is to be strengthened. This primarily concerns market access and the manufacture of medicinal products by public or hospital pharmacies and by the Confederation.
- The competences of chiropractors are to be expanded.
- It is to be possible to dispense medicines (particularly antibiotics) individually. The legal basis for this will be established – in accordance with the Federal Council’s decision of 25 June 2025.
- A supervision fee for medical devices is to be introduced. This will enable the Swiss agency for therapeutic products (Swissmedic) to finance the supervision of medical devices entirely through fees.
Mail-order sale of medicinal products
The work on mail-order sales is based on the Federal Council’s report on the mail-order sale of non-prescription medicines in response to Postulate 19.3382 Stahl “Mail-order sale of non-prescription medicines” as well as on the Federal Council’s decision of 24 November 2021 based on this report. The revision of the provisions on mail-order sales required further and more in-depth investigations. Swiss Economics therefore carried out an external in-depth regulatory impact assessment (RIA) on behalf of the FOPH to systematically analyse the economic impact and the feasibility of enforcement.
The FOPH has drafted a corresponding bill, involving the mail-order sector in the process. The bill primarily provides for the following amendments:
- Currently, the mail-order sale of medicines is prohibited. This ban is to be lifted.
- For non-prescription medicines in dispensing category D, mail-order sales without a prescription will be permitted. Specialist advice will continue to be guaranteed.
- Mail-order sales of non-prescription medicines, such as in-house specialities and formula officinalis (medicines manufactured in pharmacies or drugstores according to standardised formulations), will be permitted. Two conditions must be met for this: 1) there is an initial face-to-face consultation at the dispensing outlet and 2) the product is dispensed exclusively to the outlet’s own customers.
- In addition, provision is made when products are sold by mail order for simplified dispensing following in-depth consultation by the pharmacist (Simplified provision of List B medicinal products).
- A licence to operate a public drugstore is now sufficient as a prerequisite for a mail-order licence.
The following regulations remain essentially unchanged:
- The provisions for prescription-only medicines in categories A and B.
- The regulations for formula magistralis medicines (compounded medicines produced specifically for a particular patient in accordance with a medical prescription) and prescription-only formula officinalis medicines (medicines produced in pharmacies or drugstores according to standardised formulations).
- The requirement to hold a cantonal licence to operate a public pharmacy in order to engage in mail-order sales.
- Proof of a suitable quality assurance system, particularly with regard to 1) professional advice and 2) the safe transport of medicines.
- Mail-order sales should continue to be permitted throughout Switzerland.
Objective: To liberalise the mail-order sale of non-prescription medicines by removing existing restrictions and allowing drugstores to engage in mail-order sales. At the same time, accompanying measures are intended to ensure quality, safe patient advice and patient safety in mail-order sales.
Strengthening the supply of medicinal products
With Revision 3b of the TPA, the Federal Council is implementing further measures to strengthen the security of supply of medicines in Switzerland. Based on the reports “Proposals for implementing the measures in the FOPH report on medicine supply bottlenecks” and “Further measures to address disruptions to the supply of human medicines in Switzerland”, arrangements for market access and the manufacture of medicines are being further developed.
The following amendments are planned as part of TPA Revision 3b:
- Medicines that are not authorised in Switzerland may currently be placed on the market subject to time or quantity limits. This provision is being extended. The aim is to ensure that, in the event of shortages, medicines can be imported not only on a case-by-case basis but in the quantities required.
- Public and hospital pharmacies are to be granted the authority to manufacture medicines to prevent and manage shortages and to place them on the market without authorisation. The Armed Forces Pharmacy is also to be granted this authority with respect of highly contagious and malignant diseases.
- By optimising the simplified authorisation procedure, it should be possible to authorise proven medicines with known active ingredients and a long history of use more quickly and with less administrative effort.
Objective: These measures are intended to lower market entry barriers and reduce the administrative burden on healthcare providers without compromising patient safety.
Adjustment of the competences of chiropractors
Under the Medical Professions Act (MedBG/LPMéd), chiropractors are classified as university-trained medical professionals. However, the Therapeutic Products Act does not regulate their competences under therapeutic products law with regard to medicines and medical devices accordingly.
The Therapeutic Products Act is therefore now to be amended for chiropractors in line with their scope of practice and their university education as defined by the Medical Professions Act.
Objective: A basis for the equal treatment of chiropractic and medical prescriptions is to be established in the Therapeutic Products Act. This will permit the dispensing of prescription-only medicines by pharmacists based on prescriptions from chiropractors.
Dispensing of medicinal products on an individual dose basis
The individual dispensing of medicines is to be regulated under federal law – in accordance with the Federal Council’s decision of 25 June 2025, based on the FOPH’s final report “Individual dispensing of antibiotics (ELAB) – Clarifications with a view to federal regulation”.
At the legislative level, a general regulation is to be created which is not limited to the individual dispensing of antibiotics for the purpose of combating antibiotic resistance, but which in principle also applies to other groups of medicines for other purposes (such as security of supply).
The following shall apply to the dispensing of individual doses:
- Permitted only if the authorised and available medicinal product packs are too large for a specific treatment.
- Only for one’s own clientele or one’s own patients.
- To ensure patient safety, the Federal Council shall define requirements for the dispensing of individual doses.
- Option of making the dispensing of individual doses mandatory for certain authorised dispensers.
Objective: The dispensing of individual doses of medicines is to be explicitly and comprehensively regulated under federal law.
Supervision fee for medical devices
Swissmedic monitors the safety of medical devices on the Swiss market, which is currently funded by the federal government. As early as 2018, the introduction of a supervision fee to replace the federal contribution was discussed as part of the tightening of medical devices regulation. The proposal was rejected as the companies liable for the fee were not fully known.
With the establishment of the swiss database on medical devices (swissdamed), the conditions are now in place: For the first time, a complete overview of the economic operators responsible and of the medical devices available in Switzerland is available. The project is part of the ongoing partial revision of the Therapeutic Products Act and was developed jointly by the FOPH and Swissmedic.
The planned supervision fee is based on the model that already exists in the pharmaceutical sector. Manufacturers and importers of medical devices are to be subject to the levy in future. The maximum fee rate of 15 per mille, the same as for medicinal products, is laid down in the Therapeutic Products Act. To assess the economic impact, the FOPH, together with SECO, has commissioned an in-depth regulatory impact assessment, which will be published alongside the consultation.
Objective: Financing Swissmedic’s work in monitoring medical devices through levies and fees strengthens its political and legal independence and relieves the burden on the federal budget.
Further amendments
As part of this bill, a number of specific amendments are also to be made which have proved necessary on the basis of experience gained during implementation or for other reasons:
- Amendment of the Therapeutic Products Act (TPA) in the context of legislation on torture
- Creation of a legal basis in the TPA for the recognition of foreign certificates and decisions relating to medical devices
- Amendments to the Transplantation Act and the Narcotics Act (implementation of Motion 24.3072 Jauslin)
Further information
Index
Federal Office of Public Health FOPH
Therapeutic Products Law Section
Schwarzenburgstrasse 157
Switzerland - 3003 Bern