Therapeutic Products Act (TPA): Understanding the Framework Act
Short answer
The Therapeutic Products Act governs medicinal products and medical devices in Switzerland. It establishes that medicinal products need an authorisation, that manufacturing and trade require a licence, and that Swissmedic supervises the market. It is given concrete form through Federal Council ordinances.
How is the TPA structured?
The act is organised into chapters: general provisions, medicinal products, medical devices, licensing, advertising and price comparisons, market surveillance, authorities and procedure, legal remedies, and penal provisions. For practice, the chapters on medicinal products and licensing matter most.
| Area | Articles | Content |
|---|---|---|
| Purpose and definitions | Art. 1 to 4 | Scope, definition of medicinal product and medical device |
| Manufacturing | Art. 5 to 8 | Manufacturing licence, principles of manufacturing |
| Authorisation | Art. 9 to 17 | Authorisation requirement, conditions, simplified procedures, duration |
| Import, export, trade | Art. 18 to 22 | Licences for import, export and trading abroad |
| Dispensing | Art. 23 to 27 | Dispensing categories, prescription, mail order |
| Duties | Art. 28 to 33 | The Responsible Person, reporting duties, integrity |
| Medical devices | Art. 45 to 51 | Requirements, conformity, ordinance-making power |
| Market surveillance | Art. 58 to 67 | Inspections, measures, vigilance |
| Penal provisions | Art. 86 to 90 | Misdemeanours and contraventions |
What does Art. 9 TPA say about the authorisation requirement?
Ready-to-use medicinal products and veterinary medicinal products may only be placed on the market if authorised by Swissmedic. The act names exceptions, such as formula preparations compounded by a pharmacy, medicinal products for clinical trials, and blood products in certain constellations.
- Formula magistralis: preparation compounded by a pharmacy for a specific person on prescription.
- Formula officinalis: preparation compounded to a pharmacopoeia for the pharmacy's own customers.
- Formula hospitalis: preparation compounded by a hospital pharmacy for its own use.
- Medicinal products for clinical trials, with authorisation under human research law.
- Individual imports by healthcare professionals under Art. 49 MPLO.
- Temporary permit under Art. 9b TPA for unauthorised medicinal products.
What changed in the 2019 revision?
The second stage of the revision of therapeutic products law took effect in 2019. It strengthened self-medication, abolished dispensing category C, expanded pharmacists' competencies, refined the integrity and transparency rules, and created the temporary authorisation under Art. 9a TPA as a standalone instrument.
What sanctions does the TPA provide for?
The act distinguishes misdemeanours from contraventions. Anyone who places a medicinal product on the market without authorisation, manufactures without a licence, or endangers human health can face imprisonment or a fine. Administrative measures such as suspension, recall and seizure exist alongside these.
Frequently asked questions
Does the TPA also apply to medical devices?
Yes, it is the framework act for both product categories. The detail for medical devices is set out in the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices.
Who is the enforcement authority?
Swissmedic for authorisation, licensing and market surveillance. The cantons are responsible for retail, professional practice and parts of inspection activity, and the FOPH for reimbursement.
What is the TPA called in French and Italian?
Loi sur les produits thérapeutiques (LPTh) and Legge sugli agenti terapeutici (LATer). Both versions are equally binding.
What is the difference between an act and an ordinance?
The act is passed by Parliament and contains the principles. The ordinances are issued by the Federal Council or Swissmedic and govern the detail, such as procedural steps, deadlines and documents.
Does the TPA apply in Liechtenstein?
Yes, under the customs treaty, Liechtenstein largely adopts Swiss therapeutic products law. A Swissmedic authorisation therefore also has effect there.
Sources
- Fedlex SR 812.21 Therapeutic Products Act (TPA)
- Swissmedic: Legal Basis
- FOPH: Revision of Therapeutic Products Law
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