Legal Basis of Swiss Therapeutic Products Law
Swiss therapeutic products law rests on one act and a series of ordinances. This hub explains which piece of legislation governs what, where to find the binding text, and which articles you need most often in practice.
How is Swiss therapeutic products law structured?
The Therapeutic Products Act (TPA, SR 812.21) is the framework act for medicinal products and medical devices. It is given concrete form through Federal Council ordinances, chiefly the Therapeutic Products Ordinance (TPO), the Medicinal Products Licensing Ordinance (MPLO), and the Medical Devices Ordinance (MedDO).
| Legislation | SR number | Governs | Short form FR/IT |
|---|---|---|---|
| Therapeutic Products Act | 812.21 | Authorisation, licensing, market surveillance, criminal law | LPTh / LATer |
| Therapeutic Products Ordinance | 812.212.21 | Authorisation procedures, variations, dispensing categories | OMéd / OM |
| Medicinal Products Authorisation Requirements Ordinance | 812.212.22 | Requirements for the authorisation dossier | OEMéd / OOMed |
| Medicinal Products Licensing Ordinance | 812.212.1 | Establishment licences, GMP, GDP, the Responsible Person | OAMéd / OAMed |
| Ordinance on the Simplified Authorisation of Medicinal Products | 812.212.23 | Simplified authorisation, orphan drugs, notification procedure | OASMéd / OOSM |
| Medical Devices Ordinance | 812.213 | Medical devices, CH-REP, conformity | ODim / ODmed |
| Human Research Act | 810.30 | Research on human subjects, ethics committees | LRH / LRUm |
| Narcotics Act | 812.121 | Controlled substances, licences | LStup / LStup |
The original text on Fedlex in one of the three official languages is always the binding one. English versions are translations with no legal effect, even where published on federal websites.
Which articles do you need most often?
In authorisation practice, fewer than twenty provisions answer ninety percent of the questions: the authorisation requirement, the authorisation conditions, the simplified procedures, the consideration of foreign decisions, and the dispensing categories.
- Art. 9 TPA: authorisation requirement and exceptions.
- Art. 10 TPA: authorisation requirements, including Swiss domicile.
- Art. 11 TPA: application documents.
- Art. 11a and 11b TPA: first applicant protection.
- Art. 12 TPA: authorisation of an essentially similar medicinal product.
- Art. 13 TPA: consideration of foreign assessment results.
- Art. 14 TPA: simplified authorisation procedures, including parallel import.
- Art. 9a and 9b TPA: temporary authorisation and temporary permit.
- Art. 16 to 16b TPA: authorisation duration, sunset clause, renewal.
- Art. 40 to 45 TPO: dispensing categories.
How do you stay up to date?
Through Fedlex's amendment tracking, the Swissmedic Journal, and the newsletters from Swissmedic and the FOPH. Changes to ordinances generally take effect on 1 January or 1 July; transitional periods are set out in the final provisions of each piece of legislation.
All guides in this hub
5 guides
- Featured3 min
Therapeutic Products Act (TPA): Understanding the Framework Act
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.
Read the guide - Featured3 min
Therapeutic Products Ordinance (TPO): The Procedural Ordinance
The Therapeutic Products Ordinance gives concrete form to the TPA for medicinal products. It governs authorisation procedures and their timelines, the four variation classes, dispensing categories, pharmacovigilance, and the marketing authorisation holder's duties. Its annex is the key working document for variation management.
Read the guide - 3 min
Medical Devices Ordinance (MedDO) at a Glance
The MedDO governs medical devices in Switzerland. It is modelled in content on the EU MDR but is autonomous Swiss law. For foreign manufacturers, the key obligation is naming an authorised representative in Switzerland, the so-called CH-REP.
Read the guide - 3 min
Human Research Act (HRA) and Clinical Trials in Switzerland
Clinical trials with medicinal products in Switzerland need two authorisations: the competent ethics committee and, depending on the category, Swissmedic. The legal basis is the Human Research Act and the Clinical Trials Ordinance. Applications are filed via the BASEC portal, coordinated with the Swissmedic Portal.
Read the guide - 3 min
Narcotics: Licences and Control in Switzerland
Narcotics are subject to the Narcotics Act in addition to therapeutic products law. Anyone manufacturing, trading, importing or exporting them needs a special licence from Swissmedic and a separate import or export licence for every shipment. Storage, record-keeping and prescriptions are strictly regulated.
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Frequently asked questions
Where do I find the binding legal text?
On fedlex.admin.ch, the Confederation's official publication platform. The consolidated version in German, French or Italian, as of the relevant date, is authoritative.
Does EU law apply in Switzerland?
Not directly. Switzerland adopts individual technical standards and its ordinances reference international guidelines, such as PIC/S and ICH. For medical devices, the MedDO is modelled on the EU MDR but is autonomous Swiss law.
What does SR mean in the numbers?
SR stands for Systematic Compilation (Systematische Rechtssammlung). The number identifies the legislation permanently, regardless of revisions.
What are the pieces of legislation called in French and Italian?
The TPA is the LPTh or the LATer, the TPO is the OMéd or the OM, the MPLO is the OAMéd or the OAMed. The official short forms appear in the title of each piece of legislation.
Who enforces the TPA?
Swissmedic for authorisation, licensing and market surveillance, the cantons for retail, professional practice and parts of inspection activity, and the FOPH for reimbursement via the Specialities List.
Sources
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