Therapeutic Products Ordinance (TPO): The Procedural Ordinance
Short answer
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.
What topics does the TPO cover?
The ordinance covers the entire lifecycle: submission and procedure types, assessment and timelines, temporary authorisation, co-marketing, variations and renewal, medicinal product information, dispensing categories, pharmacovigilance and reporting duties.
| Article | Topic | Practical relevance |
|---|---|---|
| Art. 3 to 5 | Application and documents | What is submitted and in what form |
| Art. 6 | Procedure with pre-notification | Plannable, shortened regulatory time |
| Art. 7 | Accelerated authorisation procedure | Prioritisation for high medical need |
| Art. 15 | Co-marketing medicinal products | Notification procedure for identical products |
| Art. 16 | Foreign authorisation | Implementation of Art. 13 TPA |
| Art. 18 to 20 | Temporary authorisation | Conditions, duration, conversion |
| Art. 21 to 24 | Variations | Four classes with different procedures |
| Art. 40 to 45 | Dispensing categories | Assignment and dispensing without a prescription |
| Annex | Variation categories | Conditions and documents per variation |
Why does the annex matter so much?
Because it states the category, the conditions and the documents to submit for every variation. Anyone meeting all of a category's conditions stays in the lower class; anyone missing a condition must submit in the next higher class. This determines the timeline, the fee and when implementation is allowed.
- Describe the variation and find the matching category in the annex.
- Check and document each of the category's conditions individually.
- Where a condition is not met, choose the next higher class.
- Assemble the documents named in the annex.
- Group related variations, with the group's class following the highest class it contains.
- Submit and, where approval is required, wait for the decision.
What does the TPO govern on pharmacovigilance?
The marketing authorisation holder must operate a pharmacovigilance system, name a responsible person domiciled in Switzerland, report adverse reactions within the set deadlines, submit periodic safety update reports, and evaluate signals. Reports are filed via the Swissmedic Portal.
- Serious adverse reactions: report within 15 days.
- Non-serious cases: periodic reporting under the requirements.
- Quality defects with a health risk: immediate reporting.
- Periodic safety update reports at the set frequency.
- A person responsible for pharmacovigilance domiciled in Switzerland.
How does the TPO relate to the AMZV and the VAZV?
The TPO governs the procedure, the Medicinal Products Authorisation Requirements Ordinance (AMZV) the content requirements for the documentation, and the Ordinance on the Simplified Authorisation of Medicinal Products (VAZV) the special routes for complementary medicinal products, orphan drugs and the notification procedure. All three apply in parallel.
Frequently asked questions
Where do I find the variation categories?
In the TPO annex on Fedlex. Swissmedic also publishes guidance explaining how to apply it; the ordinance text is what is binding.
Does the TPO also apply to veterinary medicinal products?
Yes, with special provisions, for example on withdrawal periods and dispensing to animal owners. Additional rules apply for livestock.
Does the TPO govern prices?
No. Prices and reimbursement are a matter for the FOPH via the Specialities List and the health insurance ordinances.
What is the TPO called in French?
Ordonnance sur les médicaments (OMéd), and in Italian, Ordinanza sui medicamenti (OM).
What is the difference between the TPO and the AMZV?
The TPO governs the procedure and the timelines, the AMZV the content requirements for the dossier and the medicinal product information.
Sources
- Fedlex SR 812.212.21 Therapeutic Products Ordinance (TPO)
- Fedlex SR 812.212.22 AMZV
- Fedlex SR 812.212.23 VAZV
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