What Is Swissmedic?
Short answer
Swissmedic is the Swiss Agency for Therapeutic Products, the national authorisation and supervisory authority for medicinal products and medical devices. It is a public-law institution of the Confederation based in Bern, funded predominantly through fees, and employs around 450 people.
What legal form and funding does Swissmedic have?
Swissmedic is a public-law institution of the Confederation with its own legal personality, its own accounts, and an Agency Council as its supervisory body. It is funded predominantly through fees from applicants and licence holders, supplemented by a federal contribution for public-interest services.
- Legal form: public-law institution of the Confederation, operational since 2002.
- Oversight: the Agency Council, elected by the Federal Council.
- Funding: predominantly fees, supplemented by a federal contribution.
- Location: Hallerstrasse 7, 3012 Bern.
- Staff: around 450 employees across technical, oversight and support areas.
What tasks does Swissmedic carry out in detail?
It reviews and decides authorisation applications, grants establishment licences, carries out or commissions inspections, supervises the market with batch testing and recalls, operates the vigilance systems, controls narcotics, and prosecutes breaches of the Therapeutic Products Act.
| Phase | Swissmedic's role | Your point of contact |
|---|---|---|
| Before submission | Scientific and regulatory advice | Advice request via the Portal |
| Authorisation procedure | Assessment and decision | Authorisation division |
| Licensing procedure | Review and inspection | Licensing division |
| After authorisation | Variations, renewal, vigilance | Technical division and vigilance unit |
| Market surveillance | Batch testing, recalls, measures | Market Surveillance |
| Illegal therapeutic products | Prosecution and cooperation with customs | Criminal Law division |
How does Swissmedic cooperate internationally?
Swissmedic is a member of PIC/S, applies ICH guidelines, is part of the Access Consortium with Australia, Canada, Singapore and the United Kingdom, and takes part in initiatives for global health products. An agreement with the EU covers recognition of GMP inspections, but not of authorisations.
- PIC/S: mutual trust in GMP and GDP inspections.
- ICH: applying the international quality, safety and efficacy guidelines.
- Access Consortium: work-sharing assessment with four partner authorities.
- Agreement with the EU on mutual recognition of conformity assessment in the GMP field.
- Cooperation with the WHO on products for global health.
How transparent is Swissmedic?
Authorisations and key decisions are published in the Swissmedic Journal. Public assessment reports, the Swiss Public Assessment Reports, are issued for new active substances. The approved medicinal product information is freely accessible via AIPS.
Frequently asked questions
Who owns Swissmedic?
It is an institution of the Confederation. The Federal Council elects the Agency Council, which exercises oversight; Swissmedic is operationally independent.
Is Swissmedic the same as the FOPH?
No. Swissmedic decides on authorisation and licensing, the FOPH on reimbursement and prices. The two are legally separate.
How many medicinal products are authorised in Switzerland?
There are several thousand authorisations for human medicinal products, spread across considerably more pack presentations. Swissmedic publishes the exact figure in its lists and annual report.
Can I challenge Swissmedic decisions?
Yes. Decisions can be appealed to the Federal Administrative Court, and in some cases further to the Federal Supreme Court. The appeal period is stated in the decision.
Is Swissmedic responsible for cosmetics or food supplements?
No, that falls under food law and the Federal Food Safety and Veterinary Office. Swissmedic only steps in where a product is effectively marketed as a medicinal product.
Sources
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