Swiss Agency for Therapeutic Products
Swiss regulator; PIC/S member applying GMP/GDP inspection standards.
What this page does not claim
SPEQ curates and cross-references these bodies. It is not affiliated with, accredited by, or endorsed by any of them, and a count of decoded standards is a measure of SPEQ’s coverage, not of a body’s importance.
WHAT Swissmedic COVERS
Swissmedic, the Swiss Agency for Therapeutic Products, regulates medicines and medical devices for the Swiss market under the Therapeutic Products Act (Heilmittelgesetz, HMG / TPA, SR 812.21). Good Manufacturing Practice is set by the Ordinance on Establishment Licences (Arzneimittel-Bewilligungsverordnung, AMBV / Medicinal Products Licensing Ordinance, SR 812.212.1), which makes manufacturing, import, and wholesale conditional on a Swissmedic establishment licence and incorporates the recognised GMP rules by reference.
WHAT Swissmedic PUBLISHES
- 01Establishment licences and the list of licensed Swiss manufacturers, importers, and wholesalers
- 02The recognised GMP and GDP rules incorporated by the AMBV (the PIC/S and EU GMP guides)
- 03Guidance documents and information sheets interpreting the Therapeutic Products Act and its ordinances
- 04Healthcare Professional Communications and safety alerts
- 05GMP/GDP inspection and certification information
HOW ITS REQUIREMENTS BITE
Oversight runs through the establishment licence: to hold one, a site must demonstrate GMP compliance, verified by Swissmedic inspection, and operate under a named technically responsible person. Switzerland sits outside the EEA, but a Mutual Recognition Agreement with the European Union covers GMP inspection of medicinal products, so each side can rely on the other’s inspection outcomes for many product types — which is why many manufacturers deal with one inspectorate rather than two.
What practitioners get wrong
- There is no separate Swiss GMP code — the AMBV points to the PIC/S and EU GMP guides, so work to that text, not a Swiss-specific one.
- Switzerland is not in the EEA, but the EU–Swiss MRA bridges GMP recognition, so a Swiss GMP certificate is accepted in the EU and vice versa for covered products.
- The technically responsible person (fachtechnisch verantwortliche Person) is a named, accountable role, not a formality — licensing depends on it.
- Recent therapeutic-products legislation reclassified certain patient-specific and formula preparations, so confirm which regime a given preparation falls under before assuming GMP scope.
What an inspection under this authority actually probes
WHERE IT SITS INTERNATIONALLY
Switzerland was among the founding members of the 1970 Pharmaceutical Inspection Convention and remains a PIC/S participating authority, so its recognised GMP rules are the PIC/S Guide, kept harmonised with EU GMP. The EU–Switzerland Mutual Recognition Agreement extends that alignment into mutual reliance on GMP inspections.
Swissmedic STANDARDS SPEQ DECODES · 1
DISCIPLINES IN Swissmedic’S REMIT
Swissmedic: frequently asked questions
Reference answers on Swiss Agency for Therapeutic Products’s mandate, what it publishes, and how its requirements acquire force.
What GMP does Switzerland apply?
Switzerland does not maintain a separate GMP code. The Medicinal Products Licensing Ordinance (AMBV, SR 812.212.1), issued under the Therapeutic Products Act, requires manufacturing to the recognised GMP rules and incorporates the PIC/S and EU GMP guides by reference.
Is Switzerland in PIC/S and does the EU recognise its inspections?
Yes. Switzerland was a founding member of the 1970 Pharmaceutical Inspection Convention and remains a PIC/S participating authority, and an EU–Switzerland Mutual Recognition Agreement covers GMP inspection of medicinal products so each side can rely on the other’s outcomes.
What does Swissmedic require to manufacture medicines?
An establishment licence, conditional on demonstrated GMP compliance verified by inspection and on a named technically responsible person. The licence covers manufacture, import, and wholesale as applicable.