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Frequently asked questions
Does every medicinal product need a Swissmedic marketing authorisation?
Every ready-to-use medicinal product placed on the market in Switzerland needs an authorisation (Art. 9 para. 1 TPA). Exceptions include formula magistralis preparations compounded by a pharmacy for a specific person, medicinal products for clinical trials, and individual imports by healthcare professionals under Art. 49 MPLO.
Does Swissmedic automatically recognise an EU authorisation?
No. There is no automatic recognition and no mutual recognition agreement for medicinal product authorisations. However, under Art. 13 TPA, Swissmedic can take into account the assessment results of a recognised foreign authority, which reduces dossier scope, timeline and fee.
Do I need a licence if I only store medicinal products?
Yes. Storing and delivering medicinal products for third parties is a wholesale dealing activity and requires a licence. Anyone acting purely as a logistics provider for a licence holder needs their own licence or must be recorded as a contract warehouse in that holder's licence.
Does an EU licence apply in Switzerland?
No. An establishment licence is always national. GMP certificates from the EEA, by contrast, are recognised under the Mutual Recognition Agreement on conformity assessment.