Establishment Licences from Swissmedic
Anyone in Switzerland who manufactures, imports, exports or wholesale-deals medicinal products needs an establishment licence from Swissmedic. The legal basis is the Medicinal Products Licensing Ordinance (MPLO, AMBV). This hub shows which licence you need and what the application requires.
Which establishment licence do I need?
The type of licence follows the activity, not the product category. Manufacturing, including packaging and batch release, requires a manufacturing licence. Purchasing and reselling to healthcare professionals requires a wholesale dealing licence. Import from abroad requires an import licence, export an export licence.
| Activity | Licence | Basis | Routine inspection |
|---|---|---|---|
| Manufacturing, packaging, release | Manufacturing licence | Art. 5 et seq. MPLO | GMP, every 2 to 3 years |
| Wholesale dealing in Switzerland | Wholesale dealing licence | Art. 11 et seq. MPLO | GDP, every 3 to 5 years |
| Import of ready-to-use medicinal products | Import licence | Art. 11 et seq. MPLO | GDP |
| Export | Export licence | Art. 11 et seq. MPLO | GDP |
| Trading abroad from Switzerland | Licence for trading abroad | Art. 17 et seq. MPLO | GDP |
| Broking activity | Notification requirement | MPLO | risk-based |
Several activities are combined in a single licence. The licence names the sites, the authorised activities, the product categories and the Responsible Person.
What basic requirements always apply?
Regardless of the licence type, the MPLO requires a working quality assurance system, suitable premises and equipment, sufficiently qualified staff, and a Responsible Person with direct authority to instruct on technical matters.
- A quality assurance system under GMP or GDP, with documented processes and self-inspections.
- Premises, equipment and storage conditions suited to the activities applied for.
- A Responsible Person with the required training and professional experience.
- An organisation chart with clear responsibilities and a deputising arrangement.
- Traceability of every batch and a working recall process.
How long does a licensing procedure take?
From submission to decision, four to nine months is realistic. The timeline hinges on the inspection: Swissmedic or the competent regional inspectorate checks on site whether the application matches reality. Only then is the decision issued.
All guides in this hub
6 guides
- Featured3 min
Manufacturing Licence for Medicinal Products in Switzerland
A manufacturing licence under Art. 5 et seq. MPLO is needed by anyone who manufactures, repackages, labels, tests or releases batches of medicinal products. Swissmedic requires a GMP-compliant quality system, suitable premises and a Responsible Person. A GMP inspection takes place before the decision.
Read the guide - Featured4 min
Wholesale Dealing Licence for Medicinal Products
Anyone who procures, stores and supplies medicinal products to healthcare professionals or other licence holders needs a wholesale dealing licence. Swissmedic checks compliance with Good Distribution Practice, the traceability of every batch, and the ability to trigger a recall within hours.
Read the guide - 4 min
Importing and Exporting Medicinal Products in Switzerland
Importing ready-to-use medicinal products requires a licence and, in addition, that the product is authorised in Switzerland or an exception applies. From the EEA, release there can be relied on; from third countries, full testing must be demonstrated.
Read the guide - Featured4 min
The Responsible Person Under the MPLO
Every establishment licence requires a Responsible Person. They decide independently on technical matters, release batches, and are Swissmedic's point of contact for quality. Training and practical experience requirements differ by licence type and product category.
Read the guide - 3 min
GMP and GDP Inspections in Switzerland
Inspections check whether an operation complies with Good Manufacturing Practice or Good Distribution Practice. Swissmedic and the regional inspectorates are responsible. Findings are classed as critical, major or other; corrective action must be evidenced within set deadlines.
Read the guide - 3 min
Applying for an Establishment Licence: The Twelve-Month Path
From the decision to apply to the granted licence, twelve months is a realistic plan: three months for concept and premises, four months for the quality system, one month for the application, and two to four months to inspection and decision. The critical path is never the form, it is the quality system actually being lived.
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Frequently asked questions
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.
How long is an establishment licence valid?
Generally five years. It is renewed on request, with a fresh inspection. Changes to sites, activities or the Responsible Person must be reported immediately.
Who inspects: Swissmedic or the canton?
Swissmedic grants the licence. Inspections are carried out, depending on product category and region, either by Swissmedic itself or by the competent regional inspectorate acting on Swissmedic's behalf.
What does an establishment licence cost?
A base fee for the decision plus the inspection effort at the hourly rate. For a medium-sized operation, the total typically runs into four to five figures in francs.
Sources
- Fedlex SR 812.212.1 Medicinal Products Licensing Ordinance (MPLO)
- Swissmedic: Establishment Licences
- Fedlex SR 812.21 TPA, Art. 5 and 18
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