Wholesale Dealing Licence for Medicinal Products
Short answer
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.
When do I need a wholesale dealing licence?
As soon as you possess, store or have disposal over medicinal products and pass them on to pharmacies, drugstores, hospitals, doctors or other wholesalers. The licence is also needed if you never physically handle the goods but legally control them, for example as a marketing authorisation holder using a contract warehouse.
- Full-line wholesalers and specialist distributors.
- Marketing authorisation holders who distribute their own products or use a contract warehouse.
- Contract warehouses and logistics providers that store medicinal products for third parties.
- Importers who additionally resell in Switzerland.
- Operations that distribute samples or hospital supplies.
What GDP requirements does the inspection check?
The inspection covers the quality system, personnel, premises and temperature control, documentation, supplier qualification, customer qualification, transport, returns, suspected falsification and recall processes. Temperature control across the whole chain is the main focus, followed by traceability.
| Area | Evidence | Common gap |
|---|---|---|
| Warehouse temperature control | Mapping, continuous recording, alarms | Mapping older than the last refurbishment |
| Transport | Qualified transport routes, data loggers for cold chain goods | No evidence for the last mile |
| Supplier qualification | Licence check, contract, assessment | Licence not re-checked periodically |
| Customer qualification | Entitlement check before the first delivery | Supply to unentitled recipients |
| Traceability | Batch and recipient per delivery | Batch data only on the delivery note, not in the system |
| Recall | Process, emergency contacts, drill | No documented recall exercise |
| Returns | Assessment before resale | Returns restocked without temperature evidence |
What does the application look like?
The application names the sites, activities, product categories and the Responsible Person. It is accompanied by an organisation chart, a quality manual, warehouse plans with temperature zones, mapping reports, a process list, and contracts with contract warehouses and carriers.
- Define activities: wholesale dealing, import, export, trading abroad, each applied for separately.
- Qualify the warehouse and produce a current temperature mapping.
- Name the Responsible Person; for wholesale dealing, pharmacists, druggists or equivalent qualifications with practical experience suffice.
- Document the quality system under GDP, including the recall and anti-falsification process.
- Submit the application via the Portal and schedule the inspection.
- After the inspection, remedy deficiencies and receive the decision and, if needed, the GDP certificate.
What ongoing duties does a wholesaler have?
It must be able to trace every batch to the recipient, supply only from and to entitled partners, assess temperature deviations, report suspected falsification to Swissmedic, implement recalls, and report changes to the operation. Self-inspections must be carried out annually.
Frequently asked questions
Do I need a wholesale dealing licence as a marketing authorisation holder?
Yes, as soon as you have disposal over the goods or distribute them. Anyone who hands distribution entirely to a licensed wholesaler and never has disposal themselves can do without one; this distinction must be documented contractually.
Does the licence also cover import?
No, import is a separate activity and must be explicitly included in the licence scope. In practice, wholesale dealing and import are combined in one licence.
How fast must a recall work?
For a class I recall, the goods must be blocked and the recipient chain informed within hours. Swissmedic checks during the inspection whether contact lists are up to date and the process has been tested.
What applies to cold chains?
For products at 2 to 8 degrees, qualified transport, data loggers and a documented assessment of every deviation are mandatory. Returned goods may not go back on the market without temperature evidence.
Who may be the Responsible Person in wholesale dealing?
Persons trained as a pharmacist, druggist, chemist or an equivalent qualification, with the practical experience in medicinal product distribution required under the MPLO.
Sources
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