Which activity needs which licence?
What is an establishment licence?
The Betriebsbewilligung is the official permission for a company to carry out a defined activity with medicinal products. The legal bases are the Therapeutic Products Act (HMG, SR 812.21), notably art. 5 for manufacturing and art. 18 for import, export, wholesale and trade abroad, plus the Medicinal Products Licensing Ordinance (AMBV, SR 812.212.1).
What counts is the activity, not the corporate form. Anyone manufacturing medicinal products needs a manufacturing licence under art. 5 HMG. Anyone importing, exporting, wholesaling or trading them abroad needs a licence under art. 18 HMG. One company can bundle several activities into a single licence.
Manufacturing means more than synthesis and filling. Packaging, repackaging, labelling, batch release and quality control are manufacturing steps too. Storing and shipping inside Switzerland falls under wholesale. Anyone who only arranges deals without ever owning the goods counts as a broker or agent under the AMBV and also needs a licence.
Two areas require additional permissions. Blood and labile blood products have their own Swissmedic licence. Narcotics and controlled substances require a further licence under the Narcotics Act (BetmG, SR 812.121), which sits alongside the establishment licence and is applied for separately.
| Activity | Licence required | Issuing authority |
|---|---|---|
| Manufacturing, packaging, batch release | Manufacturing licence (art. 5 HMG) | Swissmedic |
| Import from abroad | Import licence (art. 18 HMG) | Swissmedic |
| Wholesale, storage, distribution | Wholesale licence (art. 18 HMG) | Swissmedic |
| Export and trade abroad | Licence under art. 18 HMG | Swissmedic |
| Brokering and agency activity | Licence under the AMBV | Swissmedic |
| Blood and labile blood products | Licence for handling blood | Swissmedic |
| Narcotics, on top of the establishment licence | Licence under the BetmG | Swissmedic |
| Dispensing in a pharmacy or drugstore | Retail and dispensing licence | Canton, cantonal pharmacist |
Who issues what: Swissmedic or the canton?
Swissmedic issues every licence at the level of manufacturing, import, export, wholesale and trade abroad. The cantons issue the licences at dispensing level, meaning pharmacies, drugstores, doctors' practices with self-dispensing and hospital pharmacies. The competent office there is the cantonal pharmacist, the Kantonsapotheker.
The dividing line is the question of who receives the goods. Supplying professionals and companies is wholesale and needs Swissmedic. Dispensing to patients needs the canton. A pharmacy that also supplies other pharmacies or nursing homes needs both, the cantonal dispensing licence and a wholesale licence from Swissmedic.
Medical devices work differently. There is no establishment licence and no marketing authorisation for them. Instead the duties of the Medical Devices Ordinance (MepV, SR 812.213) apply: conformity assessment, technical documentation, reporting obligations and, for manufacturers outside Switzerland, a Swiss authorised representative (CH-REP) domiciled in Switzerland.
- Swissmedic: manufacturing, import, export, wholesale, trade abroad, brokering, blood
- Canton: pharmacies, drugstores, self-dispensing, hospital pharmacies, mail order
- Both are needed when a pharmacy also runs a wholesale operation
- An additional BetmG licence from Swissmedic applies to narcotics and controlled substances
- Medical devices: no establishment licence, instead MepV duties and a CH-REP
What must the responsible person be able to do?
Every licensed company must name a responsible person with technical qualifications, the fachtechnisch verantwortliche Person or FvP. She carries the technical responsibility for the licensed activity, decides on release and quarantine, and must hold authority to give instructions. Without a suitable FvP no licence is issued, and her departure must be reported to Swissmedic immediately.
The AMBV grades education and experience by activity. For manufacturing and for the release of finished medicinal products it normally requires a university degree in pharmacy, medicine, chemistry or biology plus several years of practical experience. For wholesale a lower level of education and a shorter practice are enough.
In practice presence is what decides. The FvP must actually be present at the site, to an extent that matches the size and the risk of the activity. A paper function, or one FvP splitting a few hours a week across several companies, is the most common ground for refusal in this field.
- Manufacturing and release: university degree in pharmacy, medicine, chemistry or biology plus several years of practice
- Wholesale, import and export: a lower level of education and a shorter practice are admissible
- Authority to instruct and direct reporting to the management must be evidenced
- Presence on site must match size, product range and risk
- Arrange a deputy; a change of FvP is notifiable and can trigger an amendment of the licence
GMP, GDP and the inspection regime
Manufacturing is measured against Good Manufacturing Practice, while wholesale, import and storage are measured against Good Distribution Practice. Switzerland follows the PIC/S standard in substance. Control happens through on-site inspections, which Swissmedic either performs itself or delegates to the regional inspectorates.
Besides Swissmedic, the regional therapeutic products inspectorates inspect, among them the Regionale Fachstelle Heilmittelkontrolle. The rhythm is risk-based: sterile manufacturing is checked more often than a pure trading warehouse, in practice every two to three years against four to five years. After the inspection, GMP or GDP certificates are issued.
Those certificates and the licences are public. Swiss companies can be looked up in the SwissGMDP database, and the certificates also appear in the European EudraGMDP database. For export business that entry is often the real benefit of the licence, because buyers ask for it as evidence.
- GMP for manufacturing, packaging, quality control and batch release
- GDP for wholesale, import, storage, transport and temperature control
- Inspection by Swissmedic or a regional inspectorate, on a risk-based rhythm
- Certificates searchable in SwissGMDP, also published in EudraGMDP
- Most common findings: incomplete quality assurance, weak deviation management, missing temperature mapping data, undocumented supplier qualification, an FvP present too rarely
How does the application run, what does it cost, how long does it take?
The application is filed electronically on the Swissmedic form, together with a description of the company, an organisation chart, a list of rooms and equipment, the CV and job description of the FvP and a list of activities and product categories. Completeness is the lever; an incomplete dossier extends the procedure considerably.
Fees follow the Swissmedic fee ordinance. The order of magnitude for a first establishment licence is in the four-figure Swiss franc range, with inspections charged on top according to effort. The binding figure is always the tariff in the ordinance, never a cost estimate from a consultancy.
The inspection drives the timeline. Between filing and decision, three to six months is usual, because a first issue is preceded by an inspection and the site has to be operational for it. The licence is issued for an unlimited duration as a rule, but changes are notifiable.
- Define the activities exhaustively and fix the scope of the licence
- Recruit the FvP and document her qualification, authority to instruct and presence
- Build the quality system, the rooms, the equipment and the contracts with contractors
- File the Swissmedic application form electronically with every annex
- Prepare for the inspection, run an internal self-inspection and close gaps beforehand
- After the decision, keep reporting changes to the FvP, the rooms or the activities
Frequently asked questions
Do I need an establishment licence if I am only the authorisation holder?
Not necessarily. The marketing authorisation and the establishment licence are separate. If you hold the authorisation but outsource manufacturing, import and storage entirely to licensed third parties, you need no licence yourself. As soon as you import, store or release goods, you do.
How long does an establishment licence take?
Reckon with three to six months from a complete application, because a first issue is preceded by an inspection. The site must be fully fitted out and operational for it. Incomplete documents and an FvP not yet hired are the two most common causes of delay.
Can one person be the FvP at several companies?
It is possible but limited. What decides is whether the presence matches the size and risk of each site and whether the authority to instruct is real in each of them. With several mandates at small workloads Swissmedic regularly refuses or demands a higher workload.
What applies to medical devices?
There is no establishment licence for medical devices. The duties of the Medical Devices Ordinance (MepV) apply instead: conformity assessment, technical documentation and vigilance reporting. Manufacturers without a Swiss domicile need a Swiss authorised representative (CH-REP); importers and distributors carry their own duties.
Is the licence time limited?
It is issued for an unlimited duration as a rule. It stays tied to the circumstances reported, though: a change of FvP, new rooms, new activities or new product categories must be reported to Swissmedic and can trigger an amendment or a fresh inspection.