Applying for an Establishment Licence: The Twelve-Month Path
Short answer
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.
What does a realistic timeline look like?
Plan for twelve months. Premises and equipment need qualification, a warehouse's temperature mapping should cover two seasons, the quality system needs time to bed in, and inspection dates are not freely available. Anyone wanting to be done in six months risks an inspection with findings.
| Phase | Duration | Outcome |
|---|---|---|
| Scoping: activities, product categories, sites | 1 month | Defined licence scope |
| Qualifying premises, equipment, warehouse | 3 to 5 months | Qualification reports, mapping |
| Building and implementing the quality system | 4 months | Processes in force, staff trained |
| Recruiting the Responsible Person and deputy | 2 to 4 months | Contracts, qualification evidence |
| Self-inspection and remediation | 1 month | Completed cycle |
| Preparing and submitting the application | 1 month | Complete application in the Portal |
| Inspection and decision | 2 to 4 months | Licence, and certificate if applicable |
What documents do I need?
The document list is similar across all licence types and differs in the level of detail. The core consists of the application form, the Site Master File or quality manual, the organisation chart, evidence for the Responsible Person, floor plans, and the list of processes and contracts.
- Application form with activities, product categories and sites.
- Site Master File (manufacturing) or quality manual (wholesale dealing).
- Organisation chart with reporting lines and deputising arrangements.
- CV, diplomas and work references for the Responsible Person and the deputy.
- Floor and flow diagrams, cleanliness classes, temperature zones.
- List of standard operating procedures with version status.
- Contracts with contract manufacturers, contract warehouses, laboratories and carriers.
- Commercial register extract and insurance evidence.
Which mistakes cost the most time?
First, a licence scope applied for too broadly, which triggers requirements the operation cannot meet. Second, a Responsible Person brought on board too late to help shape the system. Third, documentation written for the inspection that is not actually used day to day.
- Limit the licence scope to the activities actually planned; expand later through a variation.
- Involve the Responsible Person before building the quality system, not afterwards.
- Write processes together with the people who perform them, and use them day to day.
- Carry out a genuine self-inspection and do not gloss over the findings.
- Run a gap analysis against the GMP or GDP guide before submitting the application.
How do I maintain the licence?
Report changes to sites, activities, premises and the Responsible Person without delay. Carry out self-inspections annually, keep qualifications and training current, and submit the renewal application in good time. A licence does not lapse on its own, but it becomes invalid for changes that were not reported.
Frequently asked questions
Can I already operate before the licence is granted?
No. Licensed activities may only be carried out after the decision. Preparatory actions such as qualification and training are permitted.
Do I need a separate licence for every site?
No, one licence can name several sites. Each site is, however, assessed individually and generally inspected.
How do I find a Responsible Person?
Through professional networks, trade associations or service providers offering Responsible Person mandates. Check training, practice in the same area, and the realistically available time on site.
What does the whole project cost?
Regulatory fees run into four to five figures. The larger share is internal costs: qualification, documentation, staff and, for cold chain goods, storage technology.
How long is the licence valid?
Generally five years, with renewal on request and a fresh inspection. Changes in between must be reported at any time.
Sources
- Swissmedic: Establishment Licences and Forms
- Fedlex SR 812.212.1 MPLO
- Fedlex SR 812.21 TPA, Art. 5, 18 and 19
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