Manufacturing Licence for Medicinal Products in Switzerland
Short answer
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.
Who needs a manufacturing licence?
Every establishment in Switzerland that carries out a manufacturing step on a medicinal product. This includes contract manufacturers, operations that pack bulk goods, laboratories that perform the quality control underlying a release, and hospital pharmacies that produce beyond the formula rules.
- Full manufacturers of ready-to-use medicinal products.
- Contract manufacturers and packers, even for a single operation.
- Operations that repackage or relabel, for example for parallel imports.
- Testing laboratories whose results underpin batch release.
- Operations that manufacture medicinal products for clinical trials.
- Hospital pharmacies that manufacture medicinal products for other institutions.
What GMP requirements does Swissmedic check?
The entire quality system is reviewed: pharmaceutical quality system, personnel and training, premises and equipment, documentation, production, quality control, outsourced activities, complaints and recalls, and self-inspections. The basis is the PIC/S GMP guide, which the MPLO declares applicable.
| Chapter | Focus | Typical finding |
|---|---|---|
| Quality system | Product Quality Review, deviation management | Deviations closed without root cause analysis |
| Personnel | Qualification, training, deputising | Training records not up to date |
| Premises and equipment | Cleanliness classes, qualification, calibration | Requalification overdue |
| Documentation | Data integrity, audit trail, batch documentation | Audit trail not reviewed |
| Production | Process validation, cross-contamination | Validation without a current risk assessment |
| Quality control | Method validation, reference standards, OOS | OOS procedure without deadlines |
| Outsourced activities | Quality agreements, supplier audits | Audits not carried out as planned |
What documents does the application require?
The application consists of the form, the Site Master File, the organisation chart, evidence for the Responsible Person, a list of activities and product categories, and plans of the premises showing cleanliness classes and material flows.
- Define activities and product categories precisely; any later expansion is a variation requiring a fresh review.
- Prepare a Site Master File following the PIC/S structure and keep it up to date.
- Name the Responsible Person and provide evidence of training and practical experience.
- Document premises, equipment and qualification status, including plans.
- Submit the application via the Swissmedic Portal and provide the fee invoicing address.
- Arrange the inspection date, undergo the inspection, and remedy deficiencies within the deadline.
- Receive the decision with the licence and, if requested, a GMP certificate.
What does batch release mean for Switzerland?
Every batch placed on the Swiss market must be released by a Responsible Person. For imports from the EEA, release there can be relied on provided equivalence is documented. For imports from third countries, full testing must be demonstrated in Switzerland or the EEA.
Frequently asked questions
Do I need a licence if I only repackage?
Yes. Repackaging and relabelling are manufacturing steps and require a manufacturing licence covering that activity.
Will my EU GMP certificate be recognised?
Yes, for manufacturing in the EEA, thanks to the Mutual Recognition Agreement. For a site in Switzerland you still need a Swiss manufacturing licence.
How often are inspections carried out?
Routine inspections take place risk-based every two to three years, more often for sterile products and biological medicinal products. A follow-up inspection is carried out after serious findings.
Can one person be the Responsible Person for several operations?
Only if they are actually present and have authority to instruct at each operation. Swissmedic checks the time commitment; a mandate without presence is not accepted.
What does a manufacturing licence cost?
A base fee plus inspection effort at the hourly rate. For a medium-sized operation with two inspection days, the total is typically in the mid four-figure to low five-figure range in francs.
Sources
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