The Responsible Person Under the MPLO
Short answer
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.
What are the Responsible Person's duties?
They are accountable for the quality of the activities within the licence scope: releasing or blocking batches, assessing deviations, deciding on recalls, approving quality documents, overseeing training, and representing the operation to the inspecting authority on technical matters.
- Batch release for the Swiss market or, in wholesale dealing, release of goods for sale.
- Assessment of deviations, complaints and temperature excursions.
- Decisions on blocking, destruction and recall.
- Approval of standard operating procedures and quality agreements.
- Oversight of self-inspections and supplier qualification.
- Reporting quality defects and suspected falsification to Swissmedic.
What training and experience are needed?
Depending on the activity, the MPLO requires a university education in pharmacy, medicine, chemistry, biology or an equivalent field, plus practical experience in the relevant area. For wholesale dealing, an advanced federal diploma qualification, such as a druggist, with corresponding practice also suffices.
| Licence type | Training | Practice | Note |
|---|---|---|---|
| Manufacture of sterile medicinal products | Pharmacy or an equivalent scientific degree | several years in sterile production | highest requirements |
| Manufacture of non-sterile medicinal products | Scientific degree | several years in manufacturing | evidenced by certificates |
| Manufacture of blood products | Medicine or pharmacy | experience with labile blood products | additional requirements |
| Wholesale dealing and import | Pharmacy, druggist (advanced federal diploma) or equivalent | experience in distribution | GDP knowledge required |
| Trading abroad | as for wholesale dealing | experience in international trade | separate licence |
What does direct authority to instruct mean?
The Responsible Person must be able to decide independently on technical matters and may not be overruled. Organisationally that means: a direct line to executive management, no reporting line through production or sales management, and a documented right of veto over releases. Swissmedic examines the organisation chart for this.
How should deputising be arranged?
The operation must have an available Responsible Person at all times. A deputy with equivalent qualifications must therefore be named, formally mandated in writing, and given hands-on induction. During a prolonged absence with no valid deputy, licensed activities must stop.
- Name a deputy with equivalent training and practice.
- Record the deputy's duties, limits and duration in writing.
- Define a handover process, including open deviations and ongoing releases.
- Report any change of the Responsible Person or deputy to Swissmedic without delay.
- Suspend activities and inform Swissmedic if the role is vacant.
How far does the responsibility extend?
The Responsible Person bears technical responsibility for compliance with quality requirements; corporate responsibility stays with the operation. In the event of breaches of the TPA, both administrative measures against the operation and criminal consequences for the individuals involved can follow.
Frequently asked questions
Can I mandate an external Responsible Person?
Yes, provided the person is genuinely present, reachable and has authority to instruct at the operation. The time commitment must match the size of the operation; a mandate without presence is not accepted.
Is the Responsible Person the same as the EU Qualified Person?
Functionally yes, legally no. The Responsible Person follows the MPLO, the Qualified Person follows EU law. Anyone wanting to hold both roles must meet the requirements of both legal systems.
How many operations may one Responsible Person cover?
There is no fixed number. Swissmedic assesses whether the time on site is sufficient for the duties at each operation. Time records must be provided where there are several mandates.
Does the Responsible Person need their own licence?
No. They are approved as part of the establishment licence. A change is a notifiable variation and is reviewed by Swissmedic.
What applies to pharmacovigilance?
The person responsible for pharmacovigilance is a different role from the Responsible Person. Both can be held by the same individual if qualification and time budget allow it.
Sources
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