Your pharmacovigilance obligations as a Swiss authorisation holder
Holding a Swiss marketing authorisation means running a pharmacovigilance system: a named RPPV, on-time case reporting, periodic reports, signal management, literature monitoring, current PV agreements and documentation that survives an inspection. The basis is Art. 59 TPA with the detail in Art. 61 ff. TPO.
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What is a pharmacovigilance system?
A pharmacovigilance system is the organisation, the people, the processes and the records with which an authorisation holder monitors the safety of its products and acts on what it finds. It is not a database and not a department: it is the documented ability to detect a safety issue, assess it, decide, act and prove all of that afterwards.
Which obligations apply to whom?
The obligations sit with the marketing authorisation holder, whose name is on the authorisation. They do not move to a distributor, a licensee or a service provider, although any of those can perform the work. Companies that manufacture or distribute ready-to-use products carry a reporting duty of their own under Art. 59 TPA, which is why a distributor with patient contact needs a PV agreement rather than a handshake.
What Swissmedic checks in a PV inspection
An inspection tests whether the system you describe is the system you run. It starts from your system description, then samples cases and traces each one back to the source document. Expect the eight checkpoints below, in roughly this order.
- The named RPPV, their qualification and their documented deputy
- Day 0 against the source document, not against the database field
- Deadline compliance, and your own list of breaches with root causes
- Expectedness assessed against the current Swiss product information
- The signal management log: detection, assessment, decision, closure
- Training records for every function with patient contact
- PV agreements with partners, and evidence that they are reconciled
- Deviation and CAPA handling, including effectiveness checks
Obligation, cadence and evidence at a glance
Each obligation produces a specific artefact. If an obligation in your organisation produces no artefact, it is not being met in a way anyone can verify, whatever the process document says.
| Obligation | Who owns it | Cadence | Evidence an inspector asks for |
|---|---|---|---|
| Name and maintain an RPPV | Management, RPPV | Continuous | Appointment letter, CV, deputy arrangement |
| Run the PV system | RPPV | Continuous | System description, SOP index, change log |
| Report individual cases | Case management | Per case, 15 or 60 days | Case log with day 0, ElViS acknowledgements |
| Submit periodic reports | RPPV, medical writing | Interval set per authorisation | Submitted PSUR and the submission receipt |
| Manage signals | RPPV, safety physician | Continuous, reviewed periodically | Signal log with decisions and reasoning |
| Monitor the literature | PV, information specialist | Weekly | Search strategy, hit log, resulting ICSRs |
| Keep PV agreements current | RPPV, legal | Per partner, reviewed annually | Signed SDEA, cascade, reconciliation records |
| Train the organisation | RPPV, HR | On joining and annually | Dated attendance lists and content outline |
The three failures that cost the most
Inspection findings cluster. Three causes account for most of the serious ones, and all three are cheap to prevent and expensive to remediate after the fact.
The first is day 0. A case arrives at a sales representative or a distributor hotline and reaches the PV department days later, and the deadline is counted from the later date. Formally compliant, substantively late. The fix is a 24 hour forwarding rule for every patient-facing function, trained and evidenced.
The second is expectedness against the wrong document. Teams running an EU process assess against the SmPC, but Switzerland assesses against the Swiss product information. A reaction listed in the EU can be unexpected here, which changes both reportability and deadline.
The third is untended PV agreements. An SDEA signed in 2019, never reconciled and naming a contact who left, is a paper control. Count the cases your partner sent against the cases you received, periodically, and write down the result.
Frequently asked questions
Can we outsource our pharmacovigilance obligations?
You can outsource the work but not the responsibility. The marketing authorisation holder remains accountable to Swissmedic. What you need is a written agreement defining scope, deadlines, escalation and data handover, plus evidence that you oversee the provider.
Do these obligations apply to a small portfolio too?
Yes. The obligations scale in effort, not in existence. A holder with two authorisations and five cases a year still needs an RPPV, a described system, deadline control and a signal process, just in proportion.
Does a distributor have its own duty?
A company that distributes ready-to-use medicinal products carries a reporting duty under Art. 59 TPA. In practice the distributor forwards to the authorisation holder under an SDEA, with a cascade deadline shorter than the regulatory one.
How often does Swissmedic inspect?
Inspections are risk based rather than on a fixed cycle, and they can also be triggered by a specific concern such as repeated late reports. Being ready continuously is cheaper than preparing on notice.
Where exactly are these obligations written down?
The duty to report is in Art. 59 TPA. The operational detail, including the responsible person and the periodic reports, is in Art. 61 ff. TPO. Medical device vigilance sits in the MedDO. Swissmedic guidance documents describe the implementation.
Do you need an RPPV in Switzerland?
We act as the qualified person responsible for pharmacovigilance, run case processing and write the PSURs for your Swiss authorisations.