Swissmedic has published guidance MU100_00_001, outlining regulatory expectations and mandatory qualifications for the Responsible Person for Pharmacovigilance (RPV) and deputy roles, and clarifying that ongoing safety notification duties persist even after an establishment licence expires. As GMP Insiders reports, the framework forces a structural reset for every marketing-authorisation holder serving the Swiss market. Your pharmacovigilance chain cannot afford ambiguity on who owns the signal.
What the guidance locks in
- Defined competency expectations for the RPV and the deputy — no more informal arrangements inherited from whoever happened to be available when the licence was first granted.
- Explicit accountability for the deputy when acting in the RPV role, placing both names on the same regulatory hook.
- A specific obligation baked into the framework: safety notifications do not pause when the establishment licence lapses. Your reporting clock continues to run.
This is not a soft policy note. It is the regulator telling you exactly what an inspector will look for on day one of an audit — and what your team must already be able to demonstrate.
Where your operation is exposed
If your RPV is a part-time appointment stretched across multiple portfolios, you have a bottleneck at the very point the regulator now insists is non-negotiable. If your deputy has never been formally assessed against the new qualification criteria, you have a documentation gap that will surface the moment it is tested. And if your pharmacovigilance SOPs assume a licence-renewal cycle resets your obligations, your post-expiry workflow is already broken before the inspection begins.
The persistence clause is the single point most organisations will underestimate. Build the assumption — that duties survive the licence — into your procedures now, not after a finding.
Your immediate mandate
- Audit the current RPV and deputy against the MU100_00_001 qualification criteria this week.
- Document the chain of accountability in writing, with a clean handover protocol for deputy coverage.
- Map every ongoing safety reporting obligation against your establishment-licence status and confirm continuity.
- Brief your regulatory and quality teams on the post-expiry notification rule until it is unmissable.
The guidance is published. The expectations are codified. Operationalize them before the regulator does it for you.