QPPV & Responsible Persons
Qualified Person Responsible for Pharmacovigilance, Graduated Plan Officer (Stufenplanbeauftragter) and deputy — as a permanent function or to bridge a gap.
What is a QPPV?
The QPPV is the named person who is accountable for a marketing authorisation holder’s entire pharmacovigilance system in the EU. They must be permanently available around the clock, have an overview of the system and be able to provide information to the authorities. In Germany, further appointed roles are added: the Graduated Plan Officer (Stufenplanbeauftragter), the Information Officer and, for narcotics, the responsible person for narcotic drugs.
Why does it matter?
These roles cannot be left vacant without arrangements in place. If the appointed person is unavailable and no deputy has been appointed and trained, a gap opens immediately and becomes visible in any inspection. The role also regularly carries more load than one person can absorb alone — it needs a robust process behind it, not just a name in the register.
Who needs it?
Marketing authorisation holders without their own qualified person in-house. Companies whose QPPV is leaving, will be absent for an extended period or is going on parental leave. Start-ups preparing their first marketing authorisation. And companies that need an appointed deputy in order to be able to demonstrate the four-eyes principle at all.
What do the regulations require?
- GVP Module I, Section I.C.1.3 — requirements for the EU QPPV
- Article 10(1) of Regulation (EU) No 520/2012 — Medically Trained Person
- Section 63a AMG (German Medicines Act) — Graduated Plan Officer (Stufenplanbeauftragter), resident in a Member State of the European Union
- Section 74a AMG — Information Officer
- Section 5 BtMG (German Narcotics Act) — responsible person for narcotic drugs
How VigiPRO supports you
- Temporary or permanent assumption of the function, in each case also as deputy
- EU QPPV for human and veterinary medicinal products
- Medically Trained Person under Regulation (EU) No 520/2012
- Graduated Plan Officer and Information Officer under the AMG
- Responsible person for narcotic drugs under the BtMG
- Guaranteed 24-hour availability within the scope of the functions assumed
Why VigiPRO
The founders are a physician and a pharmacist — the medical and pharmaceutical qualifications these roles require are in-house, not bought in from a third party. Because several people in the team can fill the function, the deputy arrangement is real and not just regulated on paper.
Frequently asked questions
Does the QPPV have to be based in the same country as our company?
The EU QPPV must reside and operate in the European Union, not necessarily in the marketing authorisation holder’s country of establishment. The Graduated Plan Officer under Section 63a AMG must be resident in a Member State of the European Union — the EEA is not sufficient here.
Can an external QPPV really fill the role?
Yes, if they have genuine access to the system: to the cases, to the PSMF, to the processes and to the people who operate them. A QPPV who is only formally appointed and is given no insight is an inspection finding, whether internal or external.
How quickly can a deputy take over?
That depends on the state of the documentation. If the PSMF is up to date and the processes are described, a takeover at short notice is feasible. If the knowledge exists only in one person’s head, the onboarding becomes the actual project.
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