How do you meet the QPPV obligation without a dedicated full-time position?
We provide qualified Qualified Persons for Pharmacovigilance (QPPV) as an outsourcing, interim, or backup solution: resident in the EU or EEA, permanently available, and with a written QPPV mandate under GVP Module I. The QPPV function can be fully outsourced under GVP Module I, provided that the Pharmacovigilance System Master File (PSMF) and authority communication remain unambiguously assigned. The most common inspection finding is not the missing QPPV itself, but the absence of a documented deputy arrangement for periods of absence.
- Pharma
- Biotech
Overview
What requirements does the QPPV function place on marketing authorization holders?
QPPV mandate under GVP Module I & Implementing Regulation (EU) 520/2012 · Outsourcing, interim & backup
Last updated: 2026-06-12
Every marketing authorization holder must permanently designate a Qualified Person for Pharmacovigilance under Art. 104 of Directive 2001/83/EC. The function carries personal responsibility toward the authorities and cannot be improvised. The points at which companies most frequently fail:
- The QPPV must reside and operate in the EU or EEA and must be permanently and continuously available to the marketing authorization holder under Art. 104 of Directive 2001/83/EC; a mere job title without demonstrated availability is not sufficient.
- The QPPV is responsible for the Pharmacovigilance System Master File (PSMF) and for keeping it current under GVP Module II; they are recorded by name in the PSMF and with the EMA and national authorities.
- Full outsourcing of the QPPV function is permitted under GVP Module I, but requires a written QPPV mandate that unambiguously governs tasks, responsibilities, and information flows.
- GVP Module I requires the QPPV function to be staffed at all times; for vacation, illness, and unavailability, a deputy (backup) must be designated in writing.
Services
How we support you
Full QPPV outsourcing
An EU-resident Entourage QPPV assumes the statutory function in full: designation in the PSMF, signature, authority communication, and representation toward the EMA and national authorities. Deliverable: a signed QPPV mandate under GVP Module I with a documented availability arrangement.
Interim QPPV during a vacancy
Bridging the loss of an internal QPPV due to resignation, illness, or parental leave. Deliverable: a documented handover, an updated PSMF designation under Art. 2 of Implementing Regulation (EU) 520/2012, and a QPPV change reported to the authorities.
Backup QPPV for existing structures
A deputy designated in writing for an existing internal QPPV, as required by GVP Module I for periods of absence. Deliverable: a formal backup designation with a documented deputy arrangement in the PV procedures.
QPPV mandate & PSMF integration
Preparation of the written QPPV mandate and anchoring of the role in the Pharmacovigilance System Master File under GVP Module II. Deliverable: an inspection-ready mandate plus an updated PSMF section on the QPPV, including contact and deputy details.
Learn more →QPPV training for internal candidates
Structured preparation of internal QPPV candidates for GVP requirements, PSMF maintenance, authority communication, and signal management. Deliverable: a documented training record as evidence of qualification under GVP Module I and Implementing Regulation (EU) 520/2012.
Learn more →How we work together
What it comes down to
The obligation to appoint a Qualified Person for Pharmacovigilance under Art. 104 of Directive 2001/83/EC is not a question of a vacant position but a question of sequence: first comes EU/EEA residency and continuous availability under Art. 104 of Directive 2001/83/EC, then the written QPPV mandate under GVP Module I that unambiguously assigns responsibility, and only after that the reflection in the Pharmacovigilance System Master File under GVP Module II. Anyone who makes the designation before availability and deputy arrangements are in place has a QPPV on paper that will not hold up in an inspection.
This is precisely where the bottleneck arises that regularly affects small and mid-sized marketing authorization holders: a single internal QPPV covers normal operations but not an absence, and GVP Module I checks not only whether the function is staffed but whether it remains staffed continuously. With a backup or interim QPPV, we close this gap at exactly the point where it surfaces, without having to fund an entire full-time position; the PSMF and the authority notification keep the designation and reality aligned in the process.
Our approach
Our approach
Step
Result
Needs assessment & model selection
A defined engagement model (outsourcing, interim, or backup) and a defined scope of responsibility for the QPPV.
Designation & QPPV mandate
A signed written QPPV mandate under GVP Module I with defined tasks, availability, and escalation paths.
PSMF update
The QPPV recorded by name in the Pharmacovigilance System Master File, with the deputy arrangement documented under GVP Module II.
Authority notification
The QPPV designation or change reported to and confirmed by the EMA and national authorities.
Ongoing operation
A permanently available QPPV in operation, authority communication and PSUR release covered, backup ready for deployment.
Common pitfalls
Where projects commonly fail
The deputy is missing.
GVP Module I requires the QPPV function to be staffed at all times; without a backup designated in writing for vacation and illness, this produces a finding that is flagged in almost every PV inspection. What is cited is not the rare absence itself, but the lack of an arrangement to cover it.
The QPPV is not genuinely reachable.
Art. 104 of Directive 2001/83/EC requires the QPPV to be permanently and continuously available to the marketing authorization holder; a designation by name without a robust 24/7 availability arrangement and deputy meets the requirement only on paper.
The PSMF does not reflect the QPPV correctly.
If the QPPV changes without the Pharmacovigilance System Master File being updated under Art. 2 of Implementing Regulation (EU) 520/2012 and GVP Module II and reported to the authority, the designated and actual functions diverge.
The outsourcing runs without a proper mandate.
Full outsourcing is permitted under GVP Module I, but only with a written QPPV mandate that governs responsibilities and information flows; a mere service agreement without these provisions does not cover the regulatory responsibility.
The QPPV resides outside the EU/EEA.
The requirement that the QPPV reside and operate in the EU or EEA is overlooked; a professionally suitable person without EU/EEA residency does not meet the formal requirement.
FAQ
Frequently asked questions
Sources
- Directive 2001/83/EC - Community code relating to medicinal products for human use, Art. 104
- Regulation (EC) No 726/2004 - Art. 23 (centralized procedure, pharmacovigilance)
- Implementing Regulation (EU) No 520/2012 - Art. 2 (content of the PSMF), minimum requirements for the quality system and personnel
- EMA Good Pharmacovigilance Practices (GVP) Module I and Module II
- /output/expertise-pages/clinical-medical-affairs/qppv-services/qppv-services.md (writer source text)
- https://theentourage.de/expertise/qppv-services/ (existing page content, revised)
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Case Studies
What this looks like in practice
Regulations & standards considered
- Directive 2001/83/EC Art. 104 (MAH's QPPV obligation, continuous availability)
- Regulation (EC) No 726/2004 Art. 23 (QPPV obligation for centrally authorized medicinal products)
- Implementing Regulation (EU) No 520/2012 Art. 2 (content of the Pharmacovigilance System Master File, PSMF)
- Implementing Regulation (EU) No 520/2012 (minimum requirements for the quality system and personnel)
- GVP Module I (Pharmacovigilance Systems and their Quality Systems)
- GVP Module II (Pharmacovigilance System Master File)
Related topics
Pharmacovigilance →
The PV system under GVP Module I in which the QPPV function is embedded
Signal Detection →
Signal management as a core task within the QPPV's area of responsibility
Qualified Person on Demand →
The QP function under Art. 48 of Directive 2001/83/EC as a related designated role
Health Authority Interaction →
Structured authority communication with the EMA and national authorities
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