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Stufenplanbeauftragter (German QPPV) under § 63a AMG: duties, notification, cover
Any company placing finished medicinal products on the German market must appoint a Stufenplanbeauftragter (German QPPV) under § 63a AMG. A&O provides this person externally and at short notice: on an interim basis during a vacancy, absence or transition, or long-term on a part-time basis, on request also as EU QPPV or information officer.
Key points at a glance
Legal basis checked against the statutory text, as of October 2026
Every pharmaceutical company placing finished medicinal products on the German market must appoint a Stufenplanbeauftragter based in the EU under § 63a AMG.
The Stufenplanbeauftragter collects and assesses reports of medicinal product risks and coordinates the necessary measures. The company notifies the competent regional authority and the Federal Institute for Drugs and Medical Devices (BfArM) in advance.
A&O provides the Stufenplanbeauftragter externally, on an interim basis during a vacancy or long-term part-time, and on request together with the EU QPPV and the information officer.
At A&O Pharma
If your Stufenplanbeauftragter is absent or the position is vacant, an A&O expert takes on the role at short notice until your own solution is in place. You notify the change under § 63a(3) AMG; we continue the ongoing pharmacovigilance processes and hand them over in an orderly manner at the end.
If your portfolio does not justify a full-time position, A&O takes on the role long-term to the agreed extent. On request, the same expert can also act as EU QPPV, provided your pharmacovigilance system is set up for this.
A&O also fills the role of information officer (Informationsbeauftragter) under § 74a AMG, who is responsible for ensuring that labelling, package leaflet, summary of product characteristics and advertising match the marketing authorisation. The law allows the information officer and the Stufenplanbeauftragter to be the same person (§ 74a(2) AMG).
Process
You describe your portfolio, authorisations and the existing pharmacovigilance system. We get back to you within 1 to 2 days.
Scope, availability and deputy arrangements are set out in the contract. We review SOPs, open cases and reporting routes.
You notify the competent regional authority and BfArM of the appointment in advance (§ 63a(3) AMG). We prepare the details.
Assessing reports, coordinating measures, informing authorities. When the assignment ends, we hand over in an orderly way.
What the law requires
Under § 63a(1) of the German Medicinal Products Act (AMG), every pharmaceutical company placing finished medicinal products on the market must appoint a person resident in the EU with the necessary expert knowledge and reliability. Persons who do not require a manufacturing authorisation under § 13(2) Nos. 1, 2 or 5 or § 13(2b) AMG are exempt to that extent. According to the Federal Institute for Drugs and Medical Devices (BfArM), the obligation also applies to marketing authorisation holders not established in Germany that supply a co-distributor; two Stufenplanbeauftragte may then be needed. No Stufenplanbeauftragter is required for investigational medicinal products used in clinical trials.
establishing and running a pharmacovigilance system, collecting and assessing reports of medicinal product risks and coordinating the necessary measures (§ 63a(1) AMG)
meeting notification obligations relating to medicinal product risks and promptly providing information on the benefit-risk balance at the request of the competent federal authority
systematically recording complaints, involving the Qualified Person, informing the authority without delay of any defect that could lead to a recall and of any suspected falsification, and keeping records of all this (§ 19 of the German Ordinance on the Manufacture of Medicinal Products and Active Substances, AMWHV)
Unlike § 15 AMG, which sets out the expert knowledge required of a Qualified Person, § 63a AMG does not prescribe a specific qualification, but it does require expert knowledge and reliability. The Stufenplanbeauftragter should be independent of sales and distribution, must reside and operate in the EU and may only be deputised by persons with the same expert knowledge (§ 19(6) AMWHV). They may also act as Qualified Person under § 14 AMG (§ 63a(2) AMG).
The company notifies the competent regional authority and the competent federal authority of the Stufenplanbeauftragter and of every change in advance, or without delay if the change is unforeseen (§ 63a(3) AMG). BfArM is notified via a portal; the regional authority must be informed separately. Failing to appoint or notify is an administrative offence (§ 97(2) No. 24c AMG) punishable by a fine of up to EUR 25,000.
Article 104(3) of Directive 2001/83/EC additionally requires the marketing authorisation holder to have a QPPV who resides and operates in the EU. The Stufenplanbeauftragter is the role under German law and also covers quality defects and recalls. According to BfArM, holders whose only authorisations are centralised ones do not need a Stufenplanbeauftragter, but a person must still be designated for the duties under § 19 AMWHV.
Named individually
You know who is responsible for you before the contract starts and can reach that person directly. Cover comes from the same team.
Dr. Olaf Mundszinger
Founder and Managing Director
Dr. Klaus-Peter Kreth
Qualified Person (QP) under § 14 AMG
Alexander Trautmann
GMP Consulting and Training
Dr. Kai Huwig
Qualified Person (QP) and Head of Quality Control
Tatjana Pazer
Quality Management and Sterile Manufacturing
Dr. Thomas Lutz
Qualified Person (QP) and Head of Production
Dr. Emmanuel Bey
Analytical Development
Ute Hegener
Regulatory Affairs
Dr. Barbara Siebertz
Regulatory Affairs
Case studies
Weighing it up
| Outsourced through A&O Pharma | Hire your own person | |
|---|---|---|
| Time to fill the role | Possible at short notice, as our experts already perform this role. Notification under § 63a(3) AMG is still required. | Depends on advertising, selection, notice periods and induction. |
| Cover for holidays and illness | A deputy with the corresponding expert knowledge can be arranged within A&O. | For holidays and illness you need your own deputy with the expert knowledge required by § 63a(1) AMG (§ 19(6) AMWHV). |
| Cost structure | Fees based on the agreed scope; no full-time position needed for a small portfolio. | Salary, ancillary costs and training are incurred regardless of workload. |
| Commitment | Contract term agreed in writing, adaptable to a transition phase or portfolio. | Long-term employment; the knowledge stays in the company. |
| Expertise | Experience across several companies, with close links to A&O's Qualified Persons, regulatory affairs and GMP consulting. | Detailed knowledge of your own products and processes; expertise depends on individuals. |
Frequently asked questions
They establish and run the pharmacovigilance system, collect and assess reports of medicinal product risks and coordinate the necessary measures (§ 63a AMG). In addition, they handle complaints, quality defects, suspected falsifications and recalls under § 19 AMWHV.
Every pharmaceutical company placing finished medicinal products on the German market, subject to the exemptions in § 63a(1) AMG. According to BfArM, no Stufenplanbeauftragter is required for investigational medicinal products used in clinical trials.
§ 63a AMG requires the necessary expert knowledge and reliability but, unlike § 15 AMG for the Qualified Person, does not name a specific degree. The person must reside and operate in the EU and should be independent of sales and distribution (§ 19(6) AMWHV).
§ 63a AMG refers to an appointment and requires expert knowledge, reliability and residence in the EU; it does not require permanent employment. For the EU QPPV, GVP Module I expressly allows the role to be subcontracted, with overall responsibility remaining with the marketing authorisation holder.
The company notifies the competent regional authority and the competent federal authority before the role begins; BfArM is notified via its portal. According to BfArM, the notification may be made no more than three months before the start date and no later than one week after a change; a fee is charged.
Failing to appoint a Stufenplanbeauftragter, or failing to make the notification in full or on time, is an administrative offence (§ 97(2) No. 24c AMG). The fine can be up to EUR 25,000 (§ 97(3) AMG).
No. EU law requires the marketing authorisation holder to have a QPPV (Article 104 of Directive 2001/83/EC), while the Stufenplanbeauftragter is a role under German law with additional duties relating to quality defects. According to BfArM, where a company holds only centralised authorisations, the EU QPPV is sufficient, supplemented by a person designated for the duties under § 19 AMWHV.
Yes. § 63a(2) AMG allows the Stufenplanbeauftragter to act as Qualified Person under § 14 AMG at the same time, and § 74a(2) AMG allows the information officer to be the Stufenplanbeauftragter as well.
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