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Stufenplanbeauftragter (Section 63a AMG): duties, notification, cover
Anyone placing finished medicinal products on the German market must appoint a Stufenplanbeauftragter (graduated plan officer) under Section 63a AMG. A&O provides this person externally and at short notice: interim cover or permanently part-time, 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 graduated plan officer (Stufenplanbeauftragter) based in the EU under Section 63a AMG.
The graduated plan officer collects and assesses reports on drug risks and coordinates the necessary measures. The company notifies the state authority and BfArM in advance.
A&O provides the graduated plan officer externally, temporarily during a vacancy or permanently 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 expert from A&O takes on the role at short notice until your own solution is in place. You notify the change under Section 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 permanently 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 Section 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 (Section 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 state authority and BfArM of the appointment in advance (Section 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 Section 63a(1) of the German Medicinal Products Act (AMG), every pharmaceutical entrepreneur placing finished medicinal products on the market must appoint a qualified person resident in the EU with the necessary expertise and reliability. Persons who do not require a manufacturing authorisation under Section 13(2) nos. 1, 2, 5 or (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 without a seat in Germany that supply a co-distributor; two Stufenplanbeauftragte may then be needed. None is required for investigational medicinal products in clinical trials.
establishing and running a pharmacovigilance system, collecting and assessing reports of medicinal product risks and coordinating the necessary measures (Section 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 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 (Section 19 of the German Ordinance on the Manufacture of Medicinal Products and Active Substances, AMWHV)
Unlike Section 15 AMG for the Qualified Person, Section 63a AMG does not prescribe a specific qualification, but it does require expertise 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 this expertise (Section 19(6) AMWHV). They may also act as Qualified Person under Section 14 AMG (Section 63a(2) AMG).
The pharmaceutical entrepreneur notifies the competent regional authority and the federal authority of the Stufenplanbeauftragter and of every change in advance, or without delay if the change is unforeseen (Section 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 (Section 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 of centralised authorisations only do not need a Stufenplanbeauftragter, but a person must still be designated for the duties under Section 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
Development Analytics
Case studies
Weighing it up
| External via A&O Pharma | Hire your own person | |
|---|---|---|
| Time to fill the role | Possible at short notice, as the experts already perform this role. Notification under Section 63a(3) AMG is still required. | Depends on advertising, selection, notice periods and induction. |
| Cover for holidays and illness | A deputy with the corresponding expertise can be arranged within A&O. | For holidays and illness you need your own deputy with the expertise required by Section 63a(1) AMG (Section 19(6) AMWHV). |
| Cost structure | Fees based on the agreed scope, no full-time position for a small portfolio. | Salary, ancillary costs and training are incurred regardless of workload. |
| Commitment | Contractually agreed term, adaptable to a transition phase or portfolio. | Long-term employment relationship, knowledge stays in the company. |
| Expertise | Experience from several companies, close links to Qualified Persons, regulatory affairs and GMP consulting at A&O. | 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 (Section 63a AMG). In addition, they handle complaints, quality defects, suspected falsifications and recalls under Section 19 AMWHV.
Every pharmaceutical entrepreneur placing finished medicinal products on the German market, subject to the exemptions in Section 63a(1) AMG. According to BfArM, none is required for investigational medicinal products in clinical trials.
Section 63a AMG requires the necessary expertise and reliability but, unlike Section 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 (Section 19(6) AMWHV).
Section 63a AMG refers to an appointment and requires expertise, reliability and residence in the EU; the wording does not mention 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 pharmaceutical entrepreneur notifies the competent regional authority and the federal authority before the role begins, BfArM via a 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 (Section 97(2) no. 24c AMG). The fine can be up to EUR 25,000 (Section 97(3) AMG).
No. EU law requires the QPPV of the marketing authorisation holder (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, for centralised authorisations only, the EU QPPV is sufficient, supplemented by a person for the duties under Section 19 AMWHV.
Yes. Section 63a(2) AMG allows the Stufenplanbeauftragter to act as Qualified Person under Section 14 AMG at the same time, and Section 74a(2) AMG allows the information officer to be the Stufenplanbeauftragter as well.
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