Every named appointment the law requires, in one table. The legal basis, who has to appoint it, and the qualification the law actually demands.
German pharmaceutical and medical device law does not only regulate companies. It regulates named people. A manufacturing authorisation is granted on the condition that a specific individual is appointed, notified to the authority, and personally answerable. Fifteen of these appointments are in regular use, spread across the Arzneimittelgesetz, the AMWHV, the BtMG, the MPDG, the MPBetreibV, the Strahlenschutzgesetz, the dangerous goods rules, and three pieces of EU legislation.
Most people working in the industry can name three or four of them. The table below has all fifteen, with the paragraph you can look up yourself. Nothing here sits behind a form.
| Role | Legal basis | Who must appoint it | Qualification the law requires | |
|---|---|---|---|---|
| 1 | Sachkundige PersonQualified Person | §§ 14, 15 AMG | Every holder of a manufacturing authorisation | Named degree plus practical experience, both spelled out in § 15 AMG |
| 2 | Leiter der Herstellung und Leiter der QualitätskontrolleHead of Production and Head of Quality Control | § 12 AMWHV, EU GMP Guide Chapter 2 | Every manufacturing site | No named degree. Documented responsibility and independence from each other |
| 3 | StufenplanbeauftragterGraduated Plan Officer | § 63a AMG | Pharmaceutical entrepreneurs placing finished medicines on the German market | Expertise not defined in law, assessed case by case. Residence in an EU member state |
| 4 | InformationsbeauftragterInformation Officer | § 74a AMG | Pharmaceutical entrepreneurs placing finished medicines on the market | Expertise and reliability, not defined in law. In practice a science degree and close work with the Fachinformation |
| 5 | Verantwortliche Person (Großhandel)Responsible Person, wholesale distribution | § 52a AMG, EU GDP guidelines | Every holder of a wholesale distribution licence | Expertise matched to the products and the operation. No pharmacy degree required |
| 6 | Verantwortliche Person (Gewebeeinrichtung)Responsible Person, tissue establishment | § 20c AMG | Tissue establishments processing by non-industrial methods | Medicine, biology, biochemistry or comparable, plus two years in tissue processing |
| 7 | Sachkundige Person (Tierarzneimittel)Qualified Person, veterinary medicines | Art. 97 Regulation (EU) 2019/6, TAMG | Every holder of a veterinary manufacturing authorisation | Degree in one of six named disciplines, plus two years of practical experience in authorised manufacturing |
| 8 | Pharmaberater und PharmareferentPharmaceutical Sales Representative | §§ 75, 76 AMG | Any company sending people full-time to inform healthcare professionals about medicines | Three routes: a science degree, technical assistant training, or the examined Pharmareferent qualification |
| 9 | BtM-VerantwortlicherControlled Substances Officer | §§ 3, 5, 6, 7 BtMG | Every holder of a controlled substances licence, and separately for each further site in a non-adjacent municipality | Five routes set out in § 6 BtMG, depending on what the company does with the substances |
| 10 | Person Responsible for Regulatory CompliancePRRC | Art. 15 MDR, Art. 15 IVDR | Every medical device manufacturer and every authorised representative (micro and small enterprises may use an external PRRC) | Degree plus one year in device regulatory or quality work, or four years of that work |
| 11 | MedizinprodukteberaterMedical Device Consultant | § 83 MPDG | No appointment duty. The requirement sits on the individual doing the work | Relevant training plus product instruction, or one year of relevant work |
| 12 | Beauftragter für MedizinproduktesicherheitMedical Device Safety Officer | § 6 MPBetreibV | Health facilities with regularly more than 20 employees | Competent and reliable, with medical, scientific, nursing, pharmaceutical or technical training |
| 13 | StrahlenschutzbeauftragterRadiation Protection Officer | § 70 StrlSchG, StrlSchV | Every operator licensed or notified for work with ionising radiation | Certified Fachkunde for the application area, refreshed at least every five years |
| 14 | GefahrgutbeauftragterDangerous Goods Safety Adviser | GbV, ADR 1.8.3 | Any undertaking with duties as a Beteiligter in dangerous goods carriage | IHK Schulungsnachweis for each transport mode, valid five years |
| 15 | Verantwortliche Person (Kosmetik)Responsible Person, cosmetics | Art. 4, 5 Regulation (EC) 1223/2009 | Manufacturers, importers and own-brand distributors placing cosmetics on the EU market | No qualification prescribed. Establishment in the Union and written acceptance of the mandate |
Role names link to the full guide for that appointment. The authoritative text is always the law itself.
Want it as a one-page chart?
The table above is the whole thing, and it stays free. If you would rather have the print version, the one that goes on the wall next to the desk, leave your address and the chart arrives when you confirm.
The fifteen, one guide each
- Sachkundige Person
- Leiter der Herstellung und Leiter der Qualitätskontrolle
- Stufenplanbeauftragter
- Informationsbeauftragter
- Verantwortliche Person (Großhandel)
- Verantwortliche Person (Gewebeeinrichtung)
- Sachkundige Person (Tierarzneimittel)
- Pharmaberater und Pharmareferent
- BtM-Verantwortlicher
- Person Responsible for Regulatory Compliance
- Medizinprodukteberater
- Beauftragter für Medizinproduktesicherheit
- Strahlenschutzbeauftragter
- Gefahrgutbeauftragter
- Verantwortliche Person (Kosmetik)
Questions people ask about these roles
How many statutory named roles exist in German pharma and medtech?
Fifteen appear regularly in pharmaceutical, medical device and adjacent operations in Germany. They sit across the Arzneimittelgesetz, the AMWHV, the BtMG, the MPDG, the MPBetreibV, the Strahlenschutzgesetz, the dangerous goods rules, and three pieces of EU legislation covering medical devices, veterinary medicines and cosmetics. Some companies need one. A mid-sized manufacturer with a wholesale licence and a field force can need six or more at the same time.
Does a statutory role require a specific degree?
It depends entirely on the role. The Sachkundige Person under sections 14 and 15 AMG has its degree and its experience period written into the law. The Verantwortliche Person under the EU Cosmetics Regulation has no prescribed qualification at all. Several roles, including the Stufenplanbeauftragter under section 63a AMG and the Informationsbeauftragter under section 74a AMG, use undefined terms such as expertise and reliability, which the competent authority assesses case by case.
Why do these roles matter for a career in pharma?
A statutory appointment is a named, notified, personally held position. It cannot be delegated informally, and the authority keeps a dated record of who holds it. That makes it one of the few things on a CV a compliance reader can verify directly, and it is one reason people in these roles are difficult to replace.
Can one person hold several statutory roles at once?
Sometimes, and sometimes not. Some combinations are expressly restricted, for example the separation between the Head of Production and the Head of Quality Control. Others are common in smaller companies. Whether a specific combination is acceptable depends on the legal basis of each role, the size of the operation, and the view of the competent authority, so it is a question for a regulatory or legal adviser rather than a chart.
Is this chart legal advice?
No. It is a reference summary written for people planning a career, and it points to the legal sources so you can read them yourself. Legislation changes, and the authoritative text is always the law itself at gesetze-im-internet.de or the relevant EU register.
If you are aiming at one of these
A statutory appointment is one of the few things on a CV that a compliance reader can verify directly, which is why the CVs that win these roles read differently from ordinary ones. They name the appointment as the law names it, cite the paragraph, state whether the person held it or deputised for it, and give the scope: which site, which product classes, which authority. Most CVs do none of that, and the reader is left guessing.
AI Persona Freelance Recruitment & TA StrategyIf you want to talk about the route into one of these positions rather than read about it, the first call is free and takes twenty minutes.
This page is a reference summary and not legal advice.