Ensuring patient safety and compliance with pharmacovigilance (PV) regulations is a critical responsibility for marketing authorization holders (MAHs). For companies planning to market their medicinal products in German-speaking countries—Germany, Austria, Switzerland, and Liechtenstein (DACHL)—understanding the unique local requirements for a Local Person Responsible for PV (LPPV) is essential. While these countries are centrally located in Europe, they each have distinct national regulations that must be met. A thorough understanding of these requirements can enhance operational efficiencies and reduce compliance costs for MAHs.
Part 1: Pharmacovigilance Requirements in Germany and Austria
Pharmacovigilance requirements in Germany
Graduated Plan Officer (GPO)
Under §63a of the German Medicinal Products Act (Arzneimittelgesetz – AMG), pharmaceutical entrepreneurs holding marketing authorizations must appoint a qualified person for PV, known as the Graduated Plan Officer (GPO) or "Stufenplanbeauftragter." This requirement applies not only to MAHs but also to co-distributors and users of standard marketing authorizations.
Key responsibilities
While an EU QPPV suffices for centrally authorized products, a GPO is required for national marketing authorizations (through MRP / DCP Procedure). The GPO oversees the MAH's PV system, ensuring compliance with obligations under Regulation (EC) No. 726/2004 and Directive 2001/83/EC. Additional responsibilities include:
- Systematic recording and analysis of safety-related product complaints (PQCs)
- Primary contact person for the German competent authorities for recalls, defect management, and counterfeit notifications
- Oversight of premarketing medicinal products in Germany
- Monitoring premarketing activities, including clinical trials conducted in Germany
- Quality assurance responsibilities, bridging PV with GMP compliance
Whenever the EU QPPV covers for the GPO for centrally authorised products, the points listed above should be either covered by the EU QPPV or be delegated to other functions.
Registration process
The GPO must be registered with the competent authorities, either:
- Paul-Ehrlich-Institut (PEI) (responsible, e.g., vaccines, blood products, ATMPs, Biologicals)
- Federal Institute for Drugs and Medical Devices (BfArM) (responsible for small molecules medicinal products)
If the MAH is based in Germany, the respective state authority must also be informed.
FAQs
Q: Is a GPO required at product launch?
A: Yes, but only for nationally authorized products. Centrally authorized products can be managed by an EU QPPV (see above).
Q: Must the GPO reside in Germany?
A: No, but they must be based in an EU member state.
Q: Is fluency in German necessary?
A: Not legally required, but since authority communications are primarily in German, a German-speaking delegate must be available.
Q: What qualifications are necessary?
A: There are no formal certifications, but the GPO must demonstrate sufficient professional experience and pharmacovigilance knowledge relevant to the product portfolio.
A: Must the GPO be available 24/7?
A: Yes. The GPO must be reachable at all times by competent authorities.
Pharmacovigilance requirements in Austria
Unlike Germany, Austria does not have a legally mandated LPPV. The national legislation, regulated by the Austrian Federal Office of Health Care (BASG), mainly follows the EU framework. However, in specific circumstances, BASG may request an additional locally based person responsible for PV.
Recommended practices
- MAHs should appoint a local PV contact and notify BASG.
- If requested, a local PV representative must be available to BASG.
FAQs
Q: Is a national PV responsible person required?
A: No, unless explicitly requested by BASG.
Q: Do parallel import license holders have PV obligations?
A: Yes, they must have a pharmacovigilance system, including a PSMF, and report safety concerns to BASG.
Next steps
ProPharma has a team of qualified local professionals who can fulfill the GPO role for German markets and the locally appointed Responsible Person for Pharmacovigilance (LPPV) for Austrian markets. Our experts bring in-depth knowledge of local PV legislation and health authority expectations, ensuring full compliance and business continuity. By leveraging shared resources across Germany and Austria, we help clients streamline their PV operations, improve efficiency, and reduce costs.
Whether you are launching a new product or scaling up your EU presence, ProPharma can support your local PV strategy with fully compliant, cost-effective solutions. Contact us today to speak with one of our experts.
In part 2, we will explore the pharmacovigilance requirements in Switzerland and Liechtenstein and how ProPharma can help ensure compliance across the DACHL region.
