Pharmacovigilance Roles in Germany

Germany, as one of the largest pharmaceutical markets in Europe, adheres to stringent PV regulations that align with European Union (EU) directives while incorporating local nuances. This article explores the PV requirements in Germany, highlighting regulatory frameworks, key responsibilities, notification process, legal consequences and penalties.

Germany‘s PV requirements are primarily governed by the EU regulatory framework, as set forth in Regulation (EU) No 1235/2010 and Directive 2010/84/EU. Germany ensure compliance with these EU provisions through its national legislation, primarily the Medicinal Products Act (Arzneimittelgesetz, AMG), further supported by directives and recommendations issued by its National Competent Authorities (NCAs).

National Competent Authorities in Germany

There are two principal regulatory authorities responsible for overseeing PV activities in Germany:

• Federal Institute for Drugs and Medical Devices (BfArM):

BfArM primarily oversees human medicinal products, including chemical-based drugs and certain biopharmaceuticals. It is responsible for monitoring adverse events, managing signal detection, and ensuring compliance with safety requirements.

• Paul-Ehrlich-Institute (PEI):

PEI handles biological medical products such as vaccines, blood products, and advanced therapies. It focuses on their safety, quality, and efficacy, playing a critical role in PV and risk management activities for these specialized products.

Both authorities operate in collaboration with the EMA and actively participate in European databases such as EudraVigilance, ensuring Germany’s integration into the EU’s broader PV system.

Key Pharmacovigilance Roles and Responsibilities

• Stufenplanbeauftragter (Graduated Plan Officer, StufBa)

Unique to Germany, the Stufenplanbeauftragter (StufBa) is mandatory under the Medicinal Products Act. This role involves implementing and coordinating measures outlined in the national “Stufenplan” a graduated risk management and escalation plan. The StufBa is the key contact for authorities such BfArM or PEI during safety-related issues. While the StufBa often overlaps with the QPPV role, organizations may separate the positions to address both EU-wide and Germany-specific responsibilities effectively.

• Informationsbeauftragter (Information Officer, IB)

Another requirement specific to Germany is the appointment of an Informationsbeauftragter (IB). This role is responsible for ensuring that all information regarding medicinal products, including promotional materials, is accurate, up-to-date, and compliant with regulatory requirements. The IB must have necessary expertise in pharmaceuticals and is legally responsible for:

• Reviewing and approving marketing materials and patient information leaflets.
• Ensuring that information aligns with the SmPC.
• Acting as the company’s representative for public and regulatory inquiries concerning product information.

The IB collaborates closely with both the QPPV and StufBa to maintain consistency between safety data and product communication.

The roles of the QPPV and StufBa are often confused or not clearly distinguished. Therefore, it is essential to understand the specific requirements for each and to establish clear responsibility matrices, regardless of the approach planned by the MAH.Here are thekey differences between StufBa and QPPV:

Notification Process

The appointment of a  StufBa must be formally notified through the PharmNet.Bund portal, using the designated module entitled “Notification of the Graduated Plan Officer”.

The digital notification system enables MAHs to:

• Submit initial notifications of appointed StufBa and their deputies.
• Notify changes in personnel or contact details.
• Officially de-register individuals no longer holding the role.

This process complies with the requirements of the Online Access Act (Onlinezugangsgesetz – OZG), ensuring secure and standardized electronic communication with competent authorities.

It is important to note that even if the appointed StufBa also serves as the EU QPPV, a separate national notification as StufBa remains mandatory under German law.

Legal Consequences and Penalties

Non-compliance with the PV requirements, particularly the failure to appoint, properly qualify, or duly notify the competent authority of a designated StufBa, may result in serious regulatory and legal repercussions for the MAH.

German authorities such as BfArM or the PEI may impose administrative fines of up to €25,000 for each violation. In cases where deficiencies are deemed critical or pose a risk to public health, the marketing authorization for the product may be suspended or revoked entirely.

Beyond financial penalties, MAHs may be subject to:

• Increased regulatory scrutiny, including unannounced or more frequent PV inspections.
• Mandatory corrective actions or the imposition of compliance deadlines.
• Reputational damage, especially if findings are made public or shared with other EU authorities through regulatory networks.

Persistent or unremedied non-compliance could also undermine the MAH’s credibility with national and EU regulators, potentially affecting the approval of future applications or renewals.

Conclusion

Germany’s PV framework demonstrates a structured approach that complements EU regulations with additional national responsibilities. The mandatory appointment of roles such as the Stufenplanbeauftragter (StufBa) and the Informationsbeauftragter (IB) reflects the country’s focus on localized oversight, prompt implementation of safety measures, and regulatory transparency. To remain compliant, Marketing Authorization Holders must ensure timely role designation, effective coordination between PV functions, and full alignment with both EU and German requirements.