Contact persons for Pharmacovigilance
General inquiries regarding pharmacovigilance
Please use the contact form.
Periodic Safety Update Reports (PSUR)
Information on the obligation to submit PSURs, the submission modalities, the assessment procedure, the PSUR repository as well as on other procedural issues:
E-Mail: PSUR@bfarm.de
Telefon: +49 (0)228 99 307-5777
Risk Management Plans (RMP), Post Authorisation Safety Studies (PASS)
Information on regulatory and procedural issues:
E-Mail: 71@bfarm.de
Educational material
Information on regulatory and procedural issues:
E-Mail: 71@bfarm.de
Non-interventional studies (AWB), national notification of PASS pursuant to Section 63 f AMG
Information on notification of non-interventional studies and on national notification of non-interventional post-authorisation safety studies after licensing:
E-Mail: awb@bfarm.de
Adverse drug reactions (ADR)
Information regarding reporting of adverse drug reactions and electronic transmission:
E-Mail: uaw@bfarm.de
Prescription-only requirement
Information exclusively regarding the Expert Advisory Committee for Prescription-Only Issues:
E-Mail: verschreibungspflicht@bfarm.de
Please address your written inquiry to:
Bundesinstitut für Arzneimittel und Medizinprodukte
- Geschäftsstelle der Sachverständigen-Ausschüsse für Verschreibungs- und Apothekenpflicht -
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Pharmacy-only issues
Information exclusively regarding the Expert Advisory Committee for Pharmacy-Only Issues:
E-Mail: apothekenpflicht@bfarm.de
Please address your written inquiry to:
Bundesinstitut für Arzneimittel und Medizinprodukte
- Geschäftsstelle der Sachverständigen-Ausschüsse für Verschreibungs- und Apothekenpflicht -
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Pharmacovigilance inspections
For information on pharmacovigilance inspections, the Pharmacovigilance System Master File (PSMF), Qualified Persons Responsible for Pharmacovigilance in the EU (QPPV) and on the Officer of the Graduated Plan ("Stufenplanbeauftragte"), please contact:
E-Mail: pv-inspektionen@bfarm.de
Submission of German translations of DHPC documents, implementation as Dear Doctor/Information Letters
Information on regulatory and procedural issues:
E-Mail: DHPC@bfarm.de
European risk assessment procedures
Information exclusively on regulatory and procedural issues:
E-Mail: 75@bfarm.de
Emerging Safety Issues (ESI)
Emerging Safety Issues (ESI) pursuant to GVP module VI
E-Mail: esi@bfarm.de