Call to Pharmaceutical Companies – Questionnaire for Risk-based Inspection Planning
In their role as supervisory authorities, the Paul-Ehrlich-Institut (PEI) and the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) are commissioned by the EMA to perform regular inspections of the pharmacovigilance systems or pharmaceutical companies. In addition, national inspections are performed by the PEI, the BfArM, or both authorities.
Candidates for inspections are selected by PEI and BfArM using a risk-based approach. The criteria for risk-based inspection planning are implemented in GVP Module III (III.B.2.) – "Pharmacovigilance Inspections". The information contained in the current questionnaire is designed to rate the risk potential of all pharmacovigilance systems of holders of marketing authorisations, permits, and registrations of medicinal products for human use in Germany. The information also help estimate the appropriate duration of an inspection better. The analysis of this data capture will contribute to the planning of the inspection programmes of both federal authorities for the area of pharmacovigilance in the future.
To support the risk assessment, PEI and BfArM have designed the "Questionnaire for risk-based PV inspections" for capturing the data from pharmaceutical companies and are requesting them to complete the questionnaire.
Legal Basis for Pharmacovigilance Inspections in Germany – Risk-based Inspection Planning
With the 16th amendment of the German Medicines Act (Arzneimittelgesetz [AMG]) (16th Act on the amendment of the German Medicines Act of 10 October 2013), the amended Directive 2001/83/EC was transposed into German law (Arzneimittelgesetz, AMG). As part of this amendment, the legal basis for performing pharmacovigilance inspections was updated (Section 62 (6), Section 64, and Section 66 AMG).