Among those modules recently implemented is Module III – Pharmacovigilance Inspections, which includes guidance on the planning, conduct, reporting and follow-up of pharmacovigilance inspections in the EU and outlines the role of the different parties involved.
The objectives of pharmacovigilance inspections are to determine that the marketing authorisation holder has personnel, systems and facilities in place to meet their pharmacovigilance obligations; to identify, record and address non-compliance which may pose a risk to public health; and to use the inspection results as a basis for enforcement action if necessary.
Inspections will be carried out by inspectors appointed by the national competent authorities and will involve inspections of the premises, records, documents and pharmacovigilance system master file (PSMF) of the marketing authorisation holder.
Announced vs. Un-announced Inspections
The EMA anticipates that the majority of inspections will be announced in advance to the inspected party “to ensure the availability of relevant individuals for the inspection.” However, competent authorities may conduct “for cause inspections” when, for example, one or more triggers is identified, including:
• Change in the risk-benefit balance where further examination through an inspection is
• Delays or omissions in reporting, or poor quality or incomplete reports;
• Failure to provide the requested information or data within the deadline specified by the
• Concerns about the status or fulfilment of risk management plan (RMP) commitments; or
• Concerns following review of the pharmacovigilance system master file.
“When non-compliance with pharmacovigilance obligations is identified during an inspection, follow-up will be required until a corrective and preventive action plan is completed,” the EMA says. Follow-up actions that will be considered include re-inspections to assess appropriate implementation of the corrective and preventive action plan, and requests for submission of previously un-submitted data.
Competent authorities can issue warning letters, non-compliance statements or infringement notices when legislation or a guideline has been breached. “Competent authorities may consider making public a list of marketing authorisation holders found to be seriously or persistently non-compliant,” the EMA adds.