Fimea oversees the pharmacovigilance of marketing authorisation holders by means of
inspections. The purpose of the inspections is to:
- Determine whether the marketing authorisation holder has the necessary personnel, systems and equipment in place to maintain its pharmacovigilance obligations;
- Identify and recognise potential shortcomings in the pharmacovigilance system that may result in a threat to public health or a risk to the patient.
Types of inspection:
The pharmacovigilance inspections conducted by Fimea are usually routine inspections. The marketing authorisation holders (or firms employed by the marketing authorisation holder) to be inspected are selected based on a risk assessment. In the risk assessment, factors such as the number of marketing authorisations, the scope of operations and the company’s previous inspection history are taken into account. Companies with a pharmacovigilance system master file (PSMF) in Finland are inspected at regular intervals. If the company has a marketing authorisation obtained through the centralised procedure, the inspection is carried out in accordance with the timetable set by the European Medicines Agency (EMA).
In addition to routine inspections, the inspection may be carried out in a targeted manner if there is a particular need to do so. Such a reason may be, for example, that the marketing authorisation holder does not comply with its reporting obligations, that the commitments specified in the product’s risk management plan have not been duly fulfilled, or that significant changes are detected in the product’s adverse reaction profile in response to which the marketing authorisation holder has failed to take appropriate measures.
General course of the inspection
- The inspector contacts the marketing authorisation holder’s contact person in charge of pharmacovigilance activities and agrees tentatively on the date and time of the inspection. The inspection can also be carried out without a prior notice if deemed necessary.
- A written notice of the inspection is sent, including a request for advance material and an inspection plan.
- The inspection timetable is confirmed in the inspection kick-off meeting.
- The inspection is carried out by interviewing the personnel and inspecting documents and data systems. The functionality of the marketing authorisation holder’s pharmacovigilance system is verified by reviewing the handling and maintenance of product safety data by way of practical examples.
- In the close out meeting of the inspection, the deficiencies identified in the inspection are presented.
- The deficiencies detected (classification: critical, major and other) are detailed in an inspection report for which the inspectee is asked to comment and to provide corrective and preventive actions.