The marketing authorisation holder shall operate a pharmacovigilance system for the fulfilment of his pharmacovigilance tasks laid down in the regulations and guidelines. The pharmacovigilance system shall be used to collect information on the risks of medicinal products as regards patients’ or public health. That information shall in particular refer to adverse reactions in human beings, arising from use of the medicinal product within the terms of the marketing authorisation as well as from use outside the terms of the marketing authorisation, and to adverse reactions associated with occupational exposure.
OGYÉI, as part of an ex officio procedure, carries out on-site pharmacovigilance authority inspections at least every 3-5 years to evaluate the pharmacovigilance systems operated by the marketing authorisation holders.
The inspection can be conducted at any premises of the marketing authorisation holders or their representatives, where pharmacovigilance operations are carried out, in Hungary or abroad. The inspection can be a regular (routine) inspection or an exceptional one. The planning of inspections is based on risk assessment.
An unannounced (exceptional) inspection becomes reasonable if a suspicion has arisen that the marketing authorisation holder does not comply with the rules and regulations of Hungary and of the European Union while carrying out his pharmacovigilance activities, or if it is justified in order to protect the health of patients or obviate the potential or proved endangerment of public health.
The observations of the on-site inspection are summarised in a short on-the-spot memo, which is followed by an inspection report. The inspection report specifies the observations, lists and assesses the occurrent findings and deficiencies. If the inspection concludes that the marketing authorisation holder does not operate according to the pharmacovigilance system master file or does not comply with the pharmacovigilance regulations, OGYÉI draws the marketing authorisation holder’s attention to the inadequacies and provides the marketing authorisation holder the opportunity to correct them within a given timeframe. In the answer to the inspection report, the applicant sends the description of the planned corrective and preventive actions, which is assessed by the Institute.
Should an authority of an EEA member state, the European Commission or the European Medicines Agency (EMA) submit a justified request, OGYÉI may disclose the inspection report to them.