Both applicants submitting new MAH and marketing authorisation holders (MAH) selling authorised medicinal products are subject to pharmacovigilance inspections. In cooperation with the European Medicines Agency (EMA or the Agency), national competent authorities of Member States determine whether the inspected stakeholder or any firm employed to fulfil the stakeholder’s obligations, comply with all pharmacovigilance requirements. In doing so, different types of pharmacovigilance inspections can be conducted.
One can make a distinction between system- and product-related inspections. Both types of inspections are designed to review procedures, systems, personnel and facilities in place, and determine their regulatory compliance. They are commonly scheduled as part of an inspection plan, referred to as ‘routine’ inspections. On the other hand, ‘for cause’ inspections examine issues when a certain trigger is recognised. Examples of such triggers are failure to communicate a change in the risk-benefit balance of a product, delay in reporting obligations, failure in providing requested information to competent authorities and unsuccessful implementation of corrective and preventive actions. Such ‘for cause’ inspections are usually focussed on specific processes or issues relating to a specific product (i.e. product-related inspections).
Next to post-authorisation inspections that examine compliance to pharmacovigilance obligations, applicants and marketing authorisation holders (MAH) can be inspected before an authorisation is granted. These non-compulsory pre-authorisation inspections may be requested in specific circumstances. The authorities have principles and procedures in place (e.g. risk assessment) to avoid unnecessary surveys that may delay marketing authorisation. A negative outcome can lead to non-approval, re-inspection or early post-authorisation inspection, and imposition of safety conditions.
Regarding awareness of upcoming inspections, companies are usually notified in advance in order to ensure that all relevant personnel will be present (i.e. announced inspections). However, it can be convenient for the authority to perform an unannounced inspection or one at short notice when, for example, the inspection objectives could be compromised by the announcement itself (i.e. unannounced inspections).