Pharmacovigilance Inspections: Medicines

In order to determine that marketing authorisation holders (MAHs) of human products comply with pharmacovigilance obligations established within the EU, and to facilitate compliance, pharmacovigilance inspections of marketing authorisation holders or any firms employed to fulfil marketing authorisation holder’s are performed.

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;

  • to use the inspection results as a basis for enforcement action, where considered necessary.

Pharmacovigilance system inspections ​​are designed to review the procedures, systems, personnel and facilities in place and determine their compliance with regulatory pharmacovigilance obligations. As part of this review, product specific examples may be used to demonstrate the operation of the pharmacovigilance system.

Product-related pharmacovigilance inspections are primarily focused on product-related pharmacovigilance issues, including product-specific activities and documentation, rather than a general system review. Some aspects of the general system may still be examined as part of a product-related inspection (e.g. the system used for that product)

Pre-authorisation inspections may be performed to verify the accuracy and successful implementation of the existing or proposed pharmacovigilance system. Pharmacovigilance inspections may be performed on a routine basis or may be scheduled in response to a request from another department or committee of the HPRA where there is a specific cause for concern with respect to compliance with guidelines or regulations. A request for a routine or triggered inspection may also be received from Committee for Human Medicinal Products (CHMP).