III.B.3. Sites to be inspected

Any party carrying out pharmacovigilance activities in whole or in part, on behalf of, or in conjunction with the marketing authorisation holder may be inspected, in order to confirm their capability to support the marketing authorisation holder’s compliance with pharmacovigilance obligations.

The sites to be inspected may be located in the EU (e.g. EU QPPV site) or outside the EU. Inspections of sites outside the EU might be appropriate where the main pharmacovigilance centre, databases and/or activities are located outside the EU and it would be otherwise inefficient or impossible to confirm compliance from a site within the EU. Member States and the Agency shall cooperate in the coordination of inspections in third countries [DIR Art 111(1)].

The type and number of sites to be inspected should be selected appropriately to ensure that the key objectives within the scope of the inspection are met.