III.B.5. Inspection process

Pharmacovigilance inspections should be planned, coordinated, conducted, reported on, followed-up and documented in accordance with inspection procedures consistent with agreed Union pharmacovigilance inspection procedures developed by the PhVIWG to support harmonisation for the mutual recognition of pharmacovigilance inspections within the EU. The Union procedures on pharmacovigilance inspections are published on the webpage “Pharmacovigilance inspection procedures: human” of the Agency’s website¹. Improvement and harmonisation of inspection conduct is promoted by agreed processes and procedures, joint inspection(s) and sharing of experience and training by national competent authority inspectorates.

The Union procedures on pharmacovigilance inspections cover, at least, the following processes:

• sharing of information;
• inspection planning;
• pre-authorisation inspections;
• coordination of pharmacovigilance inspections in the EU;
• coordination of third country inspections (including inspections of contractors in third countries);
• preparation of pharmacovigilance inspections;
• conduct of pharmacovigilance inspections;
• reporting of pharmacovigilance inspections and inspection follow-up;
• communication and prioritisation of pharmacovigilance inspections and findings;
• interaction with PRAC in relation to inspections and their follow-up;
• record-keeping and archiving of documents obtained or resulting from pharmacovigilance inspections;
• unannounced inspections;
• sanctions and enforcement in case of serious non-compliance;
• recommendations on the training and experience of inspectors performing pharmacovigilance inspections.

These procedures will be revised and updated as deemed necessary. New procedures may also be developed when the need is identified in relation to the inspection process.