III.B.6. Inspection follow-up

When non-compliance with pharmacovigilance obligations is identified during an inspection, follow-up will be required until a corrective and preventive action plan is completed. The following follow-up actions should be considered, as appropriate:

• review of the marketing authorisation holder’s corrective and preventive action plan;
• review of the periodic progress reports, when deemed necessary;
• re-inspection to assess appropriate implementation of the corrective and preventive action plan;
• requests for submission of previously un-submitted data; submission of variations, e.g. to amend product information; submission of impact analyses, e.g. following review of data that were not previously considered during routine signal detection activities;
• requests for issuing safety communications, including amendments of marketing and/or advertising information;
• requests for a meeting with the marketing authorisation holder to discuss the deficiencies, the impact of the deficiencies and action plans;
• communication of the inspection findings to other regulatory authorities (including outside the EU);
• other product-related actions depending on the impact of the deficiencies and the outcome of follow-up actions (this may include recalls or actions relating to the marketing authorisations or clinical trial authorisations).

Sharing information and communication between inspectors and assessors is important for the proper follow-up of inspections. Details of the processes relating to interaction between inspectors and assessors and inspection follow-up will be elaborated further in the compilation of Union procedures on pharmacovigilance inspections mentioned in III.B.5.