Quote from VigiServe Admin on February 25, 2021, 3:32 PM

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 the 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.