III.C.5. Role of marketing authorisation holders and applicants

Marketing authorisation holders with authorised products and applicants who have submitted new applications under the centralised procedure are subject to pharmacovigilance inspections (see III.B.1.). Therefore both have responsibilities in relation to inspections, including but not limited to the following:

• always to be inspection-ready as inspections may be unannounced;
• to maintain and make available to the inspectors on request, no later than 7 calendar days after the receipt of a request, the pharmacovigilance system master file as required by Article 23(4) of Directive 2001/83/EC and Article 16(4) of Regulation (EU) 726/2004;
• to ensure that the sites selected for inspection, which may include firms employed by the marketing authorisation holder to perform pharmacovigilance activities, agree to be inspected before the inspection is performed; • to make available to the inspectors any information and/or documentation required for the preparation of the inspection within the deadline given or during the conduct of the inspection;
• to ensure that relevant staff involved in pharmacovigilance activities or related activities are present and available during the inspection for interviews or clarification of issues identified;
• to ensure that relevant pharmacovigilance data is accessible from at least one point in the Union [DIR Art 107(1)];
• to ensure that appropriate and timely corrective and preventive action plans are implemented to address findings observed during an inspection, with appropriate prioritisation of critical and/or major findings.