Pharmacovigilance

Companies placing medicinal products on the market are obliged to have an appropriate system of pharmacovigilance in place; and be able to collect, prepare and submit expedited adverse drug reactions and Periodic Safety Update Reports (PSURs) to the competent authorities at the prescribed intervals. In addition companies are required to have at least one Qualified Person (QP) for Pharmacovigilance established within the European Economic Area (EEA). This responsibility applies to all pharmaceuticals whether innovative drugs, generics or others. The current legislation requires all applications for new product licenses to incorporate a pharmacovigilance and risk management system.

System requirements

The pharmacovigilance system should be able to do the following:

• Expedited reporting
• PSUR reporting
• Responding to information requests form the competent authorities
• Handling of urgent safety restrictions and safety variations
• Continuous monitoring of the safety profile of authorised medicinal products and notifying competent authorities and health professionals of changes in the risk/benefit assessments
• Meeting CHMP commitments (for centrally registered products)
• Maintaining internal audits of the pharmacovigilance system

Pharmacovigilance data should be collated and be accessible at least at one point in the EEA. Competent authorities are responsible to inspect license holders to ensure functionality of their pharmacovigilance systems through scrutiny of Standard Operating Procedures (SOPs).

• Prepare for pharmacovigilance systems audits
• Assess your SOPs
• Write PV SOPs
• Train Personnel
• Help you with PV and risk management plans
• Implement PV systems in your company