What is the role of risk management plans in the product vigilance system?
All applications for a product licence for a high risk medicine or blood must include the submission of a product-specific risk management plan. Approval of the plan would be required before the product licence could be granted. The plan would set out a system of vigilance activities and interventions designed to identify, characterise, prevent and minimise risks related to the product. For medical devices, the risk management plan is a combination of the risk analysis and mitigation activities undertaken at the time of product design, and the corrective and preventative action (CAPA) plans and procedures incorporated in the manufacturer’s quality management system to assist in ensuring compliance with the reporting requirements of the regulatory framework. What is meant by a provisional licence? In exceptional circumstances, where the ANZTPA has assessed an application for a product licence and considers that a product licence should not be issued, the Managing Director may, in consul
