I.B.5. Principles for good pharmacovigilance practices

With the aim of fulfilling the overall quality objectives in I.B.4., the following principles should guide the design of all structures and processes as well as the conduct of all tasks and responsibilities:

• The needs of patients, healthcare professionals and the public in relation to the safety of medicines should be met.
• Upper management should provide leadership in the implementation of the quality system and motivation for all staff members in relation to the quality objectives.
• All persons within the organisation should be involved in and support the pharmacovigilance system on the basis of task ownership and responsibility in a degree according to their tasks and assigned responsibilities.
• All persons involved with the entire organisation should engage in continuous quality improvement following the quality cycle in I.B.3..
• Resources and tasks should be organised as structures and processes in a manner that will support the proactive, risk-proportionate, continuous and integrated conduct of pharmacovigilance.
• All available evidence on the risk-benefit balance of medicinal products should be sought and all relevant aspects, which could impact on the risk-benefit balance and the use of a product, should be considered for decision-making.
• Good cooperation should be fostered between marketing authorisation holders, competent authorities, public health organisations, patients, healthcare professionals, learned societies and other relevant bodies in accordance with the applicable legal provisions.