I.B.4. Overall quality objectives for pharmacovigilance

The overall quality objectives of a pharmacovigilance system are:

• complying with the legal requirements for pharmacovigilance tasks and responsibilities;
• preventing harm from adverse reactions in humans arising from the use of authorised medicinal products within or outside the terms of marketing authorisation or from occupational exposure;
• promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public; and
• contributing to the protection of patients’ and public health.