The EU Pharmacovigilance protects public health in Member States by strengthening the current European-wide system for monitoring the safety of medicines.
In particular, the legislation aims to make the reporting of adverse drug reactions (or side effects) easier and introducing special provisions for medicines that need additional monitoring. The legislation also aims to ensure that members of the public become better informed about the benefits and risks of taking medicines.
Pharmacovigilance activities include:
- Collecting and managing data on the safety of medicines
- Looking at the data to detect “signals” (any new or changing safety issue)
- Evaluating the data and making decisions with regard to safety issues
- Pro-active risk management to minimize any potential risk associated with the use of the medicine
- Acting to protect public health (including regulatory action)
- Communicating with and informing stakeholders and the public
- Audit, both of the outcomes of action taken and of the key processes involved.