Pharmacovigilance is the process of:
- Monitoring medicines including traditional herbal medicines as used in everyday practice to identify previously unrecognised risks or changes in the patterns or frequency of their adverse effects.
- Assessing the risks and benefits of medicines in order to determine what action, if any, is necessary to improve their safe use.
- Providing information to users to optimise safe and effective use of traditional herbal medicines.
- Monitoring the impact of any action taken.
The pharmacovigilance requirements are laid down in the legislation (Directive 2004/24/EC). Guidance on the main areas is provided. This guidance has been adapted for the herbal sector from Volume 9A of the Rules Governing Medicinal Products in the European Union (external link).
