(1998; 88 pages)
8.8 Monitoring of adverse reactions to herbal medicines
The regulatory authority should establish a system for monitoring or surveillance of adverse reactions to herbal medicine. In the first instance, manufacturers should be encouraged to submit reports of adverse reactions. Ultimately, post-marketing surveillance should be required for medicinal herbal products which contain either toxic ingredients or present with new indications, new processing methods or routes of administration. Practitioners and consumers should be encouraged to report any adverse effects related to the use of medicinal herbal products. The regulatory authorities should investigate reported cases of adverse effects and, if necessary, issue relevant warnings or impose further restrictions oh the use of the medicinal herbal product. Regulatory authorities are encouraged to maintain accurate records of reported adverse reactions to herbal medicines and to make available that information to other Member States on request.