(2000; 28 pages) [French]
9.1 The Drug Regulatory Authority
The Drug Regulatory Authority in the country needs to be informed about suspected adverse reactions without delay, especially when unusual (e.g. reactions not included in the approved Summary of Product Characteristics) or serious. In addition, a pharmacovigilance centre should inform the regulatory authority about any cluster of case reports that is of possible interest, or when an adverse reaction is reported in high or increasing frequency.