Division 5.9 Medical data

Where available and without prejudice to F1the EU-derived domestic legislation which transposed Article 10 of Council Directive 98/24/EC^f1, practical data and information relevant to the recognition of the symptoms of poisoning and on the effectiveness of first aid and therapeutic measures shall be submitted. Such data and information shall include reports of any studies investigating antidote pharmacology or safety pharmacology. Where relevant, the effectiveness of potential antagonists to poisoning shall be investigated and reported.

Data and information relevant to the effects of human exposure, where available, shall be used to confirm the validity of extrapolations made and conclusions reached with respect to target organs, dose-response relationships, and the reversibility of adverse effects. Such data may be generated following accidental, occupational exposure or incidents of intentional self-poisoning, and shall be reported if available.