Division 5.9 Medical dataF1

Where available, and without prejudice to the provisions of F2the EU-derived domestic legislation which transposed Article 10 of Council Directive 98/24/EC, practical data and information relevant to the recognition of the symptoms of poisoning, and on the effectiveness of first aid and therapeutic measures have to be submitted. More specific references to the investigation for antidotal pharmacology or safety pharmacology using animals shall be provided. 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 and of the necessary quality, are of particular value, in confirming the validity of extrapolations made and conclusions reached with respect to target organs, dose-response relationships, and the reversibility of toxic effects. Such data can be generated following accidental or occupational exposure.