Division 5.9.1 Medical surveillance on manufacturing plant personnel and monitoring studies

Reports of occupational health surveillance programs and of monitoring studies shall be submitted, supported with detailed information on the design of the programme, the number of exposed persons included in the programme, the nature of their exposure to the active substance, and their exposure to other potentially hazardous agents. Such reports shall, where feasible, include data relevant to the mechanism of action of the active substance. These reports shall, where available, include data from persons exposed in manufacturing plants, or during or after application of the active substance (for example from monitoring studies in operators, workers, residents, bystanders or victims of accidents). Available information on adverse health effects including allergenic responses in workers and others exposed to the active substance, shall be provided, and include where relevant details of any incident. The information provided shall, where available, include details of frequency, level and duration of exposure, symptoms observed and other relevant clinical information.