Singapore legislation
Regulation 9
of Medicines (Veterinary Medicinal Products) (Import and Product Licences) Regulations
Regulation 9
Information on adverse effects of product
Subregulation 1
The holder of a product licence or provisional product licence shall inform the licensing authority of any reports of which he is aware of adverse effects on human beings or animals, or both, associated with the use of any veterinary medicinal or any of the constituents of the veterinary medicinal product to which the licence relates.
Subregulation 2
The licensing authority may require the holder of a product licence or provisional product licence to furnish him with a copy of any such reports.