Singapore legislation
Regulation 7
of Medicines (Veterinary Medicinal Products) (Import and Product Licences) Regulations
Regulation 7
Changes in particulars
The holder of a product licence or provisional product licence shall forthwith inform the licensing authority of any material change that has been made or that he proposes to make in the particulars contained in his application, in relation to any veterinary medicinal product to which the licence relates, that is to say —
in the specification of the veterinary medicinal product;
in the specification of any of the constituents of the veterinary medicinal product;
in the composition of the veterinary medicinal product, or of any of the constituents of the veterinary medicinal product; and
in the methods and procedures described in the application for ensuring compliance with the specifications relating to the product.