Procedures for Registration of Veterinary Biologics (Excluding Vaccines)/ Diagnostic Test Kits for Animal Use in Malaysia.

The purpose of these procedures are to provide the local manufacturer, importer and distributor with guidelines on preparing submissions for registration of veterinary biologics/ diagnostic test kits of animal origin and/or for animal use, and to regulate use of veterinary biologics/ diagnostic test kits for animal use. The objective of this registration is to regulate the importation of veterinary biologic (including domestic livestock, poultry, companion animals, wildlife, and aquatic species) and thus as well as to safeguard veterinary public health and food safety by controlling indigenous animal disease and preventing the introduction and dissemination of foreign animal diseases.
Section 2.2 provides for the veterinary biologics products that are required for registration. Veterinary biologics for research purpose is not be subjected to registration procedures but shall obtain written permission from Department of Veterinary Services (DVS) prior to importation. these procedures shall apply to Peninsular Malaysia and Federal Territory of Labuan.