Does the APVMA license overseas manufacturing sites?
Imported products represent a significant share of the total Australian market for veterinary chemical products. The APVMA does not have the legislative power to licence overseas manufacturers under the Manufacturer’s Licensing Scheme (MLS). Consequently, foreign manufacturing sites are recognised as being compliant on presentation of appropriate documentary evidence. However, Registrants of those products are required to provide acceptable evidence that an overseas manufacturer complies with a standard of manufacture comparable to that which would apply if the product were manufactured in Australia. Post-registration, conditions of registration require the registrant to ensure that this GMP compliance is maintained and that evidence of this is kept current and submitted to the APVMA on request.
