Alerts provide information about significant changes to import conditions. Keep informed of alerts by following individual import cases.
Updates to the Production Questionnaire for Veterinary Therapeutics
Effective from 28 April 2020
The Animal and Biological Imports Branch has updated the Veterinary Therapeutics Production Questionnaire. This is the document submitted by applicants in support of import permit applications for the following goods:
Veterinary therapeutics and medicines
Topical therapeutic washes
Veterinary semen extenders
Embryo transfer media and washes
Human therapeutic products that are also to be used as veterinary therapeutics and medicines, and
Goods to be used in vivo in non-laboratory organisms that are also to be used as veterinary therapeutics and medicines.
The Veterinary Therapeutics Production Questionnaire is located on the department’s webpage Checklist for importing biological materials.
The following updates have been made to the document:
Format, style and accessibility tools within the document have been updated to be in line with the department’s current requirements.
Inclusion of information relating to the department’s Minimum documentary and import declaration requirements policy.
Specific questions relating to ingredients that are microalgae (or derived from microalgae) have been removed from the document. Relevant additional questions will be presented to applicants that apply to import goods containing microalgae.
Manufacturers are required to provide information about the Australian Pesticides and Veterinary Medicines Authority (APVMA) registration status of the goods and/or the Active Pharmaceutical Ingredient in the goods.
Manufacturers are required to provide information about the use of all animal derived materials used in manufacture of the goods.
Manufacturers are required to provide information about the internal change control system in place at the manufacturing facility. Change control systems ensure that any proposed changes that may affect production and quality of product are evaluated and assessed by Australian importers before they are introduced by the overseas manufacturer.
The privacy notice and manufacturer’s declaration have been updated.
Applicants are required to provide a current version of the Veterinary Therapeutics Production Questionnaire, which has been completed and signed by the manufacturer, in support of their import permit application.
Contact the Animal and Biological Imports Branch through the Client Contact Support team on 1800 900 090 or email@example.com.
This Alert applies to the following Cases: