Human Therapeutics and Medicines

Animal derived

The following information must accompany all applications to import animal derived human therapeutics:

• Complete list of ingredients
• Species of origin of animal derived ingredients
• Country of origin of animal derived ingredients
• Details of the manufacturing process including any sterilisation treatments.  Information may be presented in a flowchart of production.
• If the product contains ingredients derived from a fermentation process, include the species and country of origin of all animal derived materials used in the fermentation broth.

Plant derived

The following information must accompany all applications to import plant derived human therapeutics:

• Species of origin (botanical and common name)
• Outline whether the product is derived entirely from plant extracts, including details of extraction
• Details of the manufacturing process including any sterilisation treatments.  Information may be presented in a flowchart of production.

Human vaccines

The following information must accompany all applications to import human vaccines:

• Seed organism
• Manufacturing information including methods of inactivation (if applicable)
• Details of product testing (quality control).

Please note: It is the importers responsibility to ensure the product has complied with the requirements of all regulatory authorities and advisory bodies, including the State and Territory Departments of Health, the Therapeutics Goods Administration (TGA) and Australian Customs and Border Protection Service (ACS), prior to and after importation.

AQIS reserves the right to request information in addition to that outlined above once the import permit application is submitted.