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Therapeutics

Animal derived

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

  • Ingredients list;
  • Species of origin of animal derived ingredients;
  • Country of origin of animal derived ingredients;
  • Manufacturing details describing the way in which the product has been processed, including methods of sterilisation;
  • If the product is a fermented product, include the species and country of origin of all animal derived materials used in the broth, if applicable.

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;
  • Manufacturing details describing the way in which the product has been processed including methods of sterilisation.

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 organisations and advisory bodies, including the State and Territory Departments of Health, the Therapeutics Goods Association (TGA) and Australian Customs Service (ACS), prior to and after importation.