AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
peutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. For controlled substances (narcotics, psychotrop- ics, precursors), additional import/export controls are imposed by the Customs (Prohibited Imports) Regula- tions 1956 and the Customs (Prohibited Exports) Reg- ulations 1958, which prohibit importation or exporta- tion without a licence and/or permit. Enforcement of the import regulations are governed by the TGA, in respect of therapeutic goods pursu- ant to the ARTG. The Australian Border Force (ABF) enforces import/export controls at the point of entry. The Office of Drug Control (ODC) regulates the impor- tation and exportation of controlled substances, and the Department of Agriculture, Fisheries and Forestry administers quarantine and biosecurity controls at the border for products containing materials of biological origin (human, animal, plant or bacterial). 7.2 Importer of Record of Pharmaceuticals and Medical Devices Australian legislation does not use the phrase “import- er of record”; however, the regulatory framework for therapeutic goods centres on the role of the sponsor as the relevant importer. The sponsor is the key legal entity responsible for importing, exporting or manu- facturing therapeutic goods for supply in Australia, pursuant to Section 3 (1) of the Therapeutic Goods Act 1989 (Cth). The sponsor must: • be either an Australian resident or an incorporated body carrying on business in Australia, with a representative residing in Australia – an overseas manufacturer or supplier cannot act as the sponsor without an Australian-based presence; • hold a TGA Client ID and be registered with the TGA via the TGA Business Services (TBS) portal before importing goods; and • ensure – unless a specific exemption, exclusion or approval applies – that the product is on the ARTG before importation. For overseas companies seeking to supply the Aus- tralian market without a local presence, the most com-
mon approach is to either establish a local subsidiary or engage an Australian-based third-party sponsor. The sponsor does not need to physically handle the goods; it can engage a third-party logistics provider or customs broker to do so. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices Therapeutic goods must be included in the ARTG before they can be imported into, or exported from, Australia. For goods containing controlled substanc- es (narcotics, psychotropics, precursors), a separate licence and/or permit from the Office of Drug Control is required under the Customs (Prohibited Imports) Regulations 1956 (Cth) before importation. Note that the following exemptions may apply. Special Access Scheme (SAS) and Authorised Prescriber (AP) Unapproved therapeutic goods may be imported with- out ARTG inclusion for supply to individual patients (SAS) or a class of patients (AP), provided the goods are held under the direct control of the sponsor in a warehouse or properly secured area. Clinical Trials Goods imported for use in an approved clinical trial under the Clinical Trial Notification (CTN) or the Clini- cal Trial Approval (CTA) schemes are exempt from the ARTG requirement. Medicine Shortages (Section 19A of the Therapeutic Goods Act) The TGA can approve importation of a medicine not on the ARTG where there is a shortage of a regis- tered medicine and it is needed in the interest of public health. Personal Importation Individuals may import a medicine for personal use without being included on the ARTG, provided it does not contain a prohibited substance and is within quan- tity limits, which is typically up to three months’ sup- ply.
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