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Country of origin and medicine quality

25 June 2020

Some medicines make country of origin claims, however there is no requirement for a medicine to display the country of origin on the label.

The manufacture of medicines is often complex and can involve manufacturers in many different countries. For example, the active ingredient in a medicine might be manufactured in one country before the medicine is processed into the finished dosage form in a second country, packaged in a third, tested in a fourth, and then released for supply in a fifth. All of these activities are part of the manufacturing process. The manufacturer involved in any of these steps can also be different for different batches of the same medicine.

No matter how many manufacturers are involved or where they are located, all medicines supplied in Australia must demonstrate quality manufacture:

  • Australia-based manufacturers must be licensed by the TGA
  • manufacturing facilities located overseas must be approved by the TGA
  • manufacturing facilities must be regularly inspected by the TGA or, for some overseas facilities, a partner agency to confirm that standards are being met.

If a medicine has an AUST number on the label, it is regulated by the TGA and must meet the requirements above, regardless of its country of origin. An AUST R, AUST L or AUST L(A) number is a sign of manufacturing quality.

Sometimes medicine quality or safety issues can arise. If this happens, we can trace all manufacturers involved through the batch number and issue a recall of the affected medicines.

If you still want to know more about your medicine, you can contact the responsible company directly. Contact details for this company are always on the medicine label. Note that under the legislation, the TGA is not normally permitted to release information about medicine manufacturers.

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