Manufacturing information for non-prescription medicines
Manufacturing information for non-prescription medicines.
Unless exempt, non-prescription medicines must be manufactured in accordance with Good Manufacturing Practice (GMP). Australia has codes of GMP and quality system requirements for the manufacture of therapeutic goods, including complementary medicines.
You must ensure that your manufacturer has a licence or clearance for the steps of manufacture required for your type of medicine and dosage form. While each step in the manufacture of the medicine is required to be manufactured in accordance with GMP, not all steps are required to be entered in the medicine's ARTG entry.