LM: Licence? (8)

Listed medicines must be manufactured in accordance with Good Manufacturing Practice (GMP).

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. 

For listed medicines, the mandatory steps in manufacture are: 

• Manufacture of dosage form (for example, tablet)

• Packaging & labelling

• Release for supply

• Testing microbial

• Testing chemical & physical

It is the responsibility of the sponsor to ensure that the ARTG entry for their medicine lists all of the current manufacturers and each step for which they are responsible. If you change a manufacturer, you must update the medicine’s ARTG entry within 10 days. 

All Australian manufacturers of listed medicines must have GMP unless exempt from manufacturing requirements.

Where a product is imported, or if any steps in the manufacture (as listed above) occur outside Australia, the Australian sponsor must hold a GMP clearance issued by TGA for the specific site nominated as the manufacturing site in the ARTG.

The Good Manufacturing Practice application decision tree can help you in determining if GMP licencing, certification or clearance is required.

Check with your manufacturer to make sure that they have the appropriate licence or GMP evidence that they require to support a clearance for your medicine. As a sponsor, you are responsible for ensuring your goods are manufactured by licenced and certified manufacturers. See Manufacturing therapeutic goods for more information.