Manufacturing requirements and standards for non-prescription medicines

Good Manufacturing Practice (GMP)

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 non-prescription medicines.

See:

• Good manufacturing practice - an overview
• PIC/S Guide to GMP: Manufacturing principles for medicinal products

Manufacturer licence or clearance

You must ensure that your Australian manufacturer has a licence (or clearance for overseas manufacturers) for the steps of manufacture required for:

• your type of medicine
• the dosage form. 

The process of manufacture is broken down into parts, known as steps of manufacture. Not all the steps of manufacture have to be completed by the same manufacturer.

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.

See: Manufacturing medicines

Written agreements with manufacturer

Sponsors should maintain a good relationship with their manufacturer(s). You must record all agreements between you and your manufacturer(s) in writing.