Manufacturing principles & guidelines

If you intend to rely on any legislation referred to on this website, you should access copies of the official versions. These instruments are amended from time to time and may, on occasions, be replaced or new instruments made.

Manufacturing principles

These instruments determine principles to be observed in the manufacture of therapeutic goods for use in humans.

• Therapeutic Goods (Manufacturing Principles) Determination 2020

Therapeutic goods (multi-site manufacturing licenses) guidelines

• Therapeutic Goods (Guidelines for Multi-Site Licences) Instrument 2020
  Sets out the circumstances in which a manufacturing licence may cover two or more manufacturing sites