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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.
These instruments determine principles to be observed in the manufacture of therapeutic goods for use in humans.
- Therapeutic Goods (Manufacturing Principles) Determination 2018
- Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No. 2)
- Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No.1)
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