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regulatory guidance

30 March 2022

TGO 93 includes microbiological requirements to provide sponsors with a more complete set of quality requirements in a single TGO.

Sponsors or manufacturers should identify which of the nominated monographs apply to their products. Products are only expected to meet one...

30 March 2022

Section 15 of TGO 93 outlines key information that must be included on the label to ensure the safe use of the medicinal cannabis product.

All products

Section 15 sets out the information that must be included on the labels of all medicinal cannabis products...

30 March 2022

To minimise the risk of toxicity if accidentally ingested by a child, most medicinal cannabis products need to be packaged using child-resistant closures. The exceptions are medicinal products in the form of plant material and those products described in section 6(2) of TGO 93.

The...

30 March 2022

Domestic manufacturers of medicinal cannabis products must have a TGA manufacturing licence, demonstrating compliance with Australian Good Manufacturing Principles (GMP). Section 13 sets out equivalent GMP requirements for medicinal cannabis products manufactured overseas.

Sponsors must...

22 March 2022
Webinar - Revised evidence guidelines for listed medicines
16 March 2022
Webinar - Revised evidence guidelines for listed medicines
27 April 2022
The Therapeutic Goods Advertising Code (the Code) is the cornerstone of the therapeutic goods advertising regulatory framework.
24 January 2022
The 2021 Advertising Code took effect on 1 January 2022 and will be subject to a 6-month transition period until 30 June 2022 where both the 2018 and 2021 Advertising Codes will apply.
1 February 2022
New feature added to the consent application form on TBS portal.
26 November 2021
New guidance on the regulation of system or procedure packs and using the special conformity assessment procedure.

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