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13 April 2022

TGA updated the quality rules for medicinal cannabis

The Australian regulatory authority for therapeutic goods TGA has updated its Guidance on quality requirements for medicinal cannabis products. These are now in line with TGO 93 and refer to any medicinal cannabis product imported into or supplied in Australia cannabis plant used in the manufacture of medicinal cannabis products e.g., as an ingredient or as a starting material for an extract used as an ingredient any other ingredients used in the manufacture of medicinal cannabis products, such as excipients steps and procedures carried out in the manufacture of medicinal cannabis product.

According to the revised Therapeutic Goods (Standard for Medicinal Cannabis, TGO 93)* version of March 2022, imports of medicinal cannabis must meet GMP requirements, date child-resistant closures on high-risk goods and fulfil the requirements for microbiological testing. These requirements come along with a transition period until 1 July 2023 for compliance. All medicinal cannabis products released from that date need to comply with the requirements of TGO 93.

It is specified for the United Kingdom, Canada, South Africa and Israel, which GMP standards need to be followed and which evidence has to be kept. Any products manufactured in other countries than those, an application must be made to the TGA requesting an inspection of the manufacturing facility. The TGA will inspect for compliance according to the PIC/S Code of GMP, as adopted by Australia, and provide written confirmation of the results of the inspection.

* Unapproved medicinal cannabis products imported into and supplied/manufactured in Australia must conform with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 (TGO 93). TGO 93 is a standard that specifies minimum quality requirements for medicinal cannabis products.