TGA and ODC issue an update

The TGA and ODC have shared an update in the form of a presentation at a virtual symposium held on the 12th of August, 2021.

Key stats include:

ODC has granted 175 licenses (155 are in effect).

67 licenses (and 53 permits) for cultivation

31 for cultivation and research

57 for manufacture of medicinal cannabis products

Over 100,000 patients and 160,000 authorisations.

More than 11000 authorisations every month.

391 APs. (Authorised Prescribers)

Some interesting facts for those looking to register a CBD product for OTC.

Down-scheduled low dose CBD from S4 (Prescription) to S3(Pharmacist only).

Only for products registered by TGA

Companies need to apply to the TGA to register individual OTC products and they need to pay $28150.00 + annual charges of $1520.

OTC CBD cannot be compounded or provided through the Special Access Scheme.

CBD must be >98% of the total cannabinoid content of the preparation.

Maximum daily dose is < 150mg cannabidiol.

Packed in blister or strip packaging with a child resistant closure.

For 18 yrs and over, in packs containing not more than 30 days supply.

No advertising to general public.

Statement required "Do not use if pregnant, likely to become pregnant or breastfeeding."

The issue of imported cannabis having a different standard to the locally produced cannabis is being considered by the govt., as is the issue of child proof closures.

Finally the issue of advertising was raised.

A TGA Advertising guidance is available, and it is permissable to direct health practitioners to information about specific products.

Advertising is now a compliance priority for the TGA.

30 investigations have been undertaken since July 2020.

Cannabis / CBD has the 2nd highest number of advertising complaints to the TGA.

3 categories of advertisers are under scrutiny.

• Illegal operators.
• Clinics and Pharmacies pushing the boundariies.
• Companies licensed for cultivation, manufacture, import/export.