Just some background LGP have a few UNAPPROVED products already...

Just some background

LGP have a few UNAPPROVED products already on market that TGA can and does approve for treatment of different conditions - the current range is prescribed within this catergory through TGA approval first before the Dr can hand a script to the patient.

However these UNAPPROVED Drugs mean safety and effectiveness has yet to be established.

This is the whole reason Drs have to apply to TGA first for approval - its the TGAs job to check that the product is appropriate, and that there isn't an alternative that the patient could use that's on the ARTG ( Australian Register of Therapeutic Goods).

To be granted status on ARTG - safety and efficacy needs to be shown in a submission. That is where LGP and the others are now - choosing an appropriate indication for 150mg or less of CBD per dose and applying to TGA for registering that product on ARTG as a Scheddule 3 medicine.

That could involve clinical trials or trials /or a combination of trials/ literature proof etc but they have to establish an indication and then put together a dossier to show that for that indication 150mg is safe and effective.

Once a medicine is ARTG listed then Doctors dont need to go through the TGA for approval to prescribe - and that applies not just for Schedule 3 but also regular prescription Schedule 4 medicines.