Current list of up-scheduled codeine containing products

TGA has amended all previously Schedule 2 (Pharmacy Only) and Schedule 3 (Pharmacist Only) codeine containing products to Schedule 4 (Prescription Only) to reflect the scheduling decision from 1 February 2018.

However, not all products now denoted as Schedule 4 on the Australian Register of Therapeutic Goods (ARTG) are suitable for supply to the market.

Sponsors that wish to continue supplying their goods that were previously S2/S3 goods and are now S4 medicines, need to have applied to TGA for specific changes to their labelling, indications and Product Information to ensure safe and effective use of the goods as S4 medicines.

The list of upscheduled products below is a list of goods which have gone through this process and are approved for market supply by TGA.

Goods which are not on this list may be currently going through the up-scheduling process.

You should contact the sponsor to confirm their intention to continue marketing their goods in Australia, after 1 February 2018.

Products containing other codeine derivatives, such as pholcodine, dextromethorphan, and dihydrocodeine are unaffected by the decision to up-schedule codeine.