Consultation on temporary labelling exemptions for paracetamol

While the consultation is open you can make a submission at our consultation hub - external site.
We review the submissions. After that the submissions and our decision will be available on the same consultation page - external site.

Invitation to comment

To assist industry in transitioning to new requirements due to the upcoming changes to the scheduling of paracetamol, and to facilitate pharmacy’s ability to supply these products, we are proposing a period of labelling exemptions for signal words for certain Pharmacy medicine (Schedule 2) and Pharmacist Only medicine (Schedule 3) products.

The final decision to change the scheduling of certain paracetamol products was published in May 2023 and will:

• reduce the maximum size of packs available for general sale (e.g. supermarkets and convenience stores) from 20 to 16 tablets or capsules
• reduce the maximum size of packs available in pharmacies without the supervision of a pharmacist (i.e. ‘Pharmacy Medicine’ packs) from 100 to 50 tablets or capsules
• make other pack sizes of up to 100 tablets or capsules available only under the supervision of a pharmacist (‘Pharmacist Only’ medicines).

These new requirements are due to take effect on 1 February 2025.

You are invited to comment on the proposed labelling exemptions. Comments can be submitted through the consultation hub - external site.

The closing date for submissions is 30 September 2024.

If you have difficulty accessing the consultation hub or uploading your submission, contact medicines.scheduling@health.gov.au and include 'Proposed paracetamol labelling exemptions' in the subject line of the email.