Temporary labelling exemptions for paracetamol

Published

26 November 2024

Summary

To assist industry in transitioning to the upcoming paracetamol scheduling changes, and to facilitate pharmacy’s ability to supply these products, we are providing a 12-month 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 will take effect on 1 February 2025.

In addition, we are providing a labelling exemption until 31 January 2025 to also allow pharmacies to supply newly labelled Pharmacist Only (Schedule 3) products in anticipation of the changes to the Poisons Standard, before 1 February 2025.