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Labelling exemptions

The Health (Drugs and Poisons) Regulation 1996 (HDPR), requires that a package containing a controlled drug (S8), a restricted drug (S4) or a poison (S2 and S3) must bear a label that complies with the current Poisons Standard, part 2.

Section 11 of the HDPR describes circumstances when a package may be labelled in an alternative way (an exemption) to the Poisons Standard, part 2, and in such circumstances this alternative way must be certified by the Chief Executive (or delegate) of Queensland Health.

Applying for a labelling exemption certification

Medicines suppliers can apply for medicines to be labelled in alternative way using the Application for Exemption of Medicine Labelling form. Please populate the form with all information requested and return via email to HARU@health.qld.gov.au
If you have received an exemption from another state or territory, please attach this document to your application.

Current labelling exemptions in Queensland

Contact

Healthcare Approvals and Regulation Unit

HARU@health.qld.gov.au

Last updated: 13 January 2021