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.
- Application for Exemption of Medicine Labelling – S2, S3, S4 and S8 drugs and poisons (PDF 1535 kB) use this form to apply for a certified labelling exemption
Current labelling exemptions in Queensland
- Baxter Healthcare Pty Ltd – UNIFOL Propofol 1% (10mg/mL) Emulsion for injection – MIDAZOLAM-CLARIS midazolam (as hydrochloride) 5mg/5mL solution for injection – dated 3 Jul 2020 – expires 30 Apr 2021 (PDF 33 kB)
- Paracetamol in modified release tablets or capsules each containing 665mg or less of paracetamol – dated 3 July 2020 – expires 31 May 2021 (PDF 76 kB)
- RB (Australia) Pty Limited (Reckitt Benckiser) – Strepsils Plus Anaesthetic Spray containing 0.6% of lidocaine – dated 3 Jul 2020 – expires 31 May 2021 (PDF 77 kB)
- Pierre Fabre Australia Pty Ltd - BRAFTOVI encorafenib 50mg capsule blister pack - BRAFTOVI encorafenib 75mg capsule blister pack - MEKTOVI binimetinib 15mg film-coated tablet blister pack – dated 3 Jul 2020 – expires 31 Jul 2021 (PDF 28 kB)
- Norgine Pty Ltd – MOVICOL Ready to take, 13.125 g in pack sizes of 10 sachets – dated 5 August – expires 4 August 2021 (PDF 55 kB)
- RB (Australia) Pty Limited (Reckitt Benckiser) – Strepfen Intensive Honey & Lemon lozenge & Strepfen Intensive Sugar Free Orange lozenge – containing 8.75mg of flurbiprofen – dated 12 November 2020 – expires 30 September 2021 (PDF 60 kB)
- RB (Australia) Pty Limited (Reckitt Benckiser) – Nurofen 400 Double Strength – containing 400mg of ibuprofen – dated 8 January 2021 – expires 31 January 2022 (PDF 66 kB)
- Sandoz Pty Ltd – SUMATRIPTAN packs of two tablets containing 50mg of sumatriptan – effective from 1 February 2021 – expires 31 May 2021 (PDF 68 kB)
Contact
Healthcare Approvals and Regulation Unit
