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
- Gilead - REMDESIVIR - COVID-19 treatment - dated 16 September 2021 (PDF 28 kB)
- Moderna - COVID-19 Vaccine - dated 26 August 2021 (PDF 59 kB)
- GlaxoSmithKline - SOTROVIMAB - COIVD-19 treatment - dated 26 August 2021 (PDF 104 kB)
- AstraZeneca - COVID-19 Vaccine - dated 14 January 2021 (PDF 27 kB)
- Pfizer - COVID19 Vaccine - dated 14 January 2021 (PDF 31 kB)
- Aspen Pharmacare Australia Pty Ltd - SUMATRIPTAN Imigran packs of two tablets each containing 50mg of sumpatriptan - expires 23 September 2021 (PDF 60 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)
- Aspen Pharmacare Australia Pty Ltd - CIRCADIN melatonin 2mg prolonged release tablet blister pack - containing 30 tablets - dated 1 June 2021 - expires 1 September 2021 (PDF 76 kB)
- Merck Sharp & Dohme (Australia) Pty Ltd - dated 18 May 2021 - expiry 30 November 2021 (PDF 67 kB)
- Elocon 15 gram packs of ointments
- Novasone 15 gram packs of ointments
- Elocon Alcohol Free cream containing 0.1% of mometasone furoate
- Novasone cream containing 0.1% of mometasone furoate
- 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)
- Generic Partners Pty Ltd - MELOTIN MR melatonin 2mg modified release tablet blister pack (containing 30 tablets) - dated 20 May 2021 - expires 31 May 2022 (PDF 77 kB)
- Alphapharm Pty Ltd – SUMATRIPTAN IPTAM packs of two tablets each containing 50mg of sumatriptan – dated 15 of July 2022 – expires 1 February 2022 or until existing labelled product is exhausted, whichever is the earlier (PDF 85 kB)
- Sandoz Pty Ltd – SUMATRIPTAN packs of two tablets containing 50mg of sumatriptan – effective from 1 February 2021 – expires 31 May 2021 or until existing labelled product is exhausted, whichever is the earlier (PDF 68 kB)
Contact
Healthcare Approvals and Regulation Unit
