Updates and alerts

The following contains important announcements made under the Medicines and Poisons Act 2019 (MPA) by the Minister of Health, Chief Executive of Queensland Health or Chief Health Officer, including Queensland initiated recall orders, emergency orders, labelling and packaging exemptions, and emerging risk declarations.

Labelling and packaging exemptions

The Medicines and Poisons (Medicines) Regulation 2021 (MPMR) requires that a supplier must not supply a stock of a medicine to a buyer unless the labelling on the medicine (S2, S3, S4 and S8 medicines) complies with the labelling requirements for the medicine stated in the current Poisons Standard, part 2, section 1.

Similarly, the MPMR requires that a supplier must not supply stock of a medicine to a buyer unless the container of the medicine complies with the requirements for containers for the medicine stated in the Poisons Standard, part 2, section 2.

Section 237 of the MPMR describes circumstances when a medicine may be labelled or packaged in an alternative way (an exemption) to the Poisons Standard and in such circumstances this alternative way must be certified by the Chief Executive (or delegate) of Queensland Health or an appropriate authority (of the Commonwealth of Australia or in another state or territory).

Applying for a labelling exemption certification

Where an appropriate authority, for a purpose or in another State, has authorised (whether by approval, exemption or some other way) another way to label or package a medicine for the purpose or other State, then to the extent authorised by the appropriate authority, the other way is taken to be an alternative way approved under section 237 of the MPMR, unless the chief executive publishes a statement on the department’s website that the other way is not approved for Queensland.

Medicines suppliers can use the Application for Exemption of Medicine Labelling or Packaging form (PDF 259 kB) to apply for medicines to be labelled or packaged in alternative way if there is no exemption provided by an appropriate authority.

Please populate the form with all information requested and return via email to medicines.applications@health.qld.gov.au.

This form can also be used to notify the chief executive of an authorisation by an appropriate authority.

Labelling exemptions in effect in Queensland

Exemption

Start date

Expiry

Galderma Australia Pty Ltd – DIFFERIN adapalene 1mg/g gel tube and 1mg/g cream tube (PDF 75 kB)

27/11/23

30/04/2024 or product exhausted, whichever is earlier

Alphapharm Pty Ltd – SUMATRIPTAN IPTAM packs of 2 tablets each containing 50mg of sumatriptan (PDF 85 kB) (PDF 85 kB)

15/07/2022

1/2/2022 or product exhausted, whichever is earlier

Gilead – REMDESIVIR – COVID-19 treatment (PDF 28 kB)

16/09/2021

N/A

Moderna – COVID-19 Vaccine (PDF 59 kB)

26/08/2021

N/A

GlaxoSmithKline – SOTROVIMAB – COVID-19 treatment (PDF 104 kB)

26/08/2021

N/A

Aspen Pharmacare Australia Pty Ltd – CIRCADIN melatonin 2mg prolonged release tablet blister pack – containing 30 tablets (PDF 76 kB)

1/06/2021

01/09/2021

Generic Partners Pty Ltd – MELOTIN MR melatonin 2mg modified release tablet blister pack (containing 30 tablets) (PDF 77 kB)

20/05/2021

31/05/2022

Merck Sharp & Dohme (Australia) Pty Ltd (PDF 67 kB)

  • Elocon 15 gram packs of ointments
  • Novasone 15 gram packs of ointments
  • Elovon Alcohol-Free cream containing 0.1% of mometasone furoate
  • Novasone cream containing 0.1% of mometasone furoate

18/05/2021

30/11/2021

Aspen Pharmacare Australia Pty Ltd – SUMATRIPTAN Imigran packs of 2 tablets each containing 50mg of sumpatriptan (PDF 60 kB)

23/03/2021

23/09/2021

RB (Australia) Pty Limited (Reckitt Benckiser) – Nurofen 400 Double Strength – containing 400mg of ibuprofen (PDF 66 kB)

8/02/2021

31/01/2022

Sandoz Pty Ltd – SUMATRIPTAN packs of 2 tablets containing 50mg of sumatriptan (PDF 68 kB)

1/02/2021

31/05/2021 or product exhausted, whichever is earlier

AstraZeneca – COVID-19 vaccine (PDF 27 kB)

14/01/2021

N/A

Pfizer – COVID-19 vaccine (PDF 31 kB)

14/01/2021

N/A

RB (Australia) Pty Limited (Reckitt Benckiser) – Strepfen Intensive Honey & Lemon lozenge & Strepfen Intensive Sugar-Free Orange lozenge – containing 8.75mg of flurbiprofen (PDF 60 kB)

12/11/2020

30/09/2021

Norgine Pty Ltd – MOVICOL Ready to take, 13.125 g in pack sizes of 10 sachets (PDF 55 kB)

5/08/2020

4/08/2021

Last updated: 28 November 2023