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 |
15/07/2022 | 1/2/2022 or product exhausted, whichever is earlier | |
16/09/2021 | N/A | |
26/08/2021 | N/A | |
GlaxoSmithKline – SOTROVIMAB – COVID-19 treatment (PDF 104 kB) | 26/08/2021 | N/A |
1/06/2021 | 01/09/2021 | |
20/05/2021 | 31/05/2022 | |
Merck Sharp & Dohme (Australia) Pty Ltd (PDF 67 kB)
| 18/05/2021 | 30/11/2021 |
23/03/2021 | 23/09/2021 | |
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 |
14/01/2021 | N/A | |
14/01/2021 | N/A | |
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 |