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.
- Emergency order – COVID-19 Vaccination Service Providers – COVID-19 vaccine and influenza vaccine (PDF 237 kB)
This emergency order, made under section 58(1)(e) of the Medicines and Poisons Act authorises persons stated in the emergency order to undertake regulated activities for providing a COVID-19 vaccination service in Queensland and dealing with a COVID-19 vaccine and/or Influenza vaccine.
- Emergency order – National Medical Stockpile (Medicines) (PDF 120 kB)
This emergency order, made under section 58(1)(e) of the Medicines and Poisons Act, authorises persons stated in the emergency order to undertake particular regulated activities detailed with medicines from the National Medical Stockpile (NMS), related to (i) accessing NMS medicine stocks; (ii) distribution of NMS medicines between relevant institutions or between health practitioners for the treatment of patients; and (iii) returning unused stock of medicines to the NMS.
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 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.
If there is no exemption provided by an appropriate authority, medicines suppliers can apply for medicines to be labelled or packaged in alternative way using the Application for Exemption of Medicine Labelling or Packaging form. Please populate the form with all information requested and return via email to email@example.com.
This form can also be used to notify the chief executive of an authorisation by an appropriate authority.
- Application for Exemption of Medicine Labelling or Packaging (PDF 1535 kB) use this form to apply for a labelling or packaging 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)
- 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)
Expired labelling exemptions in Queensland
- 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 - 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 – expired 4 August 2021 (PDF 55 kB)
- Aspen Pharmacare Australia Pty Ltd - CIRCADIN melatonin 2mg prolonged release tablet blister pack - containing 30 tablets - dated 1 June 2021 - expired 1 September 2021 (PDF 76 kB)
- Sandoz Pty Ltd – SUMATRIPTAN packs of two tablets containing 50mg of sumatriptan – effective from 1 February 2021 – expired 31 May 2021 or until existing labelled product is exhausted, whichever is the earlier (PDF 68 kB)