Wholesaling of medicines
The regulation of medicines supply is shared between the States/Territories and Commonwealth. Suppliers of medicines for both human and veterinary use, must comply with all requirements, including those of the:
- Medicines and Poisons Act 2019 (Qld) (MPA)
- Therapeutic Goods Act 1989 (Cwth) (TG Act)
- Narcotic Drugs Act 1967 (Cwth)
- AgVet Code
While more relevant to manufacturing, under the MPA those persons and entities that hold a permission granted under a Commonwealth law (e.g. a licence, permit or other authority from the Office of Drug Control or the Australian Pesticides and Veterinary Medicines Authority) that explicitly authorises the supply of medicines do not require a wholesale licence under the MPA to wholesale the same substances at the same place within the same conditions.
Although no licence may be required under Queensland law, other requirements still apply e.g. in relation to buying stock, possession and security of medicines and limitations on to whom these medicines may be supplied. Find out more about Commonwealth law manufacturers (PDF 222 kB).
Carriers and logistics
A carrier is defined in the Medicines and Poisons (Medicines) Regulation 2021 (MPMR) as ‘a person engaged to deliver a medicine from place to place’. Carriers are authorised (as ‘approved persons’) to possess medicines for the purposes of delivery of the medicine. No licence or approval is required to perform this function, however there are requirements that apply. Find out more about carriers, transport and logistics (PDF 221 kB).
Some transport and logistics companies offer services beyond providing transport to carrying out some or all of the functions of supply. This may be from single or multiple premises in Queensland and interstate. Determine whether a Queensland licence is required for your business - When is a wholesale licence required under the MPA (PDF 491 kB).
An individual who is a wholesale representative is no longer required to hold a licence under the MPA. Wholesale representatives are now ‘authorised’ to carry out certain regulated activities with regulated substances as ‘approved persons’ under the MPA and Schedule 14, Part 4 of the MPMR.
Wholesale representatives must be employed by a licenced wholesaler or manufacturer either in Queensland or another State or Territory and can only give out a starter pack of an S2, S3 or S4 medicine that is not a monitored medicine. Read more about Wholesale Representatives (PDF 195 kB).
Transition of existing licences, applications and documents
On the commencement of the MPA, all wholesale licences granted under the Health (Drugs and Poisons) Regulation 1996 (HDPR) continue to be valid, subject to the conditions of the licence and the HDPR continues to apply until such time as the licence is expired, surrendered or cancelled – except for where an equivalent Commonwealth permission is held, in which case the licence will cease on commencement.
Wholesale representative licences granted under the HDPR cease when the MPA commences as the HDPR is repealed. No fees will be refunded as there is no power under the HDPR or MPA to do so.
Valid applications made for a new licence or to renew or amend an existing licence under the HDPR, are still valid but are assessed and granted or refused under the MPA.
Other documents, such as purchase orders continue for up to 6 months.
Substance management plans
Under the MPA, certain places must have a substance management plan (SMP), which is a document setting out how known and foreseeable risks associated with any dealing with a regulated substance are to be managed at, or in connection with, the place. A place where a medicine is stored for supply by wholesale is required to have an SMP.
Where an SMP applies, a person must comply with the SMP to carry out a regulated activity in the authorised way.
An SMP will not be required until 27 September 2022. Find out more about Substance management plans.
All new applications for a wholesale licence must be accompanied by Details of relevant person (PDF 362 kB) forms for those persons that are considered relevant for assessing the application. These persons include:
- executive officers of corporations
- individual sole traders
When a relevant person changes, a new form will need to be submitted. Further information on who must complete this form is on the application form.
New (initial) licence
Apply for a new (initial) licence by reading the guideline and completing the Application form - wholesale licence (medicines) - initial application (PDF 538 kB). You will need to pay a fee when submitting this application.
Existing holders of wholesale licences seeking to renew their licence (and still require a licence under the MPA) should complete an Application form - wholesale licence (medicines) - renewal application (PDF 426 kB). You will need to pay a fee when submitting this application.
To make an amendment to an existing wholesale licence (where one is still required under the MPA), complete an Application form - wholesale licence (medicines) - amendment application (PDF 531 kB). You will need to pay a fee when submitting this application if you wish to add an additional site to an existing licence.
- Fees for medicines licences
- Substance management plans
- Labelling exemptions
- Reporting matters to the chief executive including lost or stolen medicines
- Purchase order template (PDF 124 kB)
Healthcare Approvals and Regulation Unit (HARU): HARU@health.qld.gov.au.