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 158 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.
Wholesale representatives
Wholesale representatives are ‘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).
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.
Find out more about Substance management plans.
Licence applications
All new (initial) applications for a wholesale licence must include supporting documents as listed in the application form.
Details of relevant person (PDF 336 kB) forms for those persons that are considered relevant for assessing the application. These persons include:
- executive officers of corporations
- partners
- individual sole traders
- supervisors.
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 Medicines wholesale licences - supporting information for applicants (PDF 270 kB) and completing the Application form - wholesale licence (medicines) - initial application (PDF 1956 kB).
Licence renewals and/or amendments
Existing holders of wholesale licences seeking to renew and/or amend an existing licence should complete an Application form - wholesale licence (medicines) - renewal and/or amendment (PDF 2032 kB). You will need to pay a fee when submitting this application.
Supporting documents for applicants
- Medicines wholesale licences – supporting information for applicants (PDF 270 kB)
- Additional site attachment – wholesale licence (medicines) (PDF 1790 kB)
- Self-audit checklist for wholesaling S2, S3, S4 and S8 medicines (DOCX 566 kB)
Related information
- 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)
Contact
Medicines Approvals and Regulation Unit (MARU): MARU@health.qld.gov.au