Manufacturing medicines

The regulation of medicines manufacturing is shared between the States/Territories and the Commonwealth. Manufacturers of medicines for both human and veterinary use must comply with all requirements, in particular any product registration, licencing and permit requirements, including those detailed in the:

Under the MPA, persons and entities that hold a permission to manufacture regulated substances granted under a Commonwealth law (e.g. a licence, permit or other authority from the Therapeutic Goods Administration, the Office of Drug Control or the Australian Pesticides and Veterinary Medicines Authority) do not require a manufacturing licence under the MPA to manufacture the same substances at the same place within the same conditions.

Although no licence may be required under Queensland law, other requirements still apply. For example, in relation to buying raw ingredients, possession and security of medicines and limitations on to whom these medicines may be supplied. Find out more about Commonwealth law manufacturers (PDF 593 kB).

Applying the Therapeutic Goods Act 1989 (Cwth) in Queensland

Along with the MPA, the Therapeutic Goods Act 2019 (Qld) applies the Commonwealth TG Act as a law in Queensland, to the extent that the TG Act does not already apply.

The TG Act applies to non-corporates such as sole traders and partnerships. All entities that manufacture medicines must be licensed by the TGA unless exempt. Non-corporate entities include those manufacturing products containing substances in the schedules of the Poisons Standard (for which a Queensland manufacturing licence is required or manufacturers of therapeutic goods containing complimentary medicines.

Competency of manufacturing supervisors

The Medicine and Poisons (Medicines) Regulation 2021 (MPMR) requires that the holder of a manufacturing licence for medicines must appoint an appropriately qualified person (or persons) to supervise manufacturing under the licence and that the licensee must take all reasonable steps to ensure the medicine is manufactured under the supervision of that person.

The guideline Competency requirements for medicines manufacturers (PDF 203 kB) establishes the minimum competency requirements for persons supervising the manufacture of medicines under a Queensland manufacturing licence. Persons who have qualifications and experience that meet these minimum requirements may be considered ‘appropriately qualified’. Qualifications and experience that are deemed to satisfy the necessary competencies, subject to the conditions, have been provided to assist licensees.

Substance management plans

The MPA requires certain places to 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. Both a place where a medicine is manufactured under a manufacturing licence and a place where a medicine is stored for supply by wholesale (e.g. Commonwealth law manufacturers) are 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.

Applying for a manufacturing licence

All new (initial) applications for a manufacturing licence must be accompanied by Details of relevant person (PDF 343 kB) forms completed by those persons considered relevant for assessing the application. These persons include:

  • executive officers of corporations
  • partners
  • individual sole traders
  • manufacturing supervisors.

When a relevant person changes, the holder of a manufacturing licence must notify Queensland Health, and a relevant person form must be submitted for any new relevant persons. Further information on who must complete this form is available on the application form.

New (initial) licence

Apply for a new (initial) licence by reading the guideline and completing the Application form - manufacturing licence (medicines) - initial application form (PDF 555 kB). You will need to pay a fee when submitting this application.

Licence renewals

Existing holders of manufacturing licences seeking to renew their licence (and still require a licence under the MPA) should complete the Application form - manufacturing licence (medicines) - renewal application (PDF 404 kB). You will need to pay a fee when submitting this application.

Licence amendments

To make an amendment to an existing manufacturing licence (where one is still required under the MPA), complete the Application form - manufacturing licence (medicines) - amendment application (PDF 594 kB). You will need to pay a fee when submitting this application if you wish to add an additional site to an existing licence.

Related information

Contacts

Medicines Approvals and Regulation Unit (MARU): MARU@health.qld.gov.au

Last updated: 2 September 2026