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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 222 kB).

Applying the Therapeutic Goods Act 1989 (Cwth) in Queensland

Along with the introduction of the MPA, the Therapeutic Goods Act 2019 (Qld) has now commenced. This Act applies the Commonwealth TG Act as a law in Queensland, to the extent that the TG Act did not already apply.

The TG Act now applies to non-corporates such as sole traders and partnerships. All entities that manufacture medicines must be licensed by the TGA unless exempt. To allow time to meet the licencing requirements under the TG Act, non-corporate entities that did not hold a TG licence, may continue to manufacture these products for up to 2 years until 27 September 2023. Non-corporate entities include those manufacturing products containing substances in the schedules of the Poisons Standard (for which a Queensland manufacturing licence under the Health (Drugs and Poisons) Regulation 1996 (HDPR) was required) or manufacturers of therapeutic goods containing complimentary medicines.

Transitioning existing licences, applications and documents

On the commencement of the MPA, what occurs concerning existing licences for manufacturing granted under the HDPR depends on the scenario:

  • Licence holders that no longer need authorisation (i.e. Commonwealth law manufacturers) will have their licence expire on commencement. No fees will be refunded as there is no power under the HDPR or MPA to do so.
  • Licence holders that manufacture medicated feed for animals will gain MPA manufacturing licences, authorising a holder to manufacture medicated feed:
    • with each substance that was approved under the HDPR licence
    • under the supervision of the person responsible for supervising the manufacture under the HDPR licence
    • at the place that was approved for manufacturing the feed under the HDPR licence
    • for the term of the HDPR licence.
  • All other manufacturing licences granted under the HDPR will have their licences continue to be valid until expired, surrendered or cancelled, subject to the conditions of the licence and the HDPR continues to apply until such time.

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.

Competency of manufacturing supervisors

The Medicine and Poisons (Medicines) Regulation 2021 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 209 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.

An SMP will not be required until 27 September 2022. Find out more about Substance management plans.

Applying for a manufacturing licence

All new applications for manufacturing licences must be accompanied by Details of relevant person (PDF 362 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, a new form will need to be submitted. 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 510 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 329 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 510 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

Healthcare Approvals and Regulation Unit (HARU): HARU@health.qld.gov.au.

Last updated: 3 March 2022