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Manufacturing licences

Licences to manufacture regulated poisons under the Health (Drugs and Poisons) Regulation 1996 (HDPR) will continue under the Medicines and Poisons Act 2019 (MPA) which replaced the HDPR on 27 September 2021. New manufacturing licences will continue to be issued under the MPA.

Who needs a licence

A manufacturing licence is required to manufacture hazardous poisons under the MPA. Hazardous poisons include substances in schedules 2, 3, 4, 7 and 8, under the Poisons Standard when not used or intended to be used for therapeutic purposes.

Manufacturers may also apply for an approval to manufacture prohibited substances (S9 and S10 substances under the Poisons Standard).

Authorisations under the HDPR will transition as closely as possible to a new authority under the MPA. A manufacturer can apply for an amendment to their authority to manufacture additional substances. The following table summarises how the authorisations for a manufacturing licence under the HDPR will transition to the new MPA.

Transition of poison manufacturer authorities under the MPA

Person

Substance

Type of Authority

Scope

under HDPR

under MPA

Poison manufacturers

Hazardous poisons

S2, S3, S4, S7 & S8

Poison manufacturer licence for one or more

S2, S3 or S7 substances

Manufacturing licence for one or more of S2, S3, or S7 poisons

May apply to add S4 or S8 poisons

  • Authorised to buy, manufacture, possess, supply (primarily   by wholesale) and dispose of waste.
  • Must have a substance management plan
  • Must appoint a manufacturing supervisor to oversee the   manufacturing of poisons.

Poison manufacturers

S9 and S10 prohibited substances

General Approval

Manufacturing licence or General approval for S9 and/or S10 substances

  • Authorised to buy, manufacture, possess, supply (primarily by wholesale) and dispose of waste.
  • Must have a substance management plan
  • May need to appoint a manufacturing supervisor if required as a condition of general approval.

Why you need a licence

A manufacturing licence will allow the holder to manufacture, buy, possess, supply primarily by wholesale, and dispose of waste from the final manufactured product and precursor substances.

Queensland-based manufacturers of poisons that are licensed by the Australian Pesticides and Veterinary Medicines Authority (APVMA) will no longer be required to hold a separate manufacturing licence in Queensland for those products covered by the APVMA licence.

However, the manufacture of APVMA-registered S7 products (e.g. agricultural chemicals such as paraquat (herbicide)), which are not captured under the APVMA licensing requirements, will require a manufacturing licence under the MPA.

The poison must be manufactured under the supervision of a manufacturing supervisor who holds qualifications stated in the Departmental standard – Competency requirements for authority holders dealing with poisons (PDF 278 kB).

Apply for a licence

You can apply for a licence to manufacture poisons using Poisons general approval application forms and fees.

Licences across multiple sites

The holder of a manufacturing licence who operates from multiple sites may request one licence covering all sites, rather than having separate licences for each site. The licence fee will be calculated based on the number of sites under the licence.

Requirements for licence holders

Substance management plans

The holder of a manufacturing licence will be required to have a substance management plan (SMP) (PDF 258 kB) which identifies and addresses the risks associated with manufacturing the regulated poisons. An SMP may form a part of other plans or systems including quality and safety management systems or those used to demonstrate compliance with the AgVet scheme.

The SMP must comply with the Departmental standard - Substance management plans for regulated poisons (PDF 283 kB).

Authority holders will have up to 26 September 2022 to comply with new obligations such as preparation of a substance management plan under the MPA.

Quality control

The Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021 requires the holder of a manufacturing licence to implement measures to ensure that the manufactured poisons are fit for purpose and free from contamination.

Batch manufacturing records

The holder of a manufacturing licence is required to keep batch manufacturing records which include details including:

  • materials
  • procedures and controls used in manufacturing the batch of poison
  • tests carried out during the processing of the final product
  • tests for shelf life.

Security

Licensees must also ensure that adequate physical or electronic security measures are implemented while storing high-risk poisons.

Further information

Departmental standards

Last updated: 24 September 2021