Manufacturing licences
A manufacturing licence is required to manufacture regulated substances such as a schedule 7 poison under the Medicines and Poisons Act 2019 (MPA). Under limited circumstances, you can apply for a manufacturing licence for other scheduled substances (poisons).
Why you need a licence
A manufacturing licence allows licence holders to:
- manufacture, buy, possess, supply (primarily by wholesale) regulated substances (such as a schedule 7 poison)
- dispose of waste from the final manufactured product as well as any precursor substances.
Queensland-based manufacturers of poisons that are licensed by the Australian Pesticides and Veterinary Medicines Authority (APVMA) are not 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.
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
Manufacturing licence holders that operate from multiple sites can request a single licence to cover all sites. You don’t need to apply for separate licences for each site.
Licence fees are 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 253 kB).
Your SMP must:
- identify and address the risks associated with manufactuing the regulated poisons
- comply with the Departmental standard - Substance management plans for regulated poisons (PDF 283 kB).
An SMP may form a part of other plans or systems, including quality and safety management systems.
Quality control
Licence holders are responsible for implementing measures to ensure that manufactured poisons are:
- fit for purpose
- free from contamination.
This is an obligation under the Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021.
Batch manufacturing records
The holder of a manufacturing licence is required to keep batch manufacturing records which include details such as:
- 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
- Substance management plans for regulated poisons (PDF 283 kB)
- Competency requirements for authority holders dealing with poisons (PDF 338 kB)
Contact
Environmental Hazards Unit: environmentalhazards@health.qld.gov.au