To supply a product for therapeutic use, you will need to be licensed as a sponsor by the Commonwealth Theraeutic Goods Administration (TGA). Each product needs to be included in the Australian Register of Therapeutic Goods (ARTG), unless exempted by the TGA. For further information contact the TGA.
To identify if a product is a therapeutic good refer to the TGA What are 'therapeutic goods'.
To confirm if your product is included, or is a derivative of a substance in the Poisons Standard (SUSMP) advice from a chemist or pharmacologist is recommended. Many substances, especially herbs, are also known by different names in different countries.
The supply of any product, substance or its derivative which is included in Schedule 2, 3 or 4 of the Poisons Standard (SUSMP) requires a licence issued by the NSW Ministry of Health. See Application for a Licence to Supply by wholesale Poisons and/or Restricted Substances for Therapeutic Use.
The supply of any product, substance or its derivative which is included in Schedule 8 of the Poisons Standard (SUSMP) requires a licence to manufacture and/or supply drugs of addiction. Application forms can be accessed at Licences under the Poisons and Therapeutic Goods Act 1966.
[back to top]
A licence or authority is not required to supply Schedule 5 or 6 poisons by wholesale or retail in NSW.
Supply of Schedule 7 poisons requires that both the supplier and the purchaser obtain prior written authority from the NSW Ministry of Health. Refer to Summary of requirements for authority to obtain, use or supply Schedule 7 poisons for more information.
For authority to possess cyanide, you need to submit the form Application for an Authority or Renewal of an Authority to Obtain Cyanide.
For authority to possess any other schedule 7 substance (e.g. arsenic), contact Pharmaceutical Services at MOH-PharmaceuticalServices@health.nsw.gov.au.
Scheduled substances must be packaged and labelled in accordance with the requirements of the Poisons Standard (SUSMP). A guide to labelling drugs and poisons is available online from the Therapeutic Goods Administration (TGA).
Some substances and medicines are required to be packed with child resistant closures. Further information is available online from the Therapeutic Goods Administration (TGA).
Additional requirements apply to substances prescribed and supplied by prescribers and/or dispensed by pharmacists.
A scientifically qualified person in charge of a laboratory or department, or someone working under their direct personal supervision, may be supplied Schedule 2, 3, or 4 substances if the use is required for the conduct of medical or scientific research, instruction, or quality control analysis.
To supply a Schedule 8 substance, the person making the request must supply a written authority from the NSW Ministry of Health. If you are unsure about a request, contact Pharmaceutical Services at MOH-PharmaceuticalServices@health.nsw.gov.au.
All Schedule 3 and Schedule 4 substances must be stored in a room or enclosure to which the public does not have access. Additional storage requirements apply to substances of high illicit value.
Wholesalers must comply with the Therapeutic Goods Administration Australian code of good wholesaling practice for medicines in Schedules 2, 3, 4 & 8.
Schedule 6 poisons in a retail shop must be stored at least 1.2 metres off the floor and away from any stairway or ramp unless the packaging meets the legal requirements for a child-resistant container/closure. For more information see Guidance for retail storage of Schedule 6 poisons.
No, wholesale licences are only issued for commercial premises and not for domestic, residential premises.
Storage of Schedule 8 (S8) substances should be in accordance with the Australian code of good wholesaling practice for medicines in Schedules 2, 3, 4 & 8 (CGWP).
Please note that the risk rating assigned to licensed wholesalers of medicines, as noted in the CGWP is always medium to high.
All medicines are temperature sensitive with their ideal storage temperature ranges or limits stated on their packages.
Storage Location:
The following requirements are mandatory. S8 substances must be stored in a vault or a safe.
Environmental Conditions:
Security Measures:
Regulatory bodies oversee the safety, efficacy and quality of medicines. They work to prevent the misuse of medicines and control the quality of products available in the market. The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods such as medicines.
The TGA’s regulatory framework involves:
The TGA, along with similar regulatory bodies worldwide, has the power to regulate the concentration of active ingredients based on scientific evidence and public health considerations. This includes:
Regulations are enforced through a combination of legislation, guidelines, and standards that are periodically updated to reflect the latest scientific knowledge and public health needs.
These measures help to prevent adverse reactions and ensure that consumers have access to safe and effective medicines.
For more information and recent reforms to the regulatory framework, refer to the TGA website.
