From 5 November 2026, the Poisons and Therapeutic Goods Act 1966 and Poisons and Therapeutic Goods Regulation 2008 will be replaced respectively by the:
For information on licensing under the current legislation, see the webpage on Licences under the Poisons and Therapeutic Goods Act 1966 .
In NSW, a licence is usually required to obtain, wholesale, and retail supply medicines and poisons. Licences are issued under the Medicines, Poisons and Therapeutic Goods Act 2022 and the Medicines, Poisons and Therapeutic Goods Regulation 2026.
For circumstances where a licence is not required see When is a licence not required?
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Wholesale supply is the supply of medicines and poisons for the purpose of resupply.
A wholesale licence allows a person or an entity to supply medicines and poisons by wholesale to individuals authorised to obtain them, such as an authorised practitioner, a pharmacist for a pharmacy, a hospital, etc.
This licence type applies to the wholesale supply from NSW premises of Schedules 2, 3, 4, and 8 medicines, Schedule 7J poisons and Schedule 9 or 10 substances. A list of these scheduled substances is available in the Poisons Standard (SUSMP).
Retail licences apply to the following medicines or poisons:
A retail licence allows a retail business to supply Schedule 2 medicines from premises other than a pharmacy. This licence may only be issued if the retail premises is located more than 20km from the nearest pharmacy, measured by the shortest practicable route.
*Exceptions apply to some historical licences issued prior to 1989.
A retail licence is required to supply Schedule 7J poisons to individuals authorised to possess and use these poisons under the Pesticides Act 1999 or the Stock Medicines Act 1989.
Schedule 7J poisons are listed in Appendix J of the Poisons Standard (SUSMP), under the heading Appendix J – Conditions for availability and use of certain poisons included in Schedule 7.
More information is available on the Schedule 7 Poisons webpage.
An obtain licence allows individuals or entities to:
An obtain licence may be issued to the following individuals or entities on submission of an application:
Application forms for licences under the new laws will be available later in 2026. Applications must be submitted with all required supporting documentation and the proof of payment of the applicable licence fee.
The required supporting documentation will be listed in the licence application forms. These will be available in late 2026.
You will be able to request an amendment or variation to a licence via an application form which will be available in late 2026.
An amendment applies when an application for a new licence has been submitted but the licence has yet to be issued.
A variation to a licence applies when a change is requested to an issued licence.
Fees apply to submission of applications for amendments or variations. See Licence fees and schedule of payments for more information.
Fees apply when applying for a new licence, renewing a licence, and requesting an amendment or a variation to a licence. Some exceptions apply. For more information see Licence fees and schedule of payments.
The approval process can take up to 90 days from the date the completed application including all required documents, is received.
If the requested information or documentation is not received within 6 months of the last communication from the Ministry of Health, the application will be cancelled and a new application will need to be submitted.
Licences are issued to the applicant via email and include conditions of compliance. Where a licence is not granted, the reasons and option to request a review of the decision (where appropriate) will be provided to the applicant.
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An onsite inspection is required when applying for a licence to wholesale supply Schedule 4D, 8 or 9 medicines and poisons. Arrangements will be made by a NSW Health Pharmaceutical Services licensing officer.
The Medicines, Poisons and Therapeutic Goods Regulation 2026 requires that the loss or theft of a Schedule 4D, Schedule 7J, Schedule 8, Schedule 9, or Schedule 10 substance be immediately notified to the Secretary of Health.
An online notification form to report the loss or theft of these medicines or poisons will be available from 5 November 2026.
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The following links are to webpages listing current licence holders.
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Please click to expand the headings below for information on the circumstances when a licence is not required.
Ahpra registered authorised practitioners do not require a licence to obtain Schedule 2, 3, 4 and 8 medicines for the treatment of a person by the following Ahpra registered authorised practitioners:
Note: some restrictions apply to unregistered medicines.
Public health entities do not require a licence when:
Private health facilities licenced under the Private Health Facilities Act 2007 do not require a licence when:
A licence is not required by authorised individuals in residential aged care facilities when obtaining approved Schedule 2, 3, 4 and 8 medicines for the treatment of residents.
A licence is not required by authorised individuals in correctional centres and detention centres when obtaining Schedule 2, 3, 4 and 8 medicines for the treatment of inmates.
A licence is not required by veterinary practitioners when obtaining Schedule 2, 3, 4 and 8 medicines for the treatment of animals.
A licence is not required in veterinary hospitals when supplying Schedule 2, 3, 4 and 8 medicines to another veterinary hospital.
A licence is not required for representatives from a university department, university laboratory, or a research institution* when obtaining Schedule 2, 3, 4 (excluding Schedule 4D), and invitro diagnostic and analytical preparation containing less than 0.001% of a prohibited schedule substance or prohibited drug.
*A research institution is one that is a member of the Association of Australian Medical Research Institutes.
Note:
A licence is not required for other individuals or entities for the wholesale supply of scheduled medicines and poisons in certain circumstances, as they may be authorised, including to first aiders or for the purpose of first aid.
More information is available in the Medicines Poisons and Therapeutic Goods Regulation 2026.
A licence is not required to supply poisons in Schedule 5 and 6 of the Poisons Schedule.
Schedule 7 poisons which are not Schedule 7J poisons
A licence is not required to supply Schedule 7 poisons which are not Schedule 7J poisons. Suppliers must ensure that the supply is to persons who are authorised to obtain the substances.
Schedule 7 poisons which are not Schedule 7J poisons may be supplied to:
* domestic use includes domestic garden use.
Schedule 7J poisons
Wholesale supply:
A wholesale licence is generally required to wholesale supply Schedule 7J poisons. Wholesalers must ensure that the supply is to persons who are authorised to obtain the substances.
Schedule 7J poisons may be wholesale supplied to:
the holder of wholesaler licence that authorises the holder to wholesale supply the substance,
the holder of an obtain licence that authorises the holder to obtain the substance,
the holder of a retail licence that authorises the holder to make the substance available for retail sale, or
a person who is authorised to possess or use the substance under the Pesticides Act 1999.
Retail supply:
A licence is required by a retailer to supply Schedule 7J poisons. Retailers must ensure that the supply is to persons who are authorised to obtain the substances.
Schedule 7J poisons may be retail supplied to a person who is authorised to possess or use the substance under the Pesticides Act 1999, or the Stock Medicines Act 1989.
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