In NSW, the storage, distribution and supply of medicines, poisons and therapeutic goods is regulated under the Poisons and Therapeutic Goods Act 1966 (NSW) and Poisons and Therapeutic Goods Regulation 2008 (NSW). To undertake any of these activities an individual or a company requires a licence.
On this page
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When is a licence required?
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How to apply for a licence
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Licence fees and schedule of payments
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Amendments or changes to a licence
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More information
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Current licence holders
When is a licence required?
Generally, businesses that sell medicines and poisons by wholesale or retail require a licence under the Poisons and Therapeutic Goods Act 1966 (NSW).
A licence is required to undertake the following activities:
- manufacture, supply by wholesale, or supply drugs of addiction (Schedule 8 medicines)
- supply by wholesale, Schedule 2, 3 and 4 substances for human therapeutic use
- supply medicines for veterinary use
- sell substances specified in Schedule 2 of the
Poisons Standard from a retail store. This licence allows a retail store to supply Schedule 2 substances which would normally only be available for consumers to purchase from a pharmacy. This licence is usually issued if the business is more than 20km from the nearest community pharmacy.
Poisons in Schedule 5 and Schedule 6 of the
Poisons Standard can be sold without a licence.
Poisons in Schedule 7 of the
Poisons Standard require an authority to be issued under the Poisons and Therapeutic Goods Act 1966 (NSW). Applications for an authority to supply, obtain or use a Schedule 7 poison are available on
Licenses and authorisations.
How to apply for a licence
Licences can be issued to an individual on behalf of a business, or to a company.
To obtain a licence, complete the relevant application form and email it together with the relevant supporting documentation and proof of licence fee payment to
MOH‑PharmaceuticalLicensing@health.nsw.gov.au.
For information on the application process and processing times see
Processing of applications for licences under the Poisons and Therapeutic Goods Act 1966.
Application forms
For licences for cannabis products - additional requirements include:
Veterinary supply by wholesale of medicines
If the proposed activities include veterinary supply by wholesale of medicines for human therapeutic use, a licence is required. To apply refer to the application forms above.
However, if the substances to be supplied are approved
only for use in animals, a
veterinary wholesale authority is required, see
Application for Authority to Supply Therapeutic Substances by Wholesale for Veterinary Use.
Supporting documentation
The following supporting documentation may be required to be submitted as stated on the relevant application form:
Licence fees and schedule of payments
The current fees for a licence and details of how to pay the licence fee are located in the application form.
Payment of the licence fees for new applications are made online at the NSW Ministry of Health payment portal (see
Other Payments). To proceed you will need to select ‘Ministry of Health’ as the health organisation and the hospital/facility and ‘Application/Licence Fee’ as the service.
Schedule 2 retail licences renewal fees must be paid annually by 31 March each year. Renewal fees for all other licences must be paid annually by 30 September each year.
A reminder for renewal of a licence and a link for payment will be sent to the licence holder via email prior to the renewal date. Please ensure your contact details remain current and you notify the Pharmaceutical Services Unit at
MOH‑PharmaceuticalLicensing@health.nsw.gov.au if there are any changes.
Amendments or changes to a licence
The licence holder is required to notify Pharmaceutical Services Unit if there are any changes in the approved licence information.
Minor changes to an approved licence can be requested via email to
MOH‑PharmaceuticalLicensing@health.nsw.gov.au. Requests must include a cover letter and any documentation to support the request for update.
A
minor amendment can include:
- contact information (postal address, email, named individual)
- updates to the officers of the organisation (as per the Australian Securities & Investments Commission [ASIC] extract).
Substantive changes to the approved licence information may require a new application being submitted. A
substantive amendment includes:
- any change required to the existing licence, such as conditions, change in premises details, change in business entity name
- changes to the DPCP that are not minor amendments, such as new customer types, activities that are not within the approved licence type, addition of substances that require cold chain handling etc.
If you are unsure which type of amendment may apply, please contact
MOH‑PharmaceuticalLicensing@health.nsw.gov.au for assistance.
More information
For more information contact the Pharmaceutical Services Unit on
MOH‑PharmaceuticalLicensing@health.nsw.gov.au.
Current licence holders