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.
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:
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.
For more information contact the Pharmaceutical Services Unit via email at MOH‑PharmaceuticalServices@health.nsw.gov.au or by phone on (02) 9391 9944 during business hours.
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.
For licences for cannabis products - additional requirements include:
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.
The following supporting documentation may be required to be submitted as stated on the relevant application form:
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.
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:
Substantive changes to the approved licence information may require a new application being submitted. A substantive amendment includes:
If you are unsure which type of amendment may apply, please contact MOH‑PharmaceuticalLicensing@health.nsw.gov.au for assistance.
For more information contact the Pharmaceutical Services Unit on MOH‑PharmaceuticalLicensing@health.nsw.gov.au.