Pharmaceutical Services comprises the Chief Pharmacist Unit and the Pharmaceutical Regulatory Unit. Both are units of the Legal and Regulatory Services Branch of the NSW Ministry of Health.
Collectively, the Chief Pharmacist Unit and the Pharmaceutical Regulatory Unit are responsible for the administration of the Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic Goods Regulation 2008 (NSW). While the Chief Pharmacist Unit (CPU) has responsibility for the development of policies and guidelines to complement the legislation, the Pharmaceutical Regulatory Unit (PRU) is responsible for operational areas of regulatory compliance, including inspections, investigations and the issuance of a range of authorities in compliance with the legislation.
Please note that during the COVID-19 Pandemic the Pharmaceutical Regulatory Unit may not be able to meet processing timeframes as published on the website or relevant application forms.
During the reporting period 2021-2022 a total of 27,267 authority applications were processed by the Pharmaceutical Regulatory Unit, including 13,860 applications for an authority to prescribe under the NSW Opioid Treatment Program (OTP), 378 applications for an authority to prescribe a Schedule 8 cannabis medicine and 13,029 applications for an authority to prescribe other Schedule 8 medicines. Additionally, the Pharmaceutical Regulatory Unit processed 11,162 OTP exit notifications.
During the reporting period 2021-2022 a total of 412 applications were received for:
97% of the above authority applications were processed within targeted timeframes.
More information on processing timeframes for authority applications.
for the purpose of auditing compliance with the Poisons and Therapeutic Goods legislation.
In response to investigations undertaken by the Pharmaceutical Regulatory Unit, 100 practitioners were referred for further action to the NSW Health Care Complaints Commission, the respective NSW Health Professionals Authority Council or the Veterinary Practitioners Board of NSW.
Read about the Compliance Policy.