About the Pharmaceutical Services Unit

​​​​​​​​​​​​​The Pharmaceutical Services Unit (PSU) operates within the Legal and Regulatory Services Branch of the NSW Ministry of Health. Our primary goal is to ensure the safe and regulated use of medicines and poisons in NSW. We do this through administration of the Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic Goods Regulation 2008 (NSW).

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On this page​

1. Objectives
2. ​Functions of the Pharmaceutical Services Unit
3. Regulatory outcomes
4. Reports and activity for 2024-2025​ ​
   

Objectives

Our objectives are to protect the public from the potential harms of medicines and poisons and improve the safety and quality of medicine use within the community. To do this we:​

• ​ensure that medicines and poisons are appropriately accessible to the public and their packaging, labelling, storage, distribution, prescription, supply and usage comply with legislative requirements
• minimise harm from the use of medicines and poisons by developing, publishing, implementing and enforcing appropriate policy, guidance materials and educational initiatives
• promote the quality use of medicines in the community and various healthcare facilities
• adopt best practice in regulating medicines and poisons throughout NSW.

Functions of the Pharmaceutical Services Unit

​Authorisations, approvals and licensing

We manage authorities/ approvals for the prescribing of a variety of medicines. These include:

• ​medicines under the NSW Opioid Treatment Program
• Schedule 8 opioids for pain 
• Schedule 8 cannabis medicines
• psychostimulant medicines for ADHD
• psilocybine for treatment resistant depression
• MDMA for post-traumatic stress disorder
• some Schedule 4 prescription only medicines.

​We also manage licences and authorisations for individuals, businesses and facilities, to store, distribute and supply medicines, poisons and therapeutic goods. This includes the issuing of licences to manufacture or supply medicines by wholesale.

Inspections​ and investigations

We investigate the unlawful diversion, supply and misuse use of medicines and poisons. 

We also conduct inspections of facilities and health care settings to ensure compliance with the Poisons and Therapeutic Goods legislation.

Policy development and expert advice

We develop policies and guidelines that support the legislation, including best practices for the handling of medicines and addressing emerging pharmaceutical risks and issues. 

Support and representation

We provide an essential role in delivering secretariat and administrative support for statutory committees and represent NSW interests in national committees, such as the Advisory Committee on Medicines Scheduling.

Proactive regulatory oversight

We use data and regulatory tools such as SafeScript NSW to identify unsafe prescribing and supply of high-risk medicines, and underlying issues that may lead to non-compliance with the legislative requirements.

Regulatory outcomes

The regulatory outcomes of the PSU are to: 

• ​promote the safe use of medicines and poisons by publishing contemporary guidance materials
• reduce the risk of harm from inappropriate prescribing and supply of medicines and poisons by providing advice and taking compliance action on breaches of legislation
• reduce the diversion of medicines for unlawful purposes by undertaking targeted investigations.
  

​Reports and activity for 2024-2025 ​

​Authority applications​

A total of 45,041 approval applications were received by the PSU. This included:

• 18,974 applications for an approval to prescribe or supply under the NSW Opioid Treatment Program (OTP)
• 733 applications for an approval to prescribe or supply a Schedule 8 cannabis medicine
• 25,334 applications for an approval to prescribe or supply other Schedule 8 medicines.  

Additionally, the PSU processed 12,756 OTP exit notifications.

A total of 550 applications were also received and processed for:

• possession or supply of Schedule 8 or 9 substances or prohibited drugs/ plants for the purpose of research, instruction or analysis
• wholesale licences for Schedule 2, 3, 4 and 8 medicines
• supply therapeutic substances by wholesale for veterinary use
• possess and administer scheduled substances by private paramedics in NSW
• obtain and/ ​or use certain Schedule 7 substances (highly dangerous substances)
• prescribing certain restricted substances.

Applications are processed within required timeframes. For more information see Processing ti​meframes for authority applications.

Regulatory compl​iance activity

During the reporting period 2024-2025 the PSU:

• received 2,525 notifications and/ or reports of potential regulatory breaches and notifications of lost or stolen accountable medicines. These ranged from minor non-compliance matters to more substantive concerns that required further investigation or regulatory action.
• initiated 90 new investigations using a risk-based approach
• undertook 49 actions to withdraw or restrict the authorities of health practitioners to possess, supply or prescribe Schedule 4 or Schedule 8 medicines under the provisions of the Poisons and Therapeutic Goods legislation
• undertook 23 actions to restore the drug authorities of health practitioners.

PSU inspectors audited compliance with the Poisons and Therapeutic Goods legislation at 38 community pharmacies. 

In response to investigations undertaken by the PSU, 73 health 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 Complianc​e Policy.

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