On this page
- Application process
- Application processing times
- Drugs and Poisons Control Procedure (DPCP)
- Facility or premises inspections
Application process
Initial review
An application will be checked and reviewed for completeness. This includes confirmation of licence application fee payment and inclusion of the relevant supporting documents.
You will be contacted via email for any queries or requests for documentation and to inform you that your application has progressed to the next stage.
Assessment phase
The assessment phase determines if the licence is to be granted.
This phase assesses applicants to ensure that they meet the appropriate professional capability and standards. This includes a review of the required documents provided with the application. For certain types of licence, the applicant will be contacted to provide a Drugs and Poisons Control Procedure (DPCP) and to schedule a facility or premises inspection. See below for more information on DPCP and facility or premises inspections.
It is important to note that the provision of any false or misleading information is an offence under the Crimes Act 1900 (NSW).
A licensing officer will contact you if further information is required.
If your application is successful, you will be sent the licence and the conditions of compliance via email. If the decision is not to grant a licence, you will be informed of the reason(s) and your option to request a review of the decision (where appropriate).
Application processing times
Timeframes apply to the following applications:
The initial review may take up to 5 business days.
The assessment phase may take up to 20 business days.
Please note that requests for information, developing the DPCP, and facility inspections will pause the timeline ('stop-clock'). The timeline restarts when the information or activity has been completed.
Drugs and Poisons Control Procedure (DPCP)
The DPCP is a document that outlines proposed business practices and procedures to be conducted under the licence or authority for certain activities. This is developed by the applicant and includes the specific activities to be undertaken by the applicant.
A DPCP is required for licences to:
- supply by wholesale Schedule 2, 3, and 4 medicines
- manufacture or supply by wholesale, Schedule 8 medicines
- supply by wholesale Schedule 8 medicines (drugs of addiction).
A DPCP is not required when applying for a licence to supply Schedule 8 medicines (drugs of addiction) in a licensed Private Health Facility. The applicant will be sent a NSW Health Drugs of Addiction (S8) Audit Checklist to complete instead.
If a DPCP is required, the applicant will be provided with a template and a supporting guidance document. The draft DPCP is then submitted by the applicant for review and approval. The assessment phase of that application can only progress when the DPCP is received from the applicant.
To develop the DPCP please refer to the following reference materials:
Alternatively, applicants can consult with a Regulatory Consultant for advice.
For further advice, contact via email MOH-PharmaceuticalLicensing@health.nsw.gov.au
Facility or premises inspections
A facility or premises inspection is a visual review of the facility or premises where the proposed licence activities will take place. This may be either a 'remote desktop' based inspection or an in-person onsite inspection.
A remote desktop inspection requires the applicant to supply pictures and documentation of the premises. Remote desktop inspections are generally required when applying for licences involving Schedule 2, 3, and/or Schedule 4 substances (excluding Schedule 4 Appendix D substances, and Goods of High Illicit Value [GHIV]).
Onsite inspections are required for applications to wholesale supply Schedule 4 Appendix D,Goods with High Illicit Value (GHIV) or Schedule 8 substances.
Private health facilities are exempt from onsite inspections when applying for a licence to supply Schedule 8 medicines.
A facility or premises inspection may not be required when supplying by indent ('indent' refers to the supply of medicines, poisons, or therapeutic goods where the licence holder does not take possession of the scheduled substances or medicines).