Compliance Framework
Compliance Driver
Poisons and Therapeutic Goods Act 1966 (NSW)
Classification
Level 3
Centrally managed, local area(s) requirement.
Associated Legislation
Associated Standards
None
Associated Codes
None
Associated Information
None
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Administrative Information
Administrative Body
NSW Ministry of Health
Administrative Name
Administrative Address
Physical Address
73 Miller Street
North sydney NSW
Australia, 2060
Mailing Address
Locked Mail Bag 961
North Sydney NSW
Australia, 2059
Administrative Phone
02 9391 9944
Administrative Email
pharmserv@doh.health.nsw.gov.au
Administrative Website
http://www.health.nsw.gov.au/pharmaceutical/Pages/default.aspx
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General Introduction
VC Compliance Delegate
Jo Scanlan, Chief Operating Officer
Compliance Coordinator
Roland Helfer, Safety Advisor - Hazardous Substances
Business Units Impacted
Overview
The Poisons and Therapeutic Goods Act 1966 and its associated Regulation sets out the regulation, control and prohibition of the supply and use of poisons, restricted substances, drugs of addiction, certain dangerous drugs and certain therapeutic goods in NSW. This legislation is designed to protect the health and welfare of members of the community. It imposes limitations on the use of many potent drugs by restricting the distribution, prescription and administration of these drugs to appropriately qualified and authorised persons.
The NSW Poisons List, which is proclaimed under Section 8 of the Act, is based on the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) as in force at any time (except for a small number of variations).The Poisons List comprises eight schedules which categorise substances according to their classification (e.g. S4, S8). The classification system is based upon managing availability of substances eg- substances that may be dangerous if carelessly managed or misused and substances that may produce an addiction will have differing classification, supply, handling and storage requirements to those whose availability may be required more quickly for therapeutic purposes.
The Act impacts on the University in a variety of ways including but not limited to the University's research activities, teaching activities, delivery of health services and in the storage of chemicals throughout the University. Compliance Obligations
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Authorisation (Licencing/Approval) Requirements NSW Poisons List Schedule 2, 3, 4
Description
Under Clause 19 of Appendix C of the 'Poisons and Therapeutic Goods Regulation 2008 (NSW)’ states that “A scientifically qualified person in charge of a laboratory or department, or a person acting under the direct personal supervision of such a person, is authorised to possess and use any Schedule 2, 3 or 4 substance that is required for the conduct of medical or scientific research or instruction or the conduct of quality control or analysis.
Impacts
Responsible Manager
Diana Chambers, Senior Manager, Health Safety and Wellbeing
Coordinating Officer
Roland Helfer, Safety Advisor - Hazardous Substances
Coordinating Unit
People and Culture
Oversight Committee/Group
None
Business Units Impacted
Obligation Framework
Associated Legislation
Associated Standard
None
Associated Code
None
Associated Information
None
Management Tools
Rule
None
Policy
None
Procedure
None
Guideline
None
Other Websites
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Authorisation (Licencing/Approval) Requirements NSW Poisons List Schedule 5
Description
Schedule 5 deals with poisonous substances of a dangerous nature commonly used for domestic purposes which should be readily available to the public but which require caution in their handling, use and storage (there are storage requirements).
Impacts
Responsible Manager
Diana Chambers, Senior Manager, Health Safety and Wellbeing
Coordinating Officer
Roland Helfer, Safety Advisor - Hazardous Substances
Coordinating Unit
People and Culture
Oversight Committee/Group
None
Business Units Impacted
Obligation Framework
Associated Legislation
Associated Standard
None
Associated Code
None
Associated Information
None
Management Tools
Rule
None
Policy
None
Procedure
None
Guideline
None
Other Websites
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Authorisation (Licencing/Approval) Requirements NSW Poisons List Schedule 6
Description
Schedule 6 contains substances which should be readily available to the public for agricultural, pastoral, horticultural, veterinary, photographic or industrial purposes or for the destruction of pests. There are storage requirements, but no licencing/approval requirements .
Impacts
Responsible Manager
Diana Chambers, Senior Manager, Health Safety and Wellbeing
Coordinating Officer
Roland Helfer, Safety Advisor - Hazardous Substances
Coordinating Unit
People and Culture
Oversight Committee/Group
None
Business Units Impacted
Obligation Framework
Associated Legislation
Associated Standard
None
Associated Code
None
Associated Information
None
Management Tools
Rule
None
Policy
None
Procedure
None
Guideline
None
Other Websites
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Authorisation (Licencing/Approval) Requirements NSW Poisons List Schedule 7
Description
Schedule 7 substances are substances of exceptional danger which require special precautions in their manufacture or use.
Under Clause 20(8) of the Regulation, clause 20(1) which requires a person to hold an authority to obtain or use a Schedule 7 substance, does not apply to:
a. use by a person of any Schedule 7 substance that is a pesticide (within the meaning of the Pesticides Act 1999)
b. a use by a person of any Schedule 7 substance that is stock medicine (within the meaning of the Stock Medicines Act 1989)
c. the use by a person in charge of an institution or facility for scientific research, instruction, analysis or study of any Schedule 7 substance for use in that institution or facility, or the supply to, or obtaining by, such a person of any such substance for use in that institution or facility.
Impacts
School of Science and Technology - chemistry store. Schedule 2, 3, 4, 5, 6 and 7 poisons held in a locked cabinet in a restricted area controlled by the Convenor of Chemistry - therefore an 'Authorisation’ is not required as they have a suitably qualified person in charge of the store.
Responsible Manager
Diana Chambers, Senior Manager, Health Safety and Wellbeing
Coordinating Officer
Roland Helfer, Safety Advisor - Hazardous Substances
Coordinating Unit
People and Culture
Oversight Committee/Group
None
Business Units Impacted
Obligation Framework
Associated Legislation
Associated Standard
None
Associated Code
None
Associated Information
None
Management Tools
Rule
None
Policy
None
Procedure
None
Guideline
None
Other Websites
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Authorisation (Licencing/Approval) Requirements NSW Poisons List Schedule 8, 9
Description
Under Schedule 8, 9 (and prohibited substances in Schedule 1 of the NSW Drug Misuse and Trafficking Act 1985) , an Authority for research, analysis or instruction is required to possess and use these substances. Only a suitably qualified person (a person in charge of a laboratory used for the purpose of research, analysis or instruction) may apply for authorisation to possess the above substances for the purpose of research, analysis, or instruction.
Schedule 8 contains substances which are addiction producing or potentially addiction producing. Schedule 9 substances are specified in Schedule 9 of the current Poisons Standard (Part 6-3 of the Commonwealth Act). Substances in Schedule 9 are substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with the approval of Commonwealth or State or Territory Health Authorities.
Impacts
Responsible Manager
Diana Chambers, Senior Manager, Health Safety and Wellbeing
Coordinating Officer
Roland Helfer, Safety Advisor - Hazardous Substances
Coordinating Unit
People and Culture
Oversight Committee/Group
None
Business Units Impacted
Obligation Framework
Associated Legislation
Associated Standard
None
Associated Code
None
Associated Information
None
Management Tools
Rule
None
Policy
None
Procedure
None
Guideline
None
Other Websites
Compliance Overview