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To Manufacture and/or to Sell or Supply, by Wholesale, substances in any combination of Schedule 2, Schedule 3, Schedule 4, Schedule 7, Schedule 8 and/or Schedule 9

Note: This section is for the Department of Health, Drugs and Poisons Regulation use ONLY

Details of the licence(s) (and permit(s), if relevant) to which this Poisons Control Plan relates:

Licence Holder:

Licence (and Permit, if relevant) Number(s):

This registered version of the Poisons Control Plan contains pages, each of which has been stamped by the Department of Health, Drugs and Poisons Regulation.

Poisons Control Plan A Poisons Control Plan (also abbreviated in this document to PCP) must be submitted for registration in relation to all licences to indicate how the licence holder proposes to comply with the Drugs, Poisons and Controlled Substances Act 1981 (The Act), the Drugs, Poisons and Controlled Substances Regulations 2006 (The Regulations), the conditions of the licence plus relevant codes and standards.

The Act and The Regulations are administered by the Department of Health, Drugs and Poisons Regulation

It is the responsibility of the licence holder to ensure compliance with The Act and The Regulations.

Please select the type(s) of licence to which this PCP relates:

This PCP is to relate to a licence to:

Manufacture and Sell or Supply by Wholesale

Sell or Supply by Wholesale

Sell or Supply by Wholesale, by Indent Only

Note: ‘Indent’ refers to a licence to sell or supply poisons or controlled substances where the licence holder does not take possession of those poisons or controlled substances. (See also Section 4)

Department of Health 1

Poisons Control Plan For a Licence

Important InformationReferences in this PCP made to a licence or licence holder should equally be read as referencing a licence application or licence applicant.

Notes:

The electronic version of this PCP is accessible, in Word® format, from the Department of Health, Drugs and Poisons Regulation website at www.health.vic.gov.au/dpu

The PCP is an integral part of licences to manufacture and sell or supply OR licences to sell or supply substances in any combination of Schedules 2, 3, 4, 7, 8 and/or 9 by wholesale. The Act specifically excludes Heroin from all licences.

A separate licence is required to manufacture and/or to sell or supply substances in Schedules 2, 3, 4 and/or 7 to a licence to manufacture and/or to sell or supply substances in Schedules 8 and/or 9. It is recommended that a licence holder who holds more than one wholesale licence that relate to the same premises (e.g. a licence to sell or supply substances in Schedule 8 and a licence to sell or supply substances in Schedule 4) submit a single PCP for registration to relate to both licences.

A version of this PCP is available for manual completion and submission, for use when a licence holder or licence applicant is unable to prepare the PCP by or on computer. Contact the Department of Health, Drugs and Poisons Regulation to obtain this version.

Instructions• Download the PCP and save it (as a Word® document) to your computer.• Questions are asked seeking true and accurate responses. The questions are in green font. • Sample responses have been included, in blue font, to provide examples of responses that may be

acceptable to the Department of Health, Drugs and Poisons Regulation, and to indicate the expected length and detail of the responses. One or more of the sample responses may be retained, with or without amendment, but only if they are true and accurate. Additional or alternative responses should be made, where required, to reflect accurately specific circumstances that apply to the licence holder.

• Some items or sections of the PCP may not be relevant to all licences. Where this is the case, delete the sample responses and respond with ‘Not Applicable’, so that the completed PCP will not be confusing and will serve as a meaningful reference document to relevant personnel. Do NOT leave any question with a response that is blank.

• Save the completed PCP on your computer, to facilitate any necessary and/or future amendments.• Transmit the completed PCP (as a Word® document) as an email attachment to the Department of

Health, Drugs and Poisons Regulation email address at [email protected] or alternatively, if it forms part of a licence application, forward it together with the remaining required documentation.

• Other relevant documentation may also be transmitted electronically, other than application forms or documents that require original signatures.

• If a PCP has been completed manually, it will need to be posted to the Department of Health, Drugs and Poisons Regulation, GPO Box 4541, Melbourne 3001 or delivered to 50 Lonsdale Street, Melbourne.

Notes:

• The PCP must be completed and submitted in the format provided. A document comprised only of a list of responses to the PCP questions will NOT be accepted because, after being assessed and registered by the Department of Health, Drugs and Poisons Regulation, the PCP will be returned to the licence holder for use as a reference document, showing how the licence holder proposes to comply with the legislation and related standards.

• The licence holder will be required to review the PCP periodically, including at the time of annual licence renewal.


• Avoid providing too much detail and do NOT include the names of personnel or other information, which may result in additional paperwork to amend the PCP in the future. When required to identify key personnel, use position titles or a description of the role, as these are less likely to change.

• Where a reference is made to external auditors, other licences, standards or forms of accreditation (e.g. NATA, ISO 9002, TGA Licence), ensure that you clearly and unambiguously identify the reference.

• Do not use abbreviations unless these are clearly defined in the document.

Licensed Activities In Victoria, a licence is required for each location involved in the manufacture and/or the sale or supply by wholesale of scheduled poisons (other than Schedule 5 and Schedule 6 poisons). The schedules referred to in this document are as defined in the current edition (including any amendments) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), which is a Commonwealth document.

The licence document, which specifies the poisons that may be manufactured and/or sold or supplied, also contains a number of conditions with which the licence holder must comply.

Important TerminologyThe following terms must be understood in relation to licensed activities:• For the purposes of the PCP, the term licensed poisons means the scheduled poisons or controlled

substances to which the licence specifically relates.• Wholesale means to sell or supply for the purposes of resale or resupply or for the purposes of use in

connection with a trade, business, profession or industry. • Sale or supply by indent means that a product is sold or supplied (or authorised or directed to be sold or

supplied) by the licence holder but the sale or supply is from a location other than the premises to which the licence relates and/or by another legal entity. A licence holder must not possess licensed poisons at or sell or supply them from premises that are licensed only for sale or supply by indent.

• Manufacture includes the process of refining, manipulating and mixing any poison or controlled substance, including a poison or controlled substance in the raw state.

• Repacking and relabelling of poisons or controlled substances are considered manufacturing activities.

Notes: • Poisons schedules in the SUSMP should not be confused with similar numbering of classes of poisons in

Dangerous Goods legislation.• The holding of a licence under the Commonwealth Therapeutic Goods Act 1989 or any other Act does not

preclude the need in Victoria to hold a licence to manufacture and/or to sell or supply substances in Schedules 2, 3, 4, 7, 8 and/or 9.

Responsible Person(s)The licence document will identify one or more Responsible Persons, who have been nominated by the licence holder (and approved by the Department of Health, Drugs and Poisons Regulation) to fulfil the following tasks: • Ensure maintenance of the accuracy and currency of the registered PCP,• Provide annual confirmation (as required by the Department of Health, Drugs and Poisons Regulation)

that the licence holder is operating in a manner consistent with the registered PCP, • Ensure that there is a periodic review (at least annually, e.g. at the time of licence renewal) of the licence

and the registered PCP to confirm that the licence holder continues to comply with the conditions of the licence, the legislation, relevant codes and required standards and to retain documentary records of such reviews,

• Notify the Department of Health, Drugs and Poisons Regulation of any amendments, which may be required to the licence or to the conditions of the licence (e.g. change of company name, change of


address, change of Responsible Person), and • Submit for assessment to the Department of Health, Drugs and Poisons Regulation any proposed

amendments to the registered PCP.

Sections of the Poisons Control Plan1. Documentation

2. Buildings and Grounds

3. Personnel

4. Sale or Supply by Indent

5. Storage – Security and Access

6. Stock Handling and Stock Control

7. Storage – Stability

8. Lawful Sale or Supply

9. Transport

10.Records of Transactions

11.Complaints, Returned Goods and Product Recalls

12.Disposal/Destruction of Expired and/or Unwanted Poisons

13.Manufacturing Activities

14.Laboratory Chemicals


1. DocumentationReferencesCurrent versions of the following source material may be accessed on the indicated websites:

• The Drugs, Poisons and Controlled Substances Act 1981 (The Act) and the Drugs, Poisons and Controlled Substances Regulations 2006 (Regulations) may be accessed at: http://www.legislation.vic.gov.au/

• The Department of Health, Drugs and Poisons Regulation website contains application forms and information relating to licence and permit requirements in Victoria and may be accessed at http://www.health.vic.gov.au/dpu

• The current edition and amendments of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), which is the source document for poisons schedules plus labelling and packaging requirements, may be accessed at http://www.tga.gov.au/industry/scheduling-poisons-standard.htm

• The SUSMP Labelling Guidelines, which is strongly recommended as a reference for manufacturers and for licence holders with ‘own brand’ products, may be accessed at http://www.tga.gov.au/industry/labelling.htm#labelling

• Information relating to Good Manufacturing Practice (GMP) for therapeutic goods may be accessed at http://www.tga.gov.au/industry/manuf-gmp-tg.htm

• The Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8 (The Code) is enforceable under State and Territory legislation and is essential reference material for corresponding licence holders. Compliance with The Code is mandatory in Victoria, for those licence holders to which it relates. The Code may be accessed at http://www.tga.gov.au/pdf/manuf-medicines-cgwp-schedule2-3-4-8.pdf

Notes:

• Key aspects of the preceding reference documents are addressed in this PCP but reference must be made to the source material for full details of requirements.

• All references, in The Code, to the ‘Standard for the Uniform Scheduling of Drugs and Poisons’ (SUSDP) are now to be read as references to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Location of the Licence and Poisons Control Plan documents The registered PCP, which will be stamped and returned by the Department of Health, Drugs and Poisons Regulation, must be maintained by a Responsible Person (who will be named in a condition on the licence). The current licence and registered PCP documents must be readily available and able to be located for reference and review.

1.01 Indicate the intended or actual locations of the current licence and registered version of the PCP:

The licence and PCP are to be filed in the office of the Responsible Person / Manager / CEO

The licence is to be displayed in the office area and the PCP is to be filed in the office of the Warehouse Manager / Responsible Person / CEO

The Responsible Person must ensure that there is a periodic review (at least annually, such as at the time of licence renewal) of the licence and the registered PCP to confirm that the licence holder continues to comply with the conditions of the licence, the legislation, relevant codes and required standards. Proposed or required amendments to the PCP must be submitted to the Department of Health, Drugs and Poisons Regulation for assessment.

Confirmation that each review has occurred is to be recorded in a document and is to be signed and dated by the person who conducted the review. It is to be retained for the life of the PCP (and not less than three years) and is to be provided to the Department of Health, Drugs and Poisons Regulation, upon request.


http://www.tga.gov.au/pdf/manuf-medicines-cgwp-schedule2-3-4-8.pdf

http://www.tga.gov.au/pdf/manuf-medicines-cgwp-schedule2-3-4-8.pdf

http://www.tga.gov.au/industry/labelling.htm#labelling

http://www.tga.gov.au/industry/scheduling-poisons-standard.htm

http://www.health.vic.gov.au/dpu

http://www.legislation.vic.gov.au/

The Code Compliance with The Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8 is mandatory in Victoria for those licence holders to which it relates, i.e. to all licences relating to the manufacture and/or sale or supply of Schedule 2, 3, 4 and/or 8 poisons that are, or will become, medicines for therapeutic use, either human or veterinary, and includes raw materials.

The Code addresses the following ten sections and a documented plan is required for each relevant section, detailing policies and procedures, which address the specified principles and practical elements of The Code:

• Buildings and Grounds • Storage Facilities • Personnel • Stock Handling and Stock Control • Transport • Management of Complaints, Return of Unused and/or Damaged Goods and Product Recalls • Management of Records, Documentation and Standard Operating Procedures • Cold Chain Medicines • Security Arrangements and Procedures • Additional Measures for Management of Controlled Drugs (CD) and Other Goods with High Illicit Value

(GHIV) Note: The Code defines Goods with High Illicit Value (GHIV) as medicines specified in Appendix 1 (of The Code). Currently, those specified medicines are limited to products that contain pseudoephedrine (including all salts, esters or derivatives thereof) alone or in combination with any other therapeutically active substance. Each documented plan, which is to be retained as a controlled document, is to be reviewed on a continuing basis with the date of review and the signature of the reviewer to be clearly recorded on each occasion. Each documented plan and associated record of review are to be available for scrutiny by an Authorised Officer of the Department of Health, Drugs and Poisons Regulation, upon request.

The person(s) responsible for compliance with each documented plan must review the practical elements for on-going compliance by the licence holder.

Standard Operating ProceduresIt is recommended that all licence holders prepare documented Standard Operating Procedures (SOPs) and maintain a register of SOP. This is a requirement, under The Code, for all licence holders involved in the manufacture and/or the sale or supply of therapeutic medicines.

SOP, relating to key aspects of the licensed activities and referred to in the PCP, are to be provided to an Authorised Officer of the Department of Health, Drugs and Poisons Regulation, upon request,

SOP should be:

• clear, concise, comprehensible and readily available to those personnel needing to use them, and • numbered, dated, have a title and identify the position (or role) of the person responsible for the SOP, and • inclusive of detailed instruction on the subject and a date for the next review of the SOP.Note: SOP will NOT be subject to approval or registration by the Department of Health, Drugs and Poisons Regulation as these documents are intended to be for internal use by relevant personnel only.

1.02 Indicate the position or role of the person(s) to be responsible for ensuring that all relevant sections of The Code are implemented and that there is an audit strategy to ensure that all relevant principles and practices of The Code continue to be observed, and that a register of SOP is maintained:

The Responsible Person named on the licence / Security Manager / Quality Control Manager / Regulatory Affairs Officer will be responsible for all of these matters


The Responsible Person named on the licence will be responsible for maintenance of the register of SOP and the Regulatory Affairs Manager / Managing Director will be responsible for all other matters relating to The Code


2. Buildings and GroundsLicensed premises must be suitable, sanitary and adequately equipped, which will generally include a level of structural integrity and security measures that are intended to prevent, detect or deter unauthorised access to the buildings in which licensed poisons and related records are to be stored.

2.01 Describe the premises and the general security measures intended to prevent, detect or deter unauthorised access to the buildings in which licensed poisons and records are to be stored:

Single-storey building with limited (or no) external grounds / A small segregated area within larger premises / offices within an office building / multiple buildings or interconnected buildings within substantial groundsDeadlocks on all external doors / Monitored alarm system with infra-red and movement detectors / Audible alarm systemGrounds surrounded by high perimeter fence with barbed wire on top and lockable gates / on-site security personnel to restrict access / After hours patrols by contracted security company

Security Risk Assessment and Security Risk Management Plan A Security Risk Assessment by a suitably qualified agency (preferably independent) should be considered in relation to all licences relating to drugs of dependence and GHIV, and may be required by the Department of Health, Drugs and Poisons Regulation. A Security Risk Management Plan (consistent with AS/NZS ISO 31000:2009) should be established by the licence holder and regularly reviewed to address the level of risk rating. The report from a Security Risk Assessment and the Security Risk Management Plan are to be provided to the Department of Health, Drugs and Poisons Regulation, upon request.

Note: In Victoria, the term ‘drugs of dependence’ refers to those substances in Schedules 2, 3, 4, 8 and 9 of the SUSMP that are also listed in Schedule 11 of The Act. Reference should be made to The Act and the SUSMP for any further clarification.

2.02 Has the licence holder conducted a Security Risk Assessment and established a Security Risk Management Plan?

Yes No, because only minimal quantities of drugs of dependence and/or GHIV are intended to be held at any given time / No, because ……Not Applicable, because the licence does not relate to any drugs of dependence or GHIV If the response to 2.02 is ‘Yes’, then the report from the Security Risk Assessment and the Security Risk Management Plan are to be retained and provided to the Department of Health, Drugs and Poisons Regulation, upon request.

If the response to 2.02 is ‘No’, then written justification for such response is to be provided to the Department of Health, Drugs and Poisons Regulation, upon request.

If the response to 2.02 is ‘Not Applicable’, then 2.03 may be similarly responded to as ‘Not Applicable’.


2.03 Indicate how or where the Security Risk Assessment report and the Security Risk Management Plan are to be retained or located and the position or role of the person to be responsible for reviewing the documents and implementing required changes, and for organizing the conducting of on-going Security Risk Assessments and for implementation of on-going established Security Risk Management Plans:

The documents are to be filed in the office of the Security Manager, who has responsibility for these mattersThe documents, which contain the date of any review plus the name and signature of the reviewer, are to be filed in the office of the Responsible Person, and will be reviewed when there are any significant changes to the licence holder’s operating or security proceduresThe documents will be filed in the office of the Responsible Person, and will be reviewed on an annual basis, to coincide with the licence renewal Not Applicable 2.04 Does the licence holder have a documented SOP to ensure that personnel are trained in good housekeeping practices and that the security and integrity of licensed poisons during receipt, storage and dispatch are maintained?

YesNo, because…...Not Applicable, because…...

Loss or Theft of Licensed PoisonsThe loss or theft of licensed poisons must be promptly reported to Victoria Police and, in writing, to the Department of Health, Drugs and Poisons Regulation.

2.05 Does the licence holder have a documented SOP relating to identifying, recording and reporting the loss or theft of licensed poisons?

YesNot Applicable, because…...

•

3. PersonnelTrainingRelevant personnel should be trained in all procedures that relate to their roles and responsibilities under the legislation and relevant codes that relate to the quality, safety and security of the licensed poisons.

Qualifications and experiencePersonnel who may have unsupervised access to licensed poisons should be limited in number. In relation to Schedule 4, Schedule 8 and Schedule 9 poisons, personnel may be required to meet the definitions of an Experienced or Qualified Person and National Police Record Checks may be required, and must be provided to the Department of Health, Drugs and Poisons Regulation, upon request. Details of these requirements are contained in the Security and Access sections for the corresponding poisons schedules. 3.01 Does the licence holder have a documented SOP relating to the roles, responsibilities, conduct, training and periodic re-training of managers and key personnel?

YesNo, because…..Not Applicable, because…..


4. Sale or Supply by IndentSale or supply by indent means that a product is sold or supplied by the licence holder but is stored at and supplied from a location other than the premises to which this licence applies. A licence holder must not possess or supply licensed poisons at or from premises that are licensed only for sale or supply by indent.

4.01 Are ANY licensed poisons to be sold or supplied by indent?

Yes No If the response to 4.01 is ‘No’, then 4.02 and 4.03 may be responded to as ‘Not Applicable’.


4.02 Are licensed poisons to be sold or supplied ONLY by indent?

Yes NoNot Applicable If the response to 4.02 is ‘Yes’, then the sections of the PCP that relate to storage requirements may be answered as ‘Not Applicable - indent sale or supply only’.

Notes:

If the licence holder is conducting any transactions of sale or supply of the licensed poisons by indent, and the storage facility that is to supply the licensed poisons on behalf of the licence holder (or applicant) is located within Victoria, then the premises storing those poisons and from which supply in intended to be made, must also separately hold a Victorian licence covering those poisons (by the operators of those premises).

The licence holder must also ensure that any storage facility for the licensed poisons, if located outside Victoria, is appropriately licensed or otherwise approved or authorised in the jurisdiction in which those premises are located.

An SOP, or contract or written agreement, should be prepared to clearly define the responsibilities of each party in order to ensure that:

• Premises for storage and distribution of licensed poisons are either currently licensed, if in Victoria, or meet comparable standards and/or approval requirements in any other jurisdiction. Documentary confirmation of such licensing or jurisdictional approval should be obtained by the licence holder at least on an annual basis,

• Administrative procedures result in lawful sale or supply,• Details of transactions are accurately recorded in accordance with the legislation,• Procedures are in place to promptly report and deal with incidents in which stock is lost, stolen or cannot

be delivered to the intended customer, and• The loss or theft of licensed poisons is promptly reported to police and to the Department of Health, Drugs

and Poisons Regulation.4.03 Does the licence holder have a documented SOP, contract or written agreement that addresses all of the preceding issues?

YesNot Applicable


5. Storage - Security and Access Licensed poisons must be stored in a secure, stable and safe manner, including in accordance with the regulatory requirements for the corresponding poisons schedule and recommended storage temperatures (for therapeutic medicines). Regulatory requirements under Dangerous Goods or other legislation might also apply.

Different poisons schedules are associated with different levels of control, relative to the potential for misuse, abuse and/or diversion of the poisons.

Relevant personnel should be trained in all procedures that relate to their roles and responsibilities under the legislation and relevant codes.

Schedule 7 Poisons 5.01 Does the licence relate to ANY Schedule 7 poisons?

Yes No

If the response to 5.01 is ‘No’, then 5.02 to 5.07 may be responded to as ‘Not Applicable’.

Schedule 7 poisons (also referred to as Dangerous Poisons) fall into two categories - Listed Regulated Poisons and Schedule 7 poisons (other than Listed Regulated Poisons).

Listed Regulated Poisons are those Schedule 7 poisons that are more strictly controlled and are the Schedule 7 poisons that are listed in Chapter 1, Part 2 of the Victorian Poisons Code, which may be accessed at: http://www.health.vic.gov.au/dpu/poicode.htm

5.02 Indicate the Schedule 7 poisons (other than Listed Regulated Poisons) to which the licence relates (list them if only one or two poisons are applicable):

Agricultural chemicals / cleaning chemicals for industrial use / industrial raw materials Not Applicable, because this licence relates ONLY to Listed Regulated Poisons in Schedule 7 Not Applicable Note: Schedule 7 poisons (other than Listed Regulated Poisons) must be stored in a manner that does not allow unsupervised access by members of the public.

5.03 Indicate how unauthorised or unsupervised access to Schedule 7 poisons (other than Listed Regulated Poisons) is to be prevented:

The licensed Schedule 7 poisons are to be stored in a locked cabinet with the key supervised by the Responsible Person / to be stored in a storeroom where public access is not permitted / to be stored in high pallet racking in a warehouse where there is no unsupervised public access / to be stored behind the counter where public access is not permittedNot Applicable, because this licence relates ONLY to Listed Regulated Poisons in Schedule 7 Not ApplicableNot Applicable - indent sale or supply only

5.04 Does the licence relate to ANY Listed Regulated Poisons in Schedule 7?

YesNo If the response to 5.04 is ‘No’, then 5.05 to 5.07 may be responded to as ‘Not Applicable’.

5.05 Indicate the Listed Regulated Poisons in Schedule 7 to which the licence relates and the purpose


http://www.health.vic.gov.au/dpu/poicode.htm

for which supply is principally intended (list them if only one or two poisons are applicable):

Metallic cyanides for supply to permitted electroplaters / Arsenic in the form of copper chrome arsenate for supply to permitted facilities to treat timber / Cyanide solutions for supply to permitted facilities for laboratory use / Arsenic trioxide for supply to permitted pest controllers for use as a termiticideNot Applicable, because this licence relates ONLY to Schedule 7 poisons (other than Listed Regulated Poisons)Not Applicable

Note: Listed Regulated Poisons in Schedule 7 must be stored securely in a lockable facility in order to prevent unauthorised access and illegal diversion.

5.06 Indicate how Listed Regulated Poisons in Schedule 7 are to be stored:

In a lockable storeroom/cabinet / In a lockable cage separated from other goodsNot Applicable, because this licence relates ONLY to Schedule 7 poisons (other than Listed Regulated Poisons)Not Applicable - indent sale or supply onlyNot Applicable

5.07 Indicate how unauthorised or unsupervised access to Listed Regulated Poisons in Schedule 7 is to be prevented:

The key to the lockable storeroom/cabinet/cage is to be supervised by the warehouse manager / regulatory affairs officer / Responsible PersonNot Applicable, because this licence applies ONLY to Schedule 7 poisons (other than Listed Regulated Poisons)Not Applicable - indent sale or supply onlyNot Applicable

Schedule 4 Poisons (excluding Drugs of Dependence and/or Goods with High Illicit Value {GHIV i.e. products containing pseudoephedrine} in Schedule 4)5.08 Does the licence relate to ANY Schedule 4 poisons?


5.09 Indicate the types of Schedule 4 poisons to which the licence relates:

Human therapeutic goods / veterinary therapeutic goods / industrial or laboratory chemicals/ raw materialsNot Applicable 5.10 Indicate the range and expected quantity holdings of Schedule 4 poisons to which the licence relates and the purpose for which supply is principally intended (list them if only one or two poisons are applicable):

Range - minimal range of products (up to 5) / limited range of products (up to 20) / moderate range of products (up to 50) / large range of products (more than 50)Quantity holdings - minimal quantity holding (up to 5 of each product) / limited quantity holding (up to 20 of each product) / moderate quantity holding (up to 50 of each product) / large quantity holding (more than 50 of each product) Purpose - for supply to pharmacies / veterinary practitioners / hospitals / permit holders / analytical


laboratories for quality assessment / starter packs to medical practitionersNot Applicable - indent sale or supply onlyNot Applicable

The Regulations require a lockable storage facility, which must remain locked and secured to prevent access by unauthorised persons at all times, except when it is necessary to open it to carry out essential operations.

5.11 Indicate how Schedule 4 poisons are to be stored:

In a lockable storeroom/cabinet, separate from other goods / within a restricted access section of the warehouse / in a lockable cage / in a lockable storage cabinet within a commercial lockable self-storage facility (Unit number(s)….)Not Applicable - indent sale or supply onlyNot Applicable

5.12 Indicate how unauthorised or unsupervised access to Schedule 4 poisons is to be prevented:

The key to the lockable storeroom/cabinet/cage is to be supervised by the warehouse manager/ regulatory affairs officer / Responsible Person Access to the storage area is to be restricted to personnel who have been issued with a personalised electronic access cardPersonnel of a self-storage facility will accept a consignment on behalf of the licence holder, under a contracted agreement, and store the consignment in a secure area or relocate it into the licence holder’s lockable self-storage unit until an agent of the licence holder assumes responsibility for the consignment to unpack, check and store the poisons into a secure lockable inner facilityNot Applicable - indent sale or supply onlyNot Applicable

Schedule 2 and/or Schedule 3 Poisons (excluding Drugs of Dependence and/or Goods with High Illicit Value {GHIV i.e. products containing pseudoephedrine} in Schedule 2 and/or Schedule 3)5.13 Does the licence relate to ANY Schedule 2 or Schedule 3 poisons?


5.14 Indicate the types of Schedule 2 and/or Schedule 3 poisons to which the licence relates:

Human therapeutic goods / veterinary therapeutic goods / industrial or laboratory chemicals/ raw materialsNot Applicable

5.15 Indicate the range and expected quantity holdings of Schedule 2 and/or Schedule 3 poisons to which the licence relates and the purpose for which supply is principally intended (list them if only one or two poisons are applicable):

Range - minimal range of products (up to 5) / limited range of products (up to 20) / moderate range of products (up to 50) / large range of products (more than 50)Quantity holdings - minimal quantity holding (up to 5 of each product) / limited quantity holding (up to 20 of each product) / moderate quantity holding (up to 50 of each product) / large quantity holding (more than 50 of each product) Purpose - for supply to pharmacies / veterinary practitioners / hospitals / permit holders / analytical laboratories for quality assessment / starter packs to medical practitioners


Not Applicable - indent sale or supply onlyNot Applicable

As there are similar restrictions on their sale and supply, Schedule 2 and Schedule 3 poisons may be stored in the same manner as Schedule 4 poisons.

5.16 Indicate how Schedule 2 and/or Schedule 3 poisons are to be stored:

Stored with other therapeutic goods, including Schedule 4 poisons / in the general warehouse in a designated area / in the warehouse, with Schedule 4 poisons that are not drugs of dependence / in the same manner as Schedule 4 poisons / in a separate cupboardNot Applicable - indent sale or supply onlyNot Applicable

Drugs of Dependence in Schedules 2, 3 and/or 4 and/or Goods with High Illicit Value {GHIV i.e. products containing pseudoephedrine} in Schedules 2, 3 and/or Schedule 4)Notes:

In Victoria, the term ‘drugs of dependence’ refers to those substances in Schedules 2, 3 and 4 that are also listed in Schedule 11 of The Act (e.g. pseudoephedrine, benzodiazepines, anabolic steroids) in addition to many Schedule 8 and Schedule 9 poisons. The Act may be accessed at http://www.legislation.vic.gov.au/

The Code defines Goods with High Illicit Value (GHIV) as medicines specified in Appendix 1 (of The Code). Currently, those specified medicines are limited to products that contain pseudoephedrine (including all salts, esters or derivatives thereof) alone or in combination with any other therapeutically active substance,

5.17 Does the licence relate to ANY drugs of dependence or GHIV in Schedules 2, 3 and/or 4?

Yes No If the response to 5.17 is ‘No’, then 5.18 to 5.21 may be responded to as ‘Not Applicable’.

Because of the potential for drugs of dependence and/or Goods with High Illicit Value (GHIV) in Schedules 2, 3 and/or 4 to be diverted for illicit purposes, they should be stored more securely and subject to stricter reconciliation and supervision procedures than other Schedule 2, 3 and/or 4 poisons.• A monitored alarm system is required for premises at which drugs of dependence and GHIV are to be

stored. • A Security Risk Assessment by a suitably qualified agency (preferably independent) should be considered

in relation to all licences relating to drugs of dependence and GHIV, and may be required by the Department of Health, Drugs and Poisons Regulation. A Security Risk Management Plan (consistent with AS/NZS ISO 31000:2009) should be established by the licence holder and regularly reviewed to address the level of risk rating. The Security Risk Assessment Report and Security Risk Management Plan are to be provided to the Department of Health, Drugs and Poisons Regulation, upon request.

A licence holder or applicant wishing to seek an exemption to these requirements will need to provide precise details of the range and expected quantity holdings of drugs of dependence and/or GHIV and justification for the request for exemption.To deter and/or (promptly) detect the misappropriation of drugs of dependence and GHIV, a high level of security (physical and/or procedural) will be necessary. The nature and extent of security required may depend on other security factors, especially the number of employees or contractors who are to have access to the storage facilities in which drugs of dependence and/or GHIV are to be stored.


http://www.legislation.vic.gov.au/

5.18 Indicate the types of drugs of dependence or GHIV in Schedules 2, 3 and/or 4 poisons to which the licence relates:Human therapeutic goods / veterinary therapeutic goods / industrial or laboratory chemicals/ raw materialsNot Applicable

5.19 Indicate the range and expected quantity holdings of drugs of dependence and/or GHIV in Schedules 2, 3 and/or 4 to which the licence relates and the purpose for which supply is principally intended (list them if only one or two poisons are applicable) and indicate the assessed levels of risk (high, moderate or low). *Include a separate and specific response relating to products containing the GHIV substance, pseudoephedrine (if relevant):

Range - minimal range of products (up to 5) / limited range of products (up to 20) / moderate range of products (up to 50) / large range of products (more than 50)Quantity holdings - minimal quantity holding (up to 5 of each product) / limited quantity holding (up to 20 of each product) / moderate quantity holding (up to 50 of each product) / large quantity holding (more than 50 of each product) Purpose - for supply to pharmacies / veterinary practitioners / hospitals / permit holders / analytical laboratories for quality assessment / starter packs to medical practitionersRisk - wide range of human therapeutic goods (moderate to high risk) / limited range and quantity of anabolic steroids (low to moderate risk) / minimal quantities of a small range of benzodiazepines (low risk)*Pseudoephedrine as a raw material (high risk) / pseudoephedrine-containing cough and cold products (moderate to high risk)Not Applicable - indent sale or supply onlyNot Applicable

The Regulations allow for drugs of dependence (including GHIV) that are in schedules other than Schedule 8 and/or Schedule 9 to be stored together with Schedule 8 and/or Schedule 9 poisons in a compliant safe or vault, if required.

5.20 Indicate how drugs of dependence and/or GHIV in Schedules 2, 3 and/or 4 are to be stored and what security measures (additional to those for similarly scheduled drugs), including physical stock checks and inventory control, are to apply. *Include a separate and specific response relating to products containing the GHIV substance, pseudoephedrine (if relevant):

Random physical stock checks are to be carried out each week / only very small quantities of two products are to be held with keys to the storage area held by only one person / anabolic steroid preparations are stored within the limited access, lockable area/cage that surrounds the vault entrance *Goods with High Illicit Value (GHIV) products containing pseudoephedrine (specify products or raw material) are stored within the vault together with Schedule 8 poisons / Pseudoephedrine-containing cough and cold products are stored within the limited access, lockable area/cage that surrounds the vault entranceNot Applicable - indent sale or supply onlyNot Applicable


PersonnelPersonnel who may have unsupervised access to drugs of dependence and/or GHIV in Schedules 2, 3 and/or 4 should be limited in number and should meet the criteria of an Experienced or a Qualified Person:

• An Experienced Person is an adult employee who has at least five years of relevant experience in the manufacture and/or wholesaling of scheduled poisons.

• A Qualified Person is a person who holds a tertiary qualification with a substantial component of the physical sciences (including chemistry).

• A National Police Record Check is also required to be undertaken for such personnel and details must be available for scrutiny, and provided to the Department of Health, Drugs and Poisons Regulation, upon request.

A licence holder or applicant wishing to seek an exemption to these requirements will need to provide precise details of the range and expected quantity holdings of drugs of dependence and/or GHIV and justification for the request for exemption.

Relevant personnel should be trained in all procedures that relate to their roles and responsibilities under the legislation and relevant codes.

A documented SOP is required for all licences relating to drugs of dependence and/or GHIV in Schedules 2, 3 or 4 and is to include:

• Names, addresses and evidence of the National Police Record Check relating to personnel who may have unsupervised access to drugs of dependence and/or GHIV,

• Criteria to be used to determine which personnel may have unsupervised access to the facilities in which drugs of dependence and/or GHIV are to be stored,

• Details of the roles, responsibilities, conduct, training and periodic re-training of personnel who may have unsupervised access to drugs of dependence and/or GHIV,

• Details of the roles, responsibilities, conduct, training and periodic re-training of other personnel who might have supervised access to the storage facility for drugs of dependence and/or GHIV plus details of the nature of the supervision to be provided,

• Details of arrangements, tailored to the higher risks of managing drugs of dependence and/or GHIV, relating to inventory control processes and reporting arrangements in the event that discrepancies are detected,

• Details of arrangements, tailored to the higher risks of managing them, relating to the disposal and recording of expired or unwanted drugs of dependence and/or GHIV (including the use of sealed, tamper-evident containers to prevent diversion),

• Details of arrangements, tailored to the higher risks of managing them, to ensure that large quantities of drugs of dependence and/or GHIV awaiting disposal do not accumulate over time, and

• Details of training, tailored to the higher risks of managing drugs of dependence and/or GHIV, to be provided to address the identification and reporting of suspicious behaviour (by staff or others) and to facilitate rapid detection of interference or diversion of stock.

5.21 Indicate the position or role of the person who is to be responsible for ensuring that the SOP relating to drugs of dependence and/or GHIV in Schedules 2, 3 and/or 4 is maintained in the required manner and that compliance is achieved:

Security Manager / Operations Manager / Responsible PersonNot Applicable - indent sale or supply onlyNot Applicable


Schedule 8 (Controlled Drug, CD) and/or Schedule 9 (Prohibited Substance) Poisons5.22 Does the licence relate to ANY Schedule 8 and/or Schedule 9 poisons?


Because of the potential for Schedule 8 and/or Schedule 9 poisons to be diverted for illicit purposes, they must be stored more securely and be subjected to the strictest reconciliation and supervision procedures.

• A monitored alarm system is required for premises at which Schedule 8 and/or Schedule 9 poisons are to be stored.

• A Security Risk Assessment by a suitably qualified agency (preferably independent) should be considered in relation to all licences relating to Schedule 8 and/or Schedule 9 poisons, and may be required by the Department of Health, Drugs and Poisons Regulation. Such a report must indicate that the premises and security arrangements are suitable to minimise opportunities for diversion, theft and unlawful supply of Schedule 8 and/or Schedule 9 poisons. A Security Risk Management Plan (consistent with AS/NZS ISO 31000:2009) should be established by the licence holder and regularly reviewed to address the level of risk rating. Such Security Risk Assessment Report and Security Risk Management Plan are to be provided to the Department of Health, Drugs and Poisons Regulation, upon request.

A licence holder or applicant wishing to seek an exemption to these requirements will need to provide precise details of the range and expected quantity holdings of Schedule 8 and/or Schedule 9 poisons and justification for the request for exemption.

5.23 Indicate the types of Schedule 8 and/or Schedule 9 poisons to which the licence relates:

Human therapeutic goods in Schedule 8 / veterinary therapeutic goods in Schedule 8 / raw materials / laboratory standards in Schedule 8 / in Schedule 9Not Applicable

5.24 Indicate the range and expected quantity holdings of Schedule 8 and/or Schedule 9 poisons to which the licence relates and the purpose for which supply is principally intended (list them if only one or two poisons are applicable):

Range - minimal range of products (up to 5) / limited range of products (up to 20) / moderate range of products (up to 50) / large range of products (more than 50)Quantity holdings - minimal quantity holding (up to 5 of each product) / limited quantity holding (up to 20 of each product) / moderate quantity holding (up to 50 of each product) / large quantity holding (more than 50 of each product) Purpose - for supply of Schedule 8 poisons to pharmacies / veterinary practitioners / hospitals / permit holders / analytical laboratories for quality assessment / starter packs to medical practitionersPurpose - for supply of Schedule 9 poisons to permit holders / analytical laboratories for quality assessmentNot Applicable - indent sale or supply onlyNot Applicable

The Regulations require a lockable facility for the storage of Schedule 8 and/or Schedule 9 poisons that must provide not less security than a storage facility (e.g. Drug Cabinet) that is—

• constructed of mild steel plate of 10 millimetres thickness; and• constructed with continuous welding of all edges; and• fitted with a door constructed of mild steel plate of 10 millimetres thickness, swung on hinges welded to

the door and body of the cabinet, the door being flush fitting with a clearance around the door of not more


than 15 millimetres; and• fitted with a fixed locking bar, welded to the inside face of the door near the hinge edge, which engages in

a rebate when the door is closed; and• fitted with a 6 lever lock securely affixed to the rear face of the door; and• securely attached to a wall or floor in such a manner that it will resist attack by hand tools for 30 minutes

or power tools for 5 minutes.

Expert advice received by the department indicates that the requirement for the cabinet to be ‘securely attached’ is satisfied by -

HARD CORE WALL: The cabinet to be secured by use of four (4) Loxin or Dyna Bolts (each 10mm by 50mm minimum).

STUD and PLASTER WALL or HOLLOW BLOCK WALL: The cabinet to be secured by use of four (4) 10mm coach bolts through the wall and through 3mm mild steel backing plate. This backing must, at minimum, be the same size as the back of the drug cabinet.

5.25 Indicate how Schedule 8 and/or Schedule 9 poisons are to be stored:

Free standing safe (weighing approximately 350 kilograms) with twin combination locks / Reinforced concrete vault with combination and key operated locks / small safe fixed to the floor / steel drug cabinet, which meets the minimum specified standards for structure and attachment

Not Applicable - indent sale or supply onlyNot Applicable

5.26 Indicate the additional security provisions (if any) that are to apply to the storage of Schedule 8 and/or Schedule 9 poisons:

Seismic detectors connected to a monitored alarm system / monitored alarm that may only be deactivated by designated persons entering a personal identification number / alarm system that has a concealed duress alarm facility / vault door is monitored by a closed circuit TV camera with attached recording device / vault is fitted with an internal emergency duress alarm / storage facility is located within a locked area with further restricted access measuresNot Applicable - indent sale or supply onlyNot Applicable

Personnel who may have unsupervised access to Schedule 8 and/or Schedule 9 poisons should be limited in number and must meet the criteria of an Experienced or Qualified Person:

• An Experienced Person is an adult employee who has at least five years of relevant experience in the manufacture and/or wholesaling of scheduled poisons,

• A Qualified Person is a person who holds a tertiary qualification with a substantial component of the physical sciences (including chemistry),

• A National Police Record Check is also required to be undertaken for such personnel and details must be available for scrutiny, and provided to the Department of Health, Drugs and Poisons Regulation, upon request.

• A licence holder or applicant wishing to seek an exemption to these requirements will need to provide precise details of the range and expected quantity holdings of Schedule 8 and/or Schedule 9 poisons and justification for the request for exemption.

The storage facility must remain locked and secured to prevent access by any unauthorised person at all times, except when it is necessary to open it to carry out essential operations.

5.27 Indicate how unauthorised or unsupervised access to Schedule 8 and/or Schedule 9 poisons is to be prevented:

The alarm may only be deactivated by entering a Personal Identification Code, which is to be issued only to designated Experienced or Qualified Persons / Key(s) are to be held only by Qualified Persons / Two


combinations, required to open the vault, are to be known to two distinct groups of designated persons so that the vault may only be opened in the presence of a designated person from both groups / All codes and combinations are to be changed annually and immediately following the departure of a designated Experienced or Qualified Person.Not Applicable - indent sale or supply onlyNot Applicable

It is also necessary to restrict access to the storage facility for Schedule 8 and/or Schedule 9 poisons when it is opened to carry out essential operations.

5.28 Indicate how unauthorised or unsupervised access to Schedule 8 and/or Schedule 9 poisons is to be prevented when the storage facility is open:

The entrance to the vault is to be secured with a locked steel grill when there are personnel within the vault and when the vault door is open / Access to the area, in which the entrance to the vault is located, is to be restricted to personnel issued with the electronic access card and Personal Identification Number (PIN).Not Applicable - indent sale or supply onlyNot Applicable

PersonnelRelevant personnel should be trained in all procedures that relate to their roles and responsibilities under the legislation and relevant codes.

A documented SOP is required for all licences relating to Schedule 8 and/or Schedule 9 poisons and is to include:

• Names, addresses and evidence of the National Police Record Check relating to personnel who may have unsupervised access to Schedule 8 and/or Schedule 9 poisons,

• Criteria to be used to determine which personnel may have unsupervised access to the facilities in which Schedule 8 and/or Schedule 9 poisons are to be stored,

• Details of the roles, responsibilities, conduct, training and periodic re-training of personnel who may have unsupervised access to Schedule 8 and/or Schedule 9 poisons,

• Details of the roles, responsibilities, conduct, training and periodic re-training of other personnel who might have supervised access to the storage facility for Schedule 8 and/or Schedule 9 poisons plus details of the nature of the supervision to be provided,

• Details of arrangements, tailored to the higher risks of managing Schedule 8 and/or Schedule 9 poisons, relating to inventory control processes and reporting arrangements in the event that discrepancies are detected,

• Details of arrangements, tailored to the higher risks of managing them, relating to the destruction and recording of expired or unwanted Schedule 8 and/or Schedule 9 poisons (including the use of sealed, tamper-evident containers to prevent diversion and restrictions on who may destroy them),

• Details of arrangements, tailored to the higher risks of managing them, to ensure that large quantities of Schedule 8 and/or Schedule 9 poisons awaiting destruction do not accumulate over time, and

• Details of training, tailored to the higher risks of managing Schedule 8 and/or Schedule 9 poisons, to be provided to address the identification and reporting of suspicious behaviour (by staff or others) and to facilitate rapid detection of interference or diversion of stock.

5.29 Indicate the position or role of the person who is to be responsible for ensuring that SOP relating to Schedule 8 and/or Schedule 9 poisons is maintained in the required manner and that compliance is achieved:

Security Manager / Controlled Goods Manager / Vault Supervisor / Operations Manager / Responsible PersonNot Applicable - indent sale or supply only


Not Applicable

6. Stock Handling and Stock Control If licensed poisons are subject to expiry dates (e.g. therapeutic medicines) the licence holder is required to implement stock handling and stock control procedures to ensure that expiry dates are not exceeded at the time of supply or shortly thereafter. Procedures for clean-up of spillages of poisons and quarantining of poisons must also be in place.

When developing a documented SOP, the following issues should be considered and addressed:

• Efficient stock rotation to ensure expiry dates are not exceeded at the time of supply or shortly thereafter,• Physical checks for evidence of tampering or damage, upon receipt and/or before supply, and• Reporting arrangements in the event that tampering or other damage is identified,• Clean-up of spills,• Quarantining of poisons due to breakage, error or other reasons.

6.01 Does the licence holder have a documented SOP that addresses the preceding issues?

Yes

No, because…..

Not Applicable - indent sale or supply only

Drugs of dependence in all schedules (including GHIV and CD)Notes:

More stringent stock handling and stock control mechanisms are generally required and might represent a significant component of the security provisions for drugs of dependence, GHIV and CD.

To prevent fragmenting security provisions in the PCP, all stock handling and stock control issues for drugs of dependence, GHIV and Schedule 8 (CD) and Schedule 9 poisons are addressed in Section 5, relating to Storage - Security and Access.

7. Storage - Stability Licensed poisons must be stored in a secure, stable and safe manner, including in accordance with the regulatory requirements for the corresponding poisons schedule and recommended storage temperatures (for therapeutic medicines in Schedules 2, 3 4 and 8). Regulatory requirements under Dangerous Goods legislation might also apply.

Temperature control and temperature monitoring are required for therapeutic medicines.

7.01 Do any licensed poisons require temperature control to ensure minimum or maximum storage temperatures are not breached?

YesNo, because all product information documents are to be reviewed to ensure that there are no such poisons / because all products to be sold or supplied will not be therapeutic medicines If the response to 7.01 is ‘No’, then 7.02 to 7.05 may be responded to as ‘Not Applicable’.


Therapeutic medicines in Schedules 2, 3, 4 and 8 must be stored below the maximum temperatures and/or within the temperature ranges that are specified on product labels.

Air-conditioning is likely to be required for items labelled "Store below 25°C" and/or "Store below 30°C" with some therapeutic medicines requiring storage in freezers, refrigerators or cool rooms.

Temperatures in all storage areas for therapeutic medicines must be controlled and monitored, with the results recorded and reviewed so that maintenance of required storage temperatures can be confirmed and demonstrated.

Temperature control and monitoring 7.02 Indicate how temperature is to be controlled and how temperature is to be monitored within storage area(s):

The storage area has a thermostatically controlled air-conditioning system which is to be active at all times / Therapeutic goods are to be stored in a small air-conditioned storeroom

Storage temperature is to be monitored using a thermograph / computerised temperature monitor / Storage temperature is to be monitored with a number of minimum/maximum thermometers / Temperature ranges are to be manually recorded on a regular basis (please specify that basis) to confirm that temperatures are not outside therapeutic ranges


Not Applicable

7.03 Does the licence relate to ANY poisons requiring refrigerated storage facilities?

Yes NoNot Applicable - indent sale or supply onlyNot Applicable If the response to 7.03 is ‘No’ then 7.04 and 7.05 may be responded to as ‘Not Applicable’.

7.04 Indicate how temperature is to be controlled and how temperature is to be monitored within refrigerated storage area(s) and summarise actions to be taken if episodes of breach of therapeutic storage temperatures are detected:

Thermostatically controlled refrigeration unit, with a temperature-monitoring device connected to the monitored alarm system / a visual/audible signal to indicate that refrigeration has failed / Minimum/maximum thermometer within the refrigerator is to be checked each day to confirm that the specified temperature range has been maintained When the alarm is activated, the rostered manager is to be contacted to arrange for the system to be repaired and/or for short-term intervention to occur / When stock is found to have been stored outside the designated temperature range, it is to be quarantined until stability can be confirmed with the relevant manufacturer / Stock for which the integrity and stability cannot be confirmed is to be put aside for disposal/return to the supplier.Not Applicable - indent sale or supply onlyNot Applicable

7.05 Does the licence holder have a documented SOP relating to temperature control, temperature monitoring and action to be taken in the event that inadequate storage temperatures occur?

YesNo, because……Not Applicable - indent sale or supply only


Not Applicable

8. Lawful Sale or Supply8.01 Indicate the type(s) of customers to whom licensed poisons are to be sold or supplied:

Medical practitioners / veterinary practitioners / pharmacies / pharmaceutical wholesalers / hospitals / electroplaters / timber treatment plants / industrial users / manufacturers / laboratories / primary industry / retailers

Schedule 7 poisons must NOT be sold or supplied by wholesale or retail to a person who is under the age of 18 years.

8.02 Indicate how lawful sale or supply is to be ensured in relation to the age of the recipient of Schedule 7 poisons:

Proof of age must be produced when establishing an account and/or prior to any sale or supply to an individualNot Applicable, because this licence does not relate to ANY Schedule 7 poisons

The Act prohibits the sale or supply by wholesale of a Schedule 2, 3, 4, 8 and/or 9 poison and/or a Listed Regulated poison in Schedule 7, other than to a person authorised by The Act (e.g. medical practitioner, pharmacist, veterinary practitioner or dentist) to use in the lawful practice of their profession, or to a person holding a licence or permit, which authorises purchase of that specific substance.

8.03 Indicate how lawful sale or supply of a Schedule 2, 3, 4, 8 and/or 9 poison and/or a Listed Regulated Poison in Schedule 7 is to be ensured and that a customer has current authorisation:

The computer system enables all account customers to be flagged with the poisons schedules and/or limited specific poisons that they are authorised to obtain and all licensed poisons are to be identified by the relevant poisons schedule. Orders may not be generated for customers who lack the necessary authorisation.All orders are to be manually checked to ensure that a current authorisation, licence or permit is held by the customer.Before accepting an order for a poison that is not usually requested (e.g. indent sale of an imported chemical), the SUSMP is to be consulted to determine the schedule (if any) of the poison requested.The authorisation of all new customers is to be checked, with the relevant practitioner registration authority (e.g. Australian Health Practitioner Regulation Agency (AHPRA) / Veterinary Practitioners Board), before an account is initiated.All new customers are to be required to produce a copy of their current licence/permit before an account is initiated.All clients are to be required to provide a current copy of their licence/permit on an annual basis, preferentially following renewal.All orders for licensed poisons are to be personally screened by a designated manager / by the Responsible Person.A contracted agreement between the licence holder and the indent sponsor licence holder / interstate supplier exists, which specifies who is responsible for ensuring current customer authorisation before any sale or supply is made.

8.04 Indicate the position or role of the person(s) to be responsible for opening new accounts, changing account details and verifying that authorisation (to obtain licensed poisons) is legitimate and current:

Accounts manager / Security Manager / Responsible Person


8.05 Does the licence holder have a documented SOP to ensure lawful sale or supply?

YesNo, because……

Calling OrdersThe term ‘calling order’ is used to describe the situation where sale or supply is made to a person who personally collects it or arranges its collection from the licensed premises, as compared to orders that are transported by the licence holder.

The licence holder must ensure that calling orders, collected by or on behalf of a customer, are supplied lawfully. This will generally require the licence holder to verify the identity and the authorisation of the person collecting the order.

8.06 Does the licence holder intend to allow customers or their agents to collect calling orders?

Yes No If the response to 8.06 is ‘No’, then 8.07 may be responded to as ‘Not Applicable’.

8.07 Indicate how the identity/authorisation of a person collecting a calling order is to be verified:

Requests for all ‘calling orders’ are to be confirmed with the customer and will include the identity of the person who is to collect the order, which will be confirmed and documented on collection / The person's identity and authorisation are to be personally confirmed and documented, by the Warehouse Manager/Responsible Person when the person attends to collect the orderNot Applicable - indent sale or supply onlyNot Applicable

Sale or Supply by AgentsSale or supply by wholesale of all licensed poisons must only occur from the licensed premises, with the exception of agents who may supply starter packs containing Schedule 4 medicines in accordance with the provisions of the current edition of the Medicines Australia Code of Conduct.

Agents are persons who are employed or contracted, by the licence holder, to sell or supply or to promote the sale or supply of products by visiting clients or potential clients.

8.08 Does the licence holder intend to engage agents to function in this role?

Yes No If the response to 8.08 is ‘No’, then 8.09 and 8.10 may be responded to as ‘Not Applicable’.

8.09 Indicate the nature of agent activities and the means by which orders that are taken or received by them are to be processed:

Agents will visit customers and obtain orders that are to be transmitted to the licensed premises for dispatch / Agents will seek and obtain orders that are to be transmitted to another licensed wholesaler, for dispatch / Agents will supply starter packs containing Schedule 4 medicines in accordance with the provisions of the current edition of the Medicines Australia Code of Conduct / Agents act as carriers to deliver consigned stock, after an order has been processed at the licensed premisesNot Applicable - indent sale or supply only


Not Applicable

Supply of starter packs containing Schedule 4 medicinesLicence holders, who engage agents to supply starter packs containing Schedule 4 medicines, are required to ensure that those agents act in accordance with the provisions of the current edition of the Medicines Australia Code of Conduct.

A documented SOP, addressing the following issues is strongly recommended.

• Arrangements for receipts to confirm delivery of Schedule 4 medicines,• Education and training of agents,• Assessment of agents, to ensure compliance with the Code of Conduct,• Periodic retraining of agents,• Stock control procedures, • Transport requirements relating to security and stability (e.g. temperature control) of starter packs,• Procedures and action to be taken in the event that stock is lost, stolen or cannot be delivered to the

intended customer.8.10 Does the licence holder have an SOP that addresses the preceding issues?

Yes

No, because.……Not Applicable - indent sale or supply onlyNot Applicable

9. TransportCarriers are authorised under The Regulations to possess licensed poisons that have been consigned, by the licence holder, for delivery to the person to whom the consignment is addressed. However, it remains the licence holder’s responsibility to ensure that the licensed poisons are delivered to the intended recipient.

When developing a transport plan or SOP, the following issues should be considered and addressed:

• Arrangements for receipts (where applicable) to confirm delivery of consigned orders,• Ensuring carriers (including emergency contract staff) can be identified and are aware of the licence

holder’s procedures for delivery and stock security,• Ensuring carriers are aware not to telegraph their activities,• Ensuring carriers can take steps to secure stock in the event of an accident, • Minimising the time that stock is in transit, • Ensuring that security arrangements are sufficient if transported stock is to be stored overnight,• Reacting promptly in the event that stock is lost, stolen or cannot be delivered to the intended customer,• Investigating any apparent loss or theft of licensed poisons, and.• Reporting the loss or theft of licensed poisons to Victoria Police and to the Department of Health, Drugs

and Poisons Regulation.

9.01 Does the licence holder have a transport plan or SOP that addresses the preceding issues?

YesNo, because……Not Applicable - indent sale or supply onlyNot Applicable


Cold Chain Medicines

9.02 Does the licence holder intend to transport licensed poisons that are subject to cold chain control?

Yes No, because all product information documents are to be reviewed to ensure that there are no such poisons / because all products to be sold or supplied will not be therapeutic medicines If the response to 9.02 is ‘No’, then 9.03 may be responded to as ‘Not Applicable’.

A documented SOP, which is required in relation to the transport of cold chain medicines, must include details relating to:

• Policies and procedures for maintaining the integrity of the cold chain,• Identifying and documenting deviations from the cold chain plus related outcomes, and • Ensuring the receiver of cold chain medicines is alerted to the fact that cold chain storage applies.9.03 Indicate the position or role of the person responsible for maintaining the SOP and for ensuring that the organisation complies with The Code in relation to cold chain medicines:

Operations Manager / Responsible PersonNot Applicable - indent sale or supply onlyNot Applicable


10. Records of TransactionsLicence holders must record transactions of sale or supply of licensed poisons (including those transactions that are for the purposes of destruction of those poisons – see also Section 12) in a manner that shows:

• The date of each transaction;• The name, form, strength and quantity of the poison that has been sold or supplied; and• The name and address (or location) of the person to whom sale or supply is made.Note: To demonstrate that lawful sale or supply has been made the name of the authorised person or legal entity (e.g. registered health practitioner, licence or permit holder) is to be recorded. It is neither sufficient nor lawful to record only the name of a corporate entity if that entity is not authorised to obtain the licensed poison.

10.01 Indicate how transactions are to be recorded:

All records are to be computerised with reporting programs to enable records to be retrieved in relation to a number of parameters, including date, specific poisons details and the recipient's name and addressThe name of the authorised person or legal entity (e.g. registered health practitioner, licence or permit holder) to whom the sale or supply is made is recorded, even if the invoicing process also identifies a different individual or corporate entity that is to pay for the poisons

Retaining and retrieving recordsRecords of transactions relating to the sale or supply of licensed poisons must be retrievable by the name of the poison, must be retained for a minimum of three years and must be produced on demand to an Authorised Officer of the Department of Health, Drugs and Poisons Regulation.

10.02 Indicate how records of transactions are to be retained and retrieved:

Access to computerised records is to be restricted by unique passwords / back-up copies of computer records are to be created daily and stored off-site


• Recording of all transactions, including the name of the authorised person or entity (e.g. registered health practitioner, licence or permit holder) to whom sale or supply is made,

• Ensuring that records of transactions are kept secure, intact and retrievable for at least three years,• Ensuring that computer access for making and changing records is restricted and how it is to be achieved, • Ensuring that persons with the authority to amend records are limited in number and are subject to similar

criteria as persons who are authorised to have unsupervised access to the corresponding poisons, • Ensuring the SOP contains the names of persons with the authority to amend records, and• Ensuring additional requirements for records relating to Schedule 8 and/or Schedule 9 poisons (where

applicable) are met.




Schedule 8 and Schedule 9 poisons10.04 Does the licence relate to ANY Schedule 8 and/or Schedule 9 poisons?

Yes

No If the response to 10.04 is ‘No’, then 10.05 may be responded to as ‘Not Applicable’.

Records of transactions involving Schedule 8 and/or Schedule 9 poisons must not be able to be altered, obliterated, deleted or removed without detection and must show the true and accurate balance remaining after each transaction.

10.05 Indicate the manner in which records of transactions in Schedule 8 and/or Schedule 9 poisons are to be maintained to achieve the necessary requirements:

In addition to computerised records, manual records are to be maintained in the form of a bound book with consecutively numbered pages (i.e. a Drug Register) / The computer system will not permit the amendment of any records for Schedule 8 and/or Schedule 9 poisons and incorrect entries must be corrected by another entry / Access to computerised records is to be restricted by unique passwords, known only to designated Qualified and/or Experienced Persons / Physical stock checks are to be performed periodically to confirm that calculated balances are accurate / Documented procedures are to be followed in the event that any discrepancies are identifiedNot Applicable

Exceptional Orders The licence holder should promptly notify the Department of Health, Drugs and Poisons Regulation of any exceptional or unusual requests for sale or supply of licensed poisons. Where this requirement is a specific condition of a licence, failure to fulfil this responsibility renders the licence holder liable to prosecution.

Exceptional or unusual requests may include a single large order, repeated orders for small quantities that add up to an unusually large quantity or orders for poisons that are atypical for the type of customer involved.


• The manner in which exceptional or unusual orders might be identified,• The manner in which training and education is to be provided to personnel who are to be responsible for

identifying exceptional or unusual orders,• Reporting arrangements to ensure that key personnel are made aware of possibly exceptional or unusual

orders,• The position or role of persons who are to determine whether orders are considered exceptional or

unusual, and• Arrangements to ensure that exceptional or unusual orders are reported to the Department of Health,

Drugs and Poisons Regulation and that the process is documented.


Yes

No, because……


11. Complaints, Returned Goods and Product Recalls

It is a requirement of The Code, that licence holders dealing with therapeutic medicines must have documented policies and procedures to deal with complaints, returned goods and product recalls. It is recommended that other licence holders have similar documentation.

ComplaintsWhen developing a documented SOP, the following issues should be considered and addressed:

• The manner in which complaints and the resolution of complaints are to be recorded, and• The manner in which training and information is to be provided to personnel who are to be responsible for

addressing complaints.


Yes No, because……

Returned goodsWhen developing a documented SOP, the following issues should be considered and addressed:

• The manner in which returned goods (unused or damaged) are to be quarantined from other stock until their integrity is assessed to determine whether they may be resupplied,

• Arrangements to restrict access to quarantined stock and/or to ensure quarantined stock is not resupplied inadvertently,

• Arrangements for assessing the integrity of quarantined stock to determine if it may be resupplied,• The positions or roles of personnel who are authorised to assess the integrity of quarantined stock, • The manner in which training and information is to be provided to personnel who are to be responsible for

assessing the integrity of quarantined stock to determine if it may be resupplied, and• Requirements for recording transactions relating to returned goods.


Yes

No, because……



Product recallsWhen developing a documented SOP, the following issues should be considered and addressed:

• The steps to be taken in the event of a product recall,• Arrangements to identify all recipients of a product that is the subject of a recall,• Arrangements to ensure that recalled stock is quarantined from other stock to prevent it being resupplied

inadvertently,• The positions or roles of personnel who are to be responsible for coordination of a product recall, • The manner in which training and information is to be provided to personnel who are to be responsible for

coordination of a product recall, and• Requirements for recording transactions relating to a product recall.


Yes No, because……Not Applicable - indent sale or supply only


12. Disposal/Destruction of Expired and/or Unwanted PoisonsLicensed poisons must not be disposed of via general waste collection services (e.g. garbage collection) and must not be sold or supplied to persons or agencies who are not expressly authorised to possess those poisons (e.g. charitable organisations).

Disposal/destruction of Schedule 2, 3, 4 and/or 7 poisonsPoisons must be disposed of or destroyed in an appropriate manner (e.g. high temperature incineration).

It is not lawful to sell or supply expired or unwanted poisons to persons who purport to be involved in the provision of scheduled medicines to relief or welfare agencies in Australia or overseas.

Where licensed poisons are to be provided to another agency for the purposes of destruction, that agency must hold the relevant licence or permit to lawfully possess those poisons.

Disposal/destruction of Schedule 8 and/or Schedule 9 poisonsThe Regulations specify that the destruction of a Schedule 8 and/or Schedule 9 poison may only be carried out by specified categories of person in the presence of a witness with the same or similar qualifications. Medical practitioners, nurse practitioners (Schedule 8 only, not Schedule 9), pharmacists, veterinary practitioners or dentists may carry out the destruction in the presence of another person who is a medical practitioner, pharmacist, veterinary practitioner, dentist, nurse or midwife. Records of the details and method of the destruction of Schedule 8 and/or Schedule 9 poisons are also specifically mandated.

Notes:

Some agencies are licensed or permitted to possess scheduled poisons for the purposes of destruction of those poisons (e.g. industrial incineration). Such licences or permits do NOT include Schedule 8 and/or Schedule 9 poisons. Consequently, destruction of Schedule 8 and/or Schedule 9 poisons at such premises must be in the presence of authorised persons, in combination, as detailed above.

Schedule 8 and/or Schedule 9 poisons, if not incinerated, must be destroyed by being rendered unidentifiable and unrecoverable. This may be achieved in a number of ways; liquids might be adsorbed onto shredded cardboard (e.g. kitty litter) whilst solids might be rendered so by, for example, crushing and diluting with liquid and then adsorbed onto cardboard. The resultant ‘slurry’ might then be burnt or disposed of in another appropriate method, ensuring that the poisons are not identifiable or recoverable.

Records of destruction of Schedule 8 and/or Schedule 9 poisons must be in made in accordance with the method and manner as described in Section 10.


• The manner in which licensed poisons awaiting disposal or destruction are to be quarantined from other stock to ensure that stock awaiting disposal is not resupplied inadvertently,

• Arrangements for ensuring the licensed poisons awaiting disposal are stored in accordance with the security requirements applicable to the corresponding poisons schedules,

• The positions or roles of personnel who are responsible for the management of stock awaiting disposal,• The manner in which training and information is to be provided to personnel who are to be responsible for

assessing the integrity of quarantined stock to determine if it may be resupplied, • Requirements for recording transactions relating to the disposal or destruction of licensed poisons, and• References to the more stringent controls required for the disposal or destruction of Schedule 8 and/or

Schedule 9 poisons to ensure that Schedule 8 and/or Schedule 9 poisons are not inadvertently subject to less than the required levels of security.




13. Manufacturing ActivitiesThis section has been compiled with reference to the code of Good Manufacturing Practice (GMP) for therapeutic goods which may be accessed at: http://www.tga.gov.au/industry/manuf-gmp-tg.htm

Manufacture includes the process of refining, manipulating and mixing any drug or poison, including a drug or poison in the raw state.

Repacking and relabelling of scheduled poisons are considered to be manufacturing activities.

13.01 Does this licence relate to ANY manufacturing activities?


13.02 Indicate the extent and type(s) of manufacturing to which the licence relates:

Extent - minimal range of products (up to 5) / limited range of products (up to 20) / moderate range of products (up to 50) / large range of products (more than 50)Type - formulating and compounding from raw materials / dilution or repacking and relabelling only / relabelling onlyNot Applicable

The holding of a licence under the Commonwealth Therapeutic Goods Act 1989 or any other Act does not preclude the need to hold a licence to manufacture and/or sell or supply substances in Schedules 2, 3, 4, 7, 8 and/or 9 in Victoria.

However, the auditing procedures of other licensing authorities may be taken into account in relation to issuing a licence and the preparation of this PCP, provided that details of relevant audits and licences are provided to the Department of Health, Drugs and Poisons Regulation, upon request.

13.03 Are the manufacturing activities relating to this licence subject to licensing and auditing procedures of the Therapeutic Goods Administration (TGA) and/or the Australian Pesticides and Veterinary Medicines Authority (APVMA)?

Yes - TGA/APVMA licence number ………………………….Some manufacturing activities are subject to TGA / APVMA licensing and auditing procedures and some are notNo If the response to 13.03 is ‘Yes’, then 13.04 to 13.09 may be responded to as ‘Not Applicable’.


Batch manufacture and documentationA batch numbering system and documentation relating to batch manufacture may serve to minimise the expense and difficulty associated with a product recall or investigation of a complaint.

13.04 Is a batch numbering system to be implemented?

YesNo, because……Not Applicable

13.05 Are batch records to be retained?


Not Applicable

13.06 Are batch samples to be retained in the form of retrievable retention samples?


13.07 Are quality assurance methods to be applied to raw materials?


13.08 Is there to be any quality control testing for finished goods?


Note: Representative samples of batch documentation and product labels must be provided to an Authorised Officer of the Department of Health, Drugs and Poisons Regulation, upon request.


Labelling and PackagingThe SUSMP contains the minimum requirements for labelling and packaging of scheduled poisons, including exemptions for industrial and laboratory products.

The Act makes it an offence to sell or supply any scheduled poison that is labelled and/or packaged in a manner that is not compliant. Heavy penalties may apply.

A licence holder who sells or supplies a scheduled poison, for which the licence holder is principally responsible for local distribution, must ensure that the labelling and packaging requirements of the SUSMP are met.


• The manner in which formulations and manufacturing instructions are to be documented and managed to ensure that products are manufactured to the specified standard,

• The manner in which cross-contamination is to be prevented,• The manner in which ingredients and mixed components are identified during manufacture,• The manner in which details of manufactured batches are to be numbered and documented,• The manner in which batch numbers are to be attached to finished goods,• The manner in which retention samples are to be stored and documented,• The manner in which label content is to be developed and verified as meeting the legislated standards,• Arrangements to ensure that the correct label is attached to a product,• The manner in which containers are confirmed as meeting the legislated standards,• Details of quality assurance and quality control testing of raw materials and finished goods,• The positions or roles of personnel who are responsible for manufacturing activities,• The manner in which training and information is to be provided to personnel who are to be responsible for

manufacturing activities, and• The manner in which training and information is to be provided to personnel who are to be otherwise

involved in manufacturing activities.




14. Laboratory ChemicalsTo ensure that laboratory personnel are fully aware of relevant legislative responsibilities, if any Schedule 4, Schedule 8 and/or Schedule 9 poisons and/or Listed Regulated Poisons in Schedule 7 are to be stored within laboratory facilities, then this section must be completed, unless a separate PCP covers these activities (see 14.02). Such chemicals might include retention samples, analytical standards and reagent chemicals.

14.01 Does the licence holder intend to store ANY Schedule 4, Schedule 8 and/or Schedule 9 poisons and/or Listed Regulated Poisons in Schedule 7 in the laboratory?

Yes No If the response to 14.01 is ‘No’, then 14.02 to 14.09 may be responded to as ‘Not Applicable’.

14.02 Has the licence holder registered or submitted a separate PCP in relation to a permit (also issued by the Department of Health, Drugs and Poisons Regulation) relating to the use, in the laboratory, of Schedule 4, Schedule 8 and/or Schedule 9 poisons and/or Listed Regulated Poisons in Schedule 7?

Yes - permit number ………………………….NoNot Applicable If the response to 14.02 is ‘Yes’, then 14.03 to 14.09 may be responded to as ‘Not Applicable’.


• Maintenance of a comprehensive list and inventory of all Schedule 4, Schedule 8 and/or Schedule 9 poisons and/or Listed Regulated Poisons in Schedule 7 to be stored in the laboratory,

• Storage and security provisions for Schedule 4, Schedule 8 and/or Schedule 9 poisons and/or Listed Regulated Poisons in Schedule 7,

• Arrangements to ensure restricted access to the storage facilities,• The manner in which recording requirements for all transactions in Schedule 4, Schedule 8 and/or

Schedule 9 poisons and/or Listed Regulated Poisons in Schedule 7 are to be met,• Arrangements for obtaining (from internal or external sources) Schedule 4, Schedule 8 and/or Schedule 9

poisons and/or Listed Regulated Poisons in Schedule 7,• Arrangements for documenting the transfer or receipt (from internal or external sources) of Schedule 4,

Schedule 8 and/or Schedule 9 poisons and/or Listed Regulated Poisons in Schedule 7,• Details of the position or role of personnel who are authorised to obtain Schedule 4, Schedule 8 and/or

Schedule 9 poisons and/or Listed Regulated Poisons in Schedule 7 from external sources, and• Details of training and information to be provided to ensure that laboratory personnel are fully aware of

relevant responsibilities.14.03 Does the licence holder have a documented SOP that addresses the preceding issues?

YesNo, because……./because all relevant information is contained in one or more other SOPNot Applicable


Schedule 4 poisons and/or Listed Regulated Poisons in Schedule 7 14.04 List or categorise any Schedule 4 poisons and/or Listed Regulated Poisons in Schedule 7 that are required to be stored in the laboratory:

Antibiotic substances / barbituric acid / chloral hydrate / laboratory standards / retention samples / laboratory reagentsArsenic / benzene / cyanidesNot Applicable

The Regulations require a lockable storage facility, which must remain locked and secured to prevent access by any unauthorised person at all times, except when it is necessary to open it to carry out essential operations.

14.05 Indicate how Schedule 4 poisons and/or Listed Regulated Poisons in Schedule 7 are to be stored in the laboratory:

Lockable storeroom or cabinet, separated from other substancesLockable storeroom or cabinet, in a cage separated from other goodsNot Applicable

Details of all transactions, relating to Schedule 4 poisons and/or Listed Regulated Poisons in Schedule 7 must be kept for a minimum of 3 years and produced on demand to an Authorised Officer of the Department of Health, Drugs and Poisons Regulation.

14.06 Indicate the manner in which records of transactions in Schedule 4 poisons and/or Listed Regulated Poisons in Schedule 7 are to be kept:

Computerised records / manual records / batch documentationNot Applicable

Schedule 8 and/or Schedule 9 poisonsThe Regulations require a lockable facility for the storage of Schedule 8 and/or Schedule 9 poisons, which must comply with at least the minimum specific requirements of Regulation 35 (as detailed in Section 5 of this PCP), and which must remain locked and secured to prevent access by any unauthorised person at all times, except when it is necessary to open it to carry out essential operations.

14.07 List or categorise any Schedule 8 and/or Schedule 9 poisons that are required to be stored in the laboratory:

Minimal range and quantity of laboratory standards / retention samples / laboratory reagentsCodeine, Fentanyl, Morphine in Schedule 8 for QA/QC analysis / Muscimol in Schedule 9 as a quantitative reference standardNot Applicable

14.08 Indicate how Schedule 8 and/or Schedule 9 poisons are to be stored in the laboratory:

Free standing safe (weighing approximately 350 kilograms) with twin combination locks / Reinforced concrete vault with combination and key operated locks / small safe fixed to the floor / steel drug cabinet, which meets the minimum specified standards for structure and attachmentNot Applicable

Details of all transactions, relating to Schedule 8 and/or Schedule 9 poisons must be kept for a minimum of 3


years and produced on demand to an Authorised Officer of the Department of Health, Drugs and Poisons Regulation. Regulations 40 and 41 of The Regulations specify the details required to be contained in records of transactions for Schedule 8 and/or Schedule 9 poisons, and that those records of transactions must not be able to be altered, obliterated, deleted or removed without detection and must show the true and accurate balance remaining after each transaction.

14.09 Indicate the manner in which records of transactions in Schedule 8 and/or Schedule 9 poisons are to be maintained to achieve the necessary requirements:

In addition to computerised records, manual records are to be maintained in the form of a bound book with consecutively numbered pages (i.e. a Drug Register) / The computer system will not permit the amendment of any records for Schedule 8 or Schedule 9 poisons and incorrect entries must be corrected by another entry / Access to computerised records is to be restricted by unique passwords, known only to designated Qualified and/or Experienced Persons / Physical stock checks are to be performed periodically to confirm that calculated balances are accurate / Documented procedures are to be followed in the event that any discrepancies are identified.

Not Applicable


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