Voluntary Assisted Dying Regulations 2022

The Regulations are short and narrowly focused; their main legal concepts are delegation of form determination, accreditation and exemptions for language assistance, administrative timeframes, limited technical specifications for storage, and standing for Tribunal review.

• Delegation of form determination. Multiple defined forms in s 3 of the Act are declared to be "the form determined by the Minister and published in the Gazette from time to time" (regs 4-11, 14-15, 17, 19). The concept is: the Act requires particular documents but the Regulations place the power to create the actual document formats with the Minister and require Gazette publication. This creates an ongoing regulatory reference point that can be updated administratively without amending the Regulations themselves.

• Prescribed accreditation for interpreters. For the purposes of section 7(a) of the Act, the Regulations name the National Accreditation Authority for Translators and Interpreters Limited (NAATI) and any other body specified by the Minister by Gazette notice as prescribed bodies (reg 12). The concept is to define who qualifies as an accredited interpreter for the Act’s operation.

• Exemption mechanism for interpreters. The Regulations authorise the Chief Executive to grant written exemptions from s 7(a) of the Act upon application in a form and manner determined by the Chief Executive; exemptions can be conditional or unconditional (reg 13(1)-(2)). The Regulations also explicitly exempt speech pathologists assisting a person with requesting access to or accessing voluntary assisted dying from s 7(b)(iv) of the Act (reg 13(3)). The concept is targeted administrative discretion to avoid rigid application of interpreter rules in specified circumstances.

• Administrative processing timeframe. For s 67(1) of the Act (determination of applications for a permit), the prescribed period is three business days (reg 16). The concept is a short mandatory decision window for permit determinations set by regulation.

• Minimal secure storage specifications. For the purposes of sections 75(b), 76(c) and 78 of the Act, the Regulations prescribe physical attributes of the locked box used to store the voluntary assisted dying substance: steel construction, not easily penetrable, and a lock of sturdy construction (reg 18). The concept limits storage requirements to specific physical characteristics rather than detailed mechanical or electronic security regimes.

• Tribunal applicant classes. The Regulations specify that for s 85(2)(b) of the Act a family member of the person the decision relates to, and any person the Tribunal is satisfied has a sufficient interest, are prescribed applicants for review (reg 20). The concept is to identify classes with locus standi to seek Tribunal review of decisions under the Act.

Across these concepts the consistent structural device is to use subordinate regulation to set forms, limited technical standards and narrow administrative procedures, while leaving substantive obligations, penalties and oversight to the Act itself. The Regulations therefore compress a range of operational details into Gazette-based forms and a small number of concrete technical prescriptions.

The Regulations affect multiple parties involved in voluntary assisted dying under the Act by prescribing who makes decisions about procedural documents, who can act as interpreters, who may be exempted from interpreter requirements, who may apply for Tribunal review, and what physical steps must be taken to secure substances. The affected classes, and how they are affected, are:

• Practitioners (assessing, consulting, coordinating, administering). Medical practitioners required by the Act to complete specific assessment reports and administration forms must use the prescribed forms determined by the Minister and published in the Gazette (regs 4, 6, 8). The Regulations require those forms to exist and be used; they do not prescribe substantive clinical practice but set the administrative template practitioners must follow.

• Applicants for permits (self-administration and practitioner administration). Persons seeking a self-administration permit or a practitioner-administration permit must use application forms prescribed by the Minister and published in the Gazette (regs 14-15). The short three-business-day decision window (reg 16) directly affects applicants and the administrative bodies processing those permits by imposing a tight statutory timetable.

• Coordinating pharmacist/dispensing agents. The voluntary assisted dying substance dispensing form and the voluntary assisted dying substance disposal form are Ministerial forms (regs 9-10). Entities responsible for dispensing, labelling, storing and disposing of the substance must use the prescribed documentation and meet the storage specifications in reg 18 and labeling in reg 19.

• Those responsible for storage. Reg 18 prescribes the physical minimums for the locked box storing the voluntary assisted dying substance: steel construction, not easily penetrable, and a sturdy lock. Any hospital, pharmacy, residential facility, or person who has custody of the substance must meet these specified features for the purposes of the Act sections cited (75(b), 76(c), 78).

• People requiring language assistance and those who provide it. The Regulations prescribe NAATI and any other body specified by the Minister as acceptable accreditation for interpreters under s 7(a) of the Act (reg 12). Individuals and organisations needing to arrange an interpreter must secure an interpreter accredited by the prescribed bodies unless an exemption is granted. The Chief Executive can grant exemptions on application (reg 13(1)-(2)), and speech pathologists are explicitly exempted from s 7(b)(iv) when assisting persons to request access or access voluntary assisted dying (reg 13(3)).

• Family members and others seeking review. Reg 20 prescribes that family members and any other person the Tribunal is satisfied has a sufficient interest can be applicants for review under s 85(2)(b) of the Act. This expands the practical pool of potential reviewers beyond the immediate applicant, subject to the Tribunal’s satisfaction as to "sufficient interest".

• Minister and Chief Executive. The Minister gains delegated authority to determine and update a wide range of forms by Gazette (regs 4-11, 14-15, 17, 19) and to specify additional interpreter bodies by Gazette (reg 12). The Chief Executive gains discretionary administrative power to grant exemptions from interpreter requirements by written notice on application, and to set the manner and form for such applications (reg 13(1)).

• Entities relying on the prior 2021 Regulations. Those who relied on the Voluntary Assisted Dying Regulations 2021 are affected because the 2022 Regulations repeal the 2021 Regulations (Schedule 1).

In short, the Regulations place administrative obligations on medical practitioners, pharmacists and other custodians of the substance to use Ministerial forms and meet storage specs, define interpreter accreditation and an exemption process affecting both clients and providers of language assistance, impose a rapid processing requirement on permit authorities, and designate classes of Tribunal applicants. Administrative actors,the Minister and the Chief Executive,receive delegated rule-making and discretionary powers which affect how the system operates in practice.

The Regulations instantiate a set of duties and rights that are largely administrative and procedural. They do not create substantive clinical duties or prescribe penalties; rather, they require use of certain documents, define accredited interpreter bodies and exemptions, fix one time period, and set basic storage standards. Key duties and rights under the Regulations are:

Duties

• To use Minister-determined forms where the Act requires particular documents. The Regulations make it a requirement for the purposes of the Act that numerous forms are "the form determined by the Minister and published in the Gazette from time to time" (consulting assessment report form (reg 4), contact person appointment form (reg 5), coordinating medical practitioner administration form (reg 6), final review form (reg 7), first assessment report form (reg 8), voluntary assisted dying substance dispensing form (reg 9), voluntary assisted dying substance disposal form (reg 10), written declaration (reg 11), application forms for self-administration and practitioner-administration permits (regs 14-15), the permit form (reg 17), and labelling requirements (reg 19)). The duty falls on the persons required by the Act to produce these documents (practitioners, applicants, dispensers).

• To store the voluntary assisted dying substance in a locked box meeting the prescribed specifications. For the purposes of sections 75(b), 76(c) and 78 of the Act, the locked box must be constructed of steel, not be easily penetrable, and the lock must be of sturdy construction (reg 18). The duty lies on custodians of the substance.

• To employ accredited interpreters where section 7(a) of the Act requires it, unless an exemption applies. The Regulations prescribe NAATI and any other body specified by Gazette (reg 12) as the sources of accreditation.

• To apply for exemptions from interpreter requirements in the form and manner the Chief Executive prescribes; exemption decisions may be conditional (reg 13(1)-(2)). The duty is on anyone seeking exemption.

• To submit permit applications using prescribed Ministerial forms and to expect a decision in three business days (regs 14-16). Applicants must comply with the prescribed form and the processing timetable is binding for the determining authority under the Act as modified by reg 16.

Rights

• Right to have particular forms prescribed by the Minister and published in the Gazette. This is not a "right" in the constitutional sense but is a regulatory right to rely upon the current Gazetted form as fulfilling statutory documentary requirements under the Act. Affected persons may look to Gazette-published forms as authoritative.

• Right to seek exemption from interpreter accreditation requirements. An applicant may apply to the Chief Executive for exemption from s 7(a) of the Act, and the Chief Executive may grant an exemption in writing, conditional or unconditional (reg 13(1)-(2)).

• Right of speech pathologists assisting in access to voluntary assisted dying to be exempted from a specific provision of the Act. The Regulations explicitly exempt speech pathologists from s 7(b)(iv) when they assist a person in relation to requesting access to or accessing voluntary assisted dying (reg 13(3)).

• Right to Tribunal review by certain classes of applicants. Reg 20 prescribes that family members of the person whose matter is being decided, and any person the Tribunal is satisfied has a sufficient interest, are persons who can be applicants for review under s 85(2)(b) of the Act. This creates a regulated pool of potential applicants for review.

The Regulations therefore create administrative obligations and predictable rights around documentary compliance, access to interpreters and exemptions, secure storage, and reviewability. These duties are imposed indirectly by tying compliance to the Act’s requirements (for example s 3 definitions and the sections cited in reg 18), and by delegating the content of many of those duties to Ministerial forms which a practitioner or custodian must consult and use.

The Regulations themselves do not create express offences, specify penalties, or set out enforcement mechanisms. They operate as subordinate prescriptions that give effect to certain provisions of the Act by identifying forms, accreditation bodies and technical requirements. The Act provisions referenced in the Regulations (for example sections 75, 76, 78, 85, 130 and others cited in the Regulations) likely set out offences, penalties and enforcement mechanisms, but the Regulations do not replicate those penalties or create new ones. The text of the Regulations confines itself to specification and prescription.

Key enforcement-relevant features in the Regulations are:

• Delegation to Ministerial forms. Because many mandatory documents are prescribed to be the Minister's forms published in the Gazette (regs 4-11, 14-15, 17, 19), compliance assessment (for example whether a written declaration meets statutory requirements) will be judged against the current Gazetted form and the Act. The Regulation itself does not set a penalty for failing to use the Gazetted form; any sanction would therefore derive from the Act or other law, not from these Regulations.

• Storage specification as an evidentiary standard. The Regulations provide concrete storage specifications (reg 18) that can operate as a measurable compliance benchmark. Whether non-compliance with these specifications attracts penal consequence will depend on the Act provisions those specs are linked to (sections 75(b), 76(c) and 78), but the Regulations supply the objective attributes,steel construction, not easily penetrable, sturdy lock,that inspectors, Tribunal members or courts could apply when assessing compliance.

• Exemption and administrative decision-making. The Chief Executive’s discretion to grant exemptions from the interpreter requirement (reg 13(1)) creates administrative decisions made "by notice in writing". The Regulations indicate the form and manner of the application are to be determined by the Chief Executive and that exemptions may be conditional. The Regulations do not state whether these decisions are internally reviewable, appealable to the Tribunal or otherwise subject to judicial review; those matters would be governed by the Act and general administrative law, not by the Regulations themselves.

• Tribunal standing prescription. Reg 20 prescribes who may be an applicant for review under s 85(2)(b) of the Act,family members and any other person whom the Tribunal accepts as having sufficient interest. That prescription affects the universe of persons who may seek review of administrative decisions under the Act, but the Regulations do not elaborate on remedies or penalties.

Because the Regulations are operational rather than punitive, enforcement in practice will follow the enforcement architecture in the Act. The Regulations create objective benchmarks and delegate documentary formats to the Minister, which streamlines compliance assessment,but any legal sanction for non-compliance must be traced to the Act or other primary legislation. The absence of penalties in the Regulations means enforcement reliance rests on the Act’s provisions and on standard administrative processes for decision-making and review referenced by the Regulations.

The Regulations are expressly subordinate to and made under the Voluntary Assisted Dying Act 2021; they interact with that Act by prescribing forms, bodies and technical requirements "for the purposes of" particular sections of the Act. Each time a regulation begins "For the purposes of" the definition of a form in section 3 of the Act, the Regulations are functioning as delegated implementation of the Act’s definitional and procedural architecture (see regs 4-11, 14-15, 17, 19). The interaction is therefore direct and statutory:

• Delegated implementation. The Regulations implement the Act’s delegation of form-making power to subordinate law in many places. The Minister’s Gazette forms become the operative documents that satisfy statutory documentary requirements under the Act. This means the Act sets the substantive obligations while the Regulations, and the Minister’s Gazetted forms, provide the documentary means of complying.

• Cross-reference to Act sections. Reg 12 prescribes bodies for the purposes of section 7(a) of the Act; reg 13 operates pursuant to section 130(2)(a) of the Act in respect of exemptions; regs 14-17 operate with sections 65-67 of the Act; reg 18 refers to sections 75(b), 76(c) and 78 of the Act; reg 19 refers to s 76(2); reg 20 refers to s 85(2)(b). The Regulations do not modify the Act; they clarify and operationalise certain Act provisions.

• Repeal of earlier subordinate law. Schedule 1 repeals the Voluntary Assisted Dying Regulations 2021. This is a direct interaction with earlier subordinate legislation and ensures that the 2022 Regulations replace the 2021 instrument as the operative subordinate law under the Act.

• Administrative decision-making and review. The Regulations create routes for administrative action,Ministerial determination of forms, Chief Executive discretion to grant interpreter exemptions, Tribunal review applicants as prescribed in reg 20,which interact with the Act’s governance structure. For example, the Chief Executive’s power to grant exemptions is exercised "pursuant to section 130(2)(a) of the Act" (reg 13(1)). The Regulations do not, however, elaborate on external legal rights outside the Act; they rely on the Act’s allocation of review and enforcement powers.

• Gazette publication as regulatory instrument. The Regulations repeatedly require that forms or inclusions are "published in the Gazette from time to time". This interacts with broader statutory and administrative procedures for publication of delegated instruments and notices, and places a practical duty on regulated actors to consult the Gazette to know the current forms or any Ministerial specifications.

• Interface with administrative law (implicit). While the Regulations do not specify avenues of external legal challenge, their prescription of decision-making powers for the Chief Executive and the Minister implies those decisions will interact with principles of administrative law and any review mechanisms provided by the Act (for example Tribunal review under s 85 as invoked in reg 20). The Regulations themselves do not provide procedural rules for judicial review.

In sum, the Regulations are tightly integrated with the Act: they function as subordinate apparatus to make the Act operational by setting forms, accrediting interpreters, prescribing exemptions and specifying minimal security standards. They also interact with the statute book by replacing the 2021 Regulations and by relying on Gazette publication as the method for updating multiple operative items. The Regulations do not create standalone legal obligations beyond those enabled by the Act.

The Regulations contain an internal legislative history block and a Schedule repealing the prior Voluntary Assisted Dying Regulations 2021. Key factual points in the instrument’s amendment and commencement record are:

• Commencement. Regulation 2 provides that the Regulations come into operation on the day on which section 130 of the Voluntary Assisted Dying Act 2021 comes into operation. The Legislative history records the principal regulations as 2022 No. 87, Gazette 29.9.2022 p6270, and notes commencement on 29.9.2022 with a cross-reference to reg 2.

• Repeal of earlier regulations. Schedule 1 expressly repeals the Voluntary Assisted Dying Regulations 2021. This is a direct legal replacement; the 2022 instrument is intended to be the operative subordinate instrument of record.

• Ongoing gazette-based updates. A structural feature that affects amendment practice is that most of the procedural forms and the labelling requirements are to be "the form determined by the Minister and published in the Gazette from time to time" (regs 4-11, 14-15, 17, 19). That design means the Minister can update the operative forms without further legislative amendments to the Regulations, provided the updated forms are Gazette-published. Consequently, much of the instrument’s effective content is amendable through administrative publication rather than statutory amendment.

• Minister and Ministerial notices. Reg 12 similarly permits the Minister to specify additional interpreter accreditation bodies by notice in the Gazette. This gives the Minister an ongoing, administrative power to add prescribed interpreter accrediting bodies.

• Chief Executive’s procedural powers. Reg 13 delegates to the Chief Executive the power to determine the manner and form of exemption applications and to issue exemptions by written notice. Those processes can be altered administratively under the Chief Executive’s authority as set out in the Regulations.

The instrument’s formal legislative history contained in the Regulations is limited to reporting the principal regulations entry and commencement date. There are no recorded amendments or subsequent variations in the text provided. The functional amendment mechanism embedded in the Regulations is deliberate: by prescribing many items as Ministerial Gazette forms, the Regulations allow operational content to be changed by Gazette notice rather than by formal amendment to the Regulations themselves.

The Regulations as provided contain no case law, recorded litigation, or references to judicial decisions. They do, however, identify decision-making points and persons (the Minister and the Chief Executive) whose administrative choices could become the subject of litigation or Tribunals, and they supply some parameters that would be relevant to any judicial or tribunal review of administrative action. Specific observations on litigation-relevant features grounded in the instrument are:

• Tribunal review pathway identified. Reg 20 prescribes who may be an applicant for review for the purposes of s 85(2)(b) of the Act,family members and any person whom the Tribunal is satisfied has a sufficient interest. That prescription indicates the Act contains a Tribunal review mechanism. Any contest about whether a particular person has "sufficient interest" is a factual and legal question likely to require adjudication by the Tribunal; the Regulations themselves leave the evaluation of "sufficient interest" to the Tribunal.

• Administrative decisions susceptible to challenge. The Chief Executive’s power to grant interpreter exemptions by written notice on application in a form and manner the Chief Executive determines (reg 13(1)) is an administrative decision. While the Regulations do not set out appeal routes, the existence of Tribunal review under the Act and general principles of administrative law would provide possible review avenues for affected persons. The Regulations frame the decision as "pursuant to section 130(2)(a) of the Act", implicitly anchoring any review rights in the Act.

• Objective standards that can be tested. Reg 18’s storage specifications and the prescription of Gazetted forms create objective benchmarks. In any litigation or review concerning compliance with the Act’s storage or documentary requirements, the Regulations give concrete criteria against which compliance can be measured: steel construction, not easily penetrable, sturdy lock; use of the Gazette form current at the relevant time.

• No reported litigation in the text. The Regulations do not contain any record of litigation, appeals, or Tribunal decisions. There are no cross-references to judicial interpretation nor any transitional or savings provisions addressing ongoing disputes from the 2021 Regulations.

• Potential sources of disputes. The points most likely to generate litigation or Tribunal disputes, based on the Regulations, are (a) whether a person has "sufficient interest" for Tribunal standing under s 85(2)(b) as prescribed by reg 20; (b) administrative fairness and reasonableness of the Chief Executive’s grant or refusal of an interpreter exemption under reg 13; (c) whether the Gazetted forms satisfy the Act’s substantive documentary requirements; and (d) compliance with the storage specifications in reg 18 as they relate to the Act’s enforcement sections. The Regulations set the administrative scaffolding for such disputes but do not themselves resolve them.

Given the absence of cases or decisions in the instrument, researchers and practitioners seeking litigation history must consult Tribunal records, court databases or the public register of administrative decisions under the Act. The Regulations provide the operative criteria that any tribunal or court would apply, but they do not summarise or report any litigation outcomes.

The Regulations are lean but contain several operational features that can cause compliance or administrative traps if overlooked. The "gotchas" below are risks and practical pitfalls grounded directly in the Regulations’ text.

1. Reliance on Gazetted forms. Numerous statutory documents are prescribed to be "the form determined by the Minister and published in the Gazette from time to time" (regs 4-11, 14-15, 17, 19). Gotcha: the operative form may change without an amendment to these Regulations. Practitioners, applicants and dispensers must check the Gazette for the current form before acting. Using an out-of-date or non-Gazetted form could cause an application or declaration to be non-compliant with the Act.

2. Short prescribed decision period for permits. The prescribed period for determination of an application under s 67(1) is three business days (reg 16). Gotcha: administrative bodies must be resourced to meet a tight turnaround. Applicants should not assume protracted processing; the regulator is subject to a short clock, which can affect timing for access or administration. Conversely, missing the three-day deadline can have consequences under the Act, even though the Regulations do not themselves specify penalties.

3. Narrow storage specifications. The Regulations prescribe only three physical attributes for a locked box (steel construction, not easily penetrable, and a sturdy lock) (reg 18). Gotcha: these are minimum, qualitative benchmarks; they do not reference particular standards (for example, specific locks, tamper-evident measures, alarm systems, or compliance with a particular security code). Custodians who rely on more elaborate storage systems must ensure their systems at least meet these three criteria and that any higher standards are compatible with the Act’s record-keeping and access provisions.

4. Interpreter accreditation and exemptions. Reg 12 prescribes NAATI and any other body specified by Gazette as the accreditation source for interpreters under s 7(a) of the Act. Reg 13 allows the Chief Executive to grant exemptions and explicitly exempts speech pathologists from s 7(b)(iv) when assisting persons in requesting access. Gotcha: practitioners or institutions that arrange interpreters must confirm both the interpreter’s accreditation against the Gazette list and whether any exemption applies. There is an administrative application and written-notice process for exemptions, and exemptions can be conditional, which could impose particular restrictions.

5. Broad but discretionary Tribunal standing. Reg 20 permits family members and any person the Tribunal is satisfied has a sufficient interest to be applicants for review for the purposes of s 85(2)(b). Gotcha: "sufficient interest" is assessed by the Tribunal and is not defined in the Regulations. Parties should not assume automatic standing; evidentiary preparation to establish "sufficient interest" may be required.

6. Repeal of prior Regulations. Schedule 1 repeals the 2021 Regulations. Gotcha: transition arrangements are not spelled out in these Regulations. Persons who previously relied on forms or procedure under the 2021 Regulations should confirm whether transitional provisions exist in the Act or in the Gazetted materials.

7. Delegation concentration. The Minister determines many operational forms and may specify additional interpreter bodies by Gazette (regs 4-12, 14-15, 17, 19). Gotcha: this centralisation of operational rules in Ministerial Gazette forms means regulatory change can occur administratively and may be less visible than formal amendments; regulated actors need processes to monitor the Gazette.

8. No enforcement detail in the Regulations. The Regulations do not set out penalties or enforcement routes. Gotcha: compliance failures will be addressed under the Act’s enforcement framework or other law; readers must consult the Act for consequences, and should not assume the Regulations themselves provide remedial detail.

9. Chief Executive’s procedural discretion. The Regulations leave the "manner and form" of exemption applications and the grant of exemptions to the Chief Executive (reg 13(1)). Gotcha: absence of a prescribed form in the Regulations means applicants must locate the Chief Executive’s procedural directions; failure to follow those directions may delay or invalidate an exemption application.

10. Labelling requirements are Gazette-determined. Reg 19 prescribes the labelling requirements be the Minister's form in the Gazette. Gotcha: absence of explicit labelling text in the Regulations means custodians must obtain the current labelling form from the Gazette; labelling is legally consequential for dispensing and storage compliance.

Each of these points is grounded in the Regulations’ provisions and demonstrates that compliance is not solely a matter of reading the Regulations: it requires active monitoring of Gazette publications, coordination with the Minister’s office and the Chief Executive, and administrative readiness to meet short decision timeframes and procedural application requirements.

Compliance under these Regulations is primarily documentary, administrative and technical. The following is a practical compliance checklist and process, grounded in the Regulations’ text, for practitioners, custodians of the substance, applicants and administrators.

1. Maintain current Gazetted forms register

• Action: Regularly monitor the South Australian Government Gazette for any Ministerial forms published under the Regulations (regs 4-11, 14-15, 17, 19) and keep a controlled register of the current version of each required form (consulting assessment report, contact person appointment, coordinating medical practitioner administration, final review, first assessment, dispensing, disposal, written declaration, self-administration permit application, practitioner-administration permit application, permit, labelling).
• Why: The Regulations specify that these forms are the "form determined by the Minister and published in the Gazette from time to time" (multiple regs). Using an out-of-date form risks non-compliance with the Act.

2. Establish administrative capacity for a three-business-day permit decision

• Action: If you are an administrative body that receives permit applications under s 67 of the Act, put in place triage, tracking and decision-making procedures to meet the three-business-day prescribed period (reg 16). Document internal processes allocating responsibility and time deadlines.
• Why: Reg 16 fixes the prescribed period at three business days; failure to decide within that window may affect applicants’ rights under the Act.

3. Adopt and use Ministerial forms for all statutory documents

• Action: Practitioners, dispensers, and applicants must adopt the Minister’s Gazetted forms for the purposes prescribed in the Act. Integrate each current form into clinical and administrative templates and ensure staff are trained in completing them correctly.
• Why: The Regulations link compliance with the Act’s documentary requirements to these Gazetted forms (regs 4-11, 14-15, 17, 19).

4. Confer with Chief Executive about interpreter exemptions when needed

• Action: If an accredited interpreter cannot be engaged or a provider believes an exemption is justified, apply to the Chief Executive in the manner and form specified by the Chief Executive for an exemption from s 7(a) (reg 13(1)). Keep records of the application and any written notice granting or refusing the exemption. Be aware exemptions may be conditional.
• Why: Reg 13 empowers the Chief Executive to grant exemptions in writing and makes the exemption process administratively specific.

5. Verify interpreter accreditation against the Gazette list

• Action: When arranging interpreter services under s 7(a), confirm the interpreter is accredited by NAATI or by another body that the Minister has specified by Gazette notice (reg 12). Keep copies of accreditation credentials and the Gazette notice specifying any non-NAATI bodies.
• Why: The Regulations prescribe the acceptable accrediting bodies; using an unprescribed accreditor may trigger non-compliance.

6. Comply with storage specifications

• Action: Ensure any locked box used to store the voluntary assisted dying substance meets the three prescribed specifications: constructed of steel, not easily penetrable, and containing a lock of sturdy construction (reg 18). Maintain documentation and photographs evidencing the locked box’s compliance, and record access logs to the locked box as required by the Act or institutional policy.
• Why: Reg 18 sets objective benchmarks for secure storage for the purposes of sections 75(b), 76(c) and 78 of the Act.

7. Use Gazetted labelling form

• Action: Use the Minister’s Gazetted labelling form for voluntary assisted dying substances (reg 19). Integrate the labelling procedure into dispensing and transport workflows and retain records of labels applied and the associated dispensing forms (reg 9).
• Why: Reg 19 prescribes the labelling requirements by Gazetted form, which is an operational compliance item.

8. Prepare documentation to establish “sufficient interest” for Tribunal review

• Action: If you anticipate applying for Tribunal review under s 85(2)(b), prepare evidence that establishes your connection to the person or matter to show you have a sufficient interest. Family members are expressly prescribed; others must satisfy the Tribunal (reg 20).
• Why: Reg 20 prescribes which persons are applicants for review and places an evidentiary burden on non-family applicants.

9. Track transitional and repeal implications

• Action: If you acted under the 2021 Regulations, verify whether any transitional arrangements affect ongoing cases, and ensure records created under the 2021 Regulations meet the new Gazetted forms or other requirements instituted by the Minister.
• Why: Schedule 1 repeals the 2021 Regulations; absence of explicit transitional text in the Regulations requires practitioners to confirm continuity via Gazette notices and the Act.

10. Record keeping and evidence preservation

• Action: Keep contemporaneous records that show the use of Gazetted forms, the accreditation status of interpreters, any Chief Executive exemption notices, the condition and description of the locked box, labelling records, dispensing and disposal forms, and permit application and decision timelines. Where the Act requires particular records, use the Gazetted forms to fulfil that requirement.
• Why: The Regulations’ prescriptions are documentary or technical; evidentiary records will be necessary for internal governance and for any Tribunal or other review under the Act.

11. Liaise with institutional legal/compliance teams

• Action: Ensure institutional legal, clinical governance and compliance teams are informed about the Minister’s Gazetted forms and the Chief Executive’s exemption processes. Implement a notification protocol for any changes published in the Gazette.
• Why: The Regulations concentrate operational authority in the Minister and the Chief Executive and require institutions to adapt administratively to changes published in the Gazette.

Following this checklist addresses the specific regulatory prescriptions found in the Regulations. Remember that the Regulations operate within the Act; compliance requires reading the Act alongside these Regulations to ensure substantive legal obligations (including any penalties or additional duties) are met.