Human Reproductive Technology Regulations 1993

The regulations operate as administrative rule-making for licensing, exemption and oversight under the Human Reproductive Technology Act 1991. The main concepts are:

• Department and CEO administration: The Department is the administrative recipient of applications and the CEO is the official responsible for keeping prescribed registers and issuing certificates and licences in accordance with the Act and these regulations. The term Department is defined in r 1A.

• Exemption process for artificial insemination: The regulations prescribe the required application form (Schedule 1 Form 1), the undertaking to observe the Code of Practice and directions of the CEO, the information to be provided (including evidence of medical qualification), and a $50 fee (r 2(1)(b)-(c)). They also provide the form for certificates of exemption (Schedule 1 Form 2) and require that conditions specified in s 33 of the Act apply to exemptions (Form 1 and Form 2).

• Licensing and fees: Applications for practice licences and storage licences must be lodged with the Department (r 3(1)). Fees are set for practice licences ($1 800) and for storage licences on a tiered basis (r 3(2)-(3)). The storage licence fee structure differentiates premises where sperm collection will not occur, where collected sperm is not for donor insemination, where donor-insemination-intended sperm is collected, and where eggs or embryos are stored (r 3(3)(a)-(c)).

• Registers and disclosure: The CEO must keep registers required under the Act and the regulations prescribe the specific fields to be recorded for licence registers (r 4(1)), exemption registers (r 4(2)) and disciplinary proceedings registers (r 4(3)). The CEO must also keep export registers for gametes, eggs in process of fertilisation or embryos and their subsequent use or disposal, in a place and manner approved by the Minister (r 4(4)). The fee for information supplied under s 46 of the Act is prescribed at $75, with specified waivers (r 4AA).

• Authorised officers and inspection powers: The form and content of identity certificates for authorised officers are prescribed, including whether an officer generally authorised or only for specified functions, and whether the officer is to be given access to participant identifying information (r 5). A warrant authorising entry under s 55(1) must be in Schedule 1 Form 3 (r 4A). The warrant form authorises entry, the exercise of s 55(2) powers and the use of necessary force (Schedule 1 Form 3).

• Reporting and information flow: Exempt medical practitioners and persons performing artificial insemination under a licensee’s direction must provide outcome details of procedures to the storage licensee or the CEO (Form 1; r 2(3)(b)). The application and certificate forms embody undertakings to comply with the Code of Practice and any direction given by the CEO (Form 1), thereby formalising information flows between practitioners, licensees and the CEO.

These concepts convert the Act’s broad powers into day-to-day administrative steps: who pays specified fees, which forms to use, what registers will record, the limited circumstances when unlicensed persons may perform procedures, and how inspection and access to identifying information are to be controlled and documented.

The regulations affect a set of clearly identifiable actors in the reproductive technology field:

• Medical practitioners performing artificial insemination: A medical practitioner seeking exemption under s 28(1) of the Act must apply to the Department using Schedule 1 Form 1, provide evidence of medical qualification, pay $50, and sign an undertaking to observe the Code of Practice, comply with CEO directions and furnish outcome information of donor insemination procedures (r 2(1)(a)-(c); Form 1).

• Non-medical persons performing artificial insemination under direction: A person other than a medical practitioner may carry out an artificial insemination procedure without a licence or exemption where they act under the direction of a licensee and, where donor sperm is used, give a written undertaking to the licensee to furnish details of outcomes as possible and as required (r 2(3)(a)-(b)).

• Licensees: Practice licensees and storage licensees must apply to the Department, pay application and (presumably) licence fees set out in r 3, and be subject to register entries listing their name, address, licence kind, dates of grant and expiry, suspensions, conditions and managerial details (r 3; r 4(1)). Storage licensees will be recorded in registers and must supply information required by the Code or by direction under s 31(1)(b) regarding export and use of gametes and embryos (r 4(4)).

• The CEO and Department staff: The CEO is responsible for keeping registers in a place and manner approved by the Minister, issuing certificates of exemption (Form 2), determining the content of authorised officers’ identity certificates (r 4; r 5), and can direct compliance with the Code and monitor disciplinary matters (r 4(3)). The Department receives licence and exemption applications (rr 2(1)(a), 3(1)).

• Authorised officers and police: Persons appointed as authorised officers (or to whom s 59(2) applies) must carry certificates of identity stating their authorisation scope and whether they have access to participant identifying information (r 5). Warrants for entry are executed by authorised officers and may be issued by a Justice of the Peace in the Form 3 prescribed (r 4A; Schedule 1 Form 3).

• Individuals seeking information: Members of the public (or other entitled persons) requesting information under s 46 of the Act are subject to a prescribed fee of $75 (r 4AA(1)), though that fee is waived for information supplied under s 46(2) or s 46(3)(a) (r 4AA(2)).

• Entities involved in export or transfer of gametes/embryos: The CEO must keep registers of exported gametes, eggs in the process of fertilisation or embryos and their subsequent use or disposal, where required by the Code, by direction under s 31(1)(b) or by a licence condition (r 4(4)). This imposes reporting/recordkeeping duties on parties engaged in export and post-export dealing.

In practical terms, the regulations create compliance obligations for licensees and exempt practitioners, reporting and record-keeping duties for those involved in storage and export, administrative tasks and gatekeeping responsibilities for the Department and CEO, and operational identification and warrant processes for authorised officers carrying out inspections. The tiered fee structure in r 3 differentiates storage activities (sperm collection, donor insemination intent, storage of eggs/embryos), so businesses must classify their services accurately to determine fee exposure. The regulations also shape information access: authorised officers may receive access to participant identifying information only if that right is specified on their certificate (r 5(b)(iii)).

The regulations allocate duties, documentable undertakings and administrative rights across participants and regulators. Key duties and rights, with their regulatory references, are:

• Duty to lodge applications with the Department: Applications for exemptions under s 28(1) and for licences or licence renewals must be lodged with the Department (r 2(1)(a); r 3(1)). This centralises intake.

• Duty to use prescribed forms and undertakings: Exemption applications must be in writing substantially in accordance with Schedule 1 Form 1 and contain the undertaking prescribed there (r 2(1)(b); Form 1). The undertaking includes observing the Code of Practice, complying with CEO directions, furnishing outcome details of donor insemination procedures to storage licensees or the CEO and complying with consent requirements (Form 1).

• Duty to provide evidence of qualification and fee: An exemption application must be accompanied by evidence of medical qualification and a $50 fee and be signed (r 2(1)(c)(i)-(ii), (d)). Licence applications have prescribed fees: practice licence $1 800 (r 3(2)); storage licence fees vary by activity (r 3(3)).

• Right of exemption and conditions: The CEO may issue a certificate of exemption under s 28(1) in the form of Schedule 1 Form 2 (r 2(2); Form 2). That certificate embodies conditions specified in s 33 of the Act and any further specific conditions listed on the certificate (Form 2).

• Duty on non-medical operators acting under direction: A person other than a medical practitioner may perform artificial insemination without a licence, provided they act under a licensee’s direction and, for donor sperm, give a written undertaking to the licensee to furnish outcome details as possible and required (r 2(3)(a)-(b)). This creates a reporting duty to the licensee.

• Duty to maintain registers and particulars: The CEO must keep registers and the regulations prescribe exhaustive content fields for licence registers (r 4(1)), exemption registers (r 4(2)), and disciplinary proceedings registers (r 4(3)). These include names, addresses, licence kinds, dates of grant/expiry, suspensions, conditions, managerial responsibility and monitoring outcomes.

• Right to information and fee: A person may be furnished with information under s 46 of the Act for a fee of $75 (r 4AA(1)), with the fee waived in certain circumstances (r 4AA(2)). This is a specified right to obtain information subject to cost recovery and waiver rules.

• Duty to keep export-related records: The CEO is required to keep registers relating to export of gametes, eggs and embryos and their subsequent use or disposal where required by the Code, by direction under s 31(1)(b) or by a licence condition (r 4(4)). This imposes obligations on parties whose activity triggers the CEO’s recordkeeping duties.

• Rights and limits of authorised officers: Authorised officers receive a certificate of identity that must specify the officer’s name, photograph, whether they are generally authorised or authorised only for specific functions, and whether they have right of access to participant identifying information (r 5(a)-(b)). These certificates set and communicate the scope of an officer’s powers and access rights.

• Right to enter premises under warrant: Warrants authorising entry under s 55(1) must use Schedule 1 Form 3 (r 4A; Schedule 1 Form 3). The warrant as drafted authorises entry, exercise of s 55(2) powers and use of necessary force and continues until the purpose is satisfied (Schedule 1 Form 3). Execution of that warrant confers legal authority to exercise statutory inspection powers.

• Ministerial approval of register manner: The CEO keeps registers “in a place and manner approved by the Minister” for export records (r 4(4)), meaning the Minister has an approval role over where and how those registers are stored.

Collectively, these duties require administrative action, documentary compliance and record-keeping from practitioners and licensees; they vest the CEO and authorised officers with rights to collect, record and inspect information and premises; and they place limits or disclosure conditions on access to participant-identifying information by requiring explicit authorisation to be indicated on identity certificates (r 5(b)(iii)).

The regulations themselves prescribe forms, fees and administrative processes; they do not create standalone criminal penalties within the text provided. Enforcement mechanics are embedded by reference to the enforcement powers and obligations in the principal Act. The regulations operationalise enforcement by establishing:

• Inspection and entry powers executable under warrant: Warrants for entry under s 55(1) are to be in Schedule 1 Form 3 (r 4A; Schedule 1 Form 3). The Form 3 warrant authorises entry to premises, exercise of powers in s 55(2) of the Act and the use of such force as may be necessary, and it continues in effect until the purpose is satisfied (Schedule 1 Form 3). The warrant form therefore implements the Act’s inspection/enforcement powers and creates a procedural template for authorised officers and issuing Justices of the Peace.

• Authorised officer identification and access control: r 5 prescribes the requirement for certificates of identity to show the scope of an authorised officer’s powers and whether they have access to participant identifying information. This is an enforcement control designed to limit or permit access to sensitive information and to make exercises of enforcement authority auditable.

• Registers for disciplinary action and public record: r 4(3) requires the register of disciplinary proceedings to record the nature of allegations, disciplinary actions taken, whether summary determinations were made, summary penalties imposed by the CEO, allegations made to the State Administrative Tribunal, and the outcomes of such allegations and reviews. This establishes a documented trail of enforcement actions and provides a record that is capable of informing subsequent administrative or judicial review.

• Fee-based information disclosure: r 4AA prescribes a fee for information supplied under s 46 and conditions for fee waiver. This structure allows the CEO to manage disclosure of information in a cost-recovery framework and to limit improper proliferation of records by attaching a fee.

• CEO summary powers and Tribunal referral: The disciplinary-register requirements (r 4(3)(e)-(h), (l)) demonstrate that the CEO may exercise summary powers and may also refer matters to the State Administrative Tribunal. The register must record whether summary warnings or penalties were imposed and whether matters were referred and the outcomes in the Tribunal, implying that the CEO’s enforcement choices range from summary administrative sanctions to Tribunal adjudication (r 4(3)).

Because the regulations reference and give procedural content to the Act’s enforcement provisions (for example, s 55 warrants, s 46 information disclosure, s 28 exemptions and s 33 conditions), enforcement outcomes and penalties (including any criminal penalties, suspensions or revocations) depend on the Act’s substantive enforcement provisions. The regulations ensure those enforcement powers are exercised through prescribed forms, documented registers and identity controls for authorised officers, thereby shaping how penalties and enforcement measures are implemented administratively.

The regulations operate only in conjunction with the Human Reproductive Technology Act 1991 and, where expressly referenced, with the Code and with administrative processes involving the State Administrative Tribunal. Interactions visible within the text are:

• Direct dependence on the Act: The regulations repeatedly reference and implement powers and duties in the Act. Applications for exemption are made under s 28(1) of the Act and certificates of exemption are issued under that section (r 2(1), (2)). The register requirements implement s 45(1)(b)(i), (ii) and (d) of the Act (r 4(1)-(3)). Warrants under s 55(1) must be in the prescribed form (r 4A). Authorised officer certificates relate to s 59(2) (r 5). Information disclosure fee relates to s 46 (r 4AA). The regulatory text therefore prescribes procedural content to the Act’s substantive scheme.

• Interface with the Code: The exemption application form (Form 1) binds applicants to observe and comply with the Code of Practice and any direction from the CEO in so far as it relates to the relevant artificial insemination procedure (Form 1). r 4(4) requires the CEO to keep export registers for gametes and embryos where required by any provision of the Code. Thus the Code is a normative instrument whose requirements are enforced administratively via the regulations.

• Administrative law and tribunal process: The disciplinary register fields track proceedings, summary determinations and referrals to the State Administrative Tribunal and outcomes of Tribunal reviews (r 4(3)(e)-(h), (l)). This integrates the disciplinary functions under the Act with administrative review and adjudication processes conducted by the Tribunal.

• Health and fees legislation: The compilation table documents multiple amending instruments titled Health Regulations Amendment (Fees and Charges) Regulations (2017, 2018, 2020, 2021, 2023, 2024, 2025). The presence of those instruments in the compilation table and the amendment annotations on r 3 indicate that licence and storage fees are adjusted by health-fees instruments. The regulations therefore sit inside a broader statutory scheme for health-related fees and charges.

• Ministerial approval and departmental administration: r 4(4) requires that export registers be kept in a place and manner approved by the Minister, creating an executive oversight interaction where the Minister has a supervisory approval role over the CEO’s recordkeeping of export registers.

• Cross-references to other Acts not enacted or uncommenced: The uncommenced provisions table references the Assisted Reproductive Technology and Surrogacy Act 2025 s 279(1)(c) as assented to but to be proclaimed (compilation table). That indicates future statutory overlays may interact with these regulations once proclaimed, but as at the document these provisions remain uncommenced. The compilation table thus traces a legal environment where other statutes may, once commenced, change the regulatory context.

The regulations therefore function as an implementing instrument; they do not create stand-alone legal regimes but provide forms, fees and processes that give effect to statutory powers in the Act and to subordinate normative instruments like the Code. They also interact with health-fee instruments which have been used repeatedly to adjust monetary amounts in r 3 and r 4AA.

The compilation table and marginal amendment notes in the text show a multi-stage amendment history focused principally on fees, form updates, additions of interpretive definitions and procedural forms. Key amendment events and their mechanical effects, as recorded in the document, are:

• 1995 amendment: Human Reproductive Technology (Licences and Registers) Amendment Regulations 1995 (Gazette 12 May 1995 p. 1775), which is recorded as amending r 4 (r 4 amended: Gazette 12 May 1995 p. 1775). The content of that 1995 amendment is not detailed in the text, but the marginal note records the amendment to the register provisions.

• 2004 amendments effective 1 Jan 2005: The 2004 Amendment Regulations (Gazette 30 Dec 2004 p. 6939) updated the regulations with effect from 1 Jan 2005 (see compilation table). The schedule notes r 4 was amended on 30 Dec 2004 (r 4 amended: Gazette 30 Dec 2004 p. 6939), and Schedule 1 forms were later amended in 2006 and 2018.

• 2006 amendments: The term Department was inserted via r 1A on 15 Dec 2006 (r 1A inserted: Gazette 15 Dec 2006 p. 5628). Regulations r 2 and r 4 were amended (r 2 amended: Gazette 15 Dec 2006 p. 5628; r 4 amended: Gazette 15 Dec 2006 p. 5628-9). Schedule 1 Forms 1 and 2 were amended on that date (Form 1 and Form 2 amended: Gazette 15 Dec 2006 p. 5629).

• 2014 amendment: Human Reproductive Technology (Licences and Registers) Amendment Regulations 2014 published 15 Jul 2014, with parts commencing 15-16 Jul 2014 (compilation table). The marginal annotations show r 3 amended on 15 Jul 2014 (r 3 amended: Gazette 15 Jul 2014 p. 2465).

• 2017-2025 health fee amendments: Multiple Health Regulations Amendment (Fees and Charges) Regulations altered fees across years: 2017 (Pt. 8) effective 1 Jul 2017; 2018 (Pt. 8) effective 1 Jul 2018; 2020 Pt.5 effective 1 Jul 2020; 2021 Pt.5 effective 1 Jul 2021; 2023 Pt.6 effective 1 Jul 2023; 2024 Pt.6 effective 1 Jul 2024; 2025 Pt.6 effective 1 Jul 2025. These instruments repeatedly amended r 3 and likely r 4AA fee amounts. Specific amendment annotations on r 3 list several SL instruments up to SL 2025/104 r.14, indicating the storage and practice licence fees were the subject of periodic adjustment.

• 2018 amendments: Human Reproductive Technology (Licences and Registers) Amendment Regulations 2018 (Gazette 18 Sep 2018 p. 3512‑14) inserted r 4A (Form of warrant) and Schedule 1 Form 3 was added (r 4A inserted: Gazette 18 Sep 2018 p. 3513; Form 3 inserted: Gazette 18 Sep 2018 p. 3514). r 1 was also amended (Regulation 1 amended: Gazette 18 Sep 2018 p. 3513).

• 2023 amendment: Human Reproductive Technology Amendment Regulations 2023 (SL 2023/5) inserted r 4AA prescribing the fee for information under s 46 and a waiver (r 4AA inserted: SL 2023/5 r.4). This added a discrete information fee ($75) and waiver conditions.

• Form and other textual amendments: Schedule 1 forms were amended in 2006 and 2018 (Form 1 and Form 2 amended: Gazette 15 Dec 2006 p. 5629; 18 Sep 2018 p. 3513). r 5 was amended in 2006 (r 5 amended: Gazette 15 Dec 2006 p. 5629). r 4A and Form 3 insertion in 2018 introduced a standard warrant form for s 55 entries.

The compilation table documents each amending instrument, its publication date and commencement date. The repeated inclusion of health-fee instruments in later years indicates the fee schedule for licences and information has been kept under review and adjusted by separate fees-and-charges instruments rather than by wholesale redrafting of the regulations. The 2018 insertion of a standard warrant form and the 2023 insertion of an information fee are the most recent substantive additions to the regulatory mechanics.

The regulations themselves do not record or report any litigation, and there are no decisions, cases or judicial reviews included in the text provided. The regulations do, however, anticipate and interact with administrative adjudication by the State Administrative Tribunal and require registers to record Tribunal proceedings and outcomes:

• The disciplinary register prescribed at r 4(3) must record whether any allegation was made to the State Administrative Tribunal by the CEO, the outcome of any allegation to the Tribunal, and the nature and outcome of any review by the Tribunal (r 4(3)(g)-(h), (l)). This confirms that the Tribunal is the statutory forum for certain disputes under the Act and that the regulations require transparent recording of Tribunal activity.

• The CEO’s exercise of summary powers and the subsequent possibility of Tribunal referral are embedded in the register entries: the register must show whether any summary determination was made, any consent given or cause shown, and whether summary warnings or penalties were imposed by the CEO summarily (r 4(3)(e)-(f)). Those items will be relevant in any Tribunal or judicial review of administrative action.

Because the regulations are administrative and procedural, litigation arising out of their operation would typically take place under the Act or in the Tribunal or courts on grounds such as judicial review of administrative decisions, appeals from disciplinary action, or privacy and information disputes arising from register disclosures and information supplied under s 46. The regulations themselves require recordation of such litigation events (r 4(3)), but the document contains no external list of cases or litigation history. For a practitioner or researcher looking for case law, the appropriate sources are Tribunal and court databases and the Act’s published records; the regulations instruct how such matters will be recorded, not how they have been decided.

Practitioners and administrators should note the following practical pitfalls and implementation details embedded in the regulations:

• Compliance with “substantially in accordance” standard: Exemption applications must be “in writing, substantially in accordance with Schedule 1 Form 1” and contain the undertaking prescribed (r 2(1)(b)). The toleration for variation is “substantially”, not “exactly”, but the undertaking and particulars in Form 1 (including the obligation to observe the Code and to furnish outcome details) are mandatory. Missing or materially different undertakings may risk rejection or delay.

• Evidence of medical qualification required: An exemption application must be accompanied by evidence of the applicant’s medical qualification (r 2(1)(c)(ii)). An applicant that neglects to provide acceptable evidence will not meet the formal requirements for an exemption application.

• Fee waivers are limited and specific: The fee for information under s 46 is $75, but it is waived only where the information is furnished under s 46(2) or s 46(3)(a) (r 4AA). Practitioners should check the Act’s s 46 wording to see whether their particular request qualifies under those subsections before assuming a waiver applies.

• Storage licence fee depends on service classification: r 3(3) differentiates storage licence fees depending on whether sperm will be collected at the premises and whether it is intended for donor insemination, and whether eggs or embryos are stored. Misclassifying services can lead to underpayment or overpayment and possible enforcement or administrative rectification. Businesses must identify whether sperm collection for donor insemination occurs on their premises to determine fee exposure (r 3(3)(a)-(b)).

• Non-medical operators carrying out procedures must formally undertake reporting: r 2(3) allows non-medical persons to perform insemination without a licence when acting under a licensee’s direction, but the person must give a written undertaking to the licensee to furnish outcome details where donor sperm is used. That written undertaking creates a traceable reporting obligation; failure to provide outcomes could lead to licence-holder exposure.

• Register content is detailed and potentially privacy-sensitive: The licence and disciplinary registers require specific data points, including names, addresses, conditions and outcomes of monitoring or review (r 4(1)-(3)). Those entries may be accessible under s 46 requests subject to fees and waivers; controlled or uncontrolled disclosure may raise privacy considerations. Authorised officer certificates may or may not permit access to participant identifying information (r 5(b)(iii)).

• Warrants authorise force and remain effective until purpose satisfied: The prescribed warrant (Schedule 1 Form 3) expressly authorises the use of such force as may be necessary and continues until the purpose for which it was granted is satisfied (Schedule 1 Form 3). Premises operators should be aware that execution of a properly issued warrant can involve forcible entry and prolonged presence until inspection objectives are met.

• Ministerial approval of register manner: Export register storage must be in a “place and manner approved by the Minister” (r 4(4)). Administrative arrangements may therefore change depending on Ministerial approvals, and operators dealing with exports should monitor Ministerial directions and CEO notice.

• Multiple fee amendments mean periodic updates: The compilation table shows repeated amendments by Health Regulations Amendment (Fees and Charges) instruments from 2017 to 2025. Fee figures in r 3 and r 4AA may be subject to annual or periodic update and practitioners should confirm current fees at the time of application.

• Silence on public availability/access protocol: The regulations prescribe register content and a fee for information under s 46, but do not themselves set out public access protocols for those registers. Access mechanisms, exceptions and redaction rules will be determined by s 46 of the Act and by administrative practice; do not assume registers are fully public or private without consulting the Act and CEO practice.

• Disciplinary register fields presuppose CEO discretion and summary powers: r 4(3) requires recording of CEO summary determinations and penalties. Users should assume the CEO can act summarily in at least some circumstances and that such actions are to be recorded and may be subject to Tribunal challenge.

These are operational details, not policy judgements. Each “gotcha” is traceable to a regulation clause or a Schedule form and should be fact-checked against the Act’s substantive provisions (s 28, s 33, s 46, s 55, s 59 etc.) when advising clients or designing compliance systems.

Below is a practical compliance checklist and recommended administrative steps, tied to the regulatory provisions, for practitioners, clinics, licensees and authorised officers:

1. Understand institutional responsibilities and roles

   • Identify the Department responsible for receiving applications (r 1A, r 2(1)(a), r 3(1)).
   • Confirm who the CEO is and who in your organisation is “person responsible” for supervision and recordkeeping, since the registers require naming the person responsible and any approved manager (r 4(1)(f); r 4(2)(g)).

2. Exemption applications (medical practitioners)

   • Prepare an exemption application “substantially in accordance” with Schedule 1 Form 1, including the undertaking to observe the Code of Practice, comply with CEO directions and furnish outcome details for donor insemination (r 2(1)(b); Form 1).
   • Attach evidence of medical qualification and pay the $50 fee specified at r 2(1)(c)(i)-(ii).
   • Sign the application (r 2(1)(d)).
   • Keep a copy of the application and any correspondence; the Form 1 undertaking creates ongoing obligations.

3. Practice and storage licence applications

   • Lodge licence applications with the Department (r 3(1)).
   • Determine fee classification for storage licences:
     • Practice licence: $1 800 (r 3(2)).
     • Storage licence: $225 if sperm will not be collected at the premises or if sperm collected is not intended for donor insemination (r 3(3)(a)).
     • Storage licence: $1 120 if sperm intended for donor insemination is to be collected on premises (r 3(3)(b)).
     • Storage licence: $1 120 if eggs or embryos are to be stored (r 3(3)(c)).
   • Confirm current fee amounts with the Department before payment given the frequent fee amendments recorded in the compilation table.
   • Ensure application materials include the address of the premises and the name of the person responsible or manager (r 4(1)(f), (g)).

4. Reporting and recordkeeping

   • Maintain internal records to supply information required to be recorded in CEO registers: full name and address of licensee, licence kind, dates of grant and expiry, dates and periods of any suspension, currently applicable conditions, names/periods of persons responsible or managers, premises addresses and dates/outcomes of monitoring or review (r 4(1)(a)-(h)).
   • For exemption holders, track the kind of procedures covered, dates and particulars of certificates and any conditions or premises details (r 4(2)(a)-(h)).
   • For disciplinary matters, keep clear records to facilitate accurate entries in the CEO’s disciplinary register: nature of allegations, disciplinary action taken and dates, summary determinations or penalties, Tribunal allegations and outcomes, and review outcomes (r 4(3)(a)-(l)).

5. Export and post-export dealings

   • If your activities involve export of gametes, eggs in process of fertilisation or embryos, establish procedures to capture information the CEO may require under the Code, a direction under s 31(1)(b) or licence condition, because the CEO must keep export registers in a place and manner approved by the Minister (r 4(4)).
   • Retain traceable records of subsequent use or disposal post-export so that the CEO’s register obligations can be met.

6. Non-medical operators performing procedures

   • If your entity allows a non-medical person to perform artificial insemination under a licensee’s direction, ensure the person provides a written undertaking to the licensee to furnish outcome details when donor sperm is used (r 2(3)(b)).
   • Incorporate this undertaking into clinical governance and supervisory arrangements.

7. Information requests and fees

   • For requests under s 46, be prepared to pay a $75 fee (r 4AA(1)) unless the request falls within s 46(2) or s 46(3)(a), which attract fee waivers (r 4AA(2)). Confirm qualifying grounds for waiver by reference to the Act.
   • Maintain responsive processes to produce information to the CEO as required and to manage third-party requests under s 46.

8. Authorised officers and identity certificates

   • Ensure authorised officers carry certificates of identity containing the required fields: full name, photograph, whether generally authorised or limited to specific functions, whether they may access participant identifying information, holder’s signature and the CEO’s signature and date (r 5(a)-(d)).
   • Ensure operational procedures respect any limits on authorised officers’ access to participant identifying information as recorded on their certificate (r 5(b)(iii)).

9. Warrants and inspection readiness

   • Prepare premises and records to be readily accessible for inspection where a valid warrant under s 55(1) is produced in Schedule 1 Form 3. The warrant authorises entry and use of necessary force and continues until the purpose is satisfied (r 4A; Schedule 1 Form 3).
   • Train staff on rights and obligations during inspection, including the identity verification of authorised officers and request to view the warrant.

10. Monitor Ministerial approvals and regulatory changes

    • Because export register place/manner requires Ministerial approval (r 4(4)) and fees have been subject to repeated amendment (compilation table), maintain a monitoring process for regulatory updates and Ministerial directions to ensure ongoing compliance with current administrative requirements.

11. Documentation and audit

    • Keep copies of all licence/exemption applications, correspondence with the Department and CEO, undertakings received from non-medical operators, outcomes of procedures as reported to storage licensees or CEO, and internal logs of inspections and warrants. These documents will feed into the CEO’s registers and support defensible positions if enforcement action or Tribunal review arises.

This set of steps aligns with the express requirements of the regulations. For any matter implicating the substantive provisions of the Act (for example, the content of conditions attached to an exemption per s 33, or the bases for CEO summary penalties), consult the Act text and any applicable Code of Practice referenced in Form 1 and the regulations.