South Australian Public Health (Notifiable and Controlled Notifiable Conditions) Regulations 2025

The regulations operate through naming, definition and limited prescriptive delegation. The main legal constructs are: notifiable conditions, controlled notifiable conditions, notifiable adverse events following immunisation (AEFI) and prescribed classes of reporters. The regulations are short and mostly declaratory; they do not contain standalone procedural rules for notification or sanctions, but they connect to the Act by expressly declaring which conditions and classes fall within the Act’s notification and control provisions.

Notifiable and controlled notifiable conditions

• Regulation 4 lists the matters declared to be notifiable conditions for purposes of section 63 of the Act. The list is categorical and enumerative. It includes infectious agents and syndromes from common sexually transmitted infections and vaccine‑preventable diseases to rare high‑consequence agents (reg 4).
• Regulation 5 performs the parallel role for controlled notifiable conditions under section 70 of the Act. This list is a subset of the notifiable list and indicates which conditions attract the statutory powers to impose control measures under the Act (reg 5).

Definitions and clinical sources

• Regulation 3 supplies key definitions used in the instrument. Important definitional links include the Australian Immunisation Handbook as the authoritative source for classifying AEFI as "very common" or "common" and the Australian Register of Therapeutic Goods as the register for point‑of‑care tests (reg 3). The definition of "notifiable adverse event following immunisation or notifiable AEFI" is negative: it means an AEFI that is not a very common or common AEFI, as classified by the Handbook or ATAGI clinical advice (reg 3).
• The regulation defines "point‑of‑care test" narrowly: it must be an ARTG‑listed test performed by, or on behalf of, a medical practitioner at the time of the consultation (reg 3). That definition matters because the existence or non‑existence of a point‑of‑care basis for suspicion affects the exemption status of medical practitioners under regulation 7.

Prescribed classes of persons and responsible persons

• Regulation 6 prescribes two narrow classes of persons as persons of a prescribed class for the purposes of section 64(1)(c) of the Act, but only in respect of suspicion that someone is suffering, or has died from, a notifiable AEFI. The two classes are (1) registered health practitioners authorised under reg 18(3) of the Controlled Substances (Poisons) Regulations 2011 to administer a prescription drug as part of an immunisation program, and (2) pharmacists authorised under reg 18(3a) of those Regulations to administer vaccines (reg 6(1)).
• Subregulation 6(2) relieves such a prescribed person of the duty to report a suspected notifiable AEFI if they know or reasonably believe a report has already been made to the Chief Public Health Officer by a medical practitioner or another person of the same prescribed class. Subregulation 6(3) assigns the "responsible person" for the purposes of section 64(10)(c) of the Act to be the practitioner or pharmacist themselves.

Targeted medical practitioner exemptions

• Regulation 7 uses the exemption power in section 109(2)(t) of the Act to exempt medical practitioners from the application of section 64(1) of the Act in specific, limited circumstances. The exemptions are conditional on the basis of the suspicion and whether a report has already been made by a pathology service or another practitioner (reg 7(1)). Regulation 7(2) narrowly lists which notifiable conditions are "designated" for these exemption rules. Notably, chlamydia is only a designated notifiable condition under regulation 7(2)(a) for persons aged 17 or older.

Cross‑jurisdictional recognition

• Regulation 8 declares a list of other Australian states and territories’ public health statutes to be "corresponding laws" for the purpose of section 83(1) of the Act (reg 8). That has the legal effect of specifying which interstate public health statutes the Act will treat as equivalent for the identified statutory purpose.

Repeal

• Schedule 1 repeals the 2012 regulations (Schedule 1). The instrument therefore functions as the current declaratory instrument replacing the 2012 list.

The core mechanism is declaratory naming rather than procedural regulation. The instrument binds those who are subject to the Act by making explicit which conditions and which narrow classes of persons are encompassed by the notification and control provisions. Many operational matters, such as the timing, form and penalties for notification, are not specified in these regulations and are therefore to be located in the Act or other subordinate instruments referenced by the Act.

The regulations affect three categories of people and institutions explicitly: persons who are or may be infected with the listed conditions, health practitioners and pharmacists with notification or exemption implications, and public health authorities who receive and act upon reports.

Persons with listed conditions

• Any person suffering from, or who has died from, a disease listed in regulation 4 (notifiable conditions) or regulation 5 (controlled notifiable conditions) is the subject of the notification regime. The regulations determine which conditions trigger the broader notification duties in the Act (reg 4 and reg 5), and thus who is within the Act’s reporting and potential control perimeter.

Health practitioners and pharmacists

• Medical practitioners: Regulation 7 modifies the notification duty found in section 64(1) of the Act by exempting medical practitioners from that duty in limited circumstances, for example when the suspicion is not formed on the basis of a point‑of‑care test for a designated notifiable condition, or when the practitioner knows another report has already been made by a pathology service or another authorised reporter (reg 7(1)). Therefore medical practitioners remain a primary audience of the notification regime, but the regulations narrow when they must personally lodge a report.
• Registered health practitioners authorised to administer prescription drugs as part of immunisation programs: Regulation 6(1)(a) prescribes these individuals as persons of a prescribed class for suspicions of notifiable AEFI, but their reporting obligation is excused if they know a report has already been made by a medical practitioner or another prescribed person (reg 6(1)-(2)).
• Pharmacists authorised to administer vaccines: Regulation 6(1)(b) prescribes these pharmacists as a class for the purpose of notifiable AEFI. Regulation 6(3)(b) sets the pharmacist themselves as the responsible person for the purposes of section 64(10)(c) of the Act.

Pathology services and responsible officers

• Pathology services are implicitly affected through regulation 7(1)(b), which provides that a medical practitioner is exempt from the section 64(1) reporting obligation in respect of a point‑of‑care test based suspicion if the practitioner knows or reasonably believes that a report has already been made by a pathology service. That creates a functional interaction between clinical testing laboratories and reporting responsibilities.

Chief Public Health Officer and public health administration

• The Chief Public Health Officer is the recipient of reports from clinicians and pathology services under the notification framework the regulations operate within. Multiple provisions reference reports to the Chief Public Health Officer: regulation 6(2) refers to a report having been made to the Chief Public Health Officer by a medical practitioner or another prescribed person; regulation 7(1)(b) refers to a report made to the Chief Public Health Officer by a pathology service. These references centralise the Chief Public Health Officer as the statutory decision point for receiving notifications.

Commonwealth and interstate regulators

• The regulations reference Commonwealth instruments, notably the Australian Register of Therapeutic Goods (ARTG) maintained under section 9A of the Therapeutic Goods Act 1989, as relevant to the definition of point‑of‑care tests (reg 3). They also declare a set of interstate public health statutes to be corresponding laws (reg 8), which affects cross‑jurisdictional treatment and recognition of reporting and control measures.

Third parties and the public

• The public and institutions that may host or respond to public health action are indirectly affected because the list of notifiable and controlled notifiable conditions determines when statutory powers under the Act (for example, those in sections 63 and 70 of the Act) are available to public health authorities. The regulations do not themselves specify the measures that may be taken, but by declaring the conditions they determine the occasions on which those measures may be invoked.

Who decides and who pays

• Who decides: the Chief Public Health Officer and the public health agency exercise decision authority in receiving reports and, under the Act, implementing control measures. The regulations assign definitional and reporting parameters to inform those decisions (see regs 3, 4, 5, 6 and 7).
• Who pays: the regulations do not identify fees, penalties or cost recovery mechanisms. They impose reporting duties and exemptions that shape who must take action and when, but the instrument itself does not set out financial obligations or enforcement sanctions. Costs of compliance (time spent reporting, coordination with pathology services and checking ARTG listings or the Australian Immunisation Handbook) will fall on clinicians, pharmacists and public health administration.

Geographic and jurisdictional scope

• These regulations apply in South Australia and incorporate recognition of other Australian public health statutes as corresponding laws (reg 8). The declared corresponding laws potentially affect cross‑border recognition of public health measures under the Act.

This instrument primarily affects duties under the South Australian Public Health Act 2011 by specifying which conditions and classes of persons are in scope, and by creating narrow exemptions. The regulations neither create broad new duties nor independently define enforcement, rather they refine and delimit the operation of statutory duties referenced to sections of the Act.

Duties created or clarified by the regulations

• Declaration duties: By declaring a set of conditions as notifiable for the purposes of section 63 of the Act (regulation 4) and as controlled notifiable conditions for the purposes of section 70 of the Act (regulation 5), the regulations bring those conditions within the duty and powers in the relevant Act provisions. The practical duty that attaches (for example a duty to notify) remains anchored in the Act; the regulation’s effect is to determine the catalogue of conditions to which the Act applies.
• Reporting corridor for AEFI: Regulation 6 prescribes two specific classes of persons who, in respect of suspicion of a notifiable AEFI, count as persons of a prescribed class for section 64(1)(c) of the Act. That means these practitioners can be treated as having a reporting nexus under that section, subject to the limitation in subregulation 6(2).

Exemptions and limitations on duties

• Medical practitioner exemptions: Regulation 7(1) uses the section 109(2)(t) exemption power to remove the operation of section 64(1) of the Act from medical practitioners in narrowly defined situations:
  • If a medical practitioner has a suspicion (other than a suspicion formed on the basis of a point‑of‑care test) that a person has a "designated notifiable condition" as listed in regulation 7(2), the practitioner is exempt from the section 64(1) duty (reg 7(1)(a) and reg 7(2)). This means a practitioner need not personally make the statutory report in these specified circumstances.
  • If a suspicion is formed on the basis of a point‑of‑care test for a designated notifiable condition, the practitioner is exempt only if they know or reasonably believe that a pathology service has already made a report to the Chief Public Health Officer (reg 7(1)(b)).
  • When the suspicion is that a person is suffering from a notifiable AEFI, a medical practitioner is exempt from section 64(1) if they know or reasonably believe that a report has already been made to the Chief Public Health Officer by another medical practitioner or a person of a class prescribed under regulation 6(1) (reg 7(1)(c)). This mirrors the reciprocal non‑duplication rule in regulation 6(2).
• Reciprocal non‑duplication: Both regulation 6(2) and regulation 7 establish an operational rule to avoid duplicate reporting: prescribed classes and medical practitioners need not submit a report if they know a report already exists from an authorised counterpart. The practical effect is to avoid redundant notifications being made to the Chief Public Health Officer, subject to the knowledge or reasonable belief requirement.

Rights implicit in the instrument

• Right to rely on others’ prior reporting: The regulations create a practical right for certain practitioners to refrain from reporting if, on knowledge or reasonable belief, another authorised person or pathology service has already reported (regs 6(2), 7(1)(b)-(c)). This is a defensive right against duplication rather than a positive entitlement to require others to report.
• Definition reliance: By defining notifiable AEFI in negative terms tied to the Australian Immunisation Handbook and ATAGI clinical advice (reg 3), the regulations give practitioners a defined clinical reference to assess whether an AEFI needs notification. Practitioners can therefore look to that Handbook and ATAGI advice to determine whether an AEFI is "very common" or "common" and thus excluded from the notifiable AEFI category.

Delegation and responsibility

• Responsible person assignment: Regulation 6(3) specifies that, for the prescribed classes under regulation 6(1), the responsible person under section 64(10)(c) of the Act is the registered health practitioner or the pharmacist themselves. That identifies who is the decision point within those classes for compliance or responsibility.

Limitations and omissions

• No procedural detail in the regulations: The regulations do not set out notification procedures, reporting forms, timing, or follow‑up powers. Those operational duties remain in the Act or other subordinate instruments. The regulations therefore serve as definitional and scope adjustments, not as a full procedural code.
• No penalties in the instrument: The regulations do not themselves set out penalties or enforcement processes. Enforcement and any penalty regime would derive from the Act rather than from these regulations.

In sum, the regulations define when the statutory duties in the Act apply (by naming conditions), set narrow classes and reciprocal non‑duplication rules for notifiable AEFI reporting, and create specific exemptions for medical practitioners in defined circumstances. The regulations therefore alter the contours of who must act and when, while leaving the core duty and enforcement framework to the Act.

The regulations themselves do not specify penalty amounts, compliance instruments, or enforcement processes. The instrument repeatedly links the named categories and classes to provisions of the South Australian Public Health Act 2011 by stating that the declarations are "for the purposes of" specified Act sections (for example, reg 4 for section 63, reg 5 for section 70, reg 6 for section 64(1)(c), and reg 7 citing the exemption power in section 109(2)(t)). Consequently, enforcement and penalties, including any civil or criminal sanctions, are matters governed by the Act, not by these regulations.

What the regulations do indicate about enforcement architecture

• Central reporting recipient: The Chief Public Health Officer is the statutory recipient of reports referenced by these regulations. Several provisions hinge on whether a report has been made to the Chief Public Health Officer by a particular category of person (regs 6(2), 7(1)(b)-(c)). That centralisation identifies a single administrative node where compliance is registered and from which the public health agency can take statutory action under the Act.
• Non‑duplication as a compliance indicator: The regulations construct a knowledge/reasonable belief trigger that allows certain practitioners to omit reporting where an authorised report is already in the system (regs 6(2), 7(1)). Enforcement therefore will need to consider whether a non‑reporting practitioner did in fact know or reasonably believe that a report existed. This introduces evidentiary questions that enforcement bodies under the Act would need to address.
• Controlled notifiable conditions: By designating a discrete list of controlled notifiable conditions (reg 5), the regulations delineate when the Act’s specific "control" powers can be invoked. Enforcement actions that follow from a controlled notifiable condition will be governed by the statutory provisions referenced in the Act’s section 70 and related enforcement sections.

Absence of operational enforcement detail

• No notice, timing or form requirements: The regulations do not prescribe the timing for making reports, the form or the content of a notification, or the procedural steps for the Chief Public Health Officer to follow after receipt. Those procedural enforcement mechanisms must be located in the Act or other subordinate instruments.
• No penalty schedules: The instrument does not set out any fines, imprisonment terms or administrative penalties. Therefore any penal outcomes for failing to notify or for contravening a direction remain matters of the Act rather than these regulations.

Implications for enforcement practice

• Investigative focus on state of knowledge: Enforcement inquiries will likely need to focus on the knowledge or reasonable belief of the practitioner in circumstances where the exemptions apply, since the non‑reporting relief depends explicitly on that mental element (regs 6(2) and 7(1)).
• Record‑keeping and inter‑agency coordination: Because exemptions depend on reports already being made by other actors, enforcement will implicate records held by pathology services, other practitioners and the Chief Public Health Officer. The absence of an explicit reporting form in the regulations suggests that proof of a prior report will rest on administrative records kept by the public health agency and by pathology services.

In short, the regulations change who is obliged to report in certain circumstances and create non‑reporting exceptions based on knowledge of prior reporting. They do not create or detail penalty regimes; enforcement and penalties must be understood by reference to the Act provisions that the regulations modify or support.

These regulations are deliberately interconnected with other statutory instruments at both state and Commonwealth levels. The instrument embeds external references that affect its practical application and cross‑jurisdictional operation.

Interaction with the South Australian Public Health Act 2011

• The regulations are explicitly drafted to operate "for the purposes of" identified sections of the Act. Regulation 4 declares the notifiable conditions for section 63 of the Act; regulation 5 declares controlled notifiable conditions for section 70 of the Act; regulation 6 prescribes persons for section 64(1)(c); and regulation 7 uses the exemption power in section 109(2)(t). Thus the regulations function as subordinate, definitional instruments to the Act and must be read in conjunction with the parent Act to determine duties, powers and penalties. The regulations provide scope and qualification to duties established in the Act rather than creating independent statutory obligations.

Interaction with Controlled Substances (Poisons) Regulations 2011 (South Australia)

• Regulation 6(1) expressly relies on authorities created under regulation 18(3) and regulation 18(3a) of the Controlled Substances (Poisons) Regulations 2011 to identify the classes of registered health practitioners and pharmacists who are prescribed persons for notifiable AEFI purposes. That embeds an interaction with a separate South Australian subordinate instrument that governs who may administer drugs and vaccines in immunisation programs. Practitioners authorised under those provisions are placed within the notification architecture by reference.

Interaction with Commonwealth therapeutic and clinical guidance instruments

• The definition of "point‑of‑care test" in regulation 3 uses the Australian Register of Therapeutic Goods, maintained under section 9A of the Commonwealth Therapeutic Goods Act 1989, to identify which tests may qualify (reg 3). This means the ARTG listing , a Commonwealth administrative register , determines whether a given test is a "point‑of‑care test" for exemption purposes.
• The classification of AEFI as "very common" or "common" is tied to the Australian Immunisation Handbook and clinical advice by ATAGI referenced in regulation 3. These are Commonwealth level clinical guidance instruments. Accordingly, clinical classifications that determine whether an AEFI is notifiable rely on evolving Commonwealth clinical guidance.

Cross‑jurisdictional recognition

• Regulation 8 expressly declares a list of interstate public health statutes to be "corresponding laws" for the purposes of section 83(1) of the Act. The statutes named include instruments from Western Australia, the Northern Territory, the Australian Capital Territory, New South Wales, Queensland, Tasmania and Victoria (reg 8). By doing so, the regulation establishes which interstate statutes will be treated as corresponding for the statutory purpose in section 83(1). This affects the legal recognition and potentially the enforcement of public health orders or notifications that have a cross‑border element.

Interaction with pathology and reporting entities

• Regulation 7(1)(b) recognises the reporting activity of pathology services as relevant to whether a medical practitioner is obliged to report. Pathology services’ administrative acts therefore have dispositive effect on practitioner duties. The regulations do not define what constitutes a pathology service’s report, but they give it the practical consequence of allowing other clinicians to rely on the existence of that report and not duplicate notification.

Repeal of previous regulation

• Schedule 1 repeals the South Australian Public Health (Notifiable and Controlled Notifiable Conditions) Regulations 2012. The repeal makes these 2025 regulations the operative declaratory instrument. Any prior references to the 2012 regulation in administrative practice or enforcing instruments will need to be updated to reflect the replacement (Schedule 1).

Practical consequences of the interlocking references

• Because the regulations rely on external clinical guidance and Commonwealth registers to determine key definitions (e.g. ARTG listings, Australian Immunisation Handbook, ATAGI advice), updates to those external sources will alter the meaning and scope of the South Australian notifications regime without an amendment to the regulations themselves (reg 3).
• The prescribed classes depend on authorisations in the Controlled Substances (Poisons) Regulations 2011. Changes to those authorisations will affect which practitioners are treated as prescribed classes under regulation 6(1).

In short, the instrument is tightly networked with both the parent Act and a set of other state and Commonwealth instruments. Its definitions and exemptions operate by reference to external registers and guidance, and its cross‑border operation is facilitated by the declared list of corresponding laws.

The regulations carry a concise legislative history within the instrument. The document supplanting the 2012 regulations and the commencement details are explicitly recorded.

Key points recorded in the instrument

• Repeal of the 2012 instrument: Schedule 1 expressly repeals the South Australian Public Health (Notifiable and Controlled Notifiable Conditions) Regulations 2012 (Schedule 1). That makes the 2025 regulations the governing subordinate instrument for notifiable and controlled notifiable conditions in South Australia.
• Commencement: Regulation 2 specifies that the regulations come into operation on the day on which they are made (reg 2). The legislative history entry at the end provides the Gazette reference and confirms the principal regulations are numbered 48 of 2025 and were gazetted on 26 June 2025 with commencement on the same date (Legislative history: Principal regulations 2025 No 48 Gazette 26.6.2025 p2099; reg 2).
• Citation: Regulation 1 provides the short title as the South Australian Public Health (Notifiable and Controlled Notifiable Conditions) Regulations 2025. This is the formal citation for the instrument.

What the instrument does not contain on amendment history

• The regulations do not contain a schedule of prior amendments because the instrument itself replaces the 2012 regulations. There are no recorded iterations or amendment notes within the text beyond the repeal of the 2012 instrument and the commencement/Gazette record.
• The instrument does not specify transitional provisions or savings. Therefore, any continuity issues between notifications made under the 2012 regulations and the new 2025 instrument will be resolved by general administrative practice or by the parent Act, but no explicit transitional mechanism is set out in this instrument.

Interpretive relevance

• The repeal of the 2012 regulations means administrators and practitioners should treat the 2025 instrument as the current operative list of notifiable and controlled notifiable conditions. Any prior practices based on the 2012 list must be reviewed against the 2025 list to confirm continued applicability (Schedule 1).
• The Gazette entry and immediate commencement provision (reg 2 and Legislative history) indicate there is no delayed commencement, so the 2025 lists take effect immediately upon making.

Administrative consequence

• Agencies and regulated entities should ensure their reporting templates, internal guidance and electronic notification systems reflect the 2025 lists from the noted commencement date (26.6.2025 as per Gazette). The instrument does not itself mandate system changes, but because it declares the operative lists, administrative systems that process public health notifications will need to align with the 2025 instrument.

The regulations contain no litigation history, case names, judicial interpretations, or references to court decisions within the text provided. The legislative history notes only administrative facts about gazettal and commencement (Legislative history: Principal regulations 2025 No 48 Gazette 26.6.2025 p2099; reg 2), and Schedule 1 records the repeal of the 2012 regulations. There is therefore no record in this instrument of judicial challenge, precedent, or litigation‑related amendments.

Implications of the absence of litigation history

• No statutory interpretation cases are recorded in the instrument. Any questions about ambiguous wording, the application of the knowledge/reasonable belief test in regulations 6(2) and 7(1), or the interplay between point‑of‑care tests and reporting duties will need to be resolved by administrative practice, agency guidance or, if contested, by courts in future litigation. The instrument does not supply judicial gloss or examples to guide interpretation.
• Enforcement decisions and disputes are likely to turn on factual questions (for example whether a practitioner "knows or reasonably believes" a report has been made) and on how the parent Act’s enforcement mechanisms are applied. Those legal tests are not elaborated in the regulations and therefore are potential areas for future litigation.

Practical consequence for practitioners and agencies

• In the absence of case law addressing interpretive uncertainties, regulated parties should treat the regulations as the primary legal guide and record contemporaneous evidence of why they did or did not make a notification (for example, evidence that a pathology service had already reported). Because the regulations make exemptions contingent on a practitioner's state of knowledge or reasonable belief (regs 6(2), 7(1)), documentation that supports that state of knowledge will be relevant if questions arise.
• Agencies implementing the regulations will need to produce operational guidance explaining how they will determine whether a prior report exists and the evidentiary standard they will apply when assessing non‑reporting under the knowledge/reasonable belief criteria.

In summary, the instrument itself supplies no litigation history and thus leaves open how courts will interpret contested elements of the regulations. Stakeholders will need to rely on administrative guidance and careful record‑keeping until such time as judicial decisions, if any, provide interpretive clarity.

The regulations are compact but contain multiple narrowly phrased provisions that can produce unexpected compliance outcomes. The following are specific points in the instrument that merit attention because they create potential traps for practitioners, administrators and institutions.

1. Notifiable AEFI is defined negatively

• The definition of "notifiable adverse event following immunisation or notifiable AEFI" is an AEFI that is not a "very common or common AEFI" (regulation 3). The classification of what counts as "very common" or "common" is determined by the Australian Immunisation Handbook or ATAGI clinical advice (reg 3). Practitioners must therefore refer to those external and evolving clinical sources to determine whether an AEFI is notifiable. Failure to consult the correct, current guidance could lead to incorrect reporting decisions.

2. Point‑of‑care test narrowly defined and consequential

• "Point‑of‑care test" is limited to tests that are both listed on the ARTG and performed by a medical practitioner, or a person on behalf of a medical practitioner, at the time of the consultation (reg 3). This narrow definition excludes tests performed by others outside the consultation or tests not ARTG listed. The exemption status for medical practitioners in regulation 7 differs depending on whether the suspicion is formed on the basis of a point‑of‑care test. Misclassifying a test as point‑of‑care or not could erroneously trigger or remove an exemption.

3. Exemptions hinge on knowledge or reasonable belief

• Both the non‑reporting relief in regulation 6(2) and the medical practitioner exemptions in regulation 7 require that the practitioner "knows or reasonably believes" that a report has already been made to the Chief Public Health Officer by another specified actor (regs 6(2), 7(1)(b)-(c)). That introduces an evidentiary element that can be difficult to prove or disprove. Practitioners who rely on verbal assurances or informal communications without documentation may find themselves exposed if enforcement inquiries later challenge whether a reasonable belief existed.

4. Designated notifiable conditions list for exemptions is narrower than the full notifiable list

• Regulation 7(2) lists "designated notifiable conditions" for the purpose of the medical practitioner exemptions. That list includes only selected notifiable conditions (for example, chlamydia for persons aged 17 or over, COVID‑19, influenza, RSV, rotavirus, SARS‑CoV‑2 and varicella‑zoster) (reg 7(2)). For notifiable conditions outside that designated list, the medical practitioner exemptions under regulation 7 will not apply. Practitioners must therefore be careful to differentiate whether a condition is simply in the notifiable list (reg 4) or also in the designated list for exemption purposes (reg 7(2)).

5. Age‑limited designation for chlamydia

• Chlamydia trachomatis is a designated notifiable condition under regulation 7(2)(a) only for persons aged 17 years or over. That is an explicit age qualification embedded in the exemptions. A suspicion involving a person younger than 17 will not attract the medical practitioner exemption in regulation 7 and will therefore leave the practitioner subject to section 64(1) duties under the Act unless another exemption applies.

6. Overlap and duplication in disease naming

• The notifiable conditions list repeats similar diseases under different labels, for example "Coronavirus disease 2019 (COVID-19)" and elsewhere "Severe acute respiratory syndrome coronavirus 2 infection (SARS-CoV-2)" are both included (reg 4). The controlled notifiable list includes both terms too (reg 5). While this is declaratory, it could cause confusion in administration and data systems if names are not normalised. Administrative systems must map synonymous labels to a single reporting code.

7. Prescribed classes are narrow and tied to a different regulation

• The prescribed classes in regulation 6 depend on authorisations in the Controlled Substances (Poisons) Regulations 2011 (reg 6(1)). If a practitioner’s authority to administer drugs or vaccines changes under those poison regulations, their status as a prescribed class for AEFI reporting purposes will change correspondingly. Practitioners must monitor their authorisations under that other instrument.

8. Reliance on external documents that change over time

• The Australian Immunisation Handbook and ATAGI clinical advice, and the ARTG, are external, living instruments. The regulation’s definitions track those instruments "as in force from time to time" (reg 3). This means the regulatory meaning of "notifiable AEFI" and "point‑of‑care test" can shift without amendment to the South Australian regulations. Users must check the current versions of those external sources on each occasion.

9. No explicit procedural form or timeline in the regulations

• The regulations do not state how quickly a notification must be made, what form it should take, or what information must be included. Those procedural details are therefore located in the Act or other subsidiary instruments. Practitioners may be uncertain about timing and content unless they consult the parent Act and any agency guidance.

10. Exemptions may place more operational responsibility on pathology services and the Chief Public Health Officer

• The regulation 7(1)(b) exemption makes a medical practitioner’s duty contingent on a pathology service having already reported. That places an operational burden on pathology services (and on the Chief Public Health Officer’s record systems) to ensure timely reporting that clinicians can rely upon. If pathology services fail to report promptly, clinicians cannot rely on the exemption and may be technically non‑compliant.

Each of these points arises directly from the wording of the regulations. The practical takeaways are: confirm classification of AEFI against current clinical guidance, document any reliance on another party’s report, carefully treat point‑of‑care tests under the ARTG definition, and ensure internal administrative systems map disease names consistently to avoid confusion.

Compliance under these regulations is primarily a matter of correctly identifying which conditions are in scope, determining whether a suspicion is a notifiable AEFI and whether any exemptions apply, and ensuring appropriate reporting to the Chief Public Health Officer where required. Because the regulations interact with the Act and with external clinical and regulatory references, practical compliance combines legal and clinical checks.

Step 1: Identify the condition and applicable list

• Check whether the disease or medical condition appears in the notifiable conditions list (regulation 4) and whether it appears in the controlled notifiable conditions list (regulation 5). A condition’s presence in regulation 4 brings it within the scope of section 63 of the Act; presence in regulation 5 brings it within the scope of section 70 of the Act.

Step 2: For adverse events following immunisation, classify the AEFI

• If an adverse event arises after immunisation, determine whether it is a "notifiable AEFI". The regulations define notifiable AEFI as an AEFI that is not a "very common or common AEFI" (regulation 3). Consult the current Australian Immunisation Handbook and ATAGI clinical advice to determine whether the event is classified as very common or common. If the AEFI is not listed as very common or common in those references, it is a notifiable AEFI under these regulations and therefore within the notification architecture.

Step 3: Determine whether the suspicion is formed on the basis of a point‑of‑care test

• If the suspicion is derived from testing, establish whether the test is a point‑of‑care test as defined in regulation 3. Confirm that the test is listed on the ARTG and that it was performed by a medical practitioner or on behalf of a medical practitioner at the time of consultation. If both criteria are met the test qualifies as a point‑of‑care test for the purposes of the exemptions in regulation 7.

Step 4: Check whether you are a prescribed class for AEFI and whether a report already exists

• If you are a registered health practitioner authorised under regulation 18(3) of the Controlled Substances (Poisons) Regulations 2011 to administer a prescription drug as part of an immunisation program, or a pharmacist authorised under regulation 18(3a) to administer a vaccine, you are a prescribed class for notifiable AEFI purposes (reg 6(1)). If you are in one of those classes, you are not required to make a report under section 64(1) of the Act if you know or reasonably believe a report has already been made to the Chief Public Health Officer by a medical practitioner or another person of the prescribed class (reg 6(2)). Before relying on this non‑reporting rule, ensure you have a factual basis for your knowledge or reasonable belief and document it.

Step 5: For medical practitioners, apply the medical practitioner exemptions carefully

• If you are a medical practitioner and you have a suspicion about a "designated notifiable condition" as defined in regulation 7(2), determine whether your suspicion was formed on the basis of a point‑of‑care test.
  • If the suspicion was not formed on the basis of a point‑of‑care test, you are exempt from the section 64(1) reporting duty in respect of a designated notifiable condition (reg 7(1)(a)).
  • If the suspicion was formed on the basis of a point‑of‑care test, you are exempt only if you know or reasonably believe that a pathology service has already made a report to the Chief Public Health Officer (reg 7(1)(b)).
  • If the suspicion concerns a notifiable AEFI, you are exempt from reporting if you know or reasonably believe that a report has already been made by another medical practitioner or by a prescribed person under regulation 6(1) (reg 7(1)(c)).
• Document the basis for any knowledge or reasonable belief that another party has already reported. The regulations make these exemptions contingent on that mental state.

Step 6: Make the report where no exemption applies or where you are unsure

• If no exemption applies, or if you do not have documented evidence of a prior report by the specified parties, make a report to the Chief Public Health Officer in accordance with the parent Act and any reporting procedures the Department sets out. The regulations do not define the format or timing; consult the Act and agency guidance for form, content and timing.

Step 7: Maintain records and evidence

• Because exemptions depend on "knowing or reasonably believing" that another report exists, maintain contemporaneous records of communications with pathology services, other practitioners, or internal reporting systems that demonstrate why you did or did not report. Keep documentation of clinical classification decisions referencing the Australian Immunisation Handbook or ATAGI advice for AEFI classification.

Step 8: Coordinate with pathology services and other reporters

• Where your non‑reporting is contingent on a pathology service or another practitioner having reported, consider implementing or using established processes that confirm when a report has been filed. Electronic acknowledgements from the public health reporting system, or an internal confirmation protocol with the pathology provider, will reduce uncertainty and evidentiary risk.

Step 9: Monitor external references and your authorisations

• Regularly check the ARTG to confirm whether tests you use are ARTG‑listed for point‑of‑care status, check the Australian Immunisation Handbook and ATAGI advice for classification of AEFI, and verify your authorisations under the Controlled Substances (Poisons) Regulations 2011 if you rely on those authorisations to qualify as a prescribed class (reg 3 and reg 6). Because the regulations incorporate these external instruments "as in force from time to time", changes there will affect your obligations.

Step 10: Update administrative systems and training

• Ensure internal reporting systems, clinical pathways and staff training reflect the 2025 lists of notifiable and controlled notifiable conditions (regs 4 and 5) and the specific age qualification for chlamydia in the designated notifiable condition list (reg 7(2)(a)). Map synonymous disease names used in the regulations to consistent internal codes to avoid confusion when deciding whether a condition is listed.

Practical examples of documentation to keep

• Evidence of consultation of the Australian Immunisation Handbook or ATAGI advice for AEFI classification.
• Records of the ARTG search showing a test is ARTG‑listed as point‑of‑care.
• Written notes or electronic confirmations of a pathology service report having been made to the Chief Public Health Officer.
• Internal notes recording why a practitioner reasonably believed another report existed.

These steps flow directly from the text of the regulations (regs 3, 4, 5, 6 and 7). Because the regulations do not set out the mechanics of reporting, practitioners must pair the steps above with the procedural requirements contained in the parent Act and any Departmental instructions or forms.