Therapeutic Goods Act 1989

The Therapeutic Goods Act 1989 (Cth) establishes and maintains national controls on the quality, safety, efficacy and timely availability of therapeutic goods used in or exported from Australia (s 4(1)(a)). It provides a framework for uniform State and Territory poison controls (s 4(1)(b)), a pharmacist substitution scheme for scarce medicines (s 4(1)(c)), and national controls on vaping goods import, manufacture, supply and export (s 4(1)(d)). The Act maintains the Australian Register of Therapeutic Goods under Chapter 2 (s 9A(1)), with five parts for registered goods, provisionally registered goods, listed goods, biologicals under Part 3-2A and medical devices under Chapter 4 (s 9A(3)). It regulates standards (Part 3-1), registration and listing (Part 3-2), biologicals (Part 3-2A), manufacturing (Part 3-3), exemptions, approvals and authorities for unapproved uses (ss 18, 18A, 19, 19A, 32CA-32CO), variations of Register entries (s 9D), suspensions and cancellations (ss 29D-30, 32FA-32FC), public notification and recall (ss 30EA-30EE, 32CJ), shortage and discontinuation reporting (ss 30EF-30EJ), and substitution declarations for scarce medicines (ss 30EK-30EL). Provisions apply to import, export, manufacture and supply, with Secretary powers to require information, inspect, vary entries, impose conditions and arrange State performance of functions (s 9). Part 3-2A of the Act establishes the regulatory framework for biologicals, including their inclusion in the Register, exemptions from Division 4, export and supply controls, public notification and recall powers, and information-gathering requirements. Division 9 (ss 32J-32JM) empowers the Secretary to obtain information or documents relating to applications for inclusion, included biologicals, or exempt biologicals. Part 3-3 (ss 33A-36) applies manufacturing controls to biologicals other than Class 1 biologicals. Related provisions in Part 3-2 address medicine shortages (ss 30EF-30EJ), permissible ingredients and indications (ss 26BB-26BJ), approved product information (s 25AA), and false or misleading information offences (ss 31D, 31E, 41AD-41AF, 9G, 22A, 32BJ, 32BK). This group of provisions in the Therapeutic Goods Act 1989 establishes the framework for including therapeutic goods and biologicals in the Australian Register of Therapeutic Goods, imposes ongoing conditions on such inclusions, regulates exemptions and approvals for unapproved goods, creates offences and civil penalties for non-compliant import, export, manufacture, supply and use, provides for suspension, cancellation, public notification and recall, and grants the Secretary information-gathering and manufacturing oversight powers. Part 3-2 governs registration and listing of therapeutic goods (ss 15A-32), Part 3-2A governs biologicals (ss 32-32JM), and Part 3-3 governs manufacturing (ss 33A-41A). Related provisions in Part 3-1 address standards (ss 10-15AB) and Part 2 addresses interpretation, declarations and the Register (ss 3-9H). Part 3-2 of the Therapeutic Goods Act 1989 governs registration and listing of therapeutic goods other than medical devices. Section 26A requires the Secretary to list a medicine on application under s 23 if the application complies with s 23C, is accompanied by a s 26B(1) certificate or approved-form notice, meets the requirements of s 26A(2) and where applicable (2A), (3) and (4A), and the medicine is not export-only or previously cancelled. Section 26A(1A) directs the Secretary to list without inquiring into the certificate or notice correctness. Section 26AB provides for listing under s 26AE after efficacy evaluation where the medicine is not listable under s 26A. Section 26AE requires the Secretary to evaluate efficacy and other relevant matters, decide to list or not list, and on receipt of the certificate or notice include the medicine and issue a certificate without inquiring into correctness. Section 26AF prohibits use of restricted information about another medicine in s 26AE evaluations, with restricted information defined by reference to clinical trial data for non-serious indications within five years of listing. Part 3-2A governs biologicals. Section 32DB requires the Secretary to include a Class 1 biological on valid application under s 32DA, assign a unique biological number and issue a certificate. Section 32DCA permits applications for export-only biologicals with certification of safety, presentation, standards compliance, advertising requirements, quality criteria, manufacturer nomination and prohibitions under s 9K(1) or (3). Section 32DD permits applications for other biologicals, with preliminary assessment under s 32DDA against form, fee, information and prohibition certification requirements. Section 32DE requires evaluation of quality, safety, efficacy, presentation, standards, advertising compliance, overseas manufacturing procedures and prohibitions under s 9K. Section 32DF requires inclusion if preliminary assessment is passed, evaluation supports inclusion and fees are paid. Part 3-3 governs manufacturing licences. Section 38 requires the Secretary to grant a licence covering specified sites unless the applicant will be unable to comply with manufacturing principles, sites are unsatisfactory, manufacture would contravene s 9K prohibitions or prescribed circumstances exist, and the fit-and-proper test under s 38(1)(g) is met. Section 39 provides that a licence remains in force until revoked or suspended. Section 40 imposes statutory conditions including standards and manufacturing principles compliance, adverse information notification, entry and inspection powers, and document production. Section 41 permits revocation or suspension on fit-and-proper failures, request, cessation of business, site authorisation breach, unpaid charges, exemption condition breach or s 9K contraventions. The provisions establish the regulatory framework for biologicals under Part 3-2A (ss 32A-32JK) of the Therapeutic Goods Act 1989 (Cth), covering inclusion in the Register, exemptions from Division 4, automatic and imposed conditions, suspension and cancellation from the Register, public notification and recall requirements, and obligations to notify adverse effects. Parallel provisions address general criminal offences relating to Part 3-2 (s 21A), listing of certain medicines (ss 26A-26AE), compliance with standards (ss 13-15AB), and Secretary powers to require information or documents (s 31 and Division 9 of Part 3-2A). The objects include a national system of controls for quality, safety, efficacy and timely availability of therapeutic goods (s 4(1)(a)), a framework for uniform State and Territory poisons controls (s 4(1)(b)), pharmacist substitution for scarce medicines (s 4(1)(c)), and regulation of vaping goods (s 4(1)(d)). Part 3-2 does not apply to medical devices (s 15A) or biologicals on and after commencement, subject to transitional rules for currently registered or listed biologicals until inclusion under Part 3-2A (s 15B, s 32DN). The Therapeutic Goods Act 1989 regulates the manufacture, supply, import, export and presentation of therapeutic goods, including through manufacturing licences under Part 3-3, standards under Part 3-1, registration and listing under Part 3-2, and the separate framework for biologicals under Part 3-2A. It establishes the Australian Register of Therapeutic Goods (ARTG) under s 9A, with five parts covering registered goods, provisionally registered goods, listed goods, biologicals and medical devices. The Act provides for exemptions under ss 18, 18A, 19, 19A, 32CA, 32CB and 32CK-32CO, authorities for health practitioners under s 32CM, approvals where substitutes are unavailable under s 32CO, public notification and recall powers under Division 2A of Part 3-2 and Division 8 of Part 3-2A, medicine shortage and discontinuation reporting under Division 2B, and pharmacist substitution under Division 2C. It also covers international agreement prohibitions under Chapter 2A, information-gathering powers under ss 31, 32JA-32JK and 41AB, and computer-program decisions under s 7C.

Key definitions appear in s 3(1). "Therapeutic goods" means goods represented or likely to be taken for therapeutic use, as an ingredient, component or container, or in a class with sole or principal therapeutic use; this includes biologicals, medical devices and goods declared under s 7 orders, but excludes declared non-therapeutic goods, food-standard goods, traditional foods and excluded goods under s 7AA determinations. "Therapeutic use" covers preventing, diagnosing, curing or alleviating disease, ailment, defect or injury; influencing, inhibiting or modifying a physiological process; testing susceptibility; influencing, controlling or preventing conception; testing pregnancy; or replacing or modifying anatomy. "Biological" under s 32A(1) means a thing comprising, containing or derived from human cells or tissues or specified by legislative instrument, represented or likely for therapeutic use, diagnosis, physiological influence, susceptibility testing or anatomical replacement or modification. "Medicine" means therapeutic goods (other than biologicals) represented or likely to achieve principal action by pharmacological, chemical, immunological or metabolic means. "Medical device" has the meaning in s 41BD. "Sponsor" means the person exporting or arranging export, importing or arranging import, or manufacturing or arranging manufacture in Australia for supply in or outside Australia, excluding agents acting for an Australian resident or business. "Register" means the Australian Register of Therapeutic Goods under s 9A. "Registered goods" and "listed goods" refer to the respective parts of the Register. "Included in the Register" applies to biologicals under Part 3-2A and medical devices under Chapter 4. "Standard" means an order under s 10, statements in British, European or United States Pharmacopoeia monographs (as interpreted per General Notices, subject to s 3C exemptions), or homoeopathic or anthroposophic standards. "Default standard" means British, European or United States Pharmacopoeia standards. "Presentation" means the way goods are presented for supply, including name, labelling, packaging and advertising or informational material. "Unacceptable presentation" means capable of misleading or confusing as to content, proper use or identification, including false claims, same name with different active ingredients, undeclared active ingredients, unsafe use suggestions or prescribed cases. "Manufacture" (for non-device therapeutic or vaping goods) means producing or any part of the process to final state, including processing, assembling, packaging, labelling, storage, sterilising, testing and releasing. "Supply" means sale, exchange, gift, lease, loan, hire or hire-purchase, sample or advertisement supply, testing supply, or administration or application. "Advertise" means a statement, pictorial or design promoting use or supply, including on label, package or included material. Other terms include "batch", "bioburden", "container", "label", "primary pack", "quality", "indications", "directions for use", "product information", "restricted medicine" (Ministerial legislative instrument under s 3(2A) or (2B)), "health practitioner", "ethics committee", "authorised person", "Secretary" and "working day". Therapeutic goods are taken for human use unless solely for animal use (s 3(2)). Separate and distinct goods differ in formulation, composition, design, strength, size, dosage, name, indications, directions or container (s 16(1)); listable medicines are distinguished by active ingredients, quantity, dosage or other prescribed matters (s 16(1A)). Kits and composite packs are defined in s 7B. Homoeopathic and anthroposophic preparations and standards are defined in ss 3AA and 3AB. Provisional determinations for medicines are available under ss 22C-22F for prescribed kinds, with initial 6-month periods extendable once. Class 1 biologicals, export-only biologicals and other biologicals follow distinct inclusion paths under Part 3-2A (ss 32DA, 32DCA, 32DD). Reportable medicines are registered medicines containing Schedule 4 or 8 substances or determined by the Minister (s 30EH). Shortage means supply will not meet demand in the 6 months after the relevant time (s 30EI). Biologicals are regulated through three inclusion pathways: Class 1 biologicals under s 32DA, export-only biologicals under s 32DCA, and other biologicals under s 32DD. Inclusion requires approved forms, prescribed fees, certifications of safety, standards conformity, advertising compliance, quality criteria, and s 9K prohibition compliance. Evaluation under s 32DE assesses quality, safety, efficacy, presentation, manufacturing, and prohibitions. Exemptions exist under s 32CA (regulations), s 32CB (emergencies), s 32CK (special and experimental uses), s 32CM (authorities), and s 32CO (substitutes unavailable). Sponsor obligations include proper notification of manufacturers and premises (s 32BG(3)), adverse effect notifications (s 32DQ), and shortage reporting for reportable medicines (s 30EF). Manufacturing principles under s 36 apply to non-Class 1 biologicals. Recall and notification requirements under s 32HA(1) are triggered by 11 tabled circumstances, including non-conformity to standards, manufacturing principle breaches, counterfeit goods, suspension or cancellation, and unacceptable quality, safety or efficacy. Information notices under ss 32JA, 32JE-32JH require compliance within at least 14 days in specified form. Therapeutic goods are defined in subsection 3(1) to include goods represented or likely to be taken for therapeutic use, ingredients, components or containers for such goods, or goods in classes principally for therapeutic use, subject to exclusions for certain foods, goods declared not therapeutic under section 7, and excluded goods under section 7AA. Biological means a thing comprising, containing or derived from human cells or tissues, or specified by legislative instrument, represented or likely to be taken for therapeutic use, diagnosis, physiological influence, susceptibility testing or anatomical replacement or modification in humans (s 32A(1)); regulations prescribe classes (s 32AA) and rules for when biologicals are separate and distinct (s 32AB). Medicine means therapeutic goods (other than biologicals) represented or likely to achieve principal intended action by pharmacological, chemical, immunological or metabolic means (s 3(1)). Sponsor means the person who exports, imports or manufactures (or arranges such) therapeutic goods for supply, excluding agents acting for Australian residents or businesses (s 3(1)). Manufacture (for non-devices) includes production and any part of the process to final state, including processing, assembling, packaging, labelling, storage, sterilising, testing or release (s 3(1)). Supply includes sale, exchange, gift, lease, loan, hire-purchase, sampling, advertising, testing safety or efficacy, or administration or application (s 3(1)). The Register comprises five parts: registered goods, provisionally registered goods, listed goods, biologicals under Part 3-2A, and medical devices under Chapter 4 (s 9A(3)). Standards are determined by the Minister by legislative instrument (s 10(1)) and may incorporate pharmacopoeias or other instruments as in force from time to time (s 10(4)). Provisional determinations apply to prescribed kinds of medicine (ss 22C-22F), with an initial 6-month period extendable once by up to 6 months (s 22E). Permissible ingredients and indications are determined by the Minister (ss 26BB, 26BF). Public notification and recall requirements are imposed by written notice under tables in section 30EA(1) for therapeutic goods and section 32HA(1) for biologicals. Therapeutic goods are separate and distinct under s 16 if they differ in formulation, composition, design, strength, size, dosage form, model, name, indications, directions or container type, with listable medicines separate on different active ingredients, quantities, dosage form or prescribed characteristics. Section 26BB empowers the Minister by legislative instrument to determine permissible ingredients and requirements relating to containment, concentrations or total amounts, with different provision for classes of medicine. Section 26BF empowers the Minister to determine permissible indications and requirements, with regard to maintaining or enhancing health, preventing dietary deficiency or non-serious disease, ailment, defect or injury. Section 26B requires a certificate only where the applicant relies on another person's safety or efficacy evidence, either certifying good-faith belief of non-infringement or patent grant with notice to the patentee. Section 32A defines biological as a thing comprising, containing or derived from human cells or tissues or specified by legislative instrument and represented for therapeutic use, diagnosis, physiological modification or anatomical replacement in humans. Manufacturing principles under s 36 cover standards, equipment, quality assurance, qualifications and practices. Section 30EH defines reportable medicine as a registered medicine containing a Schedule 4 or 8 substance or determined by the Minister where shortage or discontinuation notification serves public health interests. Section 30EI defines shortage as supply in Australia not meeting or unlikely to meet demand for all patients who take or may need the medicine within the following 6 months. Section 30EJ empowers the Minister to determine a Medicines Watch List of medicines where shortage or discontinuation has potential for significant morbidity or death. Biological means human cells or tissues or specified things represented for therapeutic, diagnostic or physiological use (s 3, s 32A), with classes prescribed by regulations (s 32AA) and separate and distinct rules (s 32AB). Inclusion in the Register occurs by certification for Class 1 biologicals (Subdivision B, ss 32DA-32DC), certification and manufacturing steps for export only biologicals (Subdivision BA, ss 32DCA-32DCC), or evaluation for others (Subdivision C, ss 32DD-32DM). Exemptions comprise regulations (s 32CA), emergencies or national interest (s 32CB), special and experimental uses (s 32CK, s 32CM), and unavailable substitutes (s 32CO). Conditions include automatic entry, inspection, samples, manufacturing, expiry and advertising requirements (s 32EA), plus Minister determinations (s 32EC) and Secretary-imposed conditions (ss 32ED, 32EE). Suspension applies where potential risk of death, serious illness or injury exists with likely remedial action, or likely cancellation grounds (s 32FA). Cancellation covers imminent risk, cessation as biological, exempt status, request, prohibited imports, false statements, unpaid charges, or breach of conditions (ss 32GA, 32GC). Adverse effects notification covers information contradicting prior submissions, unintended harmful effects, reduced effectiveness, or unacceptable quality, safety or efficacy (s 29A(1)-(2), s 32DQ(1)-(3)). Standards comprise Ministerial orders under s 10 or default standards from British, European or United States Pharmacopoeia monographs (s 3), with special provisions for inconsistency (s 13(2)-(7)) and homoeopathic or anthroposophic standards (s 13A). Presentation is unacceptable if misleading as to content, proper use or identification (s 3). Sponsor means the exporter, importer or Australian manufacturer for supply (s 3). Therapeutic goods include goods for therapeutic use or ingredients, components or containers thereof, and biologicals under s 32A (things comprising or derived from human cells or tissues, or specified by the Secretary, represented for therapeutic, diagnostic or physiological modification purposes). Manufacturing site means premises for a particular kind of goods with the same persons controlling production and quality control (s 3). Manufacturing licence under Part 3-3 authorises specified steps at specified sites (s 38(2B)). Manufacturing principles are determined by the Minister under s 36. Standards under s 10 cover quality, quantity, manufacturing procedures, pharmacopoeia monographs (British, European, United States, homoeopathic or anthroposophic), Standards Australia standards and labelling or packaging requirements. Biological number includes combinations of numbers, letters and symbols (s 32BJ(2)). Reportable medicine is a registered medicine containing Schedule 4 or 8 substances or determined by the Minister (s 30EH). Shortage means inability to meet demand within six months (s 30EI). Kit is a package and goods for use as a unit where at least one item is therapeutic goods that are registered, listed, exempt or included (s 7B(1)). Protected information is five-year exclusivity data for new active components (s 25A). Restricted information is five-year exclusivity clinical-trial data for indications (s 26AF). Provisional registration lasts two years, extendable to a maximum of six years (s 29(2)-(3)).

The Act binds the Crown in right of the Commonwealth, States, Australian Capital Territory and Northern Territory, but does not render the Crown liable to prosecution for an offence or civil proceedings for a contravention of a civil penalty provision (s 5). It applies to corporations and to natural persons or corporations in the course of or in preparation for trade or commerce between Australia and a place outside Australia, among the States, between a State and a Territory or between two Territories, under a law of the Commonwealth relating to pharmaceutical or repatriation benefits, or in relation to the Commonwealth or an authority of the Commonwealth (s 6(1)). Without limiting that, it has the effect it would have if the reference to corporations were confined to trading corporations for their trading activities (s 6(2)). Part 4-8A (mandatory device adverse event reporting) is excluded from s 6(1). Sponsors, manufacturers, importers, exporters, health practitioners, ethics committees, pharmacists and persons supplying or advertising therapeutic goods are directly affected. The Secretary maintains the Register and exercises powers over inclusion, variation, suspension, cancellation, conditions, recalls and information requirements. Arrangements may confer functions on Commonwealth officers or authorities under corresponding State laws (ss 6AAA-6AAC). The Act affects supply of registered, listed, provisionally registered, exempt or approved goods, including biologicals and medicines. Sponsors of biologicals (defined by inclusion or exemption status), applicants for inclusion, manufacturers and persons carrying out steps in manufacture (Part 3-3), suppliers and exporters of biologicals, health practitioners granted approvals or authorities under ss 32CK, 32CM or 32CO, and persons supplying or using biologicals in treatment or experimental contexts are affected. For medicine-related provisions, sponsors of reportable medicines (those containing Schedule 4 or 8 substances or determined under s 30EH) and applicants for listing or registration under ss 26A, 26AB or 26AE are affected. Executive officers of bodies corporate face liability under ss 54B and 54BA for certain offences. The provisions affect sponsors, manufacturers, importers, exporters and suppliers of therapeutic goods and biologicals (ss 19B, 20, 32BA, 32BG, 32BF). They also affect health practitioners using goods for treatment or experimental purposes (ss 19, 32CK, 32CM), persons granted approvals or authorities for unapproved goods (ss 19A, 32CO, 32CM), and persons subject to exemptions under regulations or for national interest or emergency purposes (ss 18, 18A, 32CA, 32CB). Authorised persons appointed by the Secretary from Commonwealth or State or Territory health or law enforcement bodies exercise powers under specified provisions (s 7A). The Secretary maintains the Register and exercises evaluation, variation, suspension, cancellation, recall and information powers (ss 9A, 9D, 29D, 30, 30EA, 31, 32FA, 32GA, 32HA, 32JA). The Minister determines standards, permissible ingredients and indications, and certain exemptions (ss 10, 26BB, 26BF, 18A, 32CB). The Gene Technology Regulator is consulted on applications involving GM products or organisms (ss 30C-30E, 32DS-32DU). Administrative Review Tribunal review applies to declared reviewable State decisions (s 6B). Sponsors of medicines and biologicals, applicants for registration or listing, manufacturers carrying out steps in Australia, holders of manufacturing licences, persons importing, supplying or exporting therapeutic goods, health practitioners receiving approvals or authorities under s 19 or s 32CM, and the Secretary are affected. Section 38(1)(g) applies the fit-and-proper test to the applicant, any manager participating in decisions affecting the whole or substantial part of affairs, or any major interest holder of a body corporate. Section 19B(5) provides a defence where the defendant proves they were not the sponsor at the time. Section 30EF applies to sponsors of reportable medicines in the Register. Section 32JF applies to persons complying with conditions of s 32CB exemptions. Sponsors of therapeutic goods and biologicals, applicants for registration, listing or inclusion in the Register, manufacturers (Part 3-3, excluding Class 1 biologicals per s 33B), importers, exporters, health practitioners authorised under s 32CM(1) or (7A) or s 19(5) or (7A), persons supplying or using biologicals or exempt goods, and executive officers of bodies corporate (ss 54B, 54BA) are affected. The Act binds the Crown in right of the Commonwealth, States, Australian Capital Territory and Northern Territory, without rendering the Crown liable to prosecution or civil proceedings (s 5). It applies to corporations and to natural persons or corporations in trade or commerce between Australia and places outside Australia, among the States, between a State and a Territory, or under Commonwealth pharmaceutical or repatriation benefits laws (s 6(1)). The Act affects sponsors (exporters, importers or Australian manufacturers or arrangers for supply), manufacturers, licence holders, applicants for registration or listing, health practitioners (including medical practitioners authorised under s 32CM(1) or rules under s 32CM(7A)), persons in control of production or quality control, major interest holders of body corporates, and persons supplying or handling exempt biologicals or goods. It also affects the Secretary, the Minister, the Gene Technology Regulator (under ss 30C, 30D and 30E), ethics committees, and pharmacists dispensing under s 30EL. Part 3-3 does not apply to medical devices (s 33A) or Class 1 biologicals (s 33B). Part 3-2 does not apply to medical devices (s 15A) or, after commencement, to biologicals (s 15B).

Sponsors must notify the Secretary of manufacturers or premises before import, export, manufacture or supply (ss 20, 20A, 32BG), with "properly notified" defined as nomination in a Register application or subsequent written notice (s 32BG(3)). Sponsors must notify the Secretary in writing as soon as aware of information contradicting prior information, indicating unintended harmful effects, reduced effectiveness or unacceptable quality, safety or efficacy (ss 29A(1)-(2), 32DQ(1)-(2)). Sponsors must comply with automatic conditions on Register inclusion, including entry and inspection powers, sample delivery, manufacturer and premises notification, licensed or exempt manufacturing steps (except Class 1 or exempt), no post-expiry supply or export, and no advertising outside accepted indications (ss 28(5), 32EA(1)-(9)). Sponsors must allow authorised persons entry, inspection, imaging, sampling and copying at reasonable times, produce documents on request, keep manufacturer records per batch for 12 months post-expiry, comply with prescribed record-keeping and reporting, notify new manufacturers or premises within 10 working days, deliver samples within at least 10 working days, and comply with s 25AA(1B) notices (s 28(5)). For listed medicines under ss 26A or 26AE, Australian manufacturing steps must be by licensed or exempt persons and overseas steps certified under specified subsections (s 28(5B)), unless exempt from Part 3-3 (s 28(5C)). Claims in listing applications impose conditions on supporting information and evidence (s 28(6)). Accepted indications impose ongoing support and production conditions (ss 28(7)-(8)). Manufacturers must hold a licence or exemption to carry out manufacturing steps in Australia (s 35), comply with manufacturing principles determined by the Minister (s 36), and comply with licence conditions (s 40). The Secretary must maintain the Register (s 9A), publish an annual list of included goods (s 9E), vary entries on request or own initiative for incomplete or incorrect information (s 9D(1)), with mandatory variations where the only effect is to reduce the class of persons or add a non-comparative warning or precaution (s 9D(2)), and discretionary variations where no reduction in quality, safety or efficacy (s 9D(3)). Parallel rules apply to biologicals (s 9D(3AA)-(3A)) and medical devices (s 9D(3C)-(3D)). The Secretary may impose, vary or remove conditions by notice, immediate for imminent risk or at least 28 days otherwise (ss 28(3)-(4A), 32ED, 32EE). The Secretary may suspend if potential risk of death, serious illness or injury and action likely within the period, or likely cancellation grounds (ss 29D(1), 32FA), with periods up to 6 months extendable and Gazette or website publication (ss 29D(4)-(5), 32FB). The Secretary may cancel for imminent risk, exempt goods, request, prohibited imports, record condition non-compliance, incorrect certifications for listed medicines, significant advertising breaches, false statements, unpaid charges, unacceptable quality, safety, efficacy or presentation, change making goods separate and distinct, non-compliance with conditions or notices, adverse effect notification failure, goods required in another Register part, non-conformity to standard, or prohibition or condition contravention (s 30(1)-(2), (1A), (1C)-(1D)). Mandatory cancellation applies for protected or restricted information use or prohibition or condition contravention (ss 30(4A)-(4C)). Cancellation takes effect on the notice day for immediate grounds or at least 20 working days otherwise (s 30(5)). The Secretary may require recall steps, public or class information, publication of manufacture or distribution information, or notification of supply recipients where non-conformity to standard, manufacturing principles breach, exempt goods issues, prohibition or condition contravention, supply in contravention of ss 19B or 19D, unacceptable quality, safety, efficacy or presentation, unlicensed manufacture, suspension or cancellation, or counterfeit goods (s 30EA(1)-(2)). Similar recall powers apply to non-conforming exempt biologicals under s 32CB (s 32CJ(1)-(3)). Sponsors may apply for registration or listing (ss 23, 32DD), provisional determinations (ss 22C-22F), variations (s 9D, s 26BJ), certification of overseas manufacturing steps (s 28A), revocation of cancellation (ss 30A, 30AA), and approvals or authorities for unapproved uses (ss 19, 32CK, 32CM). Health practitioners may seek approvals for treatment or experimental use (ss 19, 32CK(1A)). Persons may apply for review of reviewable State decisions by the Administrative Review Tribunal (s 6B). The Secretary may arrange regulated disposal of unused exempt biologicals (s 32CG) or exempt goods (s 30G). Sponsors of reportable medicines must notify shortages (critical impact as soon as possible, no later than 2 working days; otherwise within 10 working days) and changes or resolution (ss 30EF(1), 30EFA(1)-(2)), and discontinuation decisions (12 months or as soon as practicable for critical; 6 months or as soon as practicable otherwise) (s 30EG(1)). The Minister may declare scarce medicines and substitutable medicines (s 30EK(1)), allowing pharmacists to dispense the substitute where State or Territory law authorises it (s 30EL). Sponsors must notify the Secretary of shortages within 2 working days (critical impact) or 10 working days (other) under s 30EF(1), using approved forms specifying the shortage period, and notify changes or resolutions under s 30EFA. Permanent discontinuation requires at least 12 months' (critical) or 6 months' (other) notice under s 30EG. Manufacturers and sponsors must notify new manufacturers or premises within 10 working days under automatic conditions in s 32EA. Persons must comply with s 32HA requirements for recall, public notification, or supply recipient details. Information or documents must be provided under ss 32JA, 32JE-32JH within the specified period, with electronic compliance permitted. Applications for inclusion require certifications under ss 32DA(3), 32DCA(4) or 32DDA. Rights include use immunity for individuals under ss 32JD and 32JK (information and derivatives inadmissible except in specified proceedings), application for inclusion or variation, and revocation of cancellation within 90 days under ss 32GD-32GDA. The Secretary must publish recall requirements (s 32HB) and cancellations (s 32GE). Sponsors must notify the Secretary of the manufacturer or premises used in manufacture at or before the time of import, export, manufacture or supply (ss 20, 20A, 32BG), with proper notification defined by nomination in a Register application or subsequent written notice. Sponsors must notify the Secretary as soon as aware of information contradicting furnished data, unintended harmful effects, reduced efficacy or unacceptable quality, safety or efficacy (ss 29A, 32DQ), and similar obligations apply after withdrawal or lapsing of applications (ss 29B, 32DR). Inclusions in the Register are subject to automatic conditions under subsection 28(5) and section 32EA, including entry and inspection powers (including overseas premises, imaging and record copying), sample delivery, manufacturer and premises notification, Australian manufacture by licensed or exempt persons or overseas certification, no supply or export after expiry date, and no advertising for unaccepted indications. Additional conditions may be imposed by legislative instrument (ss 28(2), 32EC) or Secretary notice (ss 28(2B), 32ED), with variation or removal on request or initiative (ss 28(3), 32EE). Sponsors must comply with standards (ss 14, 32EA), permissible ingredient and indication requirements (ss 26BB-26BJ), and product information approval for restricted medicines (s 25AA). Applicants for registration or listing must use approved forms, pay fees, provide prescribed information and samples, and certify compliance with prohibitions under subsection 9K(1) or (3) (ss 23B, 23C, 32DA, 32DCA, 32DD). Persons must not import, export, manufacture or supply unregistered or unlisted therapeutic goods or biologicals for human use except under exemptions, approvals or authorities (ss 19B, 32BA-32BD, 32BF). Wholesale supply of non-sponsored unregistered goods is prohibited (s 21). Health practitioners must obtain ethics committee approval for certain experimental authorities (s 32CM). Persons receiving information or document notices must comply within the specified period (not less than 14 days) and in the specified form, which may require electronic transmission or software (ss 31(3), 32JA(2)-(3), 32JE(3)-(4)). Sponsors of reportable medicines must notify shortages within 2 working days for critical impact or 10 working days otherwise (s 30EF), and discontinuation with 12 months or 6 months notice (s 30EG). Applicants under s 26A(2) must certify eligibility for listing, safety for intended uses, acceptable presentation, no ingredient outside s 26BB(1)(a) determination, compliance with s 26BB(1)(b) requirements, conformity to standards, compliance with the Therapeutic Goods Advertising Code and Part 5-1 advertising requirements, Australian manufacture steps by licensed persons, compliance with prescribed quality and safety criteria, label compliance, indications covered by s 26BF(1)(a) determination, supporting evidence for claims and indications meeting any s 26A(2B) determination, no prohibited imports under the Customs Act 1901, all manufacturers nominated, written agreements with prescribed-kind manufacturers, and correct application information. Section 26AB(2) requires parallel certifications plus sufficient information to substantiate each claim and indication. Section 26A(3) requires prior Secretary certification of acceptable overseas manufacturing and quality-control procedures, with matters for consideration including EC or EFTA attestation of conformity or non-EC or EFTA mutual recognition agreement attestation. Section 26A(4A) requires prior certification of safety of any animal-origin ingredient. Section 32DCA(4) requires certification of safety, presentation, standards compliance, advertising requirements, quality criteria, manufacturer nomination, Australian manufacturing steps and prohibitions under s 9K(1) or (3) for export-only biologicals. Section 40(4) imposes statutory conditions on licences including ensuring goods conform to applicable standards and observing manufacturing principles, notifying unintended harmful effects or lack of effectiveness or unacceptable quality, safety or efficacy, allowing authorised persons to enter sites, inspect, examine, test, sample, image or record, and produce documents or batch samples. Section 30EF(1) requires notification of shortage using approved form specifying the period under s 30EIA. Section 30EFA requires notification of any change to the shortage period or resolution. Section 30EG requires notification of permanent discontinuation decision at least 12 months in advance for critical impact or 6 months otherwise. Section 28(5) imposes automatic conditions on registration or listing including change notification, no post-expiry supply, no unaccepted indications advertising, authorised person entry and inspection, record-keeping, reporting, manufacturer and premises notification, sample delivery and product information compliance. Section 9D(2) requires the Secretary to vary the entry on request that reduces the class of persons or adds a non-comparative warning or precaution. Section 32EA imposes automatic conditions on biological inclusion including entry and inspection powers, sample delivery, manufacturer notification, Australian and overseas manufacturing compliance, expiry date observance and advertising only for accepted indications. Sponsors must notify the Secretary in writing as soon as aware of adverse effects information (s 29A(1)-(2), s 32DQ(1)-(3)), respond to information or documents notices within reasonable time (s 31(1)-(2), s 32JA), comply with inclusion conditions (s 32EA, s 32EF), ensure conformity to applicable standards (ss 14, 14A), and certify matters including safety, conformity to standards, advertising compliance, quality and safety criteria, no prohibited imports, and s 9K prohibitions in applications (s 32DA(3), s 26A(2), s 26AB(2)). Manufacturers must hold licences or exemptions and observe manufacturing principles (ss 35-36, s 32EA(5)). Health practitioners must supply in accordance with authorities or rules (s 32CN, s 21A(11A)-(11E)). Rights include applying for inclusion (s 32DD), seeking certification of overseas manufacturing steps (s 32EB), requesting revocation of suspension (s 32FC) or cancellation within 90 days (s 32GD, s 30A), and obtaining consent for non-conforming goods (s 14). The Secretary must consult the Gene Technology Regulator on applications involving GM products or genetically modified organisms (s 32DS) and take advice into account (s 32DU). Publication of suspensions, cancellations, recalls and consents is required (ss 32FA, 32GE, 32HB, 14(14)). Sponsors must notify manufacturers and premises (ss 20(1B), 32BG), notify adverse information indicating unintended harmful effects, lack of effectiveness or unacceptable quality, safety or efficacy.

Criminal offences for import, export, manufacture or supply without registration, listing, exemption, approval or authority, with harm or injury element (resulted, will result or likely, or would if used): imprisonment for 5 years or 4,000 penalty units or both (ss 19B, 32BB(1), 32BC(1), 32BD(1), 32BI(1)); without harm element: imprisonment for 12 months or 1,000 penalty units or both (ss 19B, 32BB(4), 32BC(4), 32BD(4)); strict liability: 100 penalty units (ss 19B, 32BB(4A), 32BC(4A), 32BD(4A)). Defences include proving the defendant was not the sponsor at the time (ss 32BB(5), 32BC(5), 32BD(5), legal burden per Criminal Code s 13.4) and, for harm offences, that harm did not or would not directly result from quality, safety, efficacy, labelling, packaging or improper use (ss 32BB(6), 32BC(6), 32BD(6), evidential burden per Criminal Code s 13.3(3)). Similar tiered offences apply for non-conforming goods (s 14), false statements in applications or variation requests (ss 9G, 32DO(1), 32DO(4)), condition breaches (ss 15, 32EF(1), 32EF(4), 32CP(1), 32CP(2)), advertising unaccepted indications (ss 21A, 32BJ(2A), 32BJ(2B)), setting out incorrect biological numbers (s 32BJ(1)), failure to notify manufacturers or premises (s 32BG(1)), wholesale supply of unregistered biologicals (s 32BH), using biologicals without inclusion or approval (s 32BI(1)), breaching authorities or rules (s 32CN(1), (4), (5), (7)), failure to comply with recall notices (ss 30EC(1), 30EC(4), 32CJ(6), 32CJ(7)), failure to notify adverse effects (ss 29AA, 32DQ(1)), failure to comply with information notices (ss 31(4), 31(6), 32JI(1), 32JI(2)), unlicensed manufacturing (s 35(1), (4)), breaching licence conditions (s 35B(1), (4)), and failure to notify shortages or discontinuations (ss 30EF(6), 30EFA(5), 30EG(6)). Strict liability offences carry 100 penalty units (e.g. ss 14(6), 32BB(4A), 32BG(1A), 32BJ(3), 32CP(3), 32EF(5), 32CJ(9), 32CN(4A), 32CN(9), 30EC(5), 31(4B), 31(7)). Jury may convict of lesser offence under s 53A. Executive officer liability applies under ss 54B and 54BA. Civil penalties for the same conduct reach 5,000 penalty units for individuals or 50,000 for bodies corporate (ss 14A, 19D, 32BF(1)-(4), 32BG(2), 32BK(1), 32BL, 32DP, 32DQ(2), 32EG, 32CQ, 30ECA, 31AAA). Additional civil penalty for supplying Register-included biologicals of prescribed kind without Secretary consent or without biological number on label: 200 or 2,000 penalty units (s 32BF(6)). Civil penalty for false or misleading certificates in patent proceedings: up to $10,000,000 (s 26C(5A)). Customs Act 1901 applies to prohibited imports or exports on Secretary notice (ss 9M, 14B, 32BBA). The Secretary may publish consent decisions (s 32BF(8)), notify refusal reasons within 28 days (s 32BF(9)), and require prescribed fees (s 32BF(10)). Self-incrimination is not a ground for refusal to give information or produce documents, but individuals receive use immunity except in specified proceedings (ss 31F, 32JK). Certified copies of documents are admissible (ss 32JL, 32JM). Criminal offences for exporting biologicals without inclusion, exemption or approval carry up to 5 years' imprisonment or 4,000 penalty units where harm or injury results or is likely (s 32BB(1)), with lesser penalties of 12 months or 1,000 penalty units (s 32BB(4)) or 100 penalty units strict liability (s 32BB(4A)). Similar graduated penalties apply for using biologicals without approval (s 32BI), breaching s 32HA requirements (s 32HC), false or misleading information in compliance with notices (ss 32JB, 32JI), and manufacturing without licence (s 35). Strict liability offences attract 100 penalty units (ss 32BB(4B), 32BI(6), 32HC(6)). Civil penalties reach 5,000 penalty units for individuals and 50,000 for bodies corporate for exporting without authorisation (s 32BF(2)), false representations (s 32BK), or non-compliance with information notices (s 32JC). Executive officer liability applies. Customs Act 1901 forfeiture provisions may apply on Secretary notification (s 32BBA). Publication of requirements and cancellations supports enforcement. Criminal offences are tiered. Aggravated offences where use has resulted in, will result in or is likely to result in harm or injury carry imprisonment for 5 years or 4,000 penalty units or both (ss 14, 19B, 21A, 22, 32BA, 32BI, 32HC(1), 35(1)). Offences without the harm element carry imprisonment for 12 months or 1,000 penalty units or both (ss 19B(4), 21A(4), 22(2B), 32BA(4), 32HC(4), 35(4)). Strict liability offences carry 100 penalty units (ss 14(4), 19B(5), 21A(4A), 22(3), 32BA(5), 32HC(5), 35(4A)). Specific offences include 60 penalty units for incorrect registration, listing or biological numbers on containers, packages or labels (ss 22(1), 32BJ(1)), 120 penalty units for wholesale supply of non-sponsored unregistered goods (ss 21, 32BH), and 500 penalty units for failure to comply with information notices (ss 32JB(1), 32JI(1)). Civil penalties apply for false or misleading statements in variation requests, applications or responses to notices (up to 5,000 penalty units for an individual or 50,000 for a body corporate: ss 9H, 21B, 22B, 32DP, 32JC, 32JJ, 31AAA), unregistered supply (ss 19D, 32BF), breach of consent or exemption conditions (ss 15AA, 22AA, 32CQ), breach of inclusion conditions (ss 32EG), and non-compliance with recall or notification requirements (ss 30ECA, 32HD). Executive officer liability applies under sections 54B and 54BA for certain offences. The Customs Act 1901 applies to treat non-compliant or prohibited goods as forfeited upon Secretary notification (ss 14B, 32BBA, 9M). Jury acquittal provisions allow conviction on lesser offences (ss 32HC(4), 32JB(5), 35(4)). Self-incrimination does not excuse compliance with information notices, but use immunity applies for individuals except in relation to specified offences or civil penalty proceedings (ss 31F, 32JD, 32JK). Section 14(1) creates an offence of imprisonment for 5 years or 4,000 penalty units or both for importing without consent where non-conformity with standard other than labelling or packaging has resulted in, will result in or is likely to result in harm or injury, with jury acquittal under s 53A permitting conviction under s 14(4). Section 14(4) creates a lesser offence of imprisonment for 12 months or 1,000 penalty units or both. Section 14(4A) creates a strict liability offence of 100 penalty units. Section 14A(1) creates a civil penalty of 5,000 penalty units for individuals or 50,000 for bodies corporate for the same import without the harm element. Section 15(2) creates an offence of 2,000 penalty units for breaching a condition of consent where harm results, with lesser offence of 500 penalty units under s 15(5) and strict liability of 100 penalty units under s 15(6). Section 15AA creates a civil penalty of 3,000 penalty units for individuals or 30,000 for bodies corporate for breaching a condition of consent. Section 19B(1) creates an offence of imprisonment for 5 years or 4,000 penalty units or both for importing, exporting, manufacturing or supplying unregistered or unlisted goods where harm results, with lesser offence under s 19B(4) and strict liability under s 19B(4A). Section 19D(1) creates a civil penalty of 5,000 penalty units for individuals or 50,000 for bodies corporate for the same conduct. Section 26B(2) creates an offence of 1,000 penalty units for giving a false or misleading certificate in a material particular. Section 26C(5) provides for pecuniary penalty orders up to $10,000,000 against a second person for false or misleading certificate in patent infringement proceedings. Section 32DO creates offences up to 5 years imprisonment or 4,000 penalty units if harm results for false statements in biological inclusion applications. Section 32DP imposes civil penalties of 5,000 penalty units for individuals or 50,000 for bodies corporate. Section 32EF creates offences up to 5 years or 4,000 penalty units for breaching conditions on biological inclusion where harm results. Section 32EG imposes civil penalties of 5,000 or 50,000 penalty units. Section 30EF(6) creates a civil penalty of 100 penalty units for individuals or 1,000 for bodies corporate for failure to notify shortage. Section 9G(1) creates an offence of imprisonment for 5 years or 4,000 penalty units or both for false or misleading statement in a material particular in a s 9D variation request where harm results. Section 9H creates a civil penalty of 5,000 penalty units for individuals or 50,000 for bodies corporate. Section 41AC creates an offence of 400 penalty units for failure to comply with information requirement under s 41AB. Section 41AD creates an offence of 12 months imprisonment or 1,000 penalty units or both for giving false or misleading information. Section 41AF creates a civil penalty of 5,000 or 50,000 penalty units. Section 32JI creates offences of 500 or 100 penalty units for failure to comply with information requirement under s 32JF. Section 14B applies the Customs Act 1901 to treat goods as forfeited where the Secretary notifies the Comptroller-General of Customs of an offence under s 14(1), (4), (4A), (10), (13) or (13AA) or s 41Q(1) or (2) or contravention of s 14A(1) or (3) or s 41Q(3). Section 19B(7) applies the Customs Act 1901 similarly for unregistered or unlisted goods. Criminal offences are tiered: harm or likely harm element carries up to 5 years imprisonment or 4,000 penalty units (e.g., s 32DO(1), s 32EF(1), s 21A(1), s 14(1), s 19B(1)); lesser offences without harm element carry 12 months or 1,000 penalty units (e.g., s 32DO(4), s 32EF(4), s 21A(4), s 14(4)); strict liability offences carry 100 penalty units (e.g., s 32DO(5), s 32EF(5), s 21A(4A), s 14(4A)). Specific offences cover false or misleading representations about biological status (s 32BK), advertising for unaccepted indications (s 32BL), breach of exemption or approval conditions (s 32CP), failure to notify adverse effects after withdrawal or lapse (s 32DR(3)-(4)), non-compliance with information notices (s 32JB(1), s 31(4)), and non-conformity to standards (s 14). Civil penalties reach 5,000 penalty units for individuals and 50,000 for bodies corporate (e.g., s 32BK, s 32CQ, s 32EG, s 31AAA, s 14A, s 21B). Executive officer liability applies (ss 54B, 54BA). Jury may convict on lesser offences (s 53A). Self-incrimination protection provides limited use immunity for individuals (s 32JD, s 31F).

The Act is additional to, and does not substitute for, other Acts on therapeutic goods (s 3(4)). It is not intended to apply to the exclusion of concurrent State, Australian Capital Territory or Northern Territory laws (s 4(2)). Corresponding State laws may confer functions, powers or duties on Commonwealth officers or authorities, subject to constitutional limits and regulations (ss 6AAA-6AAC); duties are taken to be imposed by the State law where possible or by this Act to the extent necessary for validity (s 6AAB). Jurisdiction is conferred on federal courts by s 6AAD. Consequences for Register inclusion or cancellation under State law are addressed in s 6AAE. Reviewable State decisions are reviewable by the Administrative Review Tribunal (s 6B). Arrangements may be made for State law fees payable to the Commonwealth (s 6C). The Minister may arrange State or Territory performance of evaluation, biological evaluation (non-Class 1 or export-only), inspection or other functions, with payment (s 9). The Customs Act 1901 applies to goods prohibited under regulations implementing international agreements (s 9M) or non-conforming goods on Secretary notice (s 14B). The Patents Act 1990 is linked through certificates under s 26B(1) for infringement proceedings; the second person must give a certificate of good faith, reasonable prospects of success and no unreasonable delay (s 26C(1)-(3)).

The Act provides transitional rules for currently registered or listed biologicals until inclusion under Part 3-2A (s 15B, s 32DN).

The draft does not detail any court challenges or controversies.

The fit-and-proper test applies to the applicant, any manager participating in decisions affecting the whole or substantial part of affairs, or any major interest holder of a body corporate under s 38(1)(g). Section 19B(5) provides a defence where the defendant proves they were not the sponsor at the time. Self-incrimination is not a ground for refusal to give information or produce documents, but individuals receive use immunity except in specified proceedings (ss 31F, 32JK). Jury may convict of lesser offence under s 53A.

Sponsors must notify the Secretary of manufacturers or premises before import, export, manufacture or supply (ss 20, 20A, 32BG), with properly notified defined as nomination in a Register application or subsequent written notice (s 32BG(3)). Sponsors must notify the Secretary in writing as soon as aware of information contradicting prior information, indicating unintended harmful effects, reduced effectiveness or unacceptable quality, safety or efficacy (ss 29A(1)-(2), 32DQ(1)-(2)). Sponsors must comply with automatic conditions on Register inclusion, including entry and inspection powers, sample delivery, manufacturer and premises notification, licensed or exempt manufacturing steps (except Class 1 or exempt),

Therapeutic Goods Act 1989

Plain English Summary

Therapeutic Goods Act 1989 — What It Does and Why It Matters

The Big Picture

The Australian Register of Therapeutic Goods (ARTG)

Who Does This Affect?

Deep Dive

What it does

Current sections

Official source available

Key Rules

Penalties

Homoeopathic and Anthroposophic Products

State and Federal Cooperation

The Register is Public

Main concepts

Who it affects

Key duties and rights

Penalties and enforcement

How it interacts with other laws

Recent changes and why

Court challenges and controversies

Gotchas

How to comply