{"id":"F2018L00774","name":"Therapeutic Goods (Charges) Regulations 2018","slug":"therapeutic-goods-charges-regulations-2018","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":97408,"registerId":"commonwealth-F2018L00774-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"## Part 1—Preliminary","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n  This instrument is the Therapeutic Goods (Charges) Regulations 2018.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n  This instrument is made under the Therapeutic Goods (Charges) Act 1989.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Definitions","content":"#### 5 Definitions\n\n> Note: Subsection 3(1) of the Act incorporates the Therapeutic Goods Act 1989. A number of expressions used in this instrument are defined in the Therapeutic Goods Act 1989, including the following:\n\n    (a) biological (see also section 6 for classes of biological, but see the note to the definition of biologic);\n    (b) current Poisons Standard;\n    (c) grouped therapeutic goods;\n    (d) medical device (see also section 6 for classes of medical device);\n    (e) medicine;\n    (f) Register;\n    (g) registered goods;\n    (h) therapeutic goods.\n  In this instrument:\n\n> Act means the Therapeutic Goods (Charges) Act 1989.\n\n> biologic means therapeutic goods in which the active ingredient is a substance of biological origin (within the ordinary meaning of the term “biological”) that:\n\n    (a) in many cases, is chemically complex and with a molecular weight of more than 1,000; and\n    (b) is not defined by a chemical name because its purity, strength and exact composition cannot be readily determined by chemical analysis.\n\n> Note: Example: Hormones, enzymes and related substances are substances of biological origin of the type described. Herbal substances and antibiotics are not.\n\n> Note: The term “biological” is not used in this definition as defined in the Therapeutic Goods Act 1989.\n\n> charge year, in relation to an annual charge, means the financial year to which the charge relates.\n\n> haematopoietic progenitor cells has the same meaning as in Schedule 9 of the Therapeutic Goods Regulations 1990.\n\n> parent goods: see subsection 8(7).\n\n> relevant goods: see subsection 8(5).","sortOrder":3},{"sectionNumber":"6","sectionType":"section","heading":"Classes of medical devices and biologicals","content":"#### 6 Classes of medical devices and biologicals\n\n  In this instrument:\n    (a) a reference to a medical device of a particular class is a reference to a medical device classified as that class under Division 3.1 of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (b) a reference to a biological of a particular class is a reference to a biological of that class within the meaning of the Therapeutic Goods Regulations 1990.","sortOrder":4},{"sectionNumber":"Part 2","sectionType":"part","heading":"Charges","content":"## Part 2—Charges","sortOrder":5},{"sectionNumber":"7","sectionType":"section","heading":"Annual charges for biologics and some other goods","content":"#### 7 Annual charges for biologics and some other goods\n\n  Registration or listing of non‑grouped therapeutic goods\n  (1) For the purposes of subsection 4(1) of the Act, the annual charges for the registration or listing of therapeutic goods (other than grouped therapeutic goods) are:\n    (a) for goods whose registration is in force at any time during the charge year and that are of a kind not mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:\n    (i) if the goods are a medicine—$1,939; and\n    (iii) in any other case—$2,149; and\n    (b) for goods:\n    (i) whose registration is in force at any time during the charge year; and\n    (ii) that are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and\n    (iii) that are a biologic;\n    $9,428; and\n    (c) for goods (other than goods produced for export) the listing of which is in force at any time during the charge year:\n    (i) if the goods are a medicine—$1,473; and\n    (iii) in any other case—$1,111.\n\n> Note: For goods of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990 that are not a biologic, see section 8.\n\n  Registration or listing of grouped therapeutic goods\n  (2) For the purposes of subsection 4(1A) of the Act, the annual charge for the registration or listing of grouped therapeutic goods is:\n    (a) for grouped goods whose registration is in force at any time during the charge year and that are of a kind not mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:\n    (i) if the goods are medicines—$1,939; and\n    (iii) in any other case—$2,149; and\n    (b) for grouped therapeutic goods:\n    (i) whose registration is in force at any time during the charge year; and\n    (ii) that are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and\n    (iii) that are biologics;\n    $9,428; and\n    (c) for grouped goods (other than goods all of which are produced for export) the listing of which is in force at any time during the charge year:\n    (i) if the goods are medicines—$1,473; and\n    (iii) in any other case—$1,111.\n\n> Note: For grouped therapeutic goods of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990 that are not biologics, see section 8.\n\n  Biologicals\n  (3) For the purposes of subsection 4(1AA) of the Act, the annual charges for inclusion of a biological (other than an export only biological) in the Register under Part 3‑2A of the Therapeutic Goods Act 1989 are:\n    (a) for a Class 1 biological whose inclusion in the Register is in force at any time during the charge year—$881; and\n    (b) for a Class 2, Class 3 or Class 4 biological whose inclusion in the Register is in force at any time during the charge year—$8,760.\n  Medical devices\n  (4) For the purposes of subsection 4(1B) of the Act, the annual charges in respect of the inclusion of kinds of medical devices (other than medical devices produced for export) in the Register under Chapter 4 of the Therapeutic Goods Act 1989 that has effect at any time during the charge year are as follows:\n    (a) for a Class I medical device (other than a Class I medical device to which paragraph (b) applies)—$114;\n    (b) for a Class I medical device that the manufacturer intends to be supplied in a sterile state or that has a measuring function—$828;\n    (c) for a Class IIa medical device or Class IIb medical device—$1,230;\n    (d) for a Class III medical device—$1,566;\n    (e) for an IVD medical device (of a class other than a Class 4 in‑house IVD medical device)—$893;\n    (f) for a Class 4 in‑house IVD medical device—nil.\n  Licences\n  (5) For the purposes of subsection 4(2) of the Act, the annual charge for a licence that is in force at any time during the charge year is as follows:\n    (a) for a licence for one or more steps in the manufacture of sterile or non‑sterile therapeutic goods—$6,020;\n    (b) for a licence for the manufacture of containers in which therapeutic goods are to be packed—$6,020;\n    (c) for a licence for the manufacture of ingredients or components for use in the manufacture of therapeutic goods—$6,020;\n    (e) for a licence for the manufacture of herbal or homoeopathic preparations that are not included in a Schedule to the current Poisons Standard (other than Schedule 5 or 6)—$6,020;\n    (f) for a licence for the manufacture of human blood and blood components (other than haematopoietic progenitor cells) at manufacturing premises covered by the licence:\n    (i) for the principal premises in the capital city of a State or Territory where human blood and blood components are manufactured—$210,610; and\n    (ii) for a fixed (non‑mobile) manufacturing site—$10,368;\n    (g) for a licence for the manufacture of haematopoietic progenitor cells at manufacturing premises covered by the licence—$9,070;\n    (h) for a licence for a single step in the manufacture of a single human tissue at manufacturing premises covered by the licence—$9,070;\n    (i) for a licence for 2 or more steps in the manufacture of human tissues at manufacturing premises covered by the licence—$17,738;\n    (j) despite paragraphs (a) to (i)—for a licence for the manufacture of a biological only—nil.\n  Only highest applicable charge is payable\n  (6) If, but for this subsection, more than one charge referred to in subsection (1) or any of paragraphs (5)(a) to (i) would otherwise apply in respect of a charge year in relation to:\n    (a) the registration or listing of particular goods; or\n    (b) a particular licence;\n  only the highest applicable charge (other than a charge payable under any of paragraphs (5)(a) to (i) only because biologicals are manufactured) applies in respect of the registration or listing of those goods or in relation to that licence in that year.\n\n> Note 1: Under regulation 43AAJ of the Therapeutic Goods Regulations 1990, the annual charge for a licence under Part 3‑3 of the Therapeutic Goods Act 1989 payable by a person whose wholesale turnover of therapeutic goods in a charge year is not more than $121,712 is half the amount mentioned in subsection (5) for the person. The reduction in the annual charge does not apply to a licence for the manufacture of human blood and blood components.\n\n> Note 2: For provisional registration of a medicine, see section 9.","sortOrder":6},{"sectionNumber":"8","sectionType":"section","heading":"Annual charges for goods that are not biologics","content":"#### 8 Annual charges for goods that are not biologics\n\n  (1) For the purposes of subsections 4(1) and (1A) of the Act, this section sets out the annual charge for the registration of therapeutic goods if:\n    (a) the registration of the goods is in force at any time during the charge year; and\n    (b) the goods are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and\n    (c) either:\n    (i) if the goods are not grouped therapeutic goods—the goods are not a biologic; or\n    (ii) if the goods are grouped therapeutic goods—the goods are not biologics.\n  When higher and lower amounts are payable\n  (2) The annual charge for the goods for the charge year is:\n    (a) if one or more of the conditions in subsections (4) to (10) apply to the goods—$5,362; or\n    (b) otherwise—$4,368.\n  New chemical entities, extensions of indications and changes to intended patient groups\n  (4) The following conditions are met:\n    (a) the registration of the goods commenced on or after 1 July 2015;\n    (b) the goods are relevant goods;\n    (c) for goods whose registration commenced before the beginning of the charge year—at the beginning of the charge year, the goods have been registered for fewer than 8 years.\n  (5) Relevant goods are goods that, at the time the registration of the goods commenced, were:\n    (a) a new chemical entity, within the meaning of subclause 1(1) of Schedule 9 to the Therapeutic Goods Regulations 1990; or\n    (b) separate and distinct from other goods that are registered:\n    (i) because of an extension of indications, within the meaning of item 4 of the table in Part 2 of Schedule 9 to the Therapeutic Goods Regulations 1990, other than an extension of indications mentioned in paragraph (bc) of that item; or\n    (ii) because of a change to the intended patient group (within the meaning of paragraph (e) of the definition of major variation in subclause 1(1) of Schedule 9 to those Regulations).\n  Goods whose parent goods have been registered for fewer than 8 years\n  (6) The following conditions are met:\n    (a) the registration of the goods commenced on or after 1 July 2015;\n    (b) the goods are not relevant goods;\n    (c) subsection (4) applies for the charge year to the parent goods of those goods.\n  (7) Goods (the initial goods) are parent goods of other goods if:\n    (a) the initial goods were registered before the other goods; and\n    (b) the initial goods are relevant goods; and\n    (c) the initial goods and the other goods have:\n    (i) the same active ingredient; or\n    (ii) the same active ingredients in the same quantitative amounts; and\n    (d) at the time the registration of the other goods commenced, the other goods were registered in relation to:\n    (i) the person in relation to whom the initial goods were registered at that time; or\n    (ii) a person authorised by the person in relation to whom the initial goods were registered at that time.\n  Grouped therapeutic goods as a result of extension of indications or changes to intended patient group\n  (8) The following conditions are met:\n    (a) the goods are grouped therapeutic goods;\n    (b) relevant goods that are included in those grouped goods were grouped on or after 1 July 2015 (whether or not other goods that are included in those grouped goods were registered before that time);\n    (c) the grouping occurred in a financial year before the charge year;\n    (d) at the beginning of the charge year, the relevant goods have been included in the grouped goods for fewer than 8 years.\n  Entries before 1 July 2015—goods other than grouped therapeutic goods\n  (9) The following conditions are met:\n    (a) the goods are not grouped therapeutic goods;\n    (b) the goods (the chargeable goods) were registered before 1 July 2015;\n    (c) immediately before 1 July 2015:\n    (i) if there is only one active ingredient contained in the chargeable goods—any other goods containing that active ingredient (and no other active ingredients) are registered in relation to the person in relation to whom the chargeable goods are registered; or\n    (ii) otherwise—any other goods containing the same active ingredients in the same quantitative amounts as the chargeable goods (and no other active ingredients) are registered in relation to the person in relation to whom the chargeable goods are registered;\n    (d) at the beginning of the charge year, the goods have been registered for fewer than 8 years.\n  Entries before 1 July 2015—grouped therapeutic goods\n  (10) The following conditions are met:\n    (a) the goods were grouped therapeutic goods immediately before 1 July 2015;\n    (b) immediately before 1 July 2015:\n    (i) if there is only one active ingredient contained in the grouped goods—any other goods containing that active ingredient (and no other active ingredients) are registered in relation to the same person in relation to whom the grouped goods are registered; or\n    (ii) otherwise—any other goods containing the same active ingredients in the same quantitative amounts as the grouped goods (and no other active ingredients) are registered in relation to the same person in relation to whom the grouped goods are registered;\n    (c) at the beginning of the charge year, the first of the goods to be registered have been registered for fewer than 8 years.\n\n> Note: For provisional registration of a medicine, see section 9.","sortOrder":7},{"sectionNumber":"9","sectionType":"section","heading":"Annual charges for provisionally registered medicines","content":"#### 9 Annual charges for provisionally registered medicines\n\n  (1) For the purposes of subsection 4(1) of the Act, the annual charges for the provisional registration of a medicine, if the provisional registration is in force at any time during the charge year, are:\n    (a) for goods that are a biologic—$21,273; and\n    (b) for goods that are not a biologic—$17,372.\n  (2) If a provisional registration for a medicine is in force at any time in a charge year, and the medicine is otherwise registered later in the same charge year, sections 7 and 8 do not apply in relation to its registration in respect of that charge year.","sortOrder":8},{"sectionNumber":"Part 3","sectionType":"part","heading":"Application and transitional provisions","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  This instrument is the Therapeutic Goods (Charges) Regulations 2018.\n\n#### 3 Authority\n\n  This instrument is made under the Therapeutic Goods (Charges) Act 1989.\n\n#### 5 Definitions\n\n> Note: Subsection 3(1) of the Act incorporates the Therapeutic Goods Act 1989. A number of expressions used in this instrument are defined in the Therapeutic Goods Act 1989, including the following:\n\n    (a) biological (see also section 6 for classes of biological, but see the note to the definition of biologic);\n    (b) current Poisons Standard;\n    (c) grouped therapeutic goods;\n    (d) medical device (see also section 6 for classes of medical device);\n    (e) medicine;\n    (f) Register;\n    (g) registered goods;\n    (h) therapeutic goods.\n  In this instrument:\n\n> Act means the Therapeutic Goods (Charges) Act 1989.\n\n> biologic means therapeutic goods in which the active ingredient is a substance of biological origin (within the ordinary meaning of the term “biological”) that:\n\n    (a) in many cases, is chemically complex and with a molecular weight of more than 1,000; and\n    (b) is not defined by a chemical name because its purity, strength and exact composition cannot be readily determined by chemical analysis.\n\n> Note: Example: Hormones, enzymes and related substances are substances of biological origin of the type described. Herbal substances and antibiotics are not.\n\n> Note: The term “biological” is not used in this definition as defined in the Therapeutic Goods Act 1989.\n\n> charge year, in relation to an annual charge, means the financial year to which the charge relates.\n\n> haematopoietic progenitor cells has the same meaning as in Schedule 9 of the Therapeutic Goods Regulations 1990.\n\n> parent goods: see subsection 8(7).\n\n> relevant goods: see subsection 8(5).\n\n#### 6 Classes of medical devices and biologicals\n\n  In this instrument:\n    (a) a reference to a medical device of a particular class is a reference to a medical device classified as that class under Division 3.1 of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (b) a reference to a biological of a particular class is a reference to a biological of that class within the meaning of the Therapeutic Goods Regulations 1990.\n\n## Part 2—Charges\n\n#### 7 Annual charges for biologics and some other goods\n\n  Registration or listing of non‑grouped therapeutic goods\n  (1) For the purposes of subsection 4(1) of the Act, the annual charges for the registration or listing of therapeutic goods (other than grouped therapeutic goods) are:\n    (a) for goods whose registration is in force at any time during the charge year and that are of a kind not mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:\n    (i) if the goods are a medicine—$1,939; and\n    (iii) in any other case—$2,149; and\n    (b) for goods:\n    (i) whose registration is in force at any time during the charge year; and\n    (ii) that are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and\n    (iii) that are a biologic;\n    $9,428; and\n    (c) for goods (other than goods produced for export) the listing of which is in force at any time during the charge year:\n    (i) if the goods are a medicine—$1,473; and\n    (iii) in any other case—$1,111.\n\n> Note: For goods of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990 that are not a biologic, see section 8.\n\n  Registration or listing of grouped therapeutic goods\n  (2) For the purposes of subsection 4(1A) of the Act, the annual charge for the registration or listing of grouped therapeutic goods is:\n    (a) for grouped goods whose registration is in force at any time during the charge year and that are of a kind not mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:\n    (i) if the goods are medicines—$1,939; and\n    (iii) in any other case—$2,149; and\n    (b) for grouped therapeutic goods:\n    (i) whose registration is in force at any time during the charge year; and\n    (ii) that are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and\n    (iii) that are biologics;\n    $9,428; and\n    (c) for grouped goods (other than goods all of which are produced for export) the listing of which is in force at any time during the charge year:\n    (i) if the goods are medicines—$1,473; and\n    (iii) in any other case—$1,111.\n\n> Note: For grouped therapeutic goods of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990 that are not biologics, see section 8.\n\n  Biologicals\n  (3) For the purposes of subsection 4(1AA) of the Act, the annual charges for inclusion of a biological (other than an export only biological) in the Register under Part 3‑2A of the Therapeutic Goods Act 1989 are:\n    (a) for a Class 1 biological whose inclusion in the Register is in force at any time during the charge year—$881; and\n    (b) for a Class 2, Class 3 or Class 4 biological whose inclusion in the Register is in force at any time during the charge year—$8,760.\n  Medical devices\n  (4) For the purposes of subsection 4(1B) of the Act, the annual charges in respect of the inclusion of kinds of medical devices (other than medical devices produced for export) in the Register under Chapter 4 of the Therapeutic Goods Act 1989 that has effect at any time during the charge year are as follows:\n    (a) for a Class I medical device (other than a Class I medical device to which paragraph (b) applies)—$114;\n    (b) for a Class I medical device that the manufacturer intends to be supplied in a sterile state or that has a measuring function—$828;\n    (c) for a Class IIa medical device or Class IIb medical device—$1,230;\n    (d) for a Class III medical device—$1,566;\n    (e) for an IVD medical device (of a class other than a Class 4 in‑house IVD medical device)—$893;\n    (f) for a Class 4 in‑house IVD medical device—nil.\n  Licences\n  (5) For the purposes of subsection 4(2) of the Act, the annual charge for a licence that is in force at any time during the charge year is as follows:\n    (a) for a licence for one or more steps in the manufacture of sterile or non‑sterile therapeutic goods—$6,020;\n    (b) for a licence for the manufacture of containers in which therapeutic goods are to be packed—$6,020;\n    (c) for a licence for the manufacture of ingredients or components for use in the manufacture of therapeutic goods—$6,020;\n    (e) for a licence for the manufacture of herbal or homoeopathic preparations that are not included in a Schedule to the current Poisons Standard (other than Schedule 5 or 6)—$6,020;\n    (f) for a licence for the manufacture of human blood and blood components (other than haematopoietic progenitor cells) at manufacturing premises covered by the licence:\n    (i) for the principal premises in the capital city of a State or Territory where human blood and blood components are manufactured—$210,610; and\n    (ii) for a fixed (non‑mobile) manufacturing site—$10,368;\n    (g) for a licence for the manufacture of haematopoietic progenitor cells at manufacturing premises covered by the licence—$9,070;\n    (h) for a licence for a single step in the manufacture of a single human tissue at manufacturing premises covered by the licence—$9,070;\n    (i) for a licence for 2 or more steps in the manufacture of human tissues at manufacturing premises covered by the licence—$17,738;\n    (j) despite paragraphs (a) to (i)—for a licence for the manufacture of a biological only—nil.\n  Only highest applicable charge is payable\n  (6) If, but for this subsection, more than one charge referred to in subsection (1) or any of paragraphs (5)(a) to (i) would otherwise apply in respect of a charge year in relation to:\n    (a) the registration or listing of particular goods; or\n    (b) a particular licence;\n  only the highest applicable charge (other than a charge payable under any of paragraphs (5)(a) to (i) only because biologicals are manufactured) applies in respect of the registration or listing of those goods or in relation to that licence in that year.\n\n> Note 1: Under regulation 43AAJ of the Therapeutic Goods Regulations 1990, the annual charge for a licence under Part 3‑3 of the Therapeutic Goods Act 1989 payable by a person whose wholesale turnover of therapeutic goods in a charge year is not more than $121,712 is half the amount mentioned in subsection (5) for the person. The reduction in the annual charge does not apply to a licence for the manufacture of human blood and blood components.\n\n> Note 2: For provisional registration of a medicine, see section 9.\n\n#### 8 Annual charges for goods that are not biologics\n\n  (1) For the purposes of subsections 4(1) and (1A) of the Act, this section sets out the annual charge for the registration of therapeutic goods if:\n    (a) the registration of the goods is in force at any time during the charge year; and\n    (b) the goods are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and\n    (c) either:\n    (i) if the goods are not grouped therapeutic goods—the goods are not a biologic; or\n    (ii) if the goods are grouped therapeutic goods—the goods are not biologics.\n  When higher and lower amounts are payable\n  (2) The annual charge for the goods for the charge year is:\n    (a) if one or more of the conditions in subsections (4) to (10) apply to the goods—$5,362; or\n    (b) otherwise—$4,368.\n  New chemical entities, extensions of indications and changes to intended patient groups\n  (4) The following conditions are met:\n    (a) the registration of the goods commenced on or after 1 July 2015;\n    (b) the goods are relevant goods;\n    (c) for goods whose registration commenced before the beginning of the charge year—at the beginning of the charge year, the goods have been registered for fewer than 8 years.\n  (5) Relevant goods are goods that, at the time the registration of the goods commenced, were:\n    (a) a new chemical entity, within the meaning of subclause 1(1) of Schedule 9 to the Therapeutic Goods Regulations 1990; or\n    (b) separate and distinct from other goods that are registered:\n    (i) because of an extension of indications, within the meaning of item 4 of the table in Part 2 of Schedule 9 to the Therapeutic Goods Regulations 1990, other than an extension of indications mentioned in paragraph (bc) of that item; or\n    (ii) because of a change to the intended patient group (within the meaning of paragraph (e) of the definition of major variation in subclause 1(1) of Schedule 9 to those Regulations).\n  Goods whose parent goods have been registered for fewer than 8 years\n  (6) The following conditions are met:\n    (a) the registration of the goods commenced on or after 1 July 2015;\n    (b) the goods are not relevant goods;\n    (c) subsection (4) applies for the charge year to the parent goods of those goods.\n  (7) Goods (the initial goods) are parent goods of other goods if:\n    (a) the initial goods were registered before the other goods; and\n    (b) the initial goods are relevant goods; and\n    (c) the initial goods and the other goods have:\n    (i) the same active ingredient; or\n    (ii) the same active ingredients in the same quantitative amounts; and\n    (d) at the time the registration of the other goods commenced, the other goods were registered in relation to:\n    (i) the person in relation to whom the initial goods were registered at that time; or\n    (ii) a person authorised by the person in relation to whom the initial goods were registered at that time.\n  Grouped therapeutic goods as a result of extension of indications or changes to intended patient group\n  (8) The following conditions are met:\n    (a) the goods are grouped therapeutic goods;\n    (b) relevant goods that are included in those grouped goods were grouped on or after 1 July 2015 (whether or not other goods that are included in those grouped goods were registered before that time);\n    (c) the grouping occurred in a financial year before the charge year;\n    (d) at the beginning of the charge year, the relevant goods have been included in the grouped goods for fewer than 8 years.\n  Entries before 1 July 2015—goods other than grouped therapeutic goods\n  (9) The following conditions are met:\n    (a) the goods are not grouped therapeutic goods;\n    (b) the goods (the chargeable goods) were registered before 1 July 2015;\n    (c) immediately before 1 July 2015:\n    (i) if there is only one active ingredient contained in the chargeable goods—any other goods containing that active ingredient (and no other active ingredients) are registered in relation to the person in relation to whom the chargeable goods are registered; or\n    (ii) otherwise—any other goods containing the same active ingredients in the same quantitative amounts as the chargeable goods (and no other active ingredients) are registered in relation to the person in relation to whom the chargeable goods are registered;\n    (d) at the beginning of the charge year, the goods have been registered for fewer than 8 years.\n  Entries before 1 July 2015—grouped therapeutic goods\n  (10) The following conditions are met:\n    (a) the goods were grouped therapeutic goods immediately before 1 July 2015;\n    (b) immediately before 1 July 2015:\n    (i) if there is only one active ingredient contained in the grouped goods—any other goods containing that active ingredient (and no other active ingredients) are registered in relation to the same person in relation to whom the grouped goods are registered; or\n    (ii) otherwise—any other goods containing the same active ingredients in the same quantitative amounts as the grouped goods (and no other active ingredients) are registered in relation to the same person in relation to whom the grouped goods are registered;\n    (c) at the beginning of the charge year, the first of the goods to be registered have been registered for fewer than 8 years.\n\n> Note: For provisional registration of a medicine, see section 9.\n\n#### 9 Annual charges for provisionally registered medicines\n\n  (1) For the purposes of subsection 4(1) of the Act, the annual charges for the provisional registration of a medicine, if the provisional registration is in force at any time during the charge year, are:\n    (a) for goods that are a biologic—$21,273; and\n    (b) for goods that are not a biologic—$17,372.\n  (2) If a provisional registration for a medicine is in force at any time in a charge year, and the medicine is otherwise registered later in the same charge year, sections 7 and 8 do not apply in relation to its registration in respect of that charge year.\n\n## Part 3—Application and transitional provisions\n\n### Division 1—Transitional provision relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n#### 10 Transitional provision relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  If, at any time during a charge year, the same medical device is included in the Register as a Class AIMD medical device and a Class III medical device, the charge in respect of the inclusion in the Register of the medical device as a Class III medical device during the charge year is nil.","sortOrder":9},{"sectionNumber":"Division 1","sectionType":"division","heading":"Transitional provision relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  This instrument is the Therapeutic Goods (Charges) Regulations 2018.\n\n#### 3 Authority\n\n  This instrument is made under the Therapeutic Goods (Charges) Act 1989.\n\n#### 5 Definitions\n\n> Note: Subsection 3(1) of the Act incorporates the Therapeutic Goods Act 1989. A number of expressions used in this instrument are defined in the Therapeutic Goods Act 1989, including the following:\n\n    (a) biological (see also section 6 for classes of biological, but see the note to the definition of biologic);\n    (b) current Poisons Standard;\n    (c) grouped therapeutic goods;\n    (d) medical device (see also section 6 for classes of medical device);\n    (e) medicine;\n    (f) Register;\n    (g) registered goods;\n    (h) therapeutic goods.\n  In this instrument:\n\n> Act means the Therapeutic Goods (Charges) Act 1989.\n\n> biologic means therapeutic goods in which the active ingredient is a substance of biological origin (within the ordinary meaning of the term “biological”) that:\n\n    (a) in many cases, is chemically complex and with a molecular weight of more than 1,000; and\n    (b) is not defined by a chemical name because its purity, strength and exact composition cannot be readily determined by chemical analysis.\n\n> Note: Example: Hormones, enzymes and related substances are substances of biological origin of the type described. Herbal substances and antibiotics are not.\n\n> Note: The term “biological” is not used in this definition as defined in the Therapeutic Goods Act 1989.\n\n> charge year, in relation to an annual charge, means the financial year to which the charge relates.\n\n> haematopoietic progenitor cells has the same meaning as in Schedule 9 of the Therapeutic Goods Regulations 1990.\n\n> parent goods: see subsection 8(7).\n\n> relevant goods: see subsection 8(5).\n\n#### 6 Classes of medical devices and biologicals\n\n  In this instrument:\n    (a) a reference to a medical device of a particular class is a reference to a medical device classified as that class under Division 3.1 of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (b) a reference to a biological of a particular class is a reference to a biological of that class within the meaning of the Therapeutic Goods Regulations 1990.\n\n## Part 2—Charges\n\n#### 7 Annual charges for biologics and some other goods\n\n  Registration or listing of non‑grouped therapeutic goods\n  (1) For the purposes of subsection 4(1) of the Act, the annual charges for the registration or listing of therapeutic goods (other than grouped therapeutic goods) are:\n    (a) for goods whose registration is in force at any time during the charge year and that are of a kind not mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:\n    (i) if the goods are a medicine—$1,939; and\n    (iii) in any other case—$2,149; and\n    (b) for goods:\n    (i) whose registration is in force at any time during the charge year; and\n    (ii) that are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and\n    (iii) that are a biologic;\n    $9,428; and\n    (c) for goods (other than goods produced for export) the listing of which is in force at any time during the charge year:\n    (i) if the goods are a medicine—$1,473; and\n    (iii) in any other case—$1,111.\n\n> Note: For goods of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990 that are not a biologic, see section 8.\n\n  Registration or listing of grouped therapeutic goods\n  (2) For the purposes of subsection 4(1A) of the Act, the annual charge for the registration or listing of grouped therapeutic goods is:\n    (a) for grouped goods whose registration is in force at any time during the charge year and that are of a kind not mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:\n    (i) if the goods are medicines—$1,939; and\n    (iii) in any other case—$2,149; and\n    (b) for grouped therapeutic goods:\n    (i) whose registration is in force at any time during the charge year; and\n    (ii) that are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and\n    (iii) that are biologics;\n    $9,428; and\n    (c) for grouped goods (other than goods all of which are produced for export) the listing of which is in force at any time during the charge year:\n    (i) if the goods are medicines—$1,473; and\n    (iii) in any other case—$1,111.\n\n> Note: For grouped therapeutic goods of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990 that are not biologics, see section 8.\n\n  Biologicals\n  (3) For the purposes of subsection 4(1AA) of the Act, the annual charges for inclusion of a biological (other than an export only biological) in the Register under Part 3‑2A of the Therapeutic Goods Act 1989 are:\n    (a) for a Class 1 biological whose inclusion in the Register is in force at any time during the charge year—$881; and\n    (b) for a Class 2, Class 3 or Class 4 biological whose inclusion in the Register is in force at any time during the charge year—$8,760.\n  Medical devices\n  (4) For the purposes of subsection 4(1B) of the Act, the annual charges in respect of the inclusion of kinds of medical devices (other than medical devices produced for export) in the Register under Chapter 4 of the Therapeutic Goods Act 1989 that has effect at any time during the charge year are as follows:\n    (a) for a Class I medical device (other than a Class I medical device to which paragraph (b) applies)—$114;\n    (b) for a Class I medical device that the manufacturer intends to be supplied in a sterile state or that has a measuring function—$828;\n    (c) for a Class IIa medical device or Class IIb medical device—$1,230;\n    (d) for a Class III medical device—$1,566;\n    (e) for an IVD medical device (of a class other than a Class 4 in‑house IVD medical device)—$893;\n    (f) for a Class 4 in‑house IVD medical device—nil.\n  Licences\n  (5) For the purposes of subsection 4(2) of the Act, the annual charge for a licence that is in force at any time during the charge year is as follows:\n    (a) for a licence for one or more steps in the manufacture of sterile or non‑sterile therapeutic goods—$6,020;\n    (b) for a licence for the manufacture of containers in which therapeutic goods are to be packed—$6,020;\n    (c) for a licence for the manufacture of ingredients or components for use in the manufacture of therapeutic goods—$6,020;\n    (e) for a licence for the manufacture of herbal or homoeopathic preparations that are not included in a Schedule to the current Poisons Standard (other than Schedule 5 or 6)—$6,020;\n    (f) for a licence for the manufacture of human blood and blood components (other than haematopoietic progenitor cells) at manufacturing premises covered by the licence:\n    (i) for the principal premises in the capital city of a State or Territory where human blood and blood components are manufactured—$210,610; and\n    (ii) for a fixed (non‑mobile) manufacturing site—$10,368;\n    (g) for a licence for the manufacture of haematopoietic progenitor cells at manufacturing premises covered by the licence—$9,070;\n    (h) for a licence for a single step in the manufacture of a single human tissue at manufacturing premises covered by the licence—$9,070;\n    (i) for a licence for 2 or more steps in the manufacture of human tissues at manufacturing premises covered by the licence—$17,738;\n    (j) despite paragraphs (a) to (i)—for a licence for the manufacture of a biological only—nil.\n  Only highest applicable charge is payable\n  (6) If, but for this subsection, more than one charge referred to in subsection (1) or any of paragraphs (5)(a) to (i) would otherwise apply in respect of a charge year in relation to:\n    (a) the registration or listing of particular goods; or\n    (b) a particular licence;\n  only the highest applicable charge (other than a charge payable under any of paragraphs (5)(a) to (i) only because biologicals are manufactured) applies in respect of the registration or listing of those goods or in relation to that licence in that year.\n\n> Note 1: Under regulation 43AAJ of the Therapeutic Goods Regulations 1990, the annual charge for a licence under Part 3‑3 of the Therapeutic Goods Act 1989 payable by a person whose wholesale turnover of therapeutic goods in a charge year is not more than $121,712 is half the amount mentioned in subsection (5) for the person. The reduction in the annual charge does not apply to a licence for the manufacture of human blood and blood components.\n\n> Note 2: For provisional registration of a medicine, see section 9.\n\n#### 8 Annual charges for goods that are not biologics\n\n  (1) For the purposes of subsections 4(1) and (1A) of the Act, this section sets out the annual charge for the registration of therapeutic goods if:\n    (a) the registration of the goods is in force at any time during the charge year; and\n    (b) the goods are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and\n    (c) either:\n    (i) if the goods are not grouped therapeutic goods—the goods are not a biologic; or\n    (ii) if the goods are grouped therapeutic goods—the goods are not biologics.\n  When higher and lower amounts are payable\n  (2) The annual charge for the goods for the charge year is:\n    (a) if one or more of the conditions in subsections (4) to (10) apply to the goods—$5,362; or\n    (b) otherwise—$4,368.\n  New chemical entities, extensions of indications and changes to intended patient groups\n  (4) The following conditions are met:\n    (a) the registration of the goods commenced on or after 1 July 2015;\n    (b) the goods are relevant goods;\n    (c) for goods whose registration commenced before the beginning of the charge year—at the beginning of the charge year, the goods have been registered for fewer than 8 years.\n  (5) Relevant goods are goods that, at the time the registration of the goods commenced, were:\n    (a) a new chemical entity, within the meaning of subclause 1(1) of Schedule 9 to the Therapeutic Goods Regulations 1990; or\n    (b) separate and distinct from other goods that are registered:\n    (i) because of an extension of indications, within the meaning of item 4 of the table in Part 2 of Schedule 9 to the Therapeutic Goods Regulations 1990, other than an extension of indications mentioned in paragraph (bc) of that item; or\n    (ii) because of a change to the intended patient group (within the meaning of paragraph (e) of the definition of major variation in subclause 1(1) of Schedule 9 to those Regulations).\n  Goods whose parent goods have been registered for fewer than 8 years\n  (6) The following conditions are met:\n    (a) the registration of the goods commenced on or after 1 July 2015;\n    (b) the goods are not relevant goods;\n    (c) subsection (4) applies for the charge year to the parent goods of those goods.\n  (7) Goods (the initial goods) are parent goods of other goods if:\n    (a) the initial goods were registered before the other goods; and\n    (b) the initial goods are relevant goods; and\n    (c) the initial goods and the other goods have:\n    (i) the same active ingredient; or\n    (ii) the same active ingredients in the same quantitative amounts; and\n    (d) at the time the registration of the other goods commenced, the other goods were registered in relation to:\n    (i) the person in relation to whom the initial goods were registered at that time; or\n    (ii) a person authorised by the person in relation to whom the initial goods were registered at that time.\n  Grouped therapeutic goods as a result of extension of indications or changes to intended patient group\n  (8) The following conditions are met:\n    (a) the goods are grouped therapeutic goods;\n    (b) relevant goods that are included in those grouped goods were grouped on or after 1 July 2015 (whether or not other goods that are included in those grouped goods were registered before that time);\n    (c) the grouping occurred in a financial year before the charge year;\n    (d) at the beginning of the charge year, the relevant goods have been included in the grouped goods for fewer than 8 years.\n  Entries before 1 July 2015—goods other than grouped therapeutic goods\n  (9) The following conditions are met:\n    (a) the goods are not grouped therapeutic goods;\n    (b) the goods (the chargeable goods) were registered before 1 July 2015;\n    (c) immediately before 1 July 2015:\n    (i) if there is only one active ingredient contained in the chargeable goods—any other goods containing that active ingredient (and no other active ingredients) are registered in relation to the person in relation to whom the chargeable goods are registered; or\n    (ii) otherwise—any other goods containing the same active ingredients in the same quantitative amounts as the chargeable goods (and no other active ingredients) are registered in relation to the person in relation to whom the chargeable goods are registered;\n    (d) at the beginning of the charge year, the goods have been registered for fewer than 8 years.\n  Entries before 1 July 2015—grouped therapeutic goods\n  (10) The following conditions are met:\n    (a) the goods were grouped therapeutic goods immediately before 1 July 2015;\n    (b) immediately before 1 July 2015:\n    (i) if there is only one active ingredient contained in the grouped goods—any other goods containing that active ingredient (and no other active ingredients) are registered in relation to the same person in relation to whom the grouped goods are registered; or\n    (ii) otherwise—any other goods containing the same active ingredients in the same quantitative amounts as the grouped goods (and no other active ingredients) are registered in relation to the same person in relation to whom the grouped goods are registered;\n    (c) at the beginning of the charge year, the first of the goods to be registered have been registered for fewer than 8 years.\n\n> Note: For provisional registration of a medicine, see section 9.\n\n#### 9 Annual charges for provisionally registered medicines\n\n  (1) For the purposes of subsection 4(1) of the Act, the annual charges for the provisional registration of a medicine, if the provisional registration is in force at any time during the charge year, are:\n    (a) for goods that are a biologic—$21,273; and\n    (b) for goods that are not a biologic—$17,372.\n  (2) If a provisional registration for a medicine is in force at any time in a charge year, and the medicine is otherwise registered later in the same charge year, sections 7 and 8 do not apply in relation to its registration in respect of that charge year.\n\n## Part 3—Application and transitional provisions\n\n### Division 1—Transitional provision relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n#### 10 Transitional provision relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  If, at any time during a charge year, the same medical device is included in the Register as a Class AIMD medical device and a Class III medical device, the charge in respect of the inclusion in the Register of the medical device as a Class III medical device during the charge year is nil.","sortOrder":10},{"sectionNumber":"10","sectionType":"section","heading":"Transitional provision relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019","content":"#### 10 Transitional provision relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  If, at any time during a charge year, the same medical device is included in the Register as a Class AIMD medical device and a Class III medical device, the charge in respect of the inclusion in the Register of the medical device as a Class III medical device during the charge year is nil.","sortOrder":11}],"analysis":{"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":false,"description":"This instrument does not expand the regulatory scope (it does not create new regulatory powers or broaden the kinds of goods regulated). It sets and differentiates annual charges and introduces transitional charging rules (e.g. AIMD/Class III device treatment). In other words, it adjusts price signals and the distribution of regulatory cost recovery among product types and licences but does not itself change what conduct is regulated. The inclusion of provisional registration charges and specific large charges for certain manufacturing premises changes financial exposure for particular actors but stays within the original purpose of the Charges Act to prescribe fees for existing regulatory activities."},"complexity_factors":["Multiple product categories with distinct fee schedules (medicines, biologics, grouped goods, devices, provisional registrations, licences) across sections 7–9","Cross‑references to other instruments and schedules (Therapeutic Goods Regulations 1990 Schedule 9 and Schedule 10; Medical Devices Regulations 2002 Division 3.1; regulation 43AAJ) increase interpretive work","Several defined terms in section 5 and reliance on definitions in the Act and other regulations (e.g. biologic, grouped therapeutic goods, parent goods, relevant goods)","Nested conditional logic in section 8 (subsections (4)–(10)) determining higher vs lower annual charges, including date‑based rules tied to 1 July 2015 and 8‑year thresholds","Special high‑value, category‑specific fees (e.g. $210,610 for principal human blood manufacturing premises) that are exceptions to otherwise more uniform charges (section 7(5)(f))","Rule limiting payable charge to the single highest applicable charge (section 7(6)) which interacts with multiple possible applicable charges","Transitional provision addressing dual classification of devices (AIMD and Class III) which overrides ordinary fees for that scenario (section 10)","Concessions referenced but located in other regulations (small wholesale turnover halving fee) require users to consult multiple instruments","Some duplication and repetition in the instrument's text (as pasted) — increases reading burden but not substantive complexity"],"plain_english_summary":"**What this instrument does (mechanically)**\n\n- This regulation sets the annual fees (charges) payable under the Therapeutic Goods (Charges) Act 1989 for: registration or listing of therapeutic goods, inclusion of biologicals and medical devices in the Register, and licences to manufacture therapeutic goods. (See sections 7–9 and 5 for definitions.)\n\n- It prescribes different dollar amounts depending on the type of product or licence: medicines vs other goods, biologics vs non-biologics, grouped vs non‑grouped goods, classes of medical devices, provisional registrations, and various manufacturing licences. (See sections 7(1)–(5), 7(3)–(4), 8(2) and 9(1).)\n\n- If more than one fee would apply to the same registration/listing or licence in a year, only the highest applicable charge is payable (subject to a limited exclusion for charges that apply only because biologics are manufactured). (See section 7(6).)\n\n- There are special rules and cross‑references: for example, very large charges for principal premises that manufacture human blood and blood components (section 7(5)(f)(i): $210,610) and a concession for small manufacturers under regulation 43AAJ of the Therapeutic Goods Regulations 1990 (note following section 7). A transitional rule treats a device listed both as an AIMD and as Class III so that the Class III charge is nil (section 10).\n\n\n**Who pays and who is affected**\n\n- Who pays: sponsors/holders of registrations or listings on the Australian Register of Therapeutic Goods (ARTG), persons who hold licences for manufacturing therapeutic goods, and persons with provisional registrations for medicines. (See sections 7–9.)\n\n- Who is affected: pharmaceutical and biologic product sponsors, medical device manufacturers and sponsors (including in‑house IVDs), manufacturers of containers/ingredients/components, manufacturers of human blood, tissues and haematopoietic progenitor cells, and any business that lists or registers therapeutic goods in Australia.\n\n\n**Why it matters (stated purpose and practical implications)**\n\n- The regulation operationalises the charging power in the Charges Act by specifying how much regulated entities must pay each financial year to remain registered/listed or licensed. The explicit purpose (implicit in the regime) is to recover costs of regulation and administration by assigning charges to regulated goods and licences.\n\n- Practical implications:\n  - Entities budgeting to enter or remain in the Australian market must allow for these recurring annual charges, which vary widely by product type (for example, biologic registration can attract a substantially higher fee than a chemical medicine — see section 7(1)(b)).\n  - High charges for certain activities (notably principal blood manufacturing premises) concentrate costs on specific operators (section 7(5)(f)).\n  - A provisional registration carries higher annual fees than ordinary registration for the same medicine in many cases (section 9(1)), which may affect sponsors' choice to use the provisional pathway.\n\n\n**Costs, incentives and trade‑offs (testing the purpose claim against effects)**\n\n- Who pays: sponsors and manufacturers bear the direct cost (sections 7–9). The regulation shifts costs of regulatory administration onto regulated firms rather than general taxation.\n\n- Concentrated benefits / diffuse costs: fees fund regulator activity (benefit to regulator and to users of the regulatory system). Costs fall most heavily on specific product types and large facilities (e.g. blood manufacturing premises) rather than being evenly distributed (section 7(5)(f)).\n\n- Incentives and private behaviour: differential fees create incentives to structure product entries and manufacturing arrangements to minimise charges (for example, grouping goods, claiming export‑only status where relevant, or structuring manufacturing sites), and may influence decisions about pursuing provisional registration because provisional charges are relatively high (section 9).\n\n- Effects on competition and entry: relatively higher fees for biologics and certain device classes (section 7(1)(b), 7(3), 7(4)) raise the fixed costs of market entry for those product types and may deter marginal entrants or favour larger incumbents who can absorb fees.\n\n- Compliance burden and classification risk: many fees depend on cross‑referenced classifications and dates (for example, Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990, Schedule 9 definitions, device classes under the Medical Devices Regulations). Firms must determine which category applies, and disputes about classification or grouping can change fee exposure (see sections 5, 6, 7 and 8). That creates administrative compliance costs and some implementation risk.\n\n- Trade‑offs and opportunity costs: the regulation trades direct user‑pays recovery of regulatory costs against increased costs for firms. High fees for some licences (notably blood manufacturing principal premises) concentrate compliance cost on those operators (section 7(5)(f)). The concession for small wholesale turnover (regulation 43AAJ — noted after section 7) reduces burden on the smallest operators but is limited in scope.\n\n- Bureaucratic discretion: classifying a product as a biologic, determining grouped goods status, and device classification are governed by other regulations and administrative decisions (sections 5–6 and cross‑references). That means fee outcomes depend materially on regulatory classification decisions made by the TGA under other instruments.\n\n\n**Other notable mechanical points**\n\n- Medical device charges vary by class and by intended features (sterile supply or measuring function) — see section 7(4)(a)–(d).\n- Some categories attract nil fees: Class 4 in‑house IVDs and licences solely for manufacture of biologicals (section 7(4)(f) and 7(5)(j)).\n- Transitional rule: if the same device appears in the Register as both an AIMD and a Class III device during a charge year, the Class III charge is set to nil for that year (section 10).\n\n\n**References to the regulation text**: Key mechanics are in sections 5–10, with cross‑references to the Therapeutic Goods Regulations 1990 (Schedules 9 and 10) and the Therapeutic Goods (Medical Devices) Regulations 2002 (device classification)."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":7,"scope_assessment":{"changed":false,"description":"The legislation appears to maintain its original scope as a charging instrument under the Therapeutic Goods (Charges) Act 1989. While the fee structure has grown complex with the addition of biologics, medical devices, and provisional registration pathways, these expansions reflect the evolution of therapeutic goods regulation rather than scope creep beyond the original purpose of setting annual charges."},"complexity_factors":["Extensive cross-referencing to external instruments: Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990, Therapeutic Goods (Medical Devices) Regulations 2002, and multiple schedules within those instruments","Nested conditional logic in section 8 with 7 separate subsections ((4) through (10)) determining whether higher ($5,362) or lower ($4,368) fees apply based on registration dates, grouping status, and 'parent goods' relationships","Dual definition system: 'biologic' is defined separately from 'biological' (which is imported from the parent Act), requiring readers to track which term applies where","Complex temporal calculations: multiple provisions require calculating time elapsed since 1 July 2015 or determining if goods have been registered for 'fewer than 8 years'","Defined terms with internal cross-references: 'parent goods' and 'relevant goods' are defined by reference to other subsections, creating definitional chains","Exception to exception structure: section 7(6) provides that only the highest charge applies, but then excludes charges payable 'only because biologicals are manufactured'","Parallel structure for grouped vs non-grouped goods requiring readers to compare nearly identical provisions in sections 7(1) and 7(2), and 8(9) vs 8(10)","Missing paragraph (d) in section 7(5) licence fee structure, suggesting amendment complexity or consolidation history"],"plain_english_summary":"This regulation sets annual fees charged by the TGA to pharmaceutical firms, medical device makers, blood/tissue banks, and manufacturing sites to keep therapeutic goods registered or licensed in Australia. Fees vary by product type, risk level, registration status (including provisional and grouped listings), and manufacturing activities.\n\nBecause complex biologics, high-risk devices, and blood manufacturing attract much higher charges, the schedule funds TGA oversight and represents a substantial compliance cost for businesses and an indirect factor in healthcare prices."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-charges-regulations-2018","history":"/api/acts/therapeutic-goods-charges-regulations-2018/history","analysis":"/api/acts/therapeutic-goods-charges-regulations-2018/analysis","conflicts":"/api/acts/therapeutic-goods-charges-regulations-2018/conflicts","importantCases":"/api/acts/therapeutic-goods-charges-regulations-2018/important-cases","documents":"/api/acts/therapeutic-goods-charges-regulations-2018/documents"}}