Commonwealth: Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 (Cth)

Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 No. 7, 2018 An Act to amend the Therapeutic Goods Act 1989, and for related purposes Contents 1 Short title 2 Commencement 3 Schedules Schedule 1—Provisional registration of medicine Therapeutic Goods Act 1989 Schedule 2—Indications and ingredients for listed medicines Part 1—Amendments Therapeutic Goods Act 1989 Part 2—Application and transitional provisions Schedule 3—New pathway for listed medicines Therapeutic Goods Act 1989 Schedule 4—Preliminary assessment of applications Part 1—Therapeutic goods Therapeutic Goods Act 1989 Part 2—Biologicals Therapeutic Goods Act 1989 Part 3—Medical devices Therapeutic Goods Act 1989 Part 4—Consequential amendments Therapeutic Goods Act 1989 Schedule 5—Conformity assessment procedures and certificates Therapeutic Goods Act 1989 Schedule 6—Advertising Part 1—Enforcement Therapeutic Goods Act 1989 Part 2—Removal of requirement for advertisements to be approved Broadcasting Services Act 1992 Therapeutic Goods Act 1989 Schedule 7—Enforcement Therapeutic Goods Act 1989 Schedule 8—Record‑keeping etc. Therapeutic Goods Act 1989 Schedule 9—Other amendments Therapeutic Goods Act 1989 Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 No. 7, 2018 An Act to amend the Therapeutic Goods Act 1989, and for related purposes [Assented to 5 March 2018] The Parliament of Australia enacts: 1 Short title This Act is the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018. 2 Commencement (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms. Commencement information Column 1 Column 2 Column 3 Provisions Commencement Date/Details 1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table The day this Act receives the Royal Assent. 5 March 2018 2. Schedules 1 and 2 The later of: 6 March 2018 (a) 1 January 2018; and (paragraph (b) applies) (b) the day after this Act receives the Royal Assent. 3. Schedule 3 Immediately after the commencement of the provisions covered by table item 2. 6 March 2018 4. Schedules 4 and 5 The later of: 6 March 2018 (a) 1 January 2018; and (paragraph (b) applies) (b) the day after this Act receives the Royal Assent. 5. Schedule 6, Part 1 Immediately after the commencement of the provisions covered by table item 4. 6 March 2018 6. Schedule 6, Part 2 1 July 2020. 1 July 2020 7. Schedule 7 Immediately after the commencement of the provisions covered by table item 4. 6 March 2018 8. Schedule 8 The later of: 6 March 2018 (a) 1 January 2018; and (paragraph (b) applies) (b) the day after this Act receives the Royal Assent. 9. Schedule 9 Immediately after the commencement of the provisions covered by table item 5. 6 March 2018 Note: This table relates only to the provisions of this Act as originally enacted. It will not be amended to deal with any later amendments of this Act. (2) Any information in column 3 of the table is not part of this Act. Information may be inserted in this column, or information in it may be edited, in any published version of this Act. 3 Schedules Legislation that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms. Schedule 1—Provisional registration of medicine Therapeutic Goods Act 1989 1 Subsection 3(1) (definition of registered goods) Repeal the definition, substitute: registered goods means: (a) therapeutic goods included in the part of the Register for goods known as registered goods; or (b) therapeutic goods included in the part of the Register for goods known as provisionally registered goods. Note: Subsection (8) provides that a reference in this Act to therapeutic goods that are registered, or to the registration of therapeutic goods, includes a reference to a medicine that is provisionally registered under section 29. 2 At the end of section 3 Add: (8) To avoid doubt: (a) a reference in this Act to therapeutic goods that are registered includes a reference to a medicine that is provisionally registered; and (b) a reference in this Act to the registration of therapeutic goods includes a reference to the provisional registration of a medicine. Note: Subsection 29(2) deals with the provisional registration of a medicine. 3 After paragraph 6AAE(6)(a) Insert: (aa) in the part of the Register for goods known as provisionally registered goods; or 4 Subsection 9A(3) Omit "4 parts", substitute "5 parts". 5 After paragraph 9A(3)(a) Insert: (aa) a part for goods to be known as provisionally registered goods; and 6 After subsection 9D(1) Insert: (1A) If: (a) a medicine is included in the part of the Register for goods known as provisionally registered goods; and (b) it appears to the Secretary that the quality, safety or efficacy of the medicine is unacceptable in relation to a class of persons; the Secretary may, on the Secretary's own initiative, vary the entry in the Register in relation to the medicine: (c) to reduce the class of persons for whom the medicine is suitable or to change the directions for use; or (d) to add a warning, or precaution, that does not include any comparison of the medicine with any other medicine by reference to quality, safety or efficacy. Note: The Secretary may also vary the product information relating to the medicine: see subsection 25AA(4). (1B) If: (a) a medicine is included in the part of the Register for goods known as provisionally registered goods; and (b) the Secretary makes a decision under subsection 29(9) to extend the provisional registration period for the medicine; the Secretary may, on the Secretary's own initiative, vary the entry in the Register in relation to the medicine to reduce the class of persons for whom the medicine is suitable or to change the directions for use. Note: The Secretary may also vary the product information relating to the medicine: see subsection 25AA(4). (1C) If the Secretary proposes to make a variation under subsection (1A) or (1B), the Secretary must: (a) give the person in relation to whom the medicine is registered written notice of the proposed variation and of the reasons for the proposed variation; and (b) give the person a reasonable opportunity to make a submission to the Secretary in relation to the proposed variation; and (c) if the person makes a submission in accordance with paragraph (b)—take the submission into account before making a decision whether or not to make the variation. (1D) Subsections (1A) and (1B) apply despite subsection 16(1). 7 After Division 1 of Part 3‑2 Insert: Division 1A—Provisional determinations for medicine 22C Applications for provisional determination (1) A person may make an application to the Secretary for a provisional determination relating to a medicine of a kind prescribed by the regulations for the purposes of this subsection. Note: If the Secretary makes the determination, the person applies under section 23 for registration of the medicine and that application passes preliminary assessment, then a different kind of evaluation of the medicine will occur under section 25. (2) An application under subsection (1) must: (a) be made in accordance with a form approved, in writing, by the Secretary; and (b) be accompanied by the prescribed application fee; and (c) contain the information that the form requires, and any further information, statement or document the Secretary requires, whether in the form or otherwise; and (d) satisfy any other requirement prescribed by the regulations for the purposes of this paragraph. (3) An approval of a form may require or permit an application or information to be given in accordance with specified software requirements: (a) on a specified kind of data processing device; or (b) by way of a specified kind of electronic transmission. 22D Provisional determinations (1) If a person makes an application, in accordance with subsection 22C(2), for a provisional determination relating to a medicine, the Secretary must decide to make, or to refuse to make, the determination. Criteria (2) The Secretary may make the determination if the Secretary is satisfied that the criteria prescribed by the regulations for the purposes of this subsection are met in relation to the medicine. Content of determination (3) The determination must specify: (a) the person to whom the determination relates; and (b) the medicine to which the determination relates; and (c) the indication of the medicine to which the determination relates; and (d) each active ingredient of the medicine to which the determination relates. The determination may specify any other matters that the Secretary considers appropriate. Notice of decision (4) As soon as practicable after making the decision, the Secretary must: (a) give the person written notice of the decision; and (b) if the Secretary refuses to make the determination—set out the reasons for the refusal in the notice. 22E Period during which provisional determination is in force (1) A provisional determination under section 22D relating to a medicine: (a) comes into force on the day on which the Secretary gives the person notice under subsection 22D(4); and (b) subject to this section and section 22F, remains in force for the initial period. Note: For revocation of the determination, see section 22F. (2) The initial period is 6 months or another period prescribed by the regulations for the purposes of this subsection. Extensions (3) The person may make an application to the Secretary to extend the initial period. (4) The application must: (a) be in a form approved, in writing, by the Secretary; and (b) be made at least 28 days before the determination would otherwise cease to be in force; and (c) be accompanied by the prescribed application fee. (5) On receiving the application, the Secretary must decide to extend, or to refuse to extend, the initial period. (6) The Secretary may extend the initial period by 6 months, or another period prescribed by the regulations for the purposes of this subsection, if the Secretary: (a) is still satisfied that the criteria prescribed by the regulations for the purposes of subsection 22D(2) are met in relation to the medicine; and (b) is satisfied that, if the Secretary were to make the extension, the person would make an application under section 23 for provisional registration of the medicine before the end of the extended period. (7) As soon as practicable after making the decision, the Secretary must: (a) give the person written notice of the decision; and (b) if the Secretary refuses to extend the initial period—set out the reasons for the refusal in the notice. (8) Only one extension may be given. Effect of application under section 23 (9) If the person to whom the provisional determination relates makes an application under section 23 for provisional registration of the medicine before the end of the initial period (or that period as extended), the determination remains in force until: (a) the person withdraws the application; or (b) the application lapses in accordance with subsection 24(2); or (c) the person gives the Secretary written notice under subsection 24E(2) that the person wishes to treat the application as having been refused; or (d) the application is finally determined. (10) For the purposes of paragraph (9)(d), an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of. 22F Revocation of provisional determination Revocation on Secretary's own initiative (1) The Secretary may revoke a provisional determination under section 22D relating to a person and a medicine if the Secretary is satisfied that the criteria prescribed by the regulations for the purposes of subsection 22D(2) are no longer met in relation to the medicine. Revocation on request (2) The Secretary must revoke a provisional determination under section 22D relating to a person and a medicine if the person requests the Secretary, in writing, to do so. Notice of revocation (3) As soon as practicable after making a revocation under this section, the Secretary must: (a) give the person written notice of the revocation; and (b) for a revocation under subsection (1)—set out the reasons for the revocation in the notice. Day revocation takes effect (4) A revocation under this section takes effect on the day on which the Secretary gives the person notice of the revocation. 8 After section 23 Insert: 23AA Applications for provisional registration of medicine If: (a) a person makes an application under section 23 for the registration of a medicine; and (b) a provisional determination under section 22D relating to the person, the medicine and the indication to which the application relates is in force when the application is made; then, for the purposes of this Act, the application is taken to be an application for provisional registration of the medicine. 9 Paragraph 25(1)(d) Repeal the paragraph, substitute: (c) unless the application is one referred to in paragraph (d)—whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established; and (d) for an application for provisional registration of a medicine: (i) whether, based on preliminary clinical data, the safety and efficacy of the medicine for the purposes for which it is to be used have been satisfactorily established; and (ii) whether the quality of the medicine for the purposes for which it is to be used has been satisfactorily established; and (iii) whether, if the Secretary were to register the medicine, the Secretary is satisfied with the applicant's plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that registration would commence; and 10 After paragraph 28(2A)(a) Insert: (aa) the provisional registration of medicine; and 11 Section 29 Omit "Where", substitute "(1) Subject to this section, if". 12 At the end of section 29 Add: Provisionally registered medicine (2) If: (a) a person makes an application for provisional registration of a medicine; and (b) in relation to that application, the Secretary decides under subsection 25(3) to register the medicine; and (c) the medicine is included in the Register in relation to the person; then: (d) the medicine is provisionally registered; and (e) the medicine remains included in the Register for the provisional registration period, unless the medicine's registration is cancelled under this Part earlier. Note: The medicine is taken not to be included in the Register while its registration is suspended: see section 29G. (3) Subject to this section, the provisional registration period is the 2 years starting on the day the registration commences. Note: Subsection 25AB(6) provides that registration commences on the day specified in the certificate of registration. Extension of provisional registration upon application (4) The person in relation to whom the medicine is provisionally registered may make an application to the Secretary to extend the provisional registration period. (5) The application must: (a) be in a form approved, in writing, by the Secretary; and (b) contain the information that the form requires, and any further information, statement or document the Secretary requires, whether in the form or otherwise; and (c) be made at least 6 months before the provisional registration of the medicine is due to end; and (d) be accompanied by the prescribed application fee. (6) On receiving the application, the Secretary must decide to grant, or to refuse to grant, an extension of the provisional registration period. In making that decision, the Secretary must have regard to: (a) whether the Secretary is satisfied with the applicant's plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years starting on the day the provisional registration commenced; and (b) such other matters (if any) as the Secretary considers relevant. (7) As soon as practicable after making the decision, the Secretary must: (a) give the applicant written notice of the decision; and (b) if the Secretary decides to extend the provisional registration period—specify in the notice the period of the extension (which must not exceed 2 years and may be less than the period sought by the applicant); and (c) if the Secretary refuses to extend the provisional registration period—set out the reasons for the refusal in the notice. Note: At the time of granting an extension, the Secretary may impose new conditions on the provisional registration or vary the existing conditions: see subsection 28(3). (8) No more than 2 extensions may be granted on applications under subsection (4). Note: Under subsection (9) the Secretary may extend the provisional registration period on his or her own initiative. Effect on provisional registration of later section 23 application (9) If: (a) before the provisional registration period ends, the person in relation to whom the medicine is provisionally registered makes an application under section 23 for registration of the medicine; and (b) the application is for the medicine to be included in the part of the Register for goods known as registered goods; then the Secretary may, in connection with the application, end or extend the provisional registration period as the Secretary considers appropriate. Note: At the time of granting an extension, the Secretary may impose new conditions on the provisional registration or vary the existing conditions: see subsection 28(3). (10) In ending or extending, under subsection (9), the provisional registration period: (a) the Secretary must have regard to any matters prescribed by the regulations for the purposes of this paragraph; and (b) the Secretary must ensure the provisional registration period continues while the Secretary is considering the application, unless the medicine's registration is cancelled under this Part; and (c) the Secretary must not extend the provisional registration period so it would end more than 6 years after the provisional registration commenced, unless the extension is for the purposes of paragraph (b). 13 After paragraph 56A(1)(d) Insert: (da) particular therapeutic goods were or were not included in the Register as provisionally registered goods; or 14 Subsection 60(2) Omit "A person whose", substitute "Subject to this section, a person whose". 15 After subsection 60(2A) Insert: (2AA) If the Secretary or a delegate of the Secretary makes a decision under subsection 9D(1A) or (1B) to vary an entry in the Register in relation to a medicine, a person is not entitled to request the Minister to reconsider the decision unless the person is the person in relation to whom the medicine is registered. (2AB) If the Secretary or a delegate of the Secretary: (a) makes a decision under section 22D in relation to an application under section 22C; or (b) makes a decision under section 22E in relation to an application under subsection 22E(3); or (c) makes a decision under section 23B in relation to an application for provisional registration of a medicine; or (d) makes a decision under subsection 25(3) in relation to an application for provisional registration of a medicine; a person is not entitled to request the Minister to reconsider the decision unless the person made the application. (2AC) If the Secretary or a delegate of the Secretary makes a decision under section 22F to revoke a provisional determination under section 22D, a person is not entitled to request the Minister to reconsider the decision unless the person made the application for that provisional determination. 16 Subsection 60(2B) After "the Secretary", insert "or a delegate of the Secretary". 17 Before subsection 60(3) Insert: (2D) If the Secretary or a delegate of the Secretary: (a) makes a decision under subsection 29(6) in relation to an application under subsection 29(4); or (b) makes a decision under subsection 29(9) to end, or extend, the provisional registration period for a medicine; a person is not entitled to request the Minister to reconsider the decision unless the person is the person in relation to whom the medicine is provisionally registered. Schedule 2—Indications and ingredients for listed medicines Part 1—Amendments Therapeutic Goods Act 1989 1 After paragraph 26A(2)(fb) Insert: (fba) if the medicine's label contains one or more indications—each indication: (i) is covered by a determination under paragraph 26BF(1)(a); and (ii) is proposed to be accepted in relation to the inclusion of the medicine in the Register; and 2 After paragraph 26A(2)(fc) Insert: (fd) each indication proposed to be accepted in relation to the inclusion of the medicine in the Register is covered by a determination under paragraph 26BF(1)(a); and (fe) if a determination under paragraph 26BF(1)(b) specifies requirements in relation to an indication proposed to be accepted in relation to the inclusion of the medicine in the Register—none of the requirements have been contravened; and 3 Paragraph 26A(2)(j) Repeal the paragraph, substitute: (j) both: (i) the applicant holds information or evidence to support any claim (other than a claim that is an indication) proposed to be accepted in relation to the inclusion of the medicine in the Register; and (ii) the information or evidence complies with any requirements specified in a determination under subsection (2B); and 4 After paragraph 26A(2)(j) Insert: (ja) both: (i) the applicant holds information or evidence to support each indication proposed to be accepted in relation to the inclusion of the medicine in the Register; and (ii) the information or evidence complies with any requirements specified in a determination under subsection (2B); and 5 After subsection 26A(2A) Insert: (2B) The Minister may, by legislative instrument, specify requirements for the purposes of subparagraph (2)(j)(ii) or (2)(ja)(ii). 6 After subsection 26BB(2) Insert: (2A) The requirements referred to in paragraph (1)(b) may relate to a particular ingredient being contained in particular medicine only in the circumstances specified in the determination in relation to the ingredient. 7 Subsection 26BB(4) Omit "and (3)", substitute ", (2A) and (3)". 8 Before subsection 26BE(1) Insert: Making an application for recommendation 9 After subsection 26BE(2) Insert: Further information about application for recommendation (2A) The Secretary may, by written notice given to a person who has made an application under subsection (1), require the person to: (a) give the Secretary such further information in connection with the application as is specified in the notice; and (b) do so within such reasonable period as is specified in the notice. Lapsing of application for recommendation (2B) An application made under subsection (1) lapses if: (a) the application contains information that is inaccurate or misleading in a material particular; or (b) information given to the Secretary by, or on behalf of, the applicant in connection with the application is inaccurate or misleading in a material particular. 10 At the end of paragraph 26BE(3)(b) Add "and". 11 After paragraph 26BE(3)(b) Insert: (c) if further information is required to be given under subsection (2A) within a specified period—the information is given within that period; 12 After subsection 26BE(5) Insert: (5A) If the Secretary refuses to make the recommendation, the Secretary must: (a) notify the applicant in writing of his or her decision; and (b) state in the notice the reasons for the decision. Partial refund of application fee in certain circumstances (5B) If: (a) an application fee is prescribed for the purposes of paragraph (2)(d); and (b) regulations made for the purposes of paragraph 63(2)(daaa) prescribe a period within which recommendations under this section must be made; and (c) the Secretary makes a recommendation in relation to an application under subsection (1), but not within that period; then 25% of the application fee must be refunded to the applicant. Deemed refusal of applications in certain circumstances (5C) If: (a) regulations made for the purposes of paragraph 63(2)(daaa) prescribe a period within which recommendations under this section must be made; and (b) at the end of that period, the Secretary has not made a recommendation in relation to an application under subsection (1); the applicant may give the Secretary written notice that the applicant wishes to treat the application as having been refused. (5D) A notice under subsection (5C) may be given at any time before the recommendation in relation to the application is made. (5E) If a notice has been given under subsection (5C), this Act (except subsection 60(5)) has effect as if: (a) the Secretary had decided not to make a recommendation under this section; and (b) the Minister had made a decision under subsection 60(3) confirming the decision of the Secretary; and (c) the Minister's decision had been made on the day on which notice was given to the Secretary under subsection (5C). 13 Subsection 26BE(8) Repeal the subsection. 14 Subsection 26BE(9) Omit "subsection (8)", substitute "subsection (2A)". 15 After section 26BE Insert: 26BF Permissible indications (1) The Minister may, by legislative instrument, make a determination in relation to either or both of the following: (a) indications; (b) requirements in relation to indications. Note: See paragraphs 26A(2)(fba), (fd) and (fe) (which deal with matters that a person seeking the listing of a medicine under section 26A must certify). (2) In deciding whether to make a determination under subsection (1) in relation to a particular indication, the Minister may have regard to whether the indication is a therapeutic use that relates to one or more of the following: (a) maintaining health; (b) enhancing health; (c) preventing a dietary deficiency; (d) a disease, ailment, defect or injury, other than a serious form of the disease, ailment, defect or injury. (3) Subsection (2) does not limit the matters to which the Minister may have regard in deciding whether to make a determination under subsection (1) in relation to a particular indication. (4) Without limiting paragraph (1)(b), the requirements may relate to: (a) the use of particular indications in specified circumstances; or (b) the use of particular indications if certain specified conditions are met. (5) A determination under paragraph (1)(b) may make different provision for different classes of medicines. 26BG Limitations on determination under section 26BF (1) The Minister may, by legislative instrument, make a determination specifying indications that must not be covered by a determination under paragraph 26BF(1)(a). (2) The determination may specify an indication either generally or in relation to specified circumstances. (3) The Minister may, by legislative instrument, vary or revoke a determination under subsection (1). 26BH Variation of determination under section 26BF—Minister's initiative The Minister may, on his or her own initiative and by legislative instrument, vary a determination under section 26BF. 26BJ Variation of determination under section 26BF—application by person Application for recommendation to vary section 26BF determination (1) A person may apply to the Secretary for a recommendation that the Minister vary a determination under section 26BF. (2) An application under subsection (1) must: (a) be made in accordance with a form approved, in writing, by the Secretary; and (b) set out the recommendation sought; and (c) be delivered to an office of the Department specified in the form; and (d) be accompanied by the prescribed application fee (if any). Limits on kinds of applications that can be made (3) A person cannot make an application under subsection (1) for a recommendation the effect of which would be for the determination to cover any of the following: (a) an indication specified in a determination under section 26BG; (b) an indication that is or contains a restricted representation (within the meaning of Part 5‑1); (c) unless subsection (4) applies—an indication that is or contains a prohibited representation (within the meaning of Part 5‑1); (d) unless subsection (5) applies—an indication that refers to preventing, curing or alleviating a disease, ailment, defect or injury. (4) For the purposes of paragraph (3)(c), this subsection applies if: (a) the indication is a therapeutic use that relates to sun protection; and (b) the prohibited representation relates to the prevention of skin cancer; and (c) the use of the prohibited representation is permitted under section 42DK. (5) For the purposes of paragraph (3)(d), this subsection applies if the indication refers to: (a) the prevention of a dietary deficiency; or (b) the prevention of skin cancer or sun damage. Further information about application for recommendation (6) The Secretary may, by written notice given to a person who has made an application under subsection (1), require the person to: (a) give the Secretary such further information in connection with the application as is specified in the notice; and (b) do so within such reasonable time as is specified in the notice. Lapsing of application for recommendation (7) An application made under subsection (1) lapses if: (a) the application contains information that is inaccurate or misleading in a material particular; or (b) information given to the Secretary by, or on behalf of, the applicant in connection with the application is inaccurate or misleading in a material particular. Decision on application for recommendation (8) If: (a) an application is made under subsection (1); and (b) any applicable prescribed application fee has been paid; and (c) if further information is required to be given under subsection (6) within a specified time—the information is given within that time; the Secretary must decide whether to make the recommendation or refuse to make the recommendation. (9) In deciding whether to make the recommendation, the Secretary may have regard to whether the indication to which the application relates is a therapeutic use that relates to one or more of the following: (a) maintaining health; (b) enhancing health; (c) preventing a dietary deficiency; (d) a disease, ailment, defect or injury, other than a serious form of the disease, ailment, defect or injury; (e) sun protection. (10) If the Secretary refuses to make the recommendation, the Secretary must: (a) notify the applicant in writing of his or her decision; and (b) state in the notice the reasons for the decision. Minister may vary section 26BF determination (11) If the Secretary makes a recommendation under subsection (8), the Minister must: (a) by legislative instrument, vary the determination under subsection 26BF(1); or (b) refuse to vary the determination. (12) In deciding whether to vary a determination under subsection 26BF(1) to include an indication not already covered by the determination, the Minister may have regard to: (a) the recommendation made under subsection (8) of this section; and (b) whether the indication is a therapeutic use that relates to one or more of the matters in paragraphs (9)(a) to (e) of this section. (13) Subsection (12) does not limit the matters to which the Minister may have regard in deciding whether to vary the determination. Applications or information may be given electronically (14) An approval of a form mentioned in paragraph (2)(a), or a notice mentioned in subsection (6), may require or permit an application or information to be given in accordance with specified software requirements: (a) on a specified kind of data processing device; or (b) by way of a specified kind of electronic transmission. 16 Subsections 28(6) and (7) Repeal the subsections, substitute: (6) If in, or in connection with, an application for the listing of therapeutic goods, a claim (other than a claim that is an indication) is made by the applicant in relation to the goods, the listing of the goods is subject to the following conditions: (a) a condition that the sponsor of the goods had, at the time when the claim was made, information or evidence that supported the claim and complied with the requirements (if any) specified in a determination made under subsection 26A(2B); (b) a condition that the sponsor retains the information or evidence at all times while the goods remain listed; (c) a condition that, at any time while the goods remain listed, the sponsor will, if asked to do so by the Secretary, give the information or evidence to the Secretary. (7) If: (a) a medicine is listed under section 26A; and (b) an indication is accepted in relation to the inclusion of the medicine in the Register; the listing of the medicine is subject to the following conditions: (c) a condition that the person in relation to whom the medicine is listed has, at all times while the medicine remains listed, information or evidence that supports the indication and complies with the requirements (if any) specified in a determination under subsection 26A(2B); (d) a condition that, at any time while the medicine remains listed, the person will, if asked to do so by the Secretary, give the information or evidence to the Secretary. 17 Paragraph 30(1)(e) Omit "(e)", substitute "(e), (fba), (fd), (fe)". 18 Paragraph 30(2)(ba) After "(j)", insert ", (ja)". 19 After subsection 60(2B) Insert: (2C) If the Secretary or a delegate of the Secretary decides, under subsection 26BJ(8), to refuse to make a recommendation, a person is not entitled to request the Minister to reconsider the decision unless the person made an application under subsection 26BJ(1) for the recommendation. 20 Before paragraph 63(2)(daa) Insert: (daaa) provide for the periods within which evaluations under section 26BE in relation to recommendations to vary a section 26BB determination are to be completed; and Part 2—Application and transitional provisions 21 Definitions In this Part: Act means the Therapeutic Goods Act 1989. transition period means the period of 3 years beginning on the day this Schedule commences. 22 Application of amendments (1) The amendments of section 26A of the Act made by this Schedule apply in relation to applications for the listing of medicines made after the commencement of this Schedule. (2) The amendments of section 26BE of the Act made by this Schedule apply in relation to applications for a recommendation to vary a determination made after the commencement of this Schedule. (3) Subsection 26BF(2) of the Act, as inserted by this Schedule, applies to determinations made under section 26BF of that Act other than the first determination so made. (4) The amendments of section 28 of the Act made by this Schedule apply in relation to medicines listed under section 26A of the Act after the commencement of this Schedule. (5) The amendments of section 30 of the Act made by this Schedule apply in relation to medicines included in the Register after the commencement of this Schedule. 23 Transitional provisions Scope of transitional provisions (1) This item applies in relation to a medicine that is listed in relation to a person under section 26A of the Act immediately before the commencement of this Schedule. (2) This item also applies in relation to a medicine if: (a) a person has made an application under section 23 of the Act for the listing of the medicine before the commencement of this Schedule; and (b) the application has not been finally determined before that commencement; and (c) after that commencement, the Secretary lists the medicine in relation to the person under section 26A of the Act. (3) This item also applies in relation to a medicine if the medicine: (a) was listed under section 26 of the Act before 11 June 1996; and (b) is, immediately before the commencement of this Schedule, listed goods; and (c) is not subject to a condition that it must not be supplied in Australia; and (d) is, is intended to be, or has been supplied in Australia. Reapplying for listing of certain medicines to include permissible indications (4) The person may, during the transition period, apply again in accordance with section 23 of the Act for the listing of the medicine in relation to the person under section 26A or 26AE of the Act. Cancellation of listing if further application not made and listing not otherwise cancelled during transition period (5) Subitem (6) applies if, during the transition period, one of the following events does not occur in relation to the medicine: (a) the medicine is listed in relation to the person under section 26A of the Act; (b) the medicine is listed in relation to the person under section 26AE of the Act; (c) the listing of the medicine is cancelled; (d) an application for the listing of the medicine in relation to the person under section 26AE of the Act that complies with section 23C of the Act has been made, but not yet decided. (6) The listing of the medicine is cancelled, and the medicine ceases to be listed, by force of this subitem immediately after the end of the transition period. (7) If: (a) during the transition period, an application for the listing of the medicine in relation to the person under section 26AE of the Act has been made; and (b) after the transition period, the application lapses; the listing of the medicine is cancelled, and the medicine ceases to be listed, by force of this subitem immediately after the application lapses. (8) Paragraph 26A(1)(e) of the Act does not apply to an application for the listing of a medicine under section 26A of the Act if the medicine had its listing cancelled only because of the operation of subitem (6) or (7). (9) Paragraph 26AB(1)(f) of the Act does not apply to an application for the listing of a medicine under section 26AE of the Act if the medicine had its listing cancelled only because of the operation of subitem (6) or (7). Cancellation of listing under section 26A if application under section 26AE made but not decided during transition period (10) Subitem (11) applies if an application for the listing of the medicine in relation to the person under section 26AE of the Act that complies with section 23C of the Act has been made, but not yet decided, during the transition period. (11) The listing of the medicine under section 26A of the Act is cancelled, and the medicine ceases to be listed under that section, by force of this subitem at the same time as the Secretary makes a decision under subsection 26AE(3) of the Act in relation to the medicine. Schedule 3—New pathway for listed medicines Therapeutic Goods Act 1989 1 Paragraphs 21A(1)(b) and (4)(b) After "subsection 26A(2)", insert "or 26AB(2)". 2 Subsection 21B(1) After "subsection 26A(2)", insert "or 26AB(2)". 3 At the end of paragraph 26(1)(ba) Add "or 26AE". 4 After section 26A Insert: 26AB Application for listing of certain medicines following efficacy evaluation (1) If: (a) an application is made under section 23 for the listing of medicine in relation to a person; and (b) the application passes preliminary assessment; and (c) the requirements of subsections (2), (3), (4) and (6) have been complied with; and (d) the medicine is not a medicine which may be listed under section 26A; and (e) the medicine is not export only medicine; and (f) the medicine is not one that has previously had its registration or listing cancelled; the Secretary must evaluate the medicine for listing under section 26AE. (2) The applicant must certify that: (a) the medicine is eligible for listing; and (b) the medicine is safe for the purposes for which it is to be used; and (c) the presentation of the medicine is not unacceptable; and (d) the medicine does not contain an ingredient that is not specified in a determination under paragraph 26BB(1)(a); and (e) if a determination under paragraph 26BB(1)(b) specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; and (f) the medicine conforms to every standard (if any) applicable to the medicine; and (g) both of the following are complied with in relation to the medicine: (i) the applicable provisions of the Therapeutic Goods Advertising Code; (ii) the other requirements (if any) relating to advertising applicable under Part 5‑1 or under the regulations; and (h) if the medicine has been manufactured in Australia—each step in the manufacture of the medicine has been carried out by a person who is the holder of a licence to carry out that step; and (i) the medicine complies with all prescribed quality or safety criteria that are applicable to the medicine; and (j) the medicine's specifications comply with any requirements that are prescribed by the regulations for the purposes of this paragraph and that are applicable to the medicine; and (k) the medicine's label: (i) complies with any requirements that are prescribed by the regulations for the purposes of this subparagraph and that are applicable to the medicine; and (ii) does not make a claim that is inconsistent with any claim made by the applicant in relation to the medicine in, or in connection with, the application; and (l) the applicant holds information or evidence showing the medicine's specifications will be maintained under the conditions set out on the medicine's label until the medicine's expiry date; and (m) the applicant has available sufficient information to substantiate each claim and each indication proposed to be accepted in relation to the inclusion of the medicine in the Register; and (n) the medicine does not contain substances that are prohibited imports for the purposes of the Customs Act 1901; and (o) all the manufacturers of the medicine are nominated as manufacturers in the application; and (p) the applicant has, with manufacturers of the medicine who are manufacturers of the prescribed kind, written agreements containing such matters as are prescribed; and (q) the information included in or with the application is complete and correct. (3) The applicant must also certify any other matters prescribed by the regulations for the purposes of this subsection. (4) Subject to subsection (9), if a step in the manufacture of the medicine has been carried out outside Australia, the Secretary must have certified, prior to the application being made, that the manufacturing and quality control procedures used in each such step are acceptable. (5) In deciding whether to certify for the purposes of subsection (4), the matters that may be taken into account include: (a) whether the applicant has provided: (i) if a step in the manufacture of the medicine has been carried out in a country that is a member of the European Community or a member of EFTA—an EC/EFTA attestation of conformity in relation to the medicine; or (ii) if a step in the manufacture of the medicine has been carried out in a country declared by the Minister under section 3B to be covered by a non‑EC/EFTA MRA—a non‑EC/EFTA attestation of conformity, for the non‑EC/EFTA MRA, in relation to the medicine; or (iii) in any other case—an acceptable form of evidence from a relevant overseas authority establishing that the manufacture of the medicine is of an acceptable standard; and (b) whether the applicant has agreed to provide, if the Secretary considers inspection of the manufacturing procedures used in the manufacture of the medicine to be necessary: (i) funds for the carrying out of that inspection by the Department; and (ii) evidence that the manufacturer has agreed to such an inspection; and (c) whether the applicant has complied with any requirements made by the Secretary under section 31 in relation to the manufacture or preparation of the medicine. (6) If the medicine includes any ingredient of animal origin, the Secretary must have certified, prior to the application being made, that he or she is satisfied of the safety of the ingredient. (7) If a medicine is exempt from the operation of Part 3‑3 or a person is exempt from the operation of that Part in relation to the manufacture of the medicine, subsection (2) has effect, in relation to the medicine, as if paragraph (2)(h) were omitted. (8) If a person (the manufacturer) is exempt from the operation of Part 3‑3 in relation to a step in the manufacture of a medicine, subsection (2) has effect, in relation to the medicine, as if the reference in paragraph (2)(h) to a person who is the holder of a licence were a reference to the manufacturer to the extent that Part 3‑3 applies to the manufacturer in relation to the manufacture of the medicine. (9) If: (a) a medicine was made outside Australia; and (b) had the medicine been made in Australia, it would have been exempt from the operation of Part 3‑3; subsection (4) does not apply in relation to the medicine. 26AC Evaluation fees for listing of medicine under section 26AE (1) This section applies if: (a) an application is made under section 23 in relation to a medicine for listing under section 26AE; and (b) the application has passed preliminary assessment. (2) A fee (the evaluation fee) specified in or determined in accordance with the regulations is payable by the applicant in respect of the evaluation of a medicine for listing under section 26AE. (3) The Secretary must notify each applicant of the amount of the evaluation fee. (4) The evaluation fee payable by an applicant: (a) is due and payable on the day on which the applicant is notified of the amount of the evaluation fee; and (b) may be recovered by the Commonwealth as a debt due to the Commonwealth. (5) If: (a) an application is made under section 23 in relation to a medicine for listing under section 26AE; and (b) the applicant has paid the whole of the evaluation fee; and (c) regulations made for the purposes of paragraph 63(2)(daaaa) prescribe a period within which evaluations under section 26AE in relation to the medicine must be completed; and (d) the evaluation is completed, but not within that period; then 25% of the evaluation fee must be refunded to the applicant. (6) For the purposes of paragraph (5)(d), the evaluation is taken to be completed when the applicant is notified of the Secretary's decision under subsection 26AE(3) in relation to the medicine. 26AD Lapsing and deemed refusal of applications for listing of medicine under section 26AE Lapsing of applications (1) An application for the listing of a medicine under section 26AE lapses if: (a) any part of the evaluation fee referred to in section 26AC remains unpaid at the end of 28 days after the day on which the amount became due and payable; or (b) the application contains information that is inaccurate or misleading in a material particular; or (c) information given to the Secretary by, or on behalf of, the applicant in connection with the application is inaccurate or misleading in a material particular. Deemed refusal of applications (2) If: (a) regulations made for the purposes of paragraph 63(2)(daaaa) prescribe a period within which evaluations under section 26AE in relation to the medicine must be completed; and (b) at the end of that period, the evaluation has not been completed; the applicant may give the Secretary written notice that the applicant wishes to treat the application as having been refused. (3) A notice under subsection (2) may be given at any time before the evaluation is completed. (4) If a notice has been given, this Act (except subsection 60(5)) has effect as if: (a) the Secretary had decided not to list the medicine which is the subject of the application; and (b) the Minister had made a decision under subsection 60(3) confirming the decision of the Secretary; and (c) the Minister's decision had been made on the day on which notice was given to the Secretary under subsection (2). 26AE Evaluation and listing of certain medicines Evaluation (1) If: (a) an application is made under section 23 for the listing of a medicine in relation to a person under this section; and (b) the application has passed preliminary assessment; the Secretary must evaluate the medicine having regard to: (c) whether the efficacy of the medicine for the purposes for which it is to be used has been satisfactorily established; and (d) such other matters (if any) as the Secretary considers relevant. (2) If a period in relation to which an evaluation under this section must be completed has been prescribed under paragraph 63(2)(daaaa), the evaluation must be completed within that period. Secretary must decide whether to list medicine (3) After an evaluation under this section of goods has been completed, the Secretary must decide: (a) to list the medicine; or (b) not to list the medicine. Decision to list (4) If the Secretary decides under subsection (3) to list the medicine, the Secretary must, in accordance with subsection (5), notify the applicant in writing of the decision within 28 days of making the decision. (5) The notice must: (a) set out the decision under subsection (3) to list the medicine in relation to the person; and (b) inform the applicant that the medicine will not be included in the Register unless and until the applicant gives the Secretary: (i) the certificate required under subsection 26B(1); or (ii) a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application. (6) If the applicant gives the Secretary the certificate referred to in subparagraph (5)(b)(i) or the notice referred to in subparagraph (5)(b)(ii), the Secretary must: (a) include the medicine in the Register; and (b) give the applicant a certificate of listing. (7) To avoid doubt, if the applicant gives the Secretary the certificate referred to in subparagraph (5)(b)(i) or the notice referred to in subparagraph (5)(b)(ii), the Secretary must include the medicine in the Register under paragraph (3)(a) without inquiring into the correctness of the certificate or the notice. Date listing commences (8) The listing of the medicine commences on the day specified for the purpose in the certificate. Refusal to list medicine (9) If: (a) an application is made for the listing of medicine in relation to a person; and (b) the Secretary decides under subsection (3) not to list the medicine; the Secretary must notify the applicant in writing of the decision, and the reasons for the decision, within 28 days of making the decision. 5 Section 26BA Omit "or 26A(1)", substitute ", 26A(1) or 26AE(5)". 6 Subsection 26BB(1) (note) After "section 26A", insert "or 26AB". 7 Subsection 28(5B) After "26A", insert "or 26AE". 8 Paragraph 28(5B)(b) After "26A(3)", insert ", 26AB(4)". 9 At the end of section 28 Add: (8) If: (a) a medicine is listed under section 26AE; and (b) an indication is accepted in relation to the inclusion of the medicine in the Register; the listing of the medicine is subject to the following conditions: (c) a condition that the person in relation to whom the medicine is listed has, at all times while the medicine remains listed, information or evidence that supports the indication; (d) a condition that, at any time while the medicine remains listed, the person will, if asked to do so by the Secretary, give the information or evidence to the Secretary. 10 Subsection 28A(1) After "section 26A", insert "or 26AE". 11 Subsection 28A(3) Repeal the subsection, substitute: (3) In deciding whether to give the certification: (a) subsection 26A(4) applies in a way corresponding to the way in which it applies for the purposes of subsection 26A(3); and (b) subsection 26AB(5) applies in a way corresponding to the way in which it applies for the purposes of subsection 26AB(4). 12 Paragraph 29D(1)(b) After "(e)", insert ", (ea)". 13 Paragraph 29D(1)(b) After "(1C)", insert ", (1D)". 14 After paragraph 30(1)(e) Insert: (ea) in the case of a medicine listed under section 26AE, it appears to the Secretary that any of the certifications under paragraph 26AB(2)(a), (d), (e), (h) or (n) are incorrect or (if applicable) the requirements under subsection 26AB(4) or (6) are not fulfilled; or 15 Subsection 30(1A) After "section 26A", insert "or 26AE". 16 After subsection 30(1C) Insert: (1D) The Secretary may, by notice in writing given to a person in relation to whom a medicine is listed under section 26AE, cancel the listing of the medicine if: (a) the Secretary, under section 31, gives to the person a notice requiring the person to give to the Secretary information or documents relating to the medicine; and (b) the notice is given for the purposes of ascertaining whether any of the certifications by the person under subsection 26AB(2) or (3) in relation to the medicine are incorrect; and (c) the person fails to comply with the notice within 20 working days after the notice is given. 17 After paragraph 30(2)(ba) Insert: (bab) in the case of a medicine listed under section 26AE, it appears to the Secretary that any of the certifications under paragraph 26AB(2)(b), (c), (f), (g), (i), (j), (k), (l), (m), (o), (p) or (q) or subsection 26AB(3) are incorrect; or 18 Paragraph 30(5)(a) Omit "or (1C)", substitute ", (1C) or (1D)". 19 Paragraph 31(2)(fa) Omit "are medicine", substitute "are listed under section 26A". 20 After paragraph 31(2)(fa) Insert: (fab) if the goods are or were listed under section 26AE—any of the matters covered by a certification by the person under subsection 26AB(2) or (3) in relation to the medicine; (fac) if the goods are or were listed under section 26AE—the efficacy of the goods in relation to the purposes for which they are to be used; 21 After paragraph 63(2)(da) Insert: (daaaa) provide for the periods within which evaluations under section 26AE in relation to specified medicines or specified classes of medicines are to be completed; and Schedule 4—Preliminary assessment of applications Part 1—Therapeutic goods Therapeutic Goods Act 1989 1 Subparagraph 19A(1)(b)(ii) Omit "that complies with section 23 has been made under that section for registration of the goods", substitute "under section 23 has been made for registration of the goods and the application has passed preliminary assessment". 2 Paragraph 19A(2)(b) Omit "that complies with section 23 has been made under that section", substitute "under section 23 has been made". 3 After paragraph 19A(2)(b) Insert: (ba) the application has passed preliminary assessment; and 4 Paragraph 19A(9)(a) After "(2)(a), (b),", insert "(ba),". 5 Section 23 Repeal the section, substitute: 23 Applications generally A person may make an application to the Secretary for registration or listing of therapeutic goods. 6 Before section 24 Insert: 23A Classes of therapeutic goods The Secretary may, by notifiable instrument, specify different classes of therapeutic goods for the purposes of section 23B. 23B Requirements relating to applications for registration of therapeutic goods and listing of medicines under section 26AE (1) If an application is made under section 23 for: (a) registration of therapeutic goods (including an application for provisional registration of a medicine); or (b) the listing of a medicine under section 26AE; the Secretary must carry out an assessment of whether the requirements set out in subsection (2) have been met in relation to the application. (2) The requirements are as follows: (a) the application must be made: (i) in accordance with the form approved, in writing, by the Secretary for that class of therapeutic goods; or (ii) in such other manner as is approved, in writing, by the Secretary for that class of therapeutic goods; (b) the prescribed application fee for that class of therapeutic goods must be paid; (c) the application must be delivered to an office of the Department specified by the Secretary; (d) the application must be accompanied by information that is: (i) of a kind determined under subsection (9) for that class of therapeutic goods; and (ii) in a form determined under subsection (10) for that class of therapeutic goods; (e) if the application is for the registration of restricted medicine—the application must be accompanied by product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine; (f) if the Secretary so requires—the applicant must: (i) deliver to the Department a reasonable number of samples of the goods; and (ii) do so in a manner approved, in writing, by the Secretary. Passing preliminary assessment (3) An application passes preliminary assessment if the Secretary: (a) has carried out an assessment, under subsection (1), in relation to the application; and (b) is satisfied that the requirements set out in subsection (2) have been met in relation to the application. (4) If the application has passed preliminary assessment, the Secretary must give a written notice to the applicant stating that the application has passed preliminary assessment. (5) Subsection (4) does not apply if the period within which the Secretary must, under section 25, evaluate the goods to which the application relates is prescribed by reference to the prescribed period within which the Secretary is required to consider an application under subsection 9D(3) to vary an entry in the Register. (6) If the application has not passed preliminary assessment, the Secretary must, by written notice given to the applicant, refuse the application. Approval of forms etc. (7) For the purposes of paragraph (2)(a), the Secretary may approve different forms and different manners for making applications for different classes of therapeutic goods that are specified under section 23A. (8) An approval of a form may require or permit an application or information to be given in accordance with specified software requirements: (a) on a specified kind of data processing device; or (b) by way of a specified kind of electronic transmission. Determination of kinds and forms of information (9) The Secretary may, by legislative instrument, determine a kind of information for the purposes of the application of subparagraph (2)(d)(i) to a class of therapeutic goods that is specified under section 23A. (10) The Secretary may, by legislative instrument, determine a form of information for the purposes of the application of subparagraph (2)(d)(ii) to a class of therapeutic goods that is specified under section 23A. 23C Requirements relating to applications for listing of therapeutic goods under section 26 or 26A (1) This section applies if an application is made under section 23 for listing of therapeutic goods under section 26 or 26A. (2) The application complies with this section if: (a) the application is made in accordance with a form approved, in writing, by the Secretary or in such other manner as is approved, in writing, by the Secretary for the purposes of this paragraph; and (b) the application is delivered to an office of the Department specified by the Secretary; and (c) the prescribed application fee has been paid; and (d) the applicant has delivered to the office to which the application was made such information, in a form approved, in writing, by the Secretary, as will allow the determination of the application; and (e) if the Secretary so requires—the applicant has delivered to the office to which the application was made a reasonable number of samples of the goods. Note: To be listed, an application must comply with this section: see sections 26, 26AA, 26A and 26AB. (3) The Secretary may, by legislative instrument, determine forms of information for the purposes of the application of paragraph (2)(d). (4) An approval of a form may require or permit an application or information to be given in accordance with specified software requirements: (a) on a specified kind of data processing device; or (b) by way of a specified kind of electronic transmission. 7 Subsection 24(1) Repeal the subsection, substitute: (1) This section applies if: (a) an application is made for the registration of therapeutic goods under section 23; and (b) the goods are goods that are required to be registered; and (c) the application has passed preliminary assessment. (1A) A fee specified in, or determined in accordance with, the regulations is payable by the applicant in respect of the evaluation of the goods for registration, and the Secretary must notify each such applicant of the amount of the evaluation fee. 8 Subsection 25(1) Omit "If an application is made for the registration of therapeutic goods in relation to a person in accordance with section 23, the Secretary must evaluate the goods for registration having regard to:", substitute: If: (a) an application is made for the registration of therapeutic goods in relation to a person under section 23; and (b) the application has passed preliminary assessment; the Secretary must evaluate the goods for registration having regard to: 9 Paragraph 25AB(1)(a) Omit "in accordance with", substitute "under". 10 After paragraph 25AB(1)(a) Insert: (aa) the application has passed preliminary assessment; and 11 Paragraph 25AB(2)(a) Omit "in accordance with", substitute "under". 12 After paragraph 25AB(2)(a) Insert: (aa) the application has passed preliminary assessment; and 13 Paragraph 25AC(a) Omit "in accordance with", substitute "under". 14 After paragraph 25AC(a) Insert: (aa) the application has passed preliminary assessment; and 15 Paragraph 25B(1)(a) Omit "in accordance with", substitute "under". 16 After paragraph 25B(1)(a) Insert: (aa) the application has passed preliminary assessment; and 17 Paragraph 26(1)(a) Omit "in accordance with", substitute "under". 18 After paragraph 26(1)(a) Insert: (aaa) the application complies with section 23C; and 19 After paragraph 26(1AA)(b) Insert: (ba) the application complies with section 23C; and 20 Paragraph 26(1A)(a) Omit "in accordance with", substitute "under". 21 After paragraph 26(1A)(a) Insert: (aa) the application complies with section 23C; and 22 Paragraph 26AA(1)(a) Omit "in accordance with", substitute "under". 23 After paragraph 26AA(1)(a) Insert: (aa) the application complies with section 23C; and 24 Paragraph 26A(1)(a) Omit "in accordance with", substitute "under". 25 After parag