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 tha