Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 (Cth)
Contents
[
The Parliament of Australia enacts:
This Act is the
Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 .
(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.
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 |
Schedules 1 and 2 | The later of: (a) 1 January 2018; and
| 6 March 2018 (paragraph (b) applies) |
Schedule 3 | Immediately after the commencement of the provisions covered by table item 2. | 6 March 2018 |
Schedules 4 and 5 | The later of: (a) 1 January 2018; and
| 6 March 2018 (paragraph (b) applies) |
Schedule 6, Part 1 | Immediately after the commencement of the provisions covered by table item 4. | 6 March 2018 |
Schedule 6, Part 2 | 1 July 2020. | 1 July 2020 |
Schedule 7 | Immediately after the commencement of the provisions covered by table item 4. | 6 March 2018 |
Schedule 8 | The later of: (a) 1 January 2018; and
| 6 March 2018 (paragraph (b) applies) |
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Note: This table relates only to the provisions of this Act as originally enacted.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.
Legislation that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.
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.
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.
Insert:
(aa) in the part of the Register for goods known as provisionally registered goods; or
Omit “4 parts”, substitute “5 parts”.
Insert:
(aa) a part for goods to be known as provisionally registered goods; and
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).
Insert:
(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.
(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.
(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.
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.
Insert:
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.
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
Insert:
(aa) the provisional registration of medicine; and
Omit “Where”, substitute “(1) Subject to this section, if”.
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).
Insert:
(da) particular therapeutic goods were or were not included in the Register as provisionally registered goods; or
Omit “A person whose”, substitute “Subject to this section, a person whose”.
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.
After “the Secretary”, insert “or a delegate of the Secretary”.
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.
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
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
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
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
Insert:
(2B) The Minister may, by legislative instrument, specify requirements for the purposes of subparagraph (2)(j)(ii) or (2)(ja)(ii).
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.
Omit “and (3)”, substitute “, (2A) and (3)”.
Insert:
Making an application for recommendation
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.
Add “and”.
Insert:
(c) if further information is required to be given under subsection (2A) within a specified period—the information is given within that period;
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).
Repeal the subsection.
Omit “subsection (8)”, substitute “subsection (2A)”.
Insert:
(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.
(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).
The Minister may, on his or her own initiative and by legislative instrument, vary a determination under section 26BF.
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.
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.
Omit “(e)”, substitute “(e), (fba), (fd), (fe)”.
After “(j)”, insert “, (ja)”.
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.
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
In this Part:
Act means theTherapeutic Goods Act 1989 .
transition period means the period of 3 years beginning on the day this Schedule commences.
(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.
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.
After “subsection 26A(2)”, insert “or 26AB(2)”.
After “subsection 26A(2)”, insert “or 26AB(2)”.
Add “or 26AE”.
Insert:
(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.
(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.
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).
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.
Omit “or 26A(1)”, substitute “, 26A(1) or 26AE(5)”.
After “section 26A”, insert “or 26AB”.
After “26A”, insert “or 26AE”.
After “26A(3)”, insert “, 26AB(4)”.
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.
After “section 26A”, insert “or 26AE”.
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).
After “(e)”, insert “, (ea)”.
After “(1C)”, insert “, (1D)”.
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
After “section 26A”, insert “or 26AE”.
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.
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
Omit “or (1C)”, substitute “, (1C) or (1D)”.
Omit “are medicine”, substitute “are listed under section 26A”.
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;
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
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”.
Omit “that complies with section 23 has been made under that section”, substitute “under section 23 has been made”.
Insert:
(ba) the application has passed preliminary assessment; and
After “(2)(a), (b),”, insert “(ba),”.
Repeal the section, substitute:
A person may make an application to the Secretary for registration or listing of therapeutic goods.
Insert:
The Secretary may, by notifiable instrument, specify different classes of therapeutic goods for the purposes of section 23B.
(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.
(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.
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.
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:
Omit “in accordance with”, substitute “under”.
Insert:
(aa) the application has passed preliminary assessment; and
Omit “in accordance with”, substitute “under”.
Insert:
(aa) the application has passed preliminary assessment; and
Omit “in accordance with”, substitute “under”.
Insert:
(aa) the application has passed preliminary assessment; and
Omit “in accordance with”, substitute “under”.
Insert:
(aa) the application has passed preliminary assessment; and
Omit “in accordance with”, substitute “under”.
Insert:
(aaa) the application complies with section 23C; and
Insert:
(ba) the application complies with section 23C; and
Omit “in accordance with”, substitute “under”.
Insert:
(aa) the application complies with section 23C; and
Omit “in accordance with”, substitute “under”.
Insert:
(aa) the application complies with section 23C; and
Omit “in accordance with”, substitute “under”.
Insert:
(aa) the application complies with section 23C; and
Insert:
(aa) the application complies with section 23C; and
Repeal the subsection, substitute:
(1) This section applies to an application for listing or registration of a therapeutic good under section 23 if:
(a) the therapeutic good is, or contains, a GM product or a genetically modified organism; and
(b) if the application is for registration—the application has passed preliminary assessment; and
(c) if the application is for the listing of a medicine under section 26AE—the application has passed preliminary assessment.
Omit “23(1)(a)”, substitute “23B(2)(a)”.
Insert:
(aa) the application has passed preliminary assessment; and
(1) The amendments made by this Part apply in relation to applications for registration or listing of therapeutic goods made after the commencement of this subitem.
(2) If regulations:
(a) were made for the purposes of subsection 24(1) of the
Therapeutic Goods Act 1989 ; and(b) were in force immediately before the commencement of this subitem;
the regulations have effect, after the commencement of this subitem, as if they had been made under subsection 24(1A) of the
Therapeutic Goods Act 1989 as inserted by this Part.
Omit “section 32DD”, substitute “section 32DDA”.
Omit “either”, substitute “any of the following conditions is satisfied”.
Omit “or” (second occurring).
Omit “or 32DD”.
Omit “and”.
Insert:
(iii) an application under section 32DD has been made for inclusion of the biological in the Register, and the application has passed preliminary assessment; and
Repeal the paragraph, substitute:
(d) either:
(i) an application that complies with section 32DA has been made for inclusion of the biological in the Register; or
(ii) an application under section 32DD has been made for inclusion of the biological in the Register, and the application has passed preliminary assessment; and
Omit “(1)”.
Repeal the subsections.
Insert:
(1) If an application is made under section 32DD for the inclusion of a biological in the Register, the Secretary must carry out an assessment of whether the requirements set out in subsection (2) of this section 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 biological; or
(ii) in such other manner as is approved, in writing, by the Secretary for that class of biological;
(b) the prescribed application fee for that class of biological 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 biological; and
(ii) in a form determined under subsection (10) for that class of biological;
(e) if the Secretary so requires—the applicant must:
(i) deliver to the Department a reasonable number of samples of the biological; 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 32DE, evaluate the biological 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 different forms etc.
(7) For the purposes of paragraph (2)(a), the Secretary may approve different forms and manners for making applications for different classes of biologicals that are prescribed by the regulations for the purposes of section 32AA.
(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 biological that is prescribed by the regulations for the purposes of section 32AA.
(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 biological that is prescribed by the regulations for the purposes of section 32AA.
Omit “in accordance with”, substitute “under”.
After “a person,”, insert “and the application has passed preliminary assessment,”.
Omit “in accordance with”, substitute “under”.
Insert:
(aa) the application has passed preliminary assessment; and
Omit “subsection 32DD(1)”, substitute “section 32DD”.
Insert:
(aa) the application has passed preliminary assessment; and
Omit “subsection 32DD(1)”, substitute “section 32DD”.
Omit “in accordance with” (first occurring), substitute “under”.
After “in the Register” (first occurring), insert “, and the application has passed preliminary assessment”.
The amendments made by this Part apply in relation to applications for inclusion of a biological in the Register made after the commencement of this item.
Repeal the note, substitute:
Note: A conformity assessment certificate may be required for an application to include a kind of medical device in the Register to pass preliminary assessment: see paragraph 41FDB(2)(e).
52
Division 3 of Part 4‑4 (note to Division heading) Repeal the note.
53
Division 4 of Part 4‑4 (note to Division heading) Repeal the note.
Omit “automatically once a proper”, substitute “once an”.
After “required certification”, insert “and the application passes preliminary assessment”.
Repeal the note, substitute:
Note 1: In some cases, an application relating to a kind of medical device will not pass preliminary assessment unless that kind of device is covered by a conformity assessment certificate under Part 4‑4: see paragraph 41FDB(2)(e).
Repeal the section.
Repeal the section, substitute:
(1) A person may make an application to the Secretary for a kind of medical device to be included in the Register.
(2) An application must not contain information that is false or misleading in a material particular.
Note: A person might also commit an offence, or contravene a civil penalty provision, if the person makes a statement in an application that is false or misleading in a material particular: see sections 41FE and 41FEA.
Insert:
(1) If an application is made under section 41FC for a kind of medical device to be included in the Register in relation to a person, 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 classification of medical device; or
(ii) in such other manner as is approved, in writing, by the Secretary for that classification of medical device;
(b) the prescribed application fee for that classification of medical device 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 (7) for that classification of medical device; and
(ii) in a form determined under subsection (8) for that classification of medical device;
(e) if regulations made for the purposes of section 41EA require the manufacturer of the kind of device to have a conformity assessment certificate relating to the kind of medical device before an application under section 41FC can be made—such a certificate is in force;
(f) the applicant has certified the matters in section 41FD.
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 not passed preliminary assessment, the Secretary must refuse the application.
Note: The Secretary is required to give notice of the refusal: see section 41FG.
Approval of forms etc.
(5) For the purposes of paragraph (2)(a), the Secretary may approve different forms and different manners for making applications for different medical device classifications.
(6) 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
(7) The Secretary may, by legislative instrument, determine a kind of information for the purposes of the application of subparagraph (2)(d)(i) to medical devices of a particular classification.
(8) The Secretary may, by legislative instrument, determine a form of information for the purposes of the application of subparagraph (2)(d)(ii) to medical devices of a particular classification.
Repeal the paragraphs, substitute:
(a) an application for a kind of medical device to be included in the Register in relation to a person has passed preliminary assessment; and
(b) the application has not been selected for audit under section 41FH;
Omit “, unless the application has been selected under section 41FH for audit”.
Omit “must give to the applicant”, substitute “must make available to the applicant”.
Repeal the section, substitute:
(1) This section applies if an application under subsection 41FC(1) for a kind of medical device to be included in the Register:
(a) is refused under subsection 41FDB(4); or
(b) is refused under subsection 41FF(1A).
(2) The Secretary must notify the applicant in writing, of the refusal within 20 working days after the application has been received and the prescribed application fee has been paid.
Insert:
(1A) This section applies to applications that have passed preliminary assessment.
After “information”, insert “or documents”.
After “is made”, insert “and the prescribed application fee is paid”.
Add “or 41FJ”.
After “includes the medical device”, insert “and the application has passed preliminary assessment”.
After “includes the medical device”, insert “and the application has passed preliminary assessment”.
(1) The amendments made by this Part apply in relation to applications for inclusion of a kind of medical device in the Register made after the commencement of this item.
(2) If, immediately before the commencement of this item, a form or manner for making an application had been approved under paragraph 41FC(1)(a) of the
Therapeutic Goods Act 1989 , then, immediately after the commencement of this item, the form or manner is taken to have been approved for the purposes of paragraph 41FDB(2)(a) of that Act, as inserted by this Part.(3) If, immediately before the commencement of this item, an application fee had been prescribed for the purposes of paragraph 41FC(2)(b) of the
Therapeutic Goods Act 1989 , then, immediately after the commencement of this item, the fee is taken to have been prescribed for the purposes of paragraph 41FDB(2)(b) of that Act, as inserted by this Part.
Insert:
passed preliminary assessment :
(a) when used in relation to a section 23 application for registration—has the meaning given by subsection 23B(3); and
(b) when used in relation to a section 23 application for listing under section 26AE—has the meaning given by subsection 23B(3); and
(c) when used in relation to a section 32DD application—has the meaning given by subsection 32DDA(3); and
(d) when used in relation to a section 41FC application—has the meaning given by subsection 41FDB(3).
Insert:
(aa) a preliminary assessment under section 23B, 32DDA or 41FDB;
Insert:
Australian conformity assessment body certificate means a certificate that is issued by an Australian conformity assessment body and that is of a kind mentioned in section 41FIA.
conformity assessment document means:
(a) a conformity assessment certificate; or
(b) an Australian conformity assessment body certificate; or
(c) an overseas regulator conformity assessment document.
overseas regulator has the meaning given by section 41BIB.
overseas regulator conformity assessment document means a certificate or other document that is issued by an overseas regulator after that regulator is satisfied that requirements, comparable to the conformity assessment procedures, have been applied to a medical device by the manufacturer of the device.
Omit “or an annual licensing charge”, substitute “, an annual licensing charge or an annual conformity assessment body determination charge”.
Add “or requirements comparable to conformity assessment procedures”.
Insert:
(aa) making conformity assessment body determinations; and
Add:
(1) A requirement that is comparable to a conformity assessment procedure is taken, for the purposes of this Chapter, not to have been applied to a medical device by the manufacturer of the device if:
(a) there has been a contravention of the requirement; and
(b) the contravention relates, wholly or partly, to that device or its manufacture.
(2) However, for the purposes of this Chapter (other than Part 4‑11), subsection (1) does not apply if:
(a) the quality management system applied in the manufacture of the medical device complies with one or more conformity assessment standards that apply to it; and
(b) the contravention is only in respect of a part or parts of the requirement to which that conformity assessment standard, or one or more of those conformity assessment standards, relate.
(1) An
overseas regulator is a body determined in an instrument under subsection (2).(2) The Secretary may, by notifiable instrument, determine a body for the purposes of subsection (1). The Secretary must be satisfied that the body:
(a) is established outside Australia; and
(b) is empowered to issue certificates or other documents to the effect that the body is satisfied that requirements, comparable to the conformity assessment procedures, have been applied to medical devices by the manufacturers of the devices.
(3) Without limiting subsection (2), the Secretary may determine a body by reference to a designation, recognition, approval or authorisation (however described) of the body:
(a) by one or more countries; or
(b) by another body.
Note: For specification by class, see subsection 13(3) of the
Legislation Act 2003 .
Omit “certificate”, substitute “document”.
Add:
(3) A conformity assessment certificate must contain any other information prescribed by the regulations for the purposes of this subsection.
Add “The certificate must specify the period for which it is to be in force (which must be no longer than 5 years).”.
Omit “(if any) specified in the certificate”, substitute “specified in the certificate, or if the Secretary extends that period, until the end of that extended period”.
Add:
Extensions
(3) The Secretary may, in writing and on his or her own initiative, extend the period for which a conformity assessment certificate is in force.
(4) An extension must be no longer than 12 months.
(5) Only one extension may be given.
(6) The Secretary:
(a) must give notice of an extension to the manufacturer in relation to whom the certificate was issued; and
(b) may give notice of an extension to the applicant for the certificate (if the applicant is not the manufacturer).
Omit “certificate”, substitute “document”.
Omit “kinds of”.
Insert:
(4A) If under the regulations the Secretary makes a conformity assessment body determination, the Secretary must assign a unique identification number to the body.
(4B) The Secretary must publish a list of the Australian conformity assessment bodies on the Department’s website.
(4C) The Secretary may also publish on the Department’s website any information relating to Australian conformity assessment bodies and either to conformity assessment body determinations or to certification‑related activities of Australian conformity assessment bodies.
Add:
Note: See subsections 41MN(10) to (12) and 41MNA(3) for offences and a civil penalty for a breach of the conditions.
Insert:
(6A) The regulations may make provision for and in relation to the effect on an Australian conformity assessment body certificate of the Australian conformity assessment body ceasing to carry on certification‑related activities.
(6B) Without limiting subsection (6A), regulations made for the purposes of that subsection may make provision in relation to a matter by conferring on the Secretary a power to make a decision of an administrative character.
After “revoke”, insert “, suspend”.
Insert:
(7A) If under the regulations the Secretary suspends a conformity assessment body determination, the conditions referred to in subsection (5) continue during the suspension.
Add:
(1) An Australian conformity assessment body certificate that is issued to a manufacturer of medical devices must specify whether it covers:
(a) all medical devices manufactured by the manufacturer; or
(b) only specified medical devices manufactured by the manufacturer.
Note: For compensation for damage to electronic equipment, see section 48D.
(4) If the authorised person believes on reasonable grounds that:
(a) information relevant to determining whether this Act or the regulations have been complied with may be accessible by operating electronic equipment at the premises; and
(b) expert assistance is required to operate the equipment; and
(c) if he or she does not take action under this subsection, the information may be destroyed, altered or otherwise interfered with;
he or she may do whatever is necessary to secure the equipment, whether by locking it up, placing a guard or otherwise.
(5) The authorised person must give notice to the occupier of the premises of his or her intention to secure equipment and of the fact that the equipment may be secured for up to 24 hours.
(6) The equipment may be secured:
(a) for a period not exceeding 24 hours; or
(b) until the equipment has been operated by the expert;
whichever happens first.
(7) The authorised person may apply to a magistrate for an extension of the 24‑hour period if the authorised person believes on reasonable grounds that the equipment needs to be secured for longer than that period.
(8) The authorised person must give notice to the occupier of the premises of his or her intention to apply for an extension, and the occupier is entitled to be heard in relation to the application.
(9) The 24‑hour period may be extended more than once.
Repeal the heading, substitute:
Omit “The”, substitute “An”.
Omit “if he or she believes on reasonable grounds that the operation of the equipment can be carried out without damage to the equipment”.
Repeal the subsection, substitute:
(2) If the authorised person, after operating the equipment, finds that evidential material in respect of an offence against this Act, in respect of a contravention of a civil penalty provision or in respect of both is accessible by doing so, he or she may:
(a) seize the equipment and any disk, tape or other associated device; or
(b) operate electronic equipment on the premises to put the evidential material in documentary form and remove the documents so produced from the premises; or
(c) operate electronic equipment on the premises to transfer the evidential material to a disk, tape or other storage device that:
(i) is brought to the premises for the exercise of the power; or
(ii) is on the premises and the use of which for that purpose has been agreed in writing by the occupier of the premises;
and remove the disk, tape or other storage device from the premises.
(2A) An authorised person may operate electronic equipment as mentioned in subsection (1) or (2) only if the authorised person believes on reasonable grounds that the operation of the equipment can be carried out without damage to the equipment.
Note: For compensation for damage to electronic equipment, see section 48D.
Omit “copy”, substitute “transfer”.
Repeal the subsection, substitute:
(7) The authorised person may apply to a magistrate for an extension of the 24‑hour period if the authorised person believes on reasonable grounds that the equipment needs to be secured for longer than that period.
Add:
(9) The 24‑hour period may be extended more than once.
After “section”, insert “48BA or”.
Repeal the subsection, substitute:
(2) Subsection (1) does not apply if possession of the document, film, computer file, thing or information by the occupier could constitute an offence against a law of the Commonwealth or contravention of a civil penalty provision.
Insert:
(1) The occupier of premises to which a warrant relates, or another person who apparently represents the occupier, must provide an authorised person executing the warrant with all reasonable facilities and assistance for the effective exercise of the authorised person’s powers.
(2) A person commits an offence if:
(a) the person is subject to subsection (1); and
(b) the person fails to comply with that subsection.
Penalty for contravention of this subsection: 30 penalty units.
After “subsection 48(1)”, insert “and section 48BA”.
After “48(1)”, insert “and section 48C”.
Repeal the heading, substitute:
Repeal the item, substitute:
|
|
|
Repeal the item, substitute:
|
|
|
Insert:
|
|
|
Insert:
(aa) makes an order under section 19B of the
Crimes Act 1914 in respect of a person charged with an offence against this Act; or
Repeal the items, substitute:
1 | Subsection 9G(1) |
2 | Subsection 14(1), (6) or (10) |
3 | Subsection 15(2) |
4 | Subsection 19B(1) |
4A | Subsection 21A(1) or (5) |
Repeal the item, substitute:
6 | Subsection 22A(1) |
Repeal the items, substitute:
9 | Subsection 30EC(1) |
10 | Subsection 30F(4B) |
11 | Subsection 31(5A) |
Repeal the items, substitute:
14 | Subsection 32BA(1) |
15 | Subsection 32BB(1) |
16 | Subsection 32BC(1) |
17 | Subsection 32BD(1) |
Repeal the items, substitute:
19 | Subsection 32CJ(6) |
20 | Subsection 32DO(1) |
Repeal the items, substitute:
23 | Subsection 32EF(1) |
24 | Subsection 32HC(1) |
25 | Subsection 32JB(2) |
Repeal the item, substitute:
27 | Subsection 35(1) or (5) |
27AA | Subsection 35B(1) |
Repeal the items, substitute:
28 | Subsection 41EI(1) |
29 | Subsection 41FE(1) |
30 | Subsection 41JB(4) |
31 | Subsection 41JH(1) |
Repeal the items, substitute:
33 | Subsection 41KC(1) |
34 | Subsection 41MA(1), (5) or (9) |
35 | Subsection 41MC(2) |
36 | Subsection 41ME(1) or (5) |
Repeal the item, substitute:
39 | Subsection 41MI(1) |
Repeal the item, substitute:
40 | Subsection 41MN(1), (5) or (10) |
Repeal the item, substitute:
46 | Subsection 42V(6) |
330 Application provision—application of the Criminal Code The amendments of section 5A of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to offences committed on or after the commencement of this item.
The amendments of section 9G of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to statements made on or after the commencement of this item.
(1) The amendments of section 14 of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to therapeutic goods imported, exported or supplied on or after the commencement of this item.(2) The amendment of section 14B of the
Therapeutic Goods Act 1989 made by this Schedule applies in relation to goods imported or exported on or after the commencement of this item.(3) The amendments of section 15 of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to acts or omissions occurring on or after the commencement of this item.(4) The amendments of section 19B of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to therapeutic goods imported, exported, manufactured or supplied on or after the commencement of this item.(5) Subsection 20(1BA) of the
Therapeutic Goods Act 1989 , as inserted by this Schedule, applies in relation to therapeutic goods imported, exported, manufactured or supplied on or after the commencement of this item.(6) The amendments of subsection 21A(1), the repeal of subsections 21A(2) and (3) and the insertion of subsections 21A(4A) and (4B) of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to statements made on or after the commencement of this item.(7) The amendment of subsection 21A(5), the repeal of subsections 21A(6) and (7) and the insertion of subsections 21A(8A) and (8B) of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to acts or omissions occurring on or after the commencement of this item.(8) The amendments of subsections 21A(9) and (11A), the substitution of subsections 21A(9A), (10) and (11), the repeal of subsections 21A(11B) and 22(7A) and the insertion of subsections 21A(11D) and (11E) of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to therapeutic goods supplied on or after the commencement of this item.(9) The amendment of subsection 21A(12), the substitution of subsections 21A(12A), (13) and (14) and the repeal of subsection 22(8) of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to the use of therapeutic goods on or after the commencement of this item.(10) The amendments of section 22A of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to statements made on or after the commencement of this item.(11) The amendment of section 30EA of the
Therapeutic Goods Act 1989 made by this Schedule applies in relation to goods supplied on or after the commencement of this item.(12) The amendments of section 30EC of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to acts or omissions occurring on or after the commencement of this item.(13) The amendments of section 30F of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given on or after the commencement of this item.(14) The amendments of section 31 of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given on or after the commencement of this item.(15) Subsections 31C(2) and (3) of the
Therapeutic Goods Act 1989 , as added by this Schedule, apply in relation to notices given on or after the commencement of this item.(16) The amendments of sections 31D and 31E of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given under section 31A, 31AA, 31B or 31BA of that Act on or after the commencement of this item.(17) The amendments of section 31F of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given under section 31, 31A, 31AA, 31B or 31BA of that Act on or after the commencement of this item.
(1) The amendments of section 32BA of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to biologicals imported on or after the commencement of this item.(2) The amendments of section 32BB of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to biologicals exported on or after the commencement of this item.(3) Section 32BBA and subsection 32BF(7) of the
Therapeutic Goods Act 1989 , as inserted or added by this Schedule, apply in relation to biologicals imported or exported on or after the commencement of this item.(4) The amendments of section 32BC of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to biologicals manufactured on or after the commencement of this item.(5) The amendments of section 32BD of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to biologicals supplied on or after the commencement of this item.(6) Subsections 32BG(1A) and (1B) of the
Therapeutic Goods Act 1989 , as inserted by this Schedule, apply in relation to biologicals imported, exported, manufactured or supplied on or after the commencement of this item.(7) The amendments of section 32BI of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to the use of biologicals on or after the commencement of this item.(8) The amendments of section 32CJ of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given on or after the commencement of this item.(9) The amendments of section 32CN of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to biologicals supplied on or after the commencement of this item.(10) The amendments of section 32DO of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to statements made on or after the commencement of this item.(11) The amendments of sections 32EF and 32HC of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to acts or omissions occurring on or after the commencement of this item.(12) The amendments of sections 32JB and 32JD of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given under section 32JA of that Act on or after the commencement of this item.(13) The amendments of sections 32JI and 32JK of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given under section 32JE, 32JF, 32JG or 32JH of that Act on or after the commencement of this item.
334
Application provisions—manufacturing of therapeutic goods (1) The amendments of section 35 of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to steps in the manufacture of therapeutic goods that are carried out on or after the commencement of this item.(2) The amendments of section 35B of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to acts or omissions occurring on or after the commencement of this item.
(1) The amendments of sections 41EI and 41FE of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to statements made on or after the commencement of this item.(2) The amendments of sections 41JB and 41JC of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given under section 41JA of that Act on or after the commencement of this item.(3) The amendments of sections 41JG, 41JH and 41JI of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to notices given under section 41JCA, 41JD, 41JE, 41JF or 41JFA of that Act on or after the commencement of this item.(4) The amendments of section 41KC of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to acts or omissions occurring on or after the commencement of this item.(5) The amendments of sections 41MA and 41MAA of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to medical devices imported, supplied or exported on or after the commencement of this item.(6) The amendments of section 41MC of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to acts or omissions occurring on or after the commencement of this item.(7) The amendments of sections 41MD and 41MJ of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to medical devices imported or exported on or after the commencement of this item.(8) The amendments of section 41ME of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to medical devices manufactured on or after the commencement of this item.(9) The amendments of section 41MF of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to medical devices supplied or exported on or after the commencement of this item.(10) The amendments of section 41MI of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to medical devices imported, exported, supplied or manufactured on or after the commencement of this item.(11) The amendments of section 41MN of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to acts or omissions occurring on or after the commencement of this item.(12) The amendments of subsections 41MO(1) and (4A), the repeal of subsections 41MO(2), (3) and (4B) and the insertion of subsections 41MO(4AA), (4AB), (4D) and (4E) of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to a medical device supplied on or after the commencement of this item.(13) The amendments of subsection 41MO(5), the repeal of subsections 41MO(6) and (7) and the addition of subsections 41MO(9) and (10) of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to use of a medical device on or after the commencement of this item.
The amendments of section 42V of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to requirements imposed on or after the commencement of this item.
Section 42YCA of the
Therapeutic Goods Act 1989 , as inserted by this Schedule, applies in relation to an act or thing required to be done within a particular period, or before a particular time, where the period ends, or the time occurs, on or after the commencement of this item.
338
Application and saving provisions—infringement notices (1) Part 5A‑2 of the
Therapeutic Goods Act 1989 , as substituted by this Schedule, applies in relation to an alleged contravention of a provision of that Act or the regulations under that Act that is an offence of strict liability, or an alleged contravention of a civil penalty provision, occurring on or after the commencement of this item.(2) Part 5A‑2 of the
Therapeutic Goods Act 1989 , and theTherapeutic Goods Regulations 1990 , as in force immediately before the commencement of this item, continue to apply on and after that commencement in relation to:
(a) an alleged commission of an offence occurring before that commencement; and
(b) an alleged contravention of a civil penalty provision occurring before that commencement.
Part 5A‑4 of the
Therapeutic Goods Act 1989 , as added by this Schedule, applies in relation to contraventions occurring, or proposed to occur, on or after the commencement of this item.
340
Application and saving provisions—entry, searches and warrants (1) The amendments of sections 46, 46A, 48, 48C, 48D and 48E of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to entries to premises on or after the commencement of this item.(2) Section 48AA of the
Therapeutic Goods Act 1989 , as inserted by this Schedule, applies in relation to warrants issued under section 50, or signed under section 51, of that Act on or after the commencement of this item.(3) Section 48BA of the
Therapeutic Goods Act 1989 , as inserted by this Schedule, applies in relation to entries to premises on or after the commencement of this item.(4) The repeal and substitution of subsection 48C(2) of the
Therapeutic Goods Act 1989 made by this Schedule does not affect the validity of anything done under that subsection before the commencement of this item.(5) Section 48FA of the
Therapeutic Goods Act 1989 , as inserted by this Schedule, applies in relation to warrants issued under section 49 or 50, or signed under section 51, of that Act on or after the commencement of this item.(6) The amendment of section 49 of the
Therapeutic Goods Act 1989 made by this Schedule applies in relation to applications for a warrant made on or after the commencement of this item.
Paragraph 54(3)(aa) of the
Therapeutic Goods Act 1989 , as inserted by this Schedule, applies in relation to an order referred to in that paragraph that is made on or after the commencement of this item (whether the person was charged with the offence before, on or after that commencement).
342
Saving provision—personal liability of an executive officer of a body corporate Despite the amendments made by this Schedule, the table in section 54BA of the
Therapeutic Goods Act 1989 , as in force immediately before the commencement of this item, continues to apply on and after that commencement in relation to the application of section 54B of that Act on or after that commencement in relation to offences committed by bodies corporate before that commencement.
After “biological”, insert “, complies with record‑keeping conditions under paragraph 32EC(2)(c) or keeps documents that relate to the biological”.
Add:
(iv) while on those premises, to inspect, and make copies of, any records kept in compliance with a condition under paragraph 32EC(2)(c); and
(v) while on those premises, to inspect, and make copies of, any documents that relate to the biological; and
Add:
; and (c) if requested to do so by an authorised person, make any record kept in compliance with a condition under paragraph 32EC(2)(c) available to the authorised person for inspection:
(i) if the authorised person requires the record to be made available immediately—immediately; and
(ii) if the authorised person requires the record to be made available at or before a time specified by the authorised person—at or before that time; and
(iii) in the form required by the authorised person.
Insert:
(ca) reporting requirements relating to the biological; or
Omit “paragraph 28(5)(c) or (ca)”, substitute “a condition under paragraph 28(5)(c) or (ca) or 32EC(2)(c)”.
The amendments made by this Schedule apply in relation to biologicals included in the Register before, on or after the commencement of this item.
Insert:
(1AA) An approval for use of the kind referred to in paragraph (1)(a) must not be granted to a person unless the person is a health practitioner.
After “be”, insert “in a form (if any) approved, in writing, by the Secretary and be”.
Insert:
(5AA) An application for an authority under subsection (5) must be in a form (if any) approved, in writing, by the Secretary.
Repeal the subsection, substitute:
(6) A person commits an offence if:
(a) the person claims, by any means, that the person or another person can arrange the supply of therapeutic goods; and
(b) none of the following subparagraphs applies in relation to the goods:
(i) the goods are registered goods or listed goods;
(ii) the goods are exempt goods;
(iii) the goods are exempt under section 18A;
(iv) the goods are the subject of an approval or authority under section 19 that covers the supply of the goods by the person or other person;
(v) the goods are the subject of an approval under section 19A that covers the supply of the goods by the person or other person.
Penalty: 60 penalty units.
Insert:
(1B) If:
(a) there is medicine included in the Register in relation to a person and there is no product information approved under this section in relation to the medicine; and
(b) the medicine becomes restricted medicine;
the Secretary may, by written notice given to the person, require the person to:
(c) give the Secretary product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine; and
(d) give the Secretary that product information within the period specified in the notice (which must be at least 30 days after the notice is given).
(1C) If the person complies with subsection (1B), the Secretary must approve product information in relation to the medicine that reflects the basis on which the medicine is registered at the time of the approval. The Secretary must, by written notice given to the person, set out the product information so approved.
Note: Subsection (4) deals with variation of the product information.
Add:
; and (h) deliver a reasonable number of samples of the subject goods if the Secretary so requests:
(i) within the period specified in the request (which must include at least 10 working days); and
(ii) in accordance with any other requirements specified in the request; and
(i) comply, in relation to the subject goods, with a notice given to the person under subsection 25AA(1B).
Repeal the subsection.
Omit “or (fb)”, substitute “, (fb) or (g)”.
Omit “otherwise than as a result of a failure to pay the annual registration or listing charge”.
Omit “that is held”, substitute “or (7A) that covers the supply of the biological”.
After “subsection 32CM(1)”, insert “or (7A)”.
Add “or (7A)”.
Omit “in relation to the person”.
After “person”, insert “or other person”.
After “person”, insert “or other person”.
Omit “that is held by the person”, substitute “or (7A) that covers the supply of the biological by the person or other person”.
After “person”, insert “or other person”.
After “subsection 32CM(1)”, insert “or (7A)”.
Insert:
(1A) An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner.
Insert:
(aa) be in a form (if any) approved, in writing, by the Secretary; and
Insert:
(1A) An application for an authority under subsection (1) must be in a form (if any) approved, in writing, by the Secretary.
Omit “or (d)”, substitute “, (d) or (g)”.
After “subsection 32CM(1)”, insert “or (7A)”.
Insert:
Removal of manufacturing sites
(9A) The holder of a licence may apply to the Secretary for a variation of the licence so that it ceases to cover one or more manufacturing sites specified in the application.
(9B) An application under subsection (9A) must:
(a) be made in accordance with a form approved by the Secretary; and
(b) be delivered to an office of the Department specified in the form; and
(c) be accompanied by the prescribed application fee.
(9C) If an application is made under subsection (9A), the Secretary may, by notice in writing given to the holder of the licence, vary the licence so that the licence does not cover each manufacturing site specified in the notice.
(9D) A variation under subsection (9C) takes effect on the day specified in the notice.
Omit “or (6)”, substitute “, (6) or (9A)”.
Before “to allow”, insert “for an application under subsection (1) or (6)—”.
Omit “or (7)(a)”, substitute “, (7)(a) or (9B)(a)”.
Add:
(6) The Secretary may, by written notice given to the applicant, require the applicant:
(a) to deliver to the office to which the application was made a reasonable number of samples of the kind of medical device to which the application relates within the period, of not less than 14 days after the day the notice is given, specified in the notice; and
(b) to do so in a manner specified in the notice.
After “by the Secretary”, insert “under subsection 41EC(6)”.
Insert:
(1A) In auditing the application, the Secretary may, by written notice given to the applicant, require the applicant:
(a) to deliver to the office to which the application was made a reasonable number of samples of the kind of medical device to which the application relates within the period, of not less than 14 days after the day the notice is given, specified in the notice; and
(b) to do so in a manner specified in the notice.
After “by the Secretary”, insert “under subsection 41FI(1A)”.
Omit “or (d)”, substitute “, (d) or (f)”.
Insert:
(1A) An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner.
After “be”, insert “in a form (if any) approved, in writing, by the Secretary and be”.
Insert:
(1A) An application for an authority under subsection (1) must be in a form (if any) approved, in writing, by the Secretary.
Repeal the section, substitute:
A person commits an offence if:
(a) the person claims, by any means, that the person or another person can arrange the supply of a medical device; and
(b) none of the following subparagraphs applies in relation to the device:
(i) the device is of a kind included in the Register;
(ii) the device is of a kind covered by an exemption in force under section 41GS;
(iii) the device is an exempt device;
(iv) the device is the subject of an approval under section 41HB or an authority under section 41HC that covers the supply of the device by the person or other person;
(v) the device is the subject of an approval under subsection 41HD(1), (1A) or (2) that covers the supply of the device by the person or other person.
Penalty: 60 penalty units.
Omit “section 19”, substitute “subsection 19(1) or (5)”.
Omit “section 41HB or 41HC”, substitute “subsection 41HB(1) or 41HC(1)”.
(1) Subsection 19(1AA) of the
Therapeutic Goods Act 1989 , as inserted by this Schedule, applies in relation to approvals granted on or after the commencement of this item.(2) The amendment of paragraph 19(2)(a) of the
Therapeutic Goods Act 1989 made by this Schedule applies in relation to applications made on or after the commencement of this item.(3) Subsection 19(5AA) of the
Therapeutic Goods Act 1989 , as inserted by this Schedule, applies in relation to applications made on or after the commencement of this item.(4) The repeal and substitution of subsection 22(6) of the
Therapeutic Goods Act 1989 made by this Schedule applies in relation to claims made on or after the commencement of this item.(5) Subsection 25AA(1B) of the
Therapeutic Goods Act 1989 , as inserted by this Schedule, applies in relation to medicine that becomes restricted medicine on or after the commencement of this item, whether the medicine was included in the Register before, on or after that commencement.(6) The amendment of subsection 28(5) of the
Therapeutic Goods Act 1989 made by this Schedule applies in relation to the registration or listing of therapeutic goods before, on or after the commencement of this item.(7) The
Therapeutic Goods Act 1989 , as in force immediately before the commencement of this item, continues to apply on and after that commencement in relation to a request referred to in subsection 28(5A) of that Act that was made before that commencement.(8) The amendment of paragraph 29D(1)(b) of the
Therapeutic Goods Act 1989 made by this Schedule applies in relation to suspensions made on or after the commencement of this item (whether the therapeutic goods were included in the Register before, on or after that commencement).
(1) The amendment of subparagraph 32BH(b)(v) of the
Therapeutic Goods Act 1989 made by this Schedule applies in relation to supplies of a biological occurring on or after the commencement of this item.(2) The amendments of section 32BI of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to uses of a biological on or after the commencement of this item.(3) The amendments of section 32BJ of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to claims made on or after the commencement of this item.(4) The amendment of paragraph 32BK(2)(e) of the
Therapeutic Goods Act 1989 made by this Schedule applies in relation to representations made on or after the commencement of this item.(5) Subsection 32CK(1A) of the
Therapeutic Goods Act 1989 , as inserted by this Schedule, applies in relation to approvals granted on or after the commencement of this item.(6) The amendment of subsection 32CK(3) of the
Therapeutic Goods Act 1989 made by this Schedule applies in relation to applications made on or after the commencement of this item.(7) Subsection 32CM(1A) of the
Therapeutic Goods Act 1989 , as inserted by this Schedule, applies in relation to applications made on or after the commencement of this item.(8) The amendment of paragraph 32FA(1)(b) of the
Therapeutic Goods Act 1989 made by this Schedule applies in relation to suspensions made on or after the commencement of this item (whether the biological was included in the Register before, on or after that commencement).(9) The amendment of subsection 32HA(1) of the
Therapeutic Goods Act 1989 made by this Schedule applies in relation to supplies of a biological occurring on or after the commencement of this item.
(1) The amendments of sections 41EC and 41EG of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to:
(a) an application for a conformity assessment certificate that is made on or after the commencement of this item; and
(b) an application for a conformity assessment certificate that was pending immediately before the commencement of this item.
(2) The amendments of sections 41FI and 41FK of the
Therapeutic Goods Act 1989 made by this Schedule apply in relation to:
(a) an application for a kind of medical device to be included in the Register that is made on or after the commencement of this item; and
(b) an application for a kind of medical device to be included in the Register that was pending immediately before the commencement of this item.
(3) The amendment of paragraph 41GA(1)(b) of the
Therapeutic Goods Act 1989 made by this Schedule applies in relation to suspensions made on or after the commencement of this item (whether the kind of medical device was included in the Register before, on or after that commencement).(4) Subsection 41HB(1A) of the
Therapeutic Goods Act 1989 , as inserted by this Schedule, applies in relation to approvals granted on or after the commencement of this item.(5) The amendment of subsection 41HB(4) of the
Therapeutic Goods Act 1989 made by this Schedule applies in relation to applications made on or after the commencement of this item.(6) Subsection 41HC(1A) of the
Therapeutic Goods Act 1989 , as inserted by this Schedule, applies in relation to applications made on or after the commencement of this item.(7) The repeal and substitution of section 41MM of the
Therapeutic Goods Act 1989 made by this Schedule applies in relation to claims made on or after the commencement of this item.
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