A Bill for an Act to amend the Therapeutic Goods Act 1989, and for related purposes
The Parliament of Australia enacts:
1 Short title
This Act may be cited as the Therapeutic Goods Amendment (2010 Measures No. 1) Act 2010.
2 Commencement
(1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
| Commencement information |
| Column 1 | Column 2 | Column 3 |
| Provision(s) | Commencement | Date/Details |
| 1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table | The day this Act receives the Royal Assent. | |
| 2. Schedule 1 | The day after this Act receives the Royal Assent. | |
| 3. Schedule 2, Part 1 | The 28th day after this Act receives the Royal Assent. | |
| 4. Schedule 2, Part 2 | The day after this Act receives the Royal Assent. | |
Note: This table relates only to the provisions of this Act as originally enacted. It will not be amended to deal with any later amendments of this Act.
(2) Any information in Column 3 of the table is not part of this Act. Information may be inserted in this column, or information in it may be edited, in any published version of this Act.
3 Schedule(s)
Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.
Schedule 1—Exempting medical devices if substitutes are not widely available
Therapeutic Goods Act 1989
1 Section 41H
Omit “3 other”, substitute “4 other”.
2 At the end of section 41H
Add:
; (d) medical devices exempted if substitutes are unavailable or in short supply.
3 At the end of Part 4‑7
Add:
41HD Approvals if substitutes for medical devices are unavailable or in short supply
(1) The Secretary may, by notice in writing, grant an approval to a person for:
(a) the importation into Australia of a specified medical device; or
(b) the importation into Australia of a specified medical device and the supply in Australia of that device;
if the Secretary is satisfied that:
(c) the kinds of medical devices included in the Register that could act as a substitute for the medical device are unavailable or are in short supply; and
(d) either:
(i) the medical device is registered or approved for general marketing in at least one foreign country specified in a determination under subsection (5); or
(ii) an application has been made in accordance with section 41FC for inclusion in the Register of the kind of medical device that includes the medical device; and
(e) the medical device is specified in a determination under subsection (6); and
(f) the approval is necessary in the interests of public health.
Note: For specification by class, see the Acts Interpretation Act 1901 and subsection 13(3) of the Legislative Instruments Act 2003.
(2) The Secretary may, by notice in writing, grant an approval to a person for:
(a) the importation into Australia of a specified medical device; or
(b) the importation into Australia of a specified medical device and the supply in Australia of that device;
if the Secretary is satisfied that:
(c) there are no kinds of medical devices that are included in the Register that could act as a substitute for the medical device; and
(d) an application has been made in accordance with section 41FC for inclusion in the Register of the kind of medical device that includes the medical device; and
(e) the medical device is specified in a determination under subsection (6); and
(f) the approval is necessary in the interests of public health.
Note: For specification by class, see the Acts Interpretation Act 1901 and subsection 13(3) of the Legislative Instruments Act 2003.
Application for approval
(3) An application for an approval must:
(a) be made to the Secretary; and
(b) be accompanied by such information relating to the medical device as is required by the Secretary.
Notification of Secretary’s decision
(4) If an application for an approval is made, the Secretary must, as soon as practicable after deciding the application, notify the applicant of:
(a) the decision; and
(b) if the decision is not to grant the approval—the reasons for the decision.
Determinations
(5) The Secretary may, by legislative instrument, make a determination specifying foreign countries for the purposes of subparagraph (1)(d)(i).
(6) The Secretary may, by legislative instrument, make a determination specifying medical devices that can be the subject of an approval under this section.
Conditions
(7) The Secretary may grant an approval subject to any conditions that are specified in the notice of approval.
Note: Breach of the conditions may be an offence: see subsection 41MN(9).
Period of approval
(8) The Secretary may grant an approval for such period as is specified in the notice of approval.
When approval lapses
(9) The approval lapses if:
(a) the period specified in the notice of approval expires; or
(b) a decision has been made on an application that has been made for inclusion in the Register of the kind of medical device that includes the medical device.
(10) The approval lapses if:
(a) the Secretary is satisfied that paragraph (1)(c), (d), (e) or (f), or paragraph (2)(c), (d), (e) or (f), as the case requires, no longer applies in relation to the medical device, or that a condition of the approval has been contravened; and
(b) the Secretary has given to the person to whom the approval was granted a notice stating that the Secretary is so satisfied.
(11) The lapsing of the approval on the expiry of the period specified in the notice of approval does not prevent another approval being granted under this section in relation to the medical device before that lapsing. The other approval may be expressed to take effect on the expiry of that period.
Approval not a legislative instrument
(12) An approval under subsection (1) or (2) is not a legislative instrument.
4 After section 41JF
Insert:
41JFA Secretary may require information relating to approvals under section 41HD
(1) The Secretary may give to a person who is granted an approval under subsection 41HD(1) or (2) in relation to a medical device a written notice requiring the person to give to the Secretary specified information or documents relating to one or more of the following:
(a) the supply of the medical device;
(b) the handling of the medical device;
(c) the monitoring of the supply of the medical device;
(d) the results of the supply of the medical device;
(e) any other matter prescribed by the regulations for the purposes of this paragraph in relation to the kind of medical device that includes the medical device.
(2) The notice must specify a reasonable period within which the person must comply. The period must be at least 10 working days starting on the day on which the notice is given.
(3) The notice may require 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.
5 Paragraph 41JG(a)
Omit “or 41JF”, substitute “, 41JF or 41JFA”.
6 Section 41JG (note)
Omit “and 41JF”, substitute “, 41JF and 41JFA”.
7 Section 41JH
Omit “or 41JF”, substitute “, 41JF or 41JFA”.
8 Paragraph 41JI(1)(c)
Omit “or 41JF”, substitute “, 41JF or 41JFA”.
9 Subsection 41JJ(1)
Omit “or 41JF”, substitute “, 41JF or 41JFA”.
10 Subsection 41KA(1) (at the end of paragraph (c) of the cell at table item 3, column headed “Circumstance relating to a kind of medical device”)
Add “or”.
11 Subsection 41KA(1) (after paragraph (c) of the cell at table item 3, column headed “Circumstance relating to a kind of medical device”)
Insert:
| (d) there is an approval under subsection 41HD(1) or (2) relating to devices of that kind; |
12 Subsection 41KA(1) (at the end of paragraph (c) of the cell at table item 4, column headed “Circumstance relating to a kind of medical device”)
Add “or”.
13 Subsection 41KA(1) (after paragraph (c) of the cell at table item 4, column headed “Circumstance relating to a kind of medical device”)
Insert:
| (d) there is an approval under subsection 41HD(1) or (2) relating to devices of that kind; |
14 Subsection 41KA(1) (paragraph (d) of the cell at table item 5, column headed “Circumstance relating to a kind of medical device”)
Omit “kind.”, substitute “kind; and”.
15 Subsection 41KA(1) (at the end of the cell at table item 5, column headed “Circumstance relating to a kind of medical device”)
Add:
| (e) there is not an approval under subsection 41HD(1) or (2) relating to devices of that kind. |
16 Subparagraph 41MI(1)(b)(iii)
Omit “and”.
17 At the end of paragraph 41MI(1)(b)
Add:
(iv) the device is the subject of an approval under subsection 41HD(1) or (2) that is held by the person; and
18 Subparagraph 41MI(2)(b)(iii)
Omit “and”.
19 At the end of paragraph 41MI(2)(b)
Add:
(iv) the device is the subject of an approval under subsection 41HD(1) or (2) that is held by the person; and
20 At the end of paragraph 41MI(4)(b)
Add:
; (iv) the device is the subject of an approval under subsection 41HD(1) or (2) that is held by the person.
21 At the end of paragraph 41MIB(1)(b)
Add:
; (iv) the device is the subject of an approval under subsection 41HD(1) or (2) that is held by the person.
22 Subparagraph 41MK(b)(iii)
Omit “and”.
23 At the end of paragraph 41MK(b)
Add:
(iv) the device is the subject of an approval under subsection 41HD(1) or (2) that is held by the person; and
24 At the end of subsection 41MLA(2)
Add:
; (d) representations that medical devices are the subject of an approval under subsection 41HD(1) or (2).
25 At the end of paragraph 41MN(9)(b)
Add:
; or (iv) a condition of an approval under subsection 41HD(1) or (2).
26 After subparagraph 46A(4)(a)(iia)
Insert:
(iib) who has been granted an approval under subsection 41HD(1) or (2); or
27 After paragraph 56A(1)(ba)
Insert:
(bb) there was no approval under subsection 41HD(1) or (2) granted to a particular person in relation to particular medical devices; or
28 After subsection 57(8)
Insert:
(9) The powers of the Secretary under section 41HD may be delegated only to either or both of the following persons:
(a) the National Manager of the Therapeutic Goods Administration;
(b) a person who holds, occupies or performs the duties of a position in the Therapeutic Goods Administration prescribed by the regulations for the purposes of this paragraph.
Schedule 2—Other amendments
Part 1—Amendments commencing on the 28th day after Royal Assent
Therapeutic Goods Act 1989
1 Paragraphs 26(1)(ea) and (eb)
Repeal the paragraphs.
2 Paragraphs 26A(2)(ca) to (cd)
Repeal the paragraphs, substitute:
(ca) the medicine does not contain an ingredient that is not specified in a determination under paragraph 26BB(1)(a); and
(cb) if a determination under paragraph 26BB(1)(b) specifies restrictions in relation to ingredients being contained in the medicine—none of the restrictions have been contravened; and
3 Section 26BB
Repeal the section, substitute:
26BB Permissible ingredients
(1) The Minister may, by legislative instrument, make a determination specifying either or both of the following:
(a) ingredients;
(b) for some or all of those ingredients—restrictions in relation to those ingredients being contained in medicine.
Note: A person seeking the listing of a medicine under section 26A must certify that:
(a) the medicine does not contain an ingredient that is not specified in the determination; and
(b) none of the restrictions specified in the determination in relation to ingredients being contained in the medicine have been contravened.
Restrictions
(2) The restrictions referred to in paragraph (1)(b) may relate to particular ingredients not being contained in particular medicine.
(3) The restrictions referred to in paragraph (1)(b) may relate to permitted concentrations or permitted total amounts of ingredients.
(4) Subsections (2) and (3) do not limit paragraph (1)(b).
(5) A determination under paragraph (1)(b) may make different provision for different classes of medicine.
Prohibited ingredients
(6) The Minister may, by legislative instrument, make a determination specifying ingredients that must not be specified under paragraph (1)(a).
Incorporation of instruments
(7) Despite subsection 14(2) of the Legislative Instruments Act 2003, a determination under this section may make provision in relation to a matter by applying, adopting or incorporating any matter contained in an instrument or other writing as in force or existing from time to time.
Note: The heading to section 26BC is altered by omitting “list of active ingredients” and substituting “determination under section 26BB”.
4 Subsection 26BD(1)
Omit “section 26BB”, substitute “subsection 26BB(1)”.
Note: The heading to section 26BD is altered by omitting “list of active ingredients” and substituting “determination under section 26BB”.
5 Section 26BE
Repeal the section.
6 Paragraph 30(1)(e)
Omit “(cc), (cd),”.
7 Application
The amendments made by items 1 and 2 apply in relation to applications for listings made on or after the commencement of those items.
Part 2—Amendments commencing on the day after Royal Assent
Therapeutic Goods Act 1989
8 Subsection 26(1)
After “subject to”, insert “this section and”.
9 After subsection 26(1)
Insert:
(1AA) If:
(a) a medicine (the original medicine) is included in the Register in relation to a person; and
(b) the person makes an application under section 23 for the listing of a medicine (the new medicine) under this section; and
(c) the Secretary is satisfied that paragraphs (1)(a) to (ba) are satisfied in relation to the application; and
(d) the Secretary is satisfied that the new medicine has the same characteristics as the original medicine apart from the characteristics specified in an instrument under subsection (1AB);
the Secretary may list the new medicine in relation to the person.
(1AB) The Minister may, by legislative instrument, specify characteristics for the purposes of paragraph (1AA)(d).
10 After paragraph 31(1)(g)
Insert:
(ga) whether the goods comply with conditions (if any) on the registration of the goods;
11 After paragraph 31(1)(h)
Insert:
(ha) if the goods are registered in relation to the person—whether the goods are being:
(i) supplied in Australia; or
(ii) imported into Australia; or
(iii) exported from Australia;
12 After paragraph 31(2)(c)
Insert:
(ca) the quality of the goods;
13 Paragraph 31(2)(f)
After “safety”, insert “and efficacy”.
14 After paragraph 31(2)(f)
Insert:
(fa) whether the goods comply with conditions (if any) on the listing of the goods;
15 After paragraph 31(2)(g)
Insert:
(ga) if the goods are listed in relation to the person—whether the goods are being:
(i) supplied in Australia; or
(ii) imported into Australia; or
(iii) exported from Australia;
16 Paragraph 41EG(f)
Repeal the paragraph, substitute:
(f) for the whole or a part of the conformity assessment fee for the application that is due and payable in accordance with regulations made for the purposes of Part 4‑10—the applicant fails to pay that whole or part in accordance with those regulations.
17 Paragraph 41FK(e)
Omit “within the period, specified in the regulations, after being notified of the decision to include the kind of medical device in the Register under section 41FJ”, substitute “in accordance with section 41LB or 41LC”.
18 After subsection 60(2)
Insert:
(2A) A request under subsection (2) may be accompanied by information in support of the request.
19 After subsection 60(3)
Insert:
(3A) Subject to subsection 60A(2), in reconsidering the initial decision:
(a) the Minister must take into account any information referred to in subsection (2A); and
(b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than:
(i) information provided in response to a request from the Minister; or
(ii) information that indicates that the quality, safety or efficacy of therapeutic goods is unacceptable.
(3B) Paragraph (3A)(a) does not limit the information the Minister may take into account in reconsidering the initial decision.
20 Subsection 60(4)
Omit “is to be taken to have confirmed the original decision”, substitute “is taken to have confirmed under subsection (3) the initial decision”.
21 Application
(1) The amendments made by items 8 and 9 apply in relation to applications for listings made on or after the commencement of those items.
(2) The amendments made by items 10 to 15 apply in relation to notices given on or after the commencement of those items.
(3) The amendments made by items 16 and 17 apply in relation to applications made on or after the commencement of those items.
(4) The amendments made by items 18 and 19 apply in relation to initial decisions made on or after the commencement of those items.