Commonwealth Numbered Acts Commonwealth Numbered ActsPart 1 -- Amendments commencing on the day after Royal Assent
1 Subsection 3(1) (definition of accessory )
Repeal the definition, substitute:
"accessory" , in relation to a medical device covered by paragraph 41BD(1)(a), (aa) or (ab), means a thing that the manufacturer of the thing specifically intended to be used together with the device to enable the device to be used as the manufacturer of the device intended.
2 Subsection 3(1) (paragraph (b) of the definition of listable goods )
Omit "subsection 17(5)", substitute "subsection 9A(5)".
3 After section 7B
Insert:
7C Secretary may arrange for use of computer programs to make decisions
(1) The Secretary may arrange for the use, under the Secretary's control, of computer programs for any purposes for which the Secretary may make decisions under this Act or the regulations.
(2) A decision made by the operation of a computer program under such an arrangement is taken to be a decision made by the Secretary.
(3) The Secretary may substitute a decision (the substituted decision ) for a decision (the initial decision ) made by the operation of a computer program under such an arrangement if the Secretary is satisfied that the initial decision is incorrect.
(4) However, the substituted decision may only be made before the end of the period of 60 days beginning on the day the initial decision is made.
4 Subsection 24D(5)
After "subsection 25(3)", insert "or (4)".
5 Paragraph 26A(1)(c)
Omit "subsection (3)", substitute "subsections (2A), (3) and (4A)".
6 Paragraph 26A(2)(e)
Omit "granted under section 38".
7 Paragraph 26A(2)(f)
After "criteria", insert "that are applicable to the medicine".
8 After paragraph 26A(2)(f)
Insert:
(fa) 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
(fb) 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
(fc) 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
9 After subsection 26A(2)
Insert:
(2A) The applicant must also certify any other matters prescribed by the regulations for the purposes of this subsection.
10 After subsection 26A(4)
Insert:
(4A) 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.
11 Paragraph 30(1)(e)
After "subsection 26A(3)", insert "or (4A)".
12 Paragraph 30(2)(ba)
After "(f),", insert "(fa), (fb), (fc),".
13 Paragraph 30(2)(ba)
After "(k)", insert "or subsection 26A(2A)".
14 After section 30
Insert:
30A Revocation of cancellation of registration or listing upon request
(1) If:
(a) the Secretary cancels the registration or listing of therapeutic goods because of the request of a person made under paragraph 30(1)(c); and
(b) before the end of the period of 90 days beginning on the day the goods ceased to be registered or listed, the person requests, in writing, the Secretary to revoke the cancellation; and
(c) the request is accompanied by the prescribed application fee;
the Secretary may, by notice in writing given to the person, revoke the cancellation.
(2) If the cancellation is revoked, the cancellation is taken never to have occurred.
15 Subsection 30EA(1) (table item 5)
Omit ", 42E(1) or 42EA(1)", substitute "or 42E(1) or section 42EA".
16 Subparagraph 41BD(1)(a)(ii)
Omit "handicap", substitute "disability".
17 After paragraph 41BD(1)(a)
Insert:
(aa) any instrument, apparatus, appliance, material or other article specified under subsection (2A); or
(ab) any instrument, apparatus, appliance, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B); or
18 Paragraph 41BD(1)(b)
Omit "such".
19 At the end of paragraph 41BD(1)(b)
Add "covered by paragraph (a), (aa) or (ab)".
20 Subsection 41BD(2)
Repeal the subsection, substitute:
(2) For the purposes of paragraph (1)(a), the purpose for which an instrument, apparatus, appliance, material or other article (the main equipment ) is to be used is to be ascertained from the information supplied, by the person under whose name the main equipment is or is to be supplied, on or in any one or more of the following:
(a) the labelling on the main equipment;
(b) the instructions for using the main equipment;
(c) any advertising material relating to the main equipment;
(d) technical documentation describing the mechanism of action of the main equipment.
21 After subsection 41BD(2)
Insert:
(2A) The Secretary may, by notice published in the Gazette , specify a particular instrument, apparatus, appliance, material or other article for the purposes of paragraph (1)(aa). The notice is not a legislative instrument.
(2B) The Secretary may, by legislative instrument, specify a particular class of instruments, apparatus, appliances, materials or other articles for the purposes of paragraph (1)(ab).
22 Subsection 41BE(3)
Repeal the subsection, substitute:
Device nomenclature codes
(3) The Minister may, by legislative instrument, determine device nomenclature codes for medical devices.
23 At the end of paragraphs 41BG(2)(f) and (3)(c)
Add:
; (iv) technical documentation describing the mechanism of action of the device.
24 At the end of section 41BG
Add:
(4) A person is not the manufacturer of a medical device if the person is included in a class of persons prescribed by the regulations for the purposes of this subsection.
25 Subsection 60(1) (after paragraph (a) of the definition of initial decision )
Insert:
(aa) under subsection 7C(3); or
26 Application--listings of medicines
The amendments made by items 5 to 10 apply in relation to applications for listings of medicines made on or after the commencement of those items.
27 Application--revocation of cancellation of registration or listing upon request
The amendment made by item 14 applies in relation to cancellations occurring before, on or after the commencement of that item.
28 Saving--device nomenclature codes
Despite the amendment made by item 22, regulations in force for the purposes of subsection 41BE(3) of the Therapeutic Goods Act 1989 immediately before the commencement of this item continue in force, after that commencement, until the first determination made under that subsection (as inserted by this Act) takes effect.
Part 2 -- Amendments commencing on a day to be fixed by Proclamation
29 Subsection 3(1) (definition of Therapeutic Goods Advertising Code )
Repeal the definition, substitute:
"Therapeutic Goods Advertising Code" means the code in force under section 42BAA.
30 Subsections 28(1) and (2)
Repeal the subsections, substitute:
(1) The registration or listing of therapeutic goods is subject to the conditions set out in a determination under subsection (2).
(2) The Minister may, by legislative instrument, make a determination setting out conditions for the purposes of subsection (1), being conditions that relate to:
(a) the manufacture of the goods; or
(b) the custody, use, supply, disposal or destruction of the goods; or
(c) the keeping of records relating to the goods; or
(d) matters dealt with in, or matters additional to matters dealt with in, standards applicable to the goods; or
(e) such other matters relating to the goods as the Minister thinks appropriate.
(2A) Without limiting subsection (2), different conditions may be specified for:
(a) the registration of therapeutic goods; and
(b) the listing of therapeutic goods; and
(c) different classes of therapeutic goods.
(2B) If the Secretary includes therapeutic goods in the Register in relation to a person, the Secretary may, by notice in writing given to the person, impose conditions on the registration or listing of those goods.
31 Subsection 28(3)
Omit "existing conditions", substitute "conditions imposed under subsection (2B) or this subsection".
32 Subsection 28(4)
After "variation", insert "or removal".
33 Subsection 28(5)
After "subsection (1)", insert ", (2B)".
34 Before paragraph 28(5)(a)
Insert:
(aa) not supply a batch of the subject goods in Australia, or export a batch of the subject goods from Australia, after the expiry date for the goods; and
(ab) not, by any means, advertise the subject goods for an indication other than those accepted in relation to the inclusion of the goods in the Register; and
35 Subsection 28(5A)
After "subsection (1),", insert "(2B),".
36 After subsection 28(5A)
Insert:
(5B) The listing of a medicine under section 26A is subject to a condition that:
(a) each step in the manufacture of the medicine that is carried out in Australia is carried out by a person who is the holder of a licence to carry out that step or who is exempt from the operation of Part 3‑3 in relation to that step; and
(b) each step in the manufacture of the medicine that is carried out outside Australia is the subject of a certification in force under subsection 26A(3) or 28A(2).
(5C) Subsection (5B) does not apply if the medicine is exempt from the operation of Part 3‑3.
37 After section 28
Insert:
28A Certification of manufacturing steps outside Australia following application for listing
(1) The person in relation to whom medicine is listed under section 26A may apply to the Secretary for a certification under this section of a step in the manufacture of the medicine that is to be carried out outside Australia.
Note: The listing of medicine is subject to the condition that each step in the manufacture of the medicine that is carried out outside Australia is the subject of a certification in force under subsection 26A(3) or subsection (2) of this section: see subsection 28(5B).
(2) If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable. The Secretary must give the person written notice of the certification.
(3) In deciding whether to give the certification, subsection 26A(4) applies in a way corresponding to the way in which it applies for the purposes of subsection 26A(3).
38 After paragraph 41JA(1)(b)
Insert:
(ba) who held, at any time during the notice period under subsection (2), a conformity assessment certificate that related to a kind of medical device; or
39 Paragraph 41JA(1)(d)
Omit ", or was at any time during the notice period under subsection (2),".
40 After paragraph 41JA(1)(d)
Insert:
or (da) in relation to whom a kind of medical device was, at any time during the notice period under subsection (2), included in the Register;
41 After paragraph 41JA(1)(i)
Insert:
(ia) the safety and efficacy of the devices for the purposes for which they are to be used;
(ib) the regulatory history of the devices in another country;
42 After subsection 41JA(1)
Insert:
(1AA) If a notice is given under subsection (1) to a person covered by paragraph (1)(ba), then paragraphs (1)(e) to (j) (to the extent to which they are relevant) apply in relation to the period the person held the certificate.
(1AB) If a notice is given under subsection (1) to a person covered by paragraph (1)(da), then paragraphs (1)(e) to (j) (to the extent to which they are relevant) apply in relation to the period the kind of medical device was included in the Register.
43 Subsection 41JA(2)
Omit "paragraph (1)(d)", substitute "paragraphs (1)(ba) and (da)".
44 Paragraph 42AA(1)(a)
Omit "veterinary surgeons,".
45 Paragraph 42AA(1)(a)
After "pharmacists,", insert "optometrists, chiropractors,".
46 Paragraph 42AA(1)(a)
Omit "dietitians, scientists working in medical laboratories or nurses", substitute "nurses, midwives, dental hygienists, dental prosthetists, dental therapists or osteopaths".
47 Paragraph 42AA(1)(c)
Omit "chiropractors,".
48 Paragraph 42AA(1)(c)
Omit ", podiatrists or osteopaths", substitute "or podiatrists".
49 At the end of subsection 42AA(1)
Add:
; or (d) a class of persons specified under subsection (1A).
50 After subsection 42AA(1)
Insert:
(1A) The Minister may, by legislative instrument, specify a class of persons for the purposes of paragraph (1)(d).
51 At the end of Division 1 of Part 5‑1
Add:
42BAA Therapeutic Goods Advertising Code
The Minister may, by legislative instrument, make a code relating to advertisements about therapeutic goods.
52 Section 42DD
Omit "a serious form of a disease, condition, ailment or defect specified in a part of the Therapeutic Goods Advertising Code that is prescribed by the regulations for the purposes of this section", substitute "a form of a disease, condition, ailment or defect identified in a part of the Therapeutic Goods Advertising Code as a serious form of a disease, condition, ailment or defect".
53 Paragraph 42DF(4)(b)
Repeal the paragraph, substitute:
(b) any advice of a committee that is established under the regulations and is prescribed by the regulations for the purposes of this paragraph; and
54 Paragraph 42DF(4)(c)
Omit "a part of the Therapeutic Goods Advertising Code that is prescribed by the regulations made for the purposes of this paragraph", substitute "the part of the Therapeutic Goods Advertising Code dealing with restricted representations".
55 Part 6‑4
Repeal the Part.
56 Saving--Therapeutic Goods Advertising Code
(1) Despite the amendment made by item 29, the Therapeutic Goods Advertising Code as in force immediately before the commencement of this item continues in force, after that commencement, until the first instrument made under section 42BAA of the Therapeutic Goods Act 1989 , as inserted by this Act, takes effect.
(2) Despite the amendment made by item 52, regulations in force for the purposes of section 42DD of the Therapeutic Goods Act 1989 immediately before the commencement of this item continue in force, after that commencement, until the first instrument made under section 42BAA of the Therapeutic Goods Act 1989 , as inserted by this Act, takes effect.
(3) Despite the amendment made by item 54, regulations in force for the purposes of paragraph 42DF(4)(c) of the Therapeutic Goods Act 1989 immediately before the commencement of this item continue in force, after that commencement, until the first instrument made under section 42BAA of the Therapeutic Goods Act 1989 , as inserted by this Act, takes effect.
57 Application and transitional--registration or listing conditions
(1) Subsection 28(1) of the Therapeutic Goods Act 1989 , as inserted by this Act, applies in relation to the registration or listing of therapeutic goods occurring before, on or after the commencement of this item.
(2) Subsection 28(2B) of the Therapeutic Goods Act 1989 , as inserted by this Act, applies in relation to the registration or listing of therapeutic goods occurring on or after the commencement of this item.
(3) Conditions in force under subsection 28(1) of the Therapeutic Goods Act 1989 immediately before the commencement of this item continue in force, on and after that commencement, as if they had been imposed, on that commencement, under subsection 28(2B) of the Therapeutic Goods Act 1989 .
(4) Subitem (3) does not prevent the variation or removal of the conditions under subsection 28(3) of the Therapeutic Goods Act 1989 on or after the commencement of this item.
(5) The amendment made by item 31 applies in relation to:
(a) conditions imposed under subsection 28(2B) of the Therapeutic Goods Act 1989 on or after the commencement of that item (including because of subitem (3)); and
(b) conditions imposed under subsection 28(3) of the Therapeutic Goods Act 1989 before, on or after the commencement of that item.
(6) The amendment made by item 34 applies in relation to the registration or listing of therapeutic goods occurring before, on or after the commencement of that item.
(7) The amendment made by item 36 applies in relation to the listing of medicine occurring before, on or after the commencement of that item.
(8) This item does not affect the conditions to which the registration or listing of therapeutic goods is subject before the commencement of this item.
58 Application--information gathering
(1) The amendments made by items 38 and 40 apply in relation to periods beginning before, on or after the commencement of those items.
(2) The amendment made by item 41 applies in relation to things occurring before, on or after the commencement of that item.
(3) Regulations in force for the purposes of subsection 41JA(2) of the Therapeutic Goods Act 1989 immediately before the commencement of this item continue in force for the purposes of that subsection on and after that commencement.
59 Application--advertisements
The amendments made by items 44 to 50 apply in relation to advertisements published or broadcast on or after the commencement of those items.
[ Minister's second reading speech made in--
House of Representatives on 19 March 2009
Senate on 15 June 2009 ]
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