Commonwealth Numbered Acts Commonwealth Numbered Acts
1 Subsection 3(1)
Insert:
"major interest holder" of a body corporate means a person who:
(a) is in a position to cast, or control the casting of, more than one‑fifth of the maximum number of votes that might be cast at a general meeting of the body corporate; or
(b) holds more than one‑fifth of the issued share capital of the body corporate (excluding any part of that issued share capital that carries no right to participate beyond a specified amount in a distribution of either profits or capital).
2 Paragraphs 38(1)(g) to (i)
Repeal the paragraphs, substitute:
(g) at least one of the following persons:
(i) the applicant;
(ii) a person (a manager ) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the applicant's affairs;
(iii) if the applicant is a body corporate--a major interest holder of the body corporate;
has, within the 10 years immediately before the application:
(iv) been convicted of an offence against this Act or a corresponding State law; or
(v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(viii) breached a condition of a manufacturing licence; or
(ix) had a manufacturing licence suspended or revoked; or
(x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies in that 10 year period, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or
(h) any other circumstances prescribed by the regulations for the purposes of this paragraph exist.
3 Subsection 38(1A)
Repeal the subsection, substitute:
(1A) A reference in paragraph (1)(g) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:
(a) section 19B of the Crimes Act 1914 ; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.
(1AA) Paragraph (1)(g) does not limit paragraph (1)(h).
4 Subsection 38(1B)
Omit "subsection (1A)", substitute "paragraph (1)(g)".
5 Subsection 38(2)
Omit "paragraphs (1)(g), (h) and (i)", substitute "paragraph (1)(g)".
6 Subsection 38(2)
Omit "one or more of those paragraphs", substitute "that paragraph".
7 After paragraph 40(4)(ab)
Insert:
(ac) give the Secretary the information specified in a notice under subsection (6) within the period, and in the manner, specified in the notice; and
8 At the end of section 40
Add:
(6) The Secretary may, by notice in writing given to the holder of a licence, require the holder to give the Secretary, within the specified period and in the specified manner, specified information to be used by the Secretary in deciding whether to revoke or suspend the licence under section 41 in the circumstances referred to in paragraph 41(1)(a).
(7) The period specified in a notice given under subsection (6) must be at least 14 days after the notice is given.
9 Paragraphs 41(1)(a) to (cd)
Repeal the paragraphs, substitute:
(a) at least one of the following persons:
(i) the holder;
(ii) a person (a manager ) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the holder's affairs;
(iii) if the holder is a body corporate--a major interest holder of the body corporate;
has:
(iv) been convicted of an offence against this Act or a corresponding State law; or
(v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(viii) breached a condition of a manufacturing licence; or
(ix) had a manufacturing licence suspended or revoked; or
(x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or
10 At the end of subsection 41(1)
Add:
; or (h) any other circumstances prescribed by the regulations for the purposes of this paragraph exist.
11 Subsection 41(1A)
Repeal the subsection, substitute:
(1A) A reference in paragraph (1)(a) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:
(a) section 19B of the Crimes Act 1914 ; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.
(1B) Paragraph (1)(a) does not limit paragraph (1)(h).
(1C) In paragraph (1)(a):
"manufacturing licence" means:
(a) a licence granted under this Part; or
(b) a licence, granted under a law of a State or Territory relating to therapeutic goods, relating to manufacturing therapeutic goods.
12 After section 41
Insert:
Nothing in section 40 or 41 affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).
13 Paragraphs 41EC(3)(a) to (c)
Repeal the paragraphs, substitute:
(a) whether at least one of the following persons:
(i) the applicant;
(ii) a person (a manager ) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the applicant's affairs;
(iii) if the applicant is a body corporate--a major interest holder of the body corporate;
has, within the 10 years immediately before the application:
(iv) been convicted of an offence against this Act or a corresponding State law; or
(v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(viii) breached a condition of a conformity assessment certificate; or
(ix) had a conformity assessment certificate suspended or revoked; or
(x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies in that 10 year period, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or
(b) whether any other circumstances prescribed by the regulations for the purposes of this paragraph exist.
14 Subsection 41EC(4)
Repeal the subsection, substitute:
(4) A reference in paragraph (3)(a) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:
(a) section 19B of the Crimes Act 1914 ; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.
(5) Paragraph (3)(a) does not limit paragraph (3)(b).
15 Paragraph 41EG(c)
Omit "relating to a kind of medical device to which the application relates".
16 After subsection 41EJ(5)
Insert:
Conditions in regulations
(5A) A conformity assessment certificate is subject to any conditions prescribed by the regulations for the purposes of this subsection.
17 Paragraph 41ET(1)(c)
Repeal the paragraph, substitute:
(c) the Secretary gives to the person a notice under section 41JA that requires the person to give to the Secretary information or documents and the person fails to comply with that notice within a further 10 working days from the day specified in that notice; or
18 Paragraphs 41ET(1)(e) to (g)
Repeal the paragraphs, substitute:
(e) at least one of the following persons:
(i) the person (the holder ) in relation to whom the certificate is issued;
(ii) a person (a manager ) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the holder's affairs;
(iii) if the holder is a body corporate--a major interest holder of the body corporate;
has:
(iv) been convicted of an offence against this Act or a corresponding State law; or
(v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(viii) breached a condition of a conformity assessment certificate; or
(ix) had a conformity assessment certificate suspended or revoked; or
(x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or
(f) any other circumstances prescribed by the regulations for the purposes of this paragraph exist.
19 Subsection 41ET(1A)
Repeal the subsection, substitute:
(1A) A reference in paragraph (1)(e) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:
(a) section 19B of the Crimes Act 1914 ; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.
(1B) Paragraph (1)(e) does not limit paragraph (1)(f).
20 At the end of section 41ET
Add:
(4) Nothing in this section affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).
21 After subsection 41JA(1)
Insert:
(1A) The Secretary may, by written notice given to a person who is an applicant for a conformity assessment certificate, require the person to give to the Secretary such further information concerning the application as is specified in the notice.
(1B) Requirements under subsections (1) and (1A) may be included in the same notice.
(1C) The Secretary may, by written notice given to a person who holds a conformity assessment certificate, require the person to give to the Secretary specified information to be used by the Secretary in deciding whether to suspend the certificate under section 41EM, or to revoke the certificate under section 41ET, in relation to the circumstances referred to in paragraph 41ET(1)(e).
(1D) Requirements under subsections (1) and (1C) may be included in the same notice.
22 At the end of section 41JA
Add:
(3) Nothing in this section affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).
23 Application and transitional
(1) The amendments of section 38 of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to applications for licences made on or after the commencement of this item.
(2) The amendments of sections 40 and 41 of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to licences granted before, on or after the commencement of this item.
(3) The amendments of section 41EC of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to applications for conformity assessment certificates made on or after the commencement of this item.
(4) The amendment of section 41EG of the Therapeutic Goods Act 1989 made by this Schedule applies in relation to notices given on or after the commencement of this item.
(5) The amendment of section 41EJ of the Therapeutic Goods Act 1989 made by this Schedule applies in relation to conformity assessment certificates issued before, on or after the commencement of this item.
(6) The amendments of section 41ET of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to conformity assessment certificates issued before, on or after the commencement of this item.
(7) Paragraph 41ET(1)(c) 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 a notice given before that commencement.
(8) Subsection 41JA(1A) of the Therapeutic Goods Act 1989 applies in relation to applications for conformity assessment certificates made on or after the commencement of this item.
(9) Subsection 41JA(1C) of the Therapeutic Goods Act 1989 applies in relation to conformity assessment certificates issued before, on or after the commencement of this item.