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Therapeutic Goods Amendment Bill (No. 1) 2003

Part 3 Other amendments

20  Subsection 3(1) (at the end of paragraph (b) of the definition of authorised person )

Add “, or a Customs officer exercising powers in a Customs place (within the meaning of section 183UA of the Customs Act 1901 )”.

21  Subsection 3(1)

Insert:

Customs officer means an officer of Customs within the meaning of the Customs Act 1901 .

22  Subsection 3(5)

After “proper use”, insert “or identification”.

23  Subsection 14(1) (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

24  Subsection 14(3) (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

25  Subsection 20(1AA)

Omit “a fine not more than 240 penalty units”, substitute “imprisonment for 12 months or a fine not more than 1,000 penalty units, or both”.

26  After subsection 20(1A)

Insert:

          (1B)  A person is guilty of an offence if:

                     (a)  the person is the sponsor of therapeutic goods for use in humans; and

                     (b)  the person:

                              (i)  imports the goods into Australia; or

                             (ii)  exports the goods from Australia; or

                            (iii)  manufactures the goods in Australia; or

                            (iv)  supplies the goods in Australia; and

                     (c)  the person has not, at the time of the importation, export, manufacture or supply, properly notified to the Secretary either or both of the following:

                              (i)  the manufacturer of the goods;

                             (ii)  premises used in the manufacture of the goods.

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

          (1C)  For the purposes of paragraph (1B)(c):

                     (a)  a manufacturer is properly notified to the Secretary if:

                              (i)  the manufacturer was nominated, as a manufacturer of the goods, in an application for the registration or listing of the goods; or

                             (ii)  the Secretary was subsequently informed in writing that the manufacturer is a manufacturer of the goods; and

                     (b)  premises are properly notified to the Secretary if:

                              (i)  the premises were nominated, as premises used in the manufacture of the goods, in an application for the registration or listing of the goods; or

                             (ii)  the Secretary was subsequently informed in writing that the premises are used in the manufacture of the goods.

27  Subsection 22(2A) (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

28  Section 22A (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

29  After paragraph 25(1)(j)

Insert:

                     (ja)  whether all of the manufacturers of the goods are nominated as manufacturers of the goods in the application; and

30  At the end of subsection 26(1)

Add:

               ; or (n)  one or more of the manufacturers of the goods are not nominated as manufacturers of the goods in the application.

31  After paragraph 26A(1)(d)

Insert:

             ; and (e)  the medicine is not one that has previously had its registration or listing cancelled;

32  At the end of subsection 28(5)

Add:

             ; and (c)  in relation to each batch of the goods—keep a record, at least until the end of the period of 12 months after the expiry date for the goods, of all of the manufacturers involved in the manufacture of that batch; and

                     (d)  if requested to do so by an authorised person, make any such record available to the authorised person for inspection:

                              (i)  at or before the time the authorised person requests, or (if the authorised person requests) immediately; and

                             (ii)  either in electronic form or in paper form, as the authorised person requests; and

                     (e)  comply, in relation to the goods, with any reporting requirements that are prescribed; and

                      (f)  if a manufacturer who was not nominated as a manufacturer of the goods in the application for the registration or listing of the goods becomes a manufacturer of the goods—inform the Secretary in writing of that fact, no later than 10 working days after the manufacturer becomes a manufacturer of the goods; and

                     (g)  if premises that were not nominated as premises to be used in the manufacture of the goods in the application become premises used in the manufacture of the goods—inform the Secretary in writing of that fact, no later than 10 working days after the premises are first used for that purpose.

33  Subsection 29A(1)

After “registered”, insert “or listed”.

34  Paragraph 29A(2)(c)

After “registration”, insert “or listing”.

35  At the end of subsection 29A(2)

Add:

                   ; (d)  information that indicates that the quality, safety or efficacy of the goods is unacceptable.

36  Subsection 29B(1)

After “registration”, insert “or listing”.

37  After paragraph 30(1)(d)

Insert:

                    (da)  the person has refused or failed to comply with the condition to which the inclusion of the goods is subject under paragraph 28(5)(d):

                              (i)  if the person was requested under that paragraph to make the record in question available at or before a requested time—before the end of the period of 24 hours after that time; or

                             (ii)  if the person was requested under that paragraph to make the record in question available immediately—within 24 hours after the request was made; or

38  Paragraph 30(2)(c)

After “subject”, insert “(other than the condition under paragraph 28(5)(d))”.

39  Subsections 30(6) and (7)

Repeal the subsections.

40  Sections 30A and 30B

Repeal the sections.

41  Saving provisions

(1)        The repeal of subsections 30(6) and (7) of the Therapeutic Goods Act 1989 does not affect the application, after the commencement of this item, of paragraph 30(6)(b) and subsection 30(7) of that Act in relation to a requirement imposed under paragraph 30(6)(a) of that Act before that commencement.

(2)        The repeal of section 30A of the Therapeutic Goods Act 1989 does not affect the application, after the commencement of this item, of subsections 30A(3) and (4) of that Act in relation to a requirement imposed under subsection 30A(2) of that Act before that commencement.

(3)        The repeal of section 30B of the Therapeutic Goods Act 1989 does not affect the application, after the commencement of this item, of subsections 30B(3), (4) and (5) of that Act in relation to a requirement imposed under subsection 30B(2) of that Act before that commencement.

42  After Division 2 of Part 3-2

Insert:

Division 2A Public notification and recovery of therapeutic goods

30EA   Public notification and recovery of therapeutic goods

             (1)  The Secretary may, in writing, impose requirements, relating to therapeutic goods, on a person if:

                     (a)  any of the circumstances referred to in the second column of an item in the following table occur in relation to the goods; and

                     (b)  the person is referred to in the third column of that item.

 

Circumstances in which requirements may be imposed

Item

Circumstance relating to therapeutic goods

Person subject to requirements

1.

The goods are supplied while they are registered goods or listed goods, but they do not conform with a standard applicable to the goods

The person in relation to whom the goods are included in the Register

2.

The goods are supplied while they are registered goods or listed goods, but the manufacturing principles have not been observed in the manufacture of the goods

The person in relation to whom the goods are included in the Register

3.

The goods are supplied while:

(a) they are exempt goods; or

(b) they are exempt under section 18A; or

(c) they are the subject of an approval or authority under section 19; or

(d) they are the subject of an approval under section 19A;

but they do not conform with a standard applicable to the goods

The person supplying the goods

4.

The goods are supplied while:

(a) they are exempt goods; or

(b) they are exempt under section 18A; or

(c) they are the subject of an approval or authority under section 19; or

(d) they are the subject of an approval under section 19A;

but the manufacturing principles have not been observed in the manufacture of the goods

The person supplying the goods

5.

The goods are supplied in contravention of subsection 20(1) or 42E(1)

The person supplying the goods

6.

The goods are supplied while they are registered goods or listed goods, but one or more steps in the manufacture of the goods has been carried out by a manufacturer while the manufacturer did not hold a licence that was in force

The person in relation to whom the goods are included in the Register

7.

The registration or listing of the goods has been cancelled under this Part

The person in relation to whom the goods were included in the Register

             (2)  The requirements may be one or more of the following:

                     (a)  to take specified steps, in the specified manner and within such reasonable period as is specified, to recover therapeutic goods that have been distributed;

                     (b)  to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, to the effect that the circumstances referred to in paragraph (1)(a) have occurred in relation to therapeutic goods;

                     (c)  to publish, in the specified manner and within such reasonable period as is specified, specified information, or information of a specified kind, relating to the manufacture or distribution of therapeutic goods.

             (3)  If the circumstances referred to in paragraph (1)(a) apply only to a batch of therapeutic goods, the Secretary may limit the imposition of the requirements to the therapeutic goods included in that batch.

             (4)  A requirement to recover therapeutic goods under this section does not apply to therapeutic goods that cannot be recovered because they have been administered to, or applied in the treatment of, a person.

30EB   Publication of requirements

                   The Secretary must cause to be published in the Gazette , as soon as practicable after imposing a requirement under section 30EA, a notice setting out particulars of the requirement.

30EC   Non-compliance with requirements

                   A person is guilty of an offence if:

                     (a)  the person does an act, or omits to do an act; and

                     (b)  the act or omission constitutes a contravention of a requirement imposed on the person under section 30EA.

Maximum penalty:    60 penalty units.

30ED   Power of cancellation unaffected

                   Imposition of a requirement under section 30EA does not affect the Secretary’s power to cancel the registration or listing of therapeutic goods under this Part.

43  Subsection 35(1) (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

44  Subsection 35(2) (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

45  Subsection 35(4) (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

46  Paragraph 38(1)(d)

Omit “person”, substitute “applicant”.

47  Subsection 38(1)

Omit all the words after “Secretary must grant”, substitute:

the applicant a licence to carry out those steps at those premises unless the Secretary is satisfied that:

                     (e)  the applicant will be unable to comply with the manufacturing principles; or

                      (f)  the premises are not satisfactory for the manufacture of the goods; or

                     (g)  the applicant is not a fit and proper person to hold a licence; or

                     (h)  a person who is participating in, or is likely to participate in, managing the applicant’s affairs is not a fit and proper person to participate in the management of the affairs of a holder of a licence; or

                      (i)  a person who has, or is likely to have, effective control over the applicant is not a fit and proper person to have effective control over a holder of a licence.

48  After subsection 38(1)

Insert:

          (1A)  Without limiting the matters to which the Secretary may have regard in considering whether the applicant or person is not a fit and proper person for the purposes of paragraph (1)(g), (h) or (i), the Secretary must have regard to:

                     (a)  any suspension or revocation of a manufacturing licence granted to:

                              (i)  the applicant or person; or

                             (ii)  another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); or

                            (iii)  another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time of the suspension or revocation; or

                     (b)  any conviction, for an offence against a law of the Commonwealth or a law of a State or Territory, against:

                              (i)  the applicant or person; or

                             (ii)  another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); or

                            (iii)  another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time the offence was committed or the time of the conviction; or

                     (c)  any failure to comply with a condition of a manufacturing licence by:

                              (i)  the applicant or person; or

                             (ii)  another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); or

                            (iii)  another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time of the failure.

          (1B)  In subsection (1A):

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.

49  Subsection 38(2)

Omit “paragraph (1)(f)”, substitute “paragraphs (1)(g), (h) and (i)”.

50  Subsection 38(2)

Omit “a person”, substitute “an applicant”.

51  Subsection 38(2)

Omit “that paragraph”, substitute “one or more of those paragraphs”.

52  Subsection 38(3)

Omit “a person”, substitute “an applicant”.

53  Paragraph 38(3)(a)

Omit “person”, substitute “applicant”.

54  Subsection 40(1)

Repeal the subsection, substitute:

             (1)  A licence may be granted subject to such conditions relating to the manufacture of the goods as the Secretary thinks appropriate.

55  Saving provision

The repeal and substitution of subsection 40(1) of the Therapeutic Goods Act 1989 does not affect the application, after the commencement of this item, of any condition that:

                     (a)  was imposed on a licence under that subsection; and

                     (b)  was in force immediately before that commencement.

56  Paragraph 40(4)(a)

Repeal the paragraph, substitute:

                     (a)  ensure that:

                              (i)  the goods conform to any standard applicable to the goods; and

                             (ii)  the holder of the licence observes the manufacturing principles in carrying out any steps in the manufacture of the goods under the licence; and

57  After paragraph 40(4)(aa)

Insert:

                    (ab)  as soon as the holder of the licence becomes aware of information of a kind mentioned in subsection (5), give the information to the Secretary in writing; and

58  Subparagraph 40(4)(b)(ii)

Omit “, with the agreement of the holder,”.

59  At the end of section 40

Add:

             (5)  The information with which paragraph (4)(ab) is concerned is information of the following kinds:

                     (a)  information that indicates that the use of the goods in accordance with the recommendations for their use may have an unintended harmful effect;

                     (b)  information that indicates that the goods, when used in accordance with the recommendations for their use, may not be as effective as was suggested by:

                              (i)  the application for registration or listing of the goods; or

                             (ii)  information already furnished by the holder of the licence under this Act; or

                            (iii)  if the holder of the licence is not the sponsor of the goods—information already furnished by the sponsor of the goods under this Act;

                     (c)  information that indicates that the quality, safety or efficacy of the goods is unacceptable.

60  Application provision

Subsection 40(4) of the Therapeutic Goods Act 1989 as amended by this Act, and subsection 40(5) of that Act, apply to any licence in force after the commencement of this item, whether or not the licence was granted after that commencement.

61  Paragraphs 41(1)(aa) and (ab)

Omit “a body corporate”, substitute “another person”.

62  Paragraph 41(1)(ab)

Omit “the body” (wherever occurring), substitute “the other person”.

63  Paragraph 41(1)(c)

Repeal the paragraph, substitute:

                     (c)  the holder is controlled by another person (whether directly, or indirectly through one or more interposed entities) and that other person has breached a condition of a licence; or

                    (ca)  the holder controls another person (whether directly, or indirectly through one or more interposed entities) and that other person has, while controlled by the holder, breached a condition of a licence; or

                    (cb)  the holder is not a fit and proper person to hold a licence; or

                    (cc)  a person who is participating in managing the holder’s affairs is not a fit and proper person to participate in the management of the affairs of a holder of a licence; or

                    (cd)  a person who has effective control over the holder is not a fit and proper person to have effective control over a holder of a licence; or

64  After subsection 41(1)

Insert:

          (1A)  Without limiting the matters to which the Secretary may have regard in considering whether the holder or another person is not a fit and proper person for the purposes of paragraph (1)(cb), (cc) or (cd), the Secretary must have regard to the matters set out in paragraphs 38(1A)(a), (b) and (c).

65  At the end of section 41EC

Add:

             (3)  In deciding whether to issue the certificate, the Secretary must also consider:

                     (a)  whether the applicant is a fit and proper person to hold a conformity assessment certificate; and

                     (b)  whether the persons who participate in, or who are likely to participate in, managing the applicant’s affairs are fit and proper persons to participate in managing the affairs of a manufacturer in respect of whom a conformity assessment certificate is issued; and

                     (c)  whether the persons who have, or are likely to have, effective control over the applicant are fit and proper persons to have effective control over a manufacturer in respect of whom a conformity assessment certificate is issued.

             (4)  Without limiting the matters to which the Secretary may have regard in considering whether the applicant or person is a fit and proper person for the purposes of paragraph (3)(a), (b) or (c), the Secretary must have regard to:

                     (a)  any suspension or revocation of a conformity assessment certificate issued to:

                              (i)  the applicant or person; or

                             (ii)  another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); or

                            (iii)  another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time of the suspension or revocation; or

                     (b)  any conviction, for an offence against a law of the Commonwealth or a law of a State or Territory, against:

                              (i)  the applicant or person; or

                             (ii)  another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); or

                            (iii)  another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time the offence was committed or the time of the conviction; or

                     (c)  any failure to comply with a condition of a conformity assessment certificate by:

                              (i)  the applicant or person; or

                             (ii)  another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); or

                            (iii)  another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time of the failure.

66  At the end of subsection 41ET(1)

Add:

               ; or (e)  the manufacturer is not a fit and proper person to be a manufacturer in respect of whom a conformity assessment certificate is issued; or

                      (f)  a person who is participating in managing the manufacturer’s affairs is not a fit and proper person to participate in managing the affairs of a manufacturer in respect of whom a conformity assessment certificate is issued; or

                     (g)  a person who has effective control over the manufacturer is not a fit and proper person to have effective control over a manufacturer in respect of whom a conformity assessment certificate is issued.

67  After subsection 41ET(1)

Insert:

          (1A)  Without limiting the matters to which the Secretary may have regard in considering whether the holder or another person is not a fit and proper person for the purposes of paragraph (1)(e), (f) or (g), the Secretary must have regard to the matters set out in paragraphs 41EC(4)(a), (b) and (c).

68  Section 41FE (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

69  Subsection 41MA(1) (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

70  Subsection 41MA(2) (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

71  Subsection 41MA(3) (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

72  Subsection 41ME(1) (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

73  Subsection 41ME(2) (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

74  Subsection 41MF(1) (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

75  Subsection 41MF(2) (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

76  Section 41MH (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

77  Subsection 41MI(1) (penalty)

Repeal the penalty, substitute:

Maximum penalty:    Imprisonment for 12 months or 1,000 penalty units, or both.

78  Subsection 42E(4)

Omit “500 penalty units”, substitute “2,000 penalty units”.

79  Subsection 54AA(1)

After “whichever of n or (3) applies”, insert “whichever of subsection (2) or (3) applies”.

80  After section 54AA

Insert:

54AB   Damage etc. to documents

             (1)  A person is guilty of an offence if:

                     (a)  the person damages, destroys, alters, conceals or falsifies a document; and

                     (b)  the document is created, retained or issued for the purposes of this Act, or for purposes that include the purposes of this Act.

Maximum penalty:    Imprisonment for 5 years or 2,000 penalty units, or both.

             (2)  Strict liability applies to paragraph (1)(b).

Note:          For strict liability, see section 6.1 of the Criminal Code .



 

Schedule 2 Amendment of the Broadcasting Services Act 1992

   

1  Clause 1 of Schedule 2 (definition of medicine )

Repeal the definition.

2  Subclauses 6(2) to (8) of Schedule 2

Repeal the subclauses, substitute:

             (2)  A broadcaster must not broadcast an advertisement relating to therapeutic goods that is required to be approved under the Therapeutic Goods Act 1989 unless the text of the advertisement has been so approved.

3  Saving and transitional provisions

(1)        If, before the date of commencement of items 1 and 2 of this Schedule:

                     (a)  a person has applied, under clause 6 of Schedule 2 to the Broadcasting Services Act 1992 , to the Secretary (the Health Secretary ) of the Department whose Minister (the Health Minister ) is responsible for the administration of the Therapeutic Goods Act 1989 for approval of an advertisement proposed for broadcasting; and

                     (b)  a decision has not been made by the Health Secretary before that date;

that application is to be treated, on and after that date, for all purposes as if it were an application for approval under the Therapeutic Goods Regulations 1990 .

(2)        If, before the date of commencement of items 1 and 2 of this Schedule:

                     (a)  the Health Secretary has made a decision in relation to an application, under clause 6 of Schedule 2 to the Broadcasting Services Act 1992 , for approval of an advertisement proposed for broadcasting; and

                     (b)  an appeal from that decision has not been made to the Minister responsible for the administration of the Broadcasting Services Act 1992 ;

the person who sought that approval has the same right to appeal to the Health Minister under the Therapeutic Goods Regulations 1990 , on and after that date, as if that decision had been made under those regulations.

(3)        If, before the date of commencement of items 1 and 2 of this Schedule:

                     (a)  the Health Secretary has made a decision in relation to an application, under clause 6 of Schedule 2 to the Broadcasting Services Act 1992 , for approval of an advertisement proposed for broadcasting; and

                     (b)  an appeal from that decision has been made to the Minister responsible for the administration of the Broadcasting Services Act 1992 ; and

                     (c)  the appeal has not been finally determined before that date;

that appeal is to continue to be dealt with under the Broadcasting Services Act 1992 , on and after that date, as if the amendments made by items 1 and 2 had not been made.

 

 

 

 

[ Minister’s second reading speech made in—

House of Representatives on 27 June 2002

Senate on 15 May 2003 ]

 

(143/02)