Commonwealth Numbered Acts Commonwealth Numbered Acts
1 Subsection 3(1) (definition of manufacturing premises )
Repeal the definition.
2 Subsection 3(1)
Insert:
"manufacturing site" means premises:
(a) that are for use in the manufacture of a particular kind of therapeutic goods; and
(b) at which the same persons have control of the management of the production of the goods and the procedures for quality control.
3 Subsection 3(1)
Insert:
"manufacturing site authorisation" means an authorisation referred to in subsection 38(2B) or 40B(4).
4 Paragraph 37(1)(c)
Omit "identify the manufacturing premises", substitute "in accordance with subsections (1A) and (1B), identify one or more manufacturing sites".
5 After subsection 37(1)
Insert:
Manufacturing sites
(1A) Subject to subsection (1B), an application under subsection (1) must relate to one manufacturing site only. This does not prevent other applications from relating to other manufacturing sites.
(1B) If an applicant is of the view that, having regard to the guidelines under section 38A, a licence could be granted covering 2 or more manufacturing sites, the applicant may:
(a) identify those sites in the application; and
(b) state the applicant's reasons for the applicant's view.
6 Paragraph 37(2)(b)
Omit "the premises,", substitute "each manufacturing site identified in the application and the".
Note: The following heading to subsection 37(2) is inserted " Further information ".
7 Paragraph 37(2)(b)
Omit "on those premises", substitute "at that site".
Note: The following heading to subsection 37(3) is inserted " Applications or information may be given electronically ".
8 Paragraph 38(1)(a)
Omit "particular manufacturing premises", substitute "one or more manufacturing sites".
9 Subsection 38(1)
Omit "to carry out those steps at those premises", substitute "covering one or more manufacturing sites specified in the licence".
10 Paragraph 38(1)(f)
Omit "the premises", substitute "one or more of the manufacturing sites identified in the application".
Note 1: The following heading to subsection 38(1A) is inserted " Interpretation ".
Note 2: The following heading to subsection 38(2) is inserted " Special circumstances justifying grant of licence ".
11 After subsection 38(2)
Insert:
Guidelines
(2A) The Secretary must have regard to the guidelines under section 38A in granting licences under this section.
What the licence authorises
(2B) For each manufacturing site covered by a licence, the Secretary must authorise, in the licence, the holder of the licence to carry out specified steps in the manufacture of specified therapeutic goods at that manufacturing site.
Note 1: For specification by class, see subsection 46(3) of the Acts Interpretation Act 1901 .
Note 2: Sections 40A and 40B deal with variation of authorisations.
Note 1: The following heading to subsection 38(3) is inserted " Notice of decision ".
Note 2: The following heading to subsection 38(4) is inserted " Publication in Gazette ".
12 After section 38
Insert:
38A Guidelines for multi‑site licences
The Secretary must, by legislative instrument, make guidelines setting out the circumstances in which a licence may cover 2 or more manufacturing sites.
38B Splitting multi‑site licences
(1) This section applies if a licence (the old licence ):
(a) either:
(i) was in force under this Part immediately before the commencement of this section; or
(ii) was suspended under this Part immediately before that commencement; and
(b) related to premises that comprise 2 or more sites (the old sites ).
(2) As soon as practicable after the commencement of this section, the Secretary must:
(a) by writing, revoke the old licence; and
(b) on the day that the Secretary revokes the old licence, grant new licences (each of which is a new licence ) to the holder of the old licence which, when considered together, cover the old sites.
The Secretary must give the holder written notice of the revocation and grant.
Note: Subsections (5) and (6) deal with when each new licence commences and when the old licence ends.
Guidelines
(3) The Secretary must have regard to the guidelines under section 38A in granting licences under this section.
Application of this Part
(4) Subject to this section, subsections 38(2B) and (4) and sections 39 to 41A apply to a new licence in the same way as they apply to a licence granted under section 38.
Note: This means, for example, that:
(a) the Secretary must give a manufacturing site authorisation under subsection 38(2B) in relation to each manufacturing site covered by a new licence; and
(b) the Secretary may impose conditions on a new licence under subsection 40(1) and the statutory conditions under subsection 40(4) will apply to a new licence; and
(c) the Secretary may revoke or suspend a new licence under section 41.
Commencement of new licence
(5) The day specified under subsection 39(1) for the commencement of each new licence granted to the holder of the old licence must be the day (the transition day ) after the day each new licence is granted.
Note: Subsection (7) deals with suspending a new licence from the transition day.
When revocation of old licence takes effect
(6) The revocation of the holder's old licence takes effect immediately before the start of the transition day.
Suspension of new licence
(7) If:
(a) subparagraph (1)(a)(ii) applies in relation to an old licence; and
(b) the period of suspension of the old licence is due to end at the end of a day (the relevant day ) after the transition day;
the Secretary may, on the day that the Secretary grants a new licence to the holder of the old licence and by notice in writing given to the holder, suspend the new licence for a period starting on the transition day and ending at the end of the relevant day.
(8) Subsection 41(2) does not apply in relation to a suspension under subsection (7) of this section. However, subsections 41(4) to (6) do apply in relation to the suspension.
(9) To avoid doubt, subsection (7) does not prevent subsection 41(1) from applying in relation to a new licence.
Licence charges
(10) Subsection 4(2) of the Therapeutic Goods (Charges) Act 1989 does not apply in relation to a new licence for the financial year in which the new licence is granted.
No review of revocation of old licence
(11) The revocation of the old licence is taken not to be an initial decision for the purposes of section 60.
13 Subparagraph 40(4)(b)(i)
Omit "the manufacturing premises to which the licence relates", substitute "each manufacturing site covered by the licence".
14 Subparagraph 40(4)(b)(ii)
Repeal the subparagraph, substitute:
(ii) while at such a site, to inspect the site, any therapeutic goods at the site and the processes relating to the manufacture of therapeutic goods at the site and to examine, take measurements of, conduct tests on or take samples of any therapeutic goods at the site or any thing at the site that relates to any therapeutic goods; and
(iii) while at such a site, to make any still or moving image or any recording of that site or those goods or processes; and
15 Paragraph 40(4)(c)
Omit "enters premises", substitute "enters a site".
16 Paragraph 40(4)(c)
Omit "those premises", substitute "that site".
17 Paragraph 40(4)(c)
Omit "the premises", substitute "that site".
18 Subparagraph 40(4)(d)(i)
Omit "those premises", substitute "that site".
19 After section 40
Insert:
40A Variation of manufacturing site authorisations--Secretary's own initiative
(1) The Secretary may, on his or her own initiative and by notice in writing given to the holder of a licence, vary a manufacturing site authorisation in relation to the licence.
(2) A variation under subsection (1) takes effect:
(a) if the notice states that the variation is necessary to prevent imminent risk of death, serious illness or serious injury--on the day on which the notice is given to the holder; or
(b) in any other case--on the day specified in the notice (which must not be earlier than 28 days after the notice is given to the holder).
40B Variation of licences--application by licence holder
Addition of manufacturing sites
(1) If the holder of a licence is of the view that, having regard to the guidelines under section 38A, the licence could cover one or more additional manufacturing sites, the holder may apply to the Secretary for a variation of the licence so that it covers one or more additional manufacturing sites specified in the application.
(2) An application under subsection (1) must:
(a) be made in accordance with a form approved by the Secretary; and
(b) identify the therapeutic goods or classes of therapeutic goods that the holder proposes to manufacture at each additional manufacturing site specified in the application; and
(c) identify the steps in the manufacture of those goods that the holder proposes to carry out under the licence; and
(d) if the holder proposes to carry out steps in the manufacture of blood or blood components under the licence--contain information relating to those steps set out in regulations made for the purposes of paragraph 37(1)(da); and
(e) state the names, qualifications and experience of the persons who are to have control of the manufacture of the goods and of the quality control measures that are to be employed; and
(f) be delivered to an office of the Department specified in the form; and
(g) be accompanied by the prescribed application fee.
(3) If an application is made under subsection (1) and any applicable prescribed inspection fees have been paid, the Secretary may, by notice in writing given to the holder of the licence, vary the licence so that the licence covers each additional manufacturing site specified in the notice.
(4) For each manufacturing site specified under subsection (3), the Secretary must, in the notice under that subsection, vary the licence to authorise the holder of the licence to carry out specified steps in the manufacture of specified therapeutic goods at that manufacturing site.
Note 1: For specification by class, see subsection 46(3) of the Acts Interpretation Act 1901 .
Note 2: Section 40A and subsections (6) to (9) of this section deal with variation of authorisations.
(5) A variation under subsection (3) or (4) takes effect on the day on which the notice is given to the holder.
Variation of manufacturing site authorisations
(6) The holder of a licence may apply to the Secretary for a variation of a manufacturing site authorisation in relation to the licence.
(7) An application under subsection (6) must:
(a) be made in accordance with a form approved by the Secretary; and
(b) set out the variation sought; and
(c) be delivered to an office of the Department specified in the form; and
(d) be accompanied by the prescribed application fee.
(8) If an application is made under subsection (6) and any applicable prescribed inspection fees have been paid, the Secretary may, by notice in writing given to the holder of the licence, vary the manufacturing site authorisation.
(9) A variation under subsection (8) takes effect on the day on which the notice is given to the holder.
Further information
(10) The Secretary may, by notice in writing given to the holder of a licence who has made an application under subsection (1) or (6), require the holder:
(a) to give to the Secretary, within such reasonable time as is specified in the notice, such further information concerning the application as is specified in the notice; or
(b) to allow an authorised person, at any reasonable time specified in the notice, to inspect each manufacturing site identified in the application and the equipment, processes and facilities that will be used in the manufacture of therapeutic goods at that site.
Applications or information may be given electronically
(11) An approval of a form mentioned in paragraph (2)(a) or (7)(a), or a notice mentioned in subsection (10), 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.
20 After paragraph 41(1)(e)
Insert:
(ea) the holder contravenes a manufacturing site authorisation in relation to the licence; or
21 Before section 41A
Insert:
(1) The regulations may make provision for and in relation to the transfer of licences.
(2) Regulations made for the purposes of subsection (1) may make provision for and in relation to:
(a) the making of an application for the transfer of a licence; and
(b) the payment of a fee in respect of an application; and
(c) the assessment of an application; and
(d) the conditions of a licence upon the transfer of the licence; and
(e) the review of decisions made under the regulations.
(3) Subsection (2) does not limit subsection (1).
22 Section 41A
Omit "premises", substitute "sites".
23 Paragraph 58(3)(b)
Omit "manufacturing premises", substitute "a manufacturing site".
24 Paragraph 58(3)(b)
Omit "those premises", substitute "that site".
25 Application and transitional--amendments made by this Schedule
(1) The amendments made by items 4 to 7 apply in relation to applications for licences made on or after the commencement of those items.
(2) The amendments made by items 8 to 11 apply in relation to applications for licences:
(a) made on or after the commencement of those items; and
(b) made before the commencement of those items that have not been decided by the Secretary before that commencement.
(3) In relation to an application covered by paragraph (2)(b) of this item, paragraph 38(1)(a) of the Therapeutic Goods Act 1989 applies on and after the commencement of this item as if the application was in respect of the one or more manufacturing sites constituted by the manufacturing premises the subject of the application.
(4) The amendments made by items 13 to 22 apply in relation to licences granted before, on or after the commencement of those items.
26 Transitional--existing licences
(1) This item applies to a licence that:
(a) was in force under Part 3‑3 of the Therapeutic Goods Act 1989 immediately before the commencement of this item; or
(b) was suspended under that Part immediately before that commencement.
(2) The Therapeutic Goods Act 1989 applies in relation to the licence on and after that commencement as if the licence covered the one or more manufacturing sites constituted by the manufacturing premises to which the licence related immediately before that commencement.
(3) Subitem (2) is subject to section 38B of the Therapeutic Goods Act 1989 (about splitting multi‑site licences).
(4) If section 38B of the Therapeutic Goods Act 1989 does not apply in relation to the licence, that Act applies in relation to the licence on and after the commencement of this item as if:
(a) the licence authorised the holder of the licence, at the manufacturing site constituted by the manufacturing premises to which the licence related immediately before that commencement, to carry out the steps in the manufacture of therapeutic goods that the licence allowed the holder to carry out immediately before that commencement; and
(b) that authorisation were an authorisation referred to in subsection 38(2B) of that Act.
(5) Subitem (4) does not prevent the variation of that authorisation under section 40A or 40B of the Therapeutic Goods Act 1989 .
Note: A contravention of that authorisation may lead to the licence being revoked or suspended: see paragraph 41(1)(ea) of the Therapeutic Goods Act 1989 .