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Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010

Schedule 2 Other amendments

Part 1 Amendments commencing on the 28th day after Royal Assent

Therapeutic Goods Act 1989

1A  Paragraph 9D(2)(a)

Omit “product”.

1B  After subsection 9D(2)

Insert:

          (2A)  Subsection (2), to the extent to which it relates to subparagraph (2)(b)(i), applies despite subsection 16(1).

1C  Before subsection 9D(4)

Insert:

          (3C)  If:

                     (a)  the person in relation to whom a kind of medical device is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the kind of medical device; and

                     (b)  the only effect of the variation would be:

                              (i)  to reduce the class of persons for whom the kind of medical device is suitable; or

                             (ii)  to add a warning, restriction or precaution, that does not include any comparison of the kind of medical device with any other therapeutic goods by reference to quality, safety or performance;

the Secretary must vary the entry in accordance with the request.

          (3D)  If:

                     (a)  the person in relation to whom a kind of medical device is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the kind of medical device; and

                     (b)  subsection (3C) does not apply to the request; and

                     (c)  the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or performance of the kind of medical device for the purposes for which it is to be used;

the Secretary may vary the entry in accordance with the request.

1D  At the end of section 9D

Add:

Approved forms for requests

             (6)  The Secretary may, by writing, approve a form for particular kinds of requests under this section.

             (7)  If the Secretary has approved a form for a particular kind of request under this section, then any request of that kind must be in accordance with that form.

Fees

             (8)  A request under this section must be accompanied by any prescribed application fee or prescribed evaluation fee or both.

1E  Subsection 25(1)

Omit all the words from and including “Where:” to and including “having regard to:”, substitute “If an application is made for the registration of therapeutic goods in relation to a person in accordance with section 23, the Secretary must evaluate the goods for registration having regard to:”.

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 requirements in relation to ingredients being contained in the medicine—none of the requirements 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—requirements 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 requirements specified in the determination in relation to ingredients being contained in the medicine have been contravened.

Requirements

             (2)  The requirements referred to in paragraph (1)(b) may relate to particular ingredients not being contained in particular medicine.

             (3)  The requirements 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.

Limitations on determination under subsection (1)

             (6)  The Minister may, by legislative instrument, make a determination specifying either or both of the following:

                     (a)  ingredients that must not be specified under paragraph (1)(a);

                     (b)  requirements that must not be specified under paragraph (1)(b) in relation to ingredients being contained in medicine.

             (7)  A determination under paragraph (6)(b) may make different provision for different classes of medicine.

Incorporation of instruments

             (8)  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 ”.

4A  After subsection 26BD(3)

Insert:

          (3A)  In deciding whether to vary the determination, the Minister must have regard to the quality and safety of the ingredients concerned. This subsection does not limit the matters to which the Minister may have regard to in deciding whether to vary the determination.

5  Section 26BE

Repeal the section.

6  Paragraph 30(1)(e)

Omit “(cc), (cd),”.

6A  After subsection 31(1A)

Insert:

          (1B)  If:

                     (a)  a person makes an application under section 23 for the registration of therapeutic goods in accordance with a form referred to in paragraph 23(1)(a); and

                     (b)  the form is described as a pre-submission form; and

                     (c)  the person chooses a number of days specified in the form for the purposes of giving information or documents to the Secretary in the event that the person is given a notice under subsection (1) of this section in relation to the application;

then that number of days must be specified in any such notice as the time within which the person must give the required information or documents to the Secretary. The number of days so specified is taken to be a reasonable time for the purposes of subsection (1).

          (1C)  If:

                     (a)  the person in relation to whom therapeutic goods are registered makes a request under subsection 9D(3) in accordance with a form referred to in subsection 9D(6); and

                     (b)  the form is described as a pre-submission form; and

                     (c)  the person chooses a number of days specified in the form for the purposes of giving information or documents to the Secretary in the event that the person is given a notice under subsection (1) of this section in relation to the request;

then that number of days must be specified in any such notice as the time within which the person must give the required information or documents to the Secretary. The number of days so specified is taken to be a reasonable time for the purposes of subsection (1).

7  Application

(1)       The amendments made by items 1A to 1D apply in relation to requests made on or after the commencement of those items.

(2)       The amendment made by item 1E applies in relation to applications for registration made on or after the commencement of that item.

(3)       The amendments made by items 1 and 2 apply in relation to applications for listings made on or after the commencement of those items.

(4)       The amendment made by item 6A applies in relation to a notice given on or after the commencement of that item (whether the application or request was made before, on or after that commencement).



 

Part 2 Amendments commencing on the day after Royal Assent

Therapeutic Goods Act 1989

7A  After subsection 7(1)

Insert:

          (1A)  In deciding whether particular goods or classes of goods:

                     (a)  are therapeutic goods; or

                     (b)  when used, advertised, or presented for supply in a particular way, are therapeutic goods;

the Secretary must disregard paragraphs (e) and (f) of the definition of therapeutic goods in subsection 3(1).

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;

14  After paragraph 31(2)(f)

Insert:

                    (fa)  if the goods are medicine—the matters covered by a certification by the person under paragraph 26A(2)(j) in relation to the medicine;

                    (fb)  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;

15A  Paragraph 31(4)(a)

Repeal the paragraph, substitute:

                     (a)  either:

                              (i)  the person is given a notice under subsection (1) and the person is covered by paragraph (1)(ab) or (ac); or

                             (ii)  the person is given a notice under subsection (2) and the person is covered by paragraph (2)(ab) or (ac); and

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.

(2A)     The amendment made by item 15A applies in relation to notices given on or after the commencement of that item.

(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.



 

Part 3 Amendments relating to biologicals

Therapeutic Goods Act 1989

22  Before subsection 9D(3A)

Insert:

       (3AA)  If:

                     (a)  the person in relation to whom a biological is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the biological; and

                     (b)  the only effect of the variation would be:

                              (i)  to reduce the class of persons for whom the biological is suitable; or

                             (ii)  to add a warning, or precaution, that does not include any comparison of the biological with any other therapeutic goods by reference to quality, safety or efficacy;

the Secretary must vary the entry in accordance with the request.

23  After paragraph 9D(3A)(a)

Insert:

                    (aa)  subsection (3AA) does not apply to the request; and

 

(178/10)