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

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SCHEDULE

2010

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

HOUSE OF REPRESENTATIVES

___________________

 

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

 

SCHEDULE OF THE AMENDMENT(S) AGREED TO BY

THE MAIN COMMITTEE

 

(1)     Clause 2, page 2 (after table item 2), insert:

2A.  Schedule 1A

The 28th day after this Act receives the Royal Assent.

[product information for medicine]

(2)     Clause 2, page 2 (at the end of the table), add:

5.  Schedule 2, Part 3

The later of:

(a) immediately after the commencement of the provision(s) covered by table item 2; and

(b) immediately after the commencement of Schedule 1 to the Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010 .

 

[amendments relating to biologicals]

(3)     Page 9 (after line 30), after Schedule 1, insert:

Schedule 1A Product information for medicine

   

Therapeutic Goods Act 1989

1  Subsection 3(1)

Insert:

product information , in relation to therapeutic goods, means information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods.

2  Subsection 3(1)

Insert:

restricted medicine means:

                  (a)    a medicine specified in an instrument under subsection (2A); or

                  (b)    a medicine included in a class of medicine specified in an instrument under subsection (2B).

3  After subsection 3(2)

Insert:

        (2A)  The Minister may, by legislative instrument, specify medicines for the purposes of paragraph (a) of the definition of restricted medicine in subsection (1).

        (2B)  The Minister may, by legislative instrument, specify classes of medicine for the purposes of paragraph (b) of the definition of restricted medicine in subsection (1).

4  After section 7C

Insert:

7D   Form for product information for medicine

           (1)  The Secretary may, by writing, approve a form for product information in relation to medicine.

           (2)  The Secretary may approve different forms for different medicines or different classes of medicine.

5  Subsection 9D(5)

Repeal the subsection (not including the note).

6  After paragraph 23(2)(b)

Insert:

                 (ba)    if the application is for the registration of restricted medicine—the application is accompanied by product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine; and

7  After paragraph 25(1)(d)

Insert:

                 (da)    if:

                              (i)  the applicant is applying for the registration of restricted medicine; or

                             (ii)  the applicant is applying for the registration of medicine (other than restricted medicine) and the applicant has been given a notice in writing by the Secretary requiring the applicant to give to the Secretary product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine;

                          the product information given by the applicant in relation to the medicine; and

8  After subparagraph 25(4)(d)(i)

Insert:

                            (ia)  if the goods are restricted medicine or the goods are medicine in respect of which the applicant has been given a notice of the kind referred to in subparagraph (1)(da)(ii)—notify the applicant in writing of the product information that is approved in relation to the medicine; and

9  After section 25

Insert:

25AA   Approved product information for medicine

           (1)  If:

                  (a)    the Secretary includes restricted medicine in the Register in relation to a person under subparagraph 25(4)(d)(ii); or

                  (b)    an applicant for the registration of medicine (other than restricted medicine) is given a notice of the kind referred to in subparagraph 25(1)(da)(ii) and the Secretary includes the medicine in the Register in relation to the applicant under subparagraph 25(4)(d)(ii);

the product information that is approved under this section in relation to the medicine is the product information referred to in subparagraph 25(4)(d)(ia).

Note:          Subsection (4) deals with variation of the product information.

Transitional

           (2)  If:

                  (a)    at the start of the day the first instrument made under subsection 3(2A) or (2B) takes effect, there is medicine included in the Register in relation to a person; and

                  (b)    before that day, the Secretary, in a notice given under subsection 25(4) to the person in relation to the registration of the medicine, specified the product information that was approved by the Secretary in relation to the medicine;

then that product information (including as varied before that day) is, on and after that day, the product information that is approved under this section in relation to the medicine.

Note:          Subsection (4) deals with variation of the product information.

           (3)  If:

                  (a)    before the day the first instrument made under subsection 3(2A) or (2B) takes effect, a person made an application to include medicine in the Register; and

                  (b)    before that day and in relation to that application, the Secretary, in a notice given under subsection 25(4) to the person, specified the product information that was approved by the Secretary in relation to the medicine; and

                  (c)    on or after that day and in relation to that application, the Secretary includes the medicine in the Register in relation to the person under subparagraph 25(4)(d)(ii);

then that product information (including as varied before that inclusion) is, on and after the day the registration of the medicine commences, the product information that is approved under this section in relation to the medicine.

Note:          Subsection (4) deals with variation of the product information.

Variations

           (4)  If:

                  (a)    there is medicine included in the Register in relation to a person and there is product information approved under this section in relation to the medicine; and

                  (b)    either:

                              (i)  under section 9D, the Secretary varies the entry in the Register in relation to the medicine; or

                             (ii)  there is a change in the conditions to which the inclusion of the medicine is subject; and

                  (c)    as a result of that variation or change, the Secretary is satisfied that a variation to that product information is required;

the Secretary may, by notice in writing given to the person, make any variations that the Secretary considers appropriate to the product information that is approved in relation to the medicine.

           (5)  To avoid doubt, if product information that is approved in relation to medicine is varied under this section, that product information, as varied, becomes the product information that is approved under this section in relation to the medicine.

10  Application

(1)       Paragraph 23(2)(ba) and subparagraph 25(1)(da)(i) of the Therapeutic Goods Act 1989 , as inserted by this Act, apply in relation to applications for registration of medicine that are made after the day on which the first instrument made under subsection 3(2A) or (2B) of that Act takes effect.

(2)       Subparagraph 25(1)(da)(ii) of the Therapeutic Goods Act 1989 , as inserted by this Act, applies in relation to applications for registration of medicine that are made on or after the day on which the first instrument made under subsection 3(2A) or (2B) of that Act takes effect.

(3)       Subparagraph 25(4)(d)(ia) of the Therapeutic Goods Act 1989 , as inserted by this Act, applies on and after the day on which the first instrument made under subsection 3(2A) or (2B) of that Act takes effect (whether the application for registration was made before, on or after that day).

(4)       Subsection 25AA(1) of the Therapeutic Goods Act 1989 , as inserted by this Act, applies in relation to medicine included in the Register on or after the day on which the first instrument made under subsection 3(2A) or (2B) of that Act takes effect (where the notification (in relation to the medicine) referred to in subparagraph 25(4)(d)(ia) of that Act also occurred on or after that day).

Note:       Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

[product information for medicine]

(4)     Schedule 2, page 10 (before line 5), before item 1, insert:

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.

[variation of entries in Register]

(5)     Schedule 2, page 10, after proposed item 1D, insert:

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:”.

[evaluation of therapeutic goods]

(6)     Schedule 2, items 2 and 3, page 10 (line 7) to page 11 (line 20), omit the items, substitute:

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 ”.

[permissible ingredients]

(7)     Schedule 2, page 11 (before line 25), before item 5, insert:

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.

[variation of list of permissible ingredients]

(8)     Schedule 2, page 11 (after line 28), after item 6, insert:

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).

[information-gathering notices]

(9)     Schedule 2, item 7, page 11 (line 29) to page 12 (line 3), omit the item, substitute:

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).

[application]

(10)    Schedule 2, page 13 (before line 4), before item 8, insert:

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).

[declaration that goods are therapeutic goods]

(11)    Schedule 2, item 13, page 14 (lines 5 and 6), omit the item.

[information-gathering notices]

(12)    Schedule 2, item 14, page 14 (lines 7 to 10), omit the item, substitute:

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;

[information-gathering notices]

(13)    Schedule 2, page 14 (after line 17), after item 15, insert:

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

[information-gathering notices]

(14)    Schedule 2, item 21, page 15 (after line 25), after subitem (2), insert:

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

[application]

(15)    Schedule 2, page 15 (after line 29), at the end of the Schedule, add:

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

[amendments relating to biologicals]

 

 

 

 

Clerk of the Main Committee

27 October 2010