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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

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

Restrictions

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

             (3)  The restrictions 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.

Prohibited ingredients

             (6)  The Minister may, by legislative instrument, make a determination specifying ingredients that must not be specified under paragraph (1)(a).

Incorporation of instruments

             (7)  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 ”.

5  Section 26BE

Repeal the section.

6  Paragraph 30(1)(e)

Omit “(cc), (cd),”.

7  Application

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



 

Part 2 Amendments commencing on the day after Royal Assent

Therapeutic Goods Act 1989

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;

13  Paragraph 31(2)(f)

After “safety”, insert “and efficacy”.

14  After paragraph 31(2)(f)

Insert:

                    (fa)  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;

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.

(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.