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THERAPEUTIC GOODS AMENDMENT ACT 2001 NO. 14, 2001 - SCHEDULE 1

- Electronic lodgment facility for listing medicines

Therapeutic Goods Act 1989

1 Subsection 3(1)

Insert:

export only medicine means a medicine that:

(a)
is manufactured in Australia for export only, or imported into Australia for export only; and

(b)
is listable goods only because it is so manufactured or imported (and not for any other reason).

2 Subsection 3(1)

Insert:

listable goods means therapeutic goods that are required:

(a)
under the regulations; or

(b)
by a notice published in the Gazette under subsection 17(5);

to be included in the part of the Register relating to listed goods.

3 Subsection 3(1)

Insert:

working day , for a person, means any day except:

(a)
Saturday or Sunday; or

(b)
a day that is a public holiday in the State or Territory in which the person is located.

4 Subsection 16(1)

After "therapeutic goods" (first occurring), insert "(other than medicine of the kind to which subsection (1A) applies)".

5 After subsection 16(1)

Insert:

(1A) Medicines that are listable goods (other than export only medicines) are taken to be separate and distinct from other therapeutic goods if the medicines have:

(a)
different active ingredients; or

(b)
different quantities of active ingredients; or

(c)
a different dosage form; or

(d)
such other different characteristics as the regulations prescribe;

from the therapeutic goods.

6 After subsection 22(2)

Insert:

(2A) A person must not, in or in connection with a certification of any matter under subsection 26A(2), intentionally or recklessly make a statement that is false or misleading in a material particular.

Maximum penalty: 400 penalty units.

7 Paragraph 26(1)(j)

Repeal the paragraph, substitute:

(j)
if the goods have been manufactured in Australia, or imported into Australia, solely for export—a relevant authority of the country to which the goods are to be exported has not confirmed its willingness to accept the goods and:

(i)
the goods have been refused registration or listing for supply in Australia; or
(ii)
the Secretary requires such a confirmation for a reason other than because the goods have been refused registration or listing; or

8 Paragraph 26A(1)(a)

Omit "therapeutic goods", substitute "medicine".

Note: The heading to section 26A is replaced by the heading " Listing of certain medicines ".

9 Paragraph 26A(1)(b)

Repeal the paragraph.

10 Paragraph 26A(1)(d)

Repeal the paragraph, substitute:

(d)
the medicine is not export only medicine;

11 Subsection 26A(1)

Omit "is not to refuse to list the goods", substitute "must list the medicine".

12 Subsection 26A(2)

Repeal the subsection, substitute:

(2) The applicant must certify that:

(a)
the medicine is eligible for listing; and

(b)
the medicine is safe for the purposes for which it is to be used; and

(c)
the presentation of the medicine is not unacceptable; and

(d)
the medicine conforms to every standard (if any) applicable to the medicine and to every requirement (if any) relating to advertising applicable under the regulations; and

(e)
if the medicine has been manufactured in Australia—each step in the manufacture of the medicine has been carried out by a person who is the holder of a licence to carry out that step granted under section 38; and

(f)
the medicine complies with all prescribed quality or safety criteria; and

(g)
the medicine does not contain substances that are prohibited imports for the purposes of the Customs Act 1901 ; and

(h)
all the manufacturers of the medicine are nominated as manufacturers in the application; and

(i)
the applicant has, with manufacturers of the medicine who are manufacturers of the prescribed kind, written agreements containing such matters as are prescribed; and

(j)
the applicant holds information or evidence to support any claim that the applicant makes relating to the medicine; and

(k)
the information included in or with the application is correct.

13 Subsection 26A(3)

Omit "goods", substitute "medicine".

14 Subparagraph 26A(4)(a)(i)

Omit "the goods are not therapeutic devices and".

15 Subparagraph 26A(4)(a)(i)

Omit "goods" (second and third occurring), substitute "medicine".

16 Subparagraph 26A(4)(a)(ii)

Omit "goods", substitute "medicine".

17 Paragraph 26A(4)(b)

Omit "goods", substitute "medicine".

18 At the end of subsection 26A(4)

Add:

; and (c) whether the applicant has complied with any requirements made by the Secretary under section 31 in relation to the manufacture or preparation of the medicine.

19 Subsection 26A(5)

Omit "therapeutic goods are", substitute "a medicine is".

20 Subsection 26A(5)

Omit "goods" (second and third occurring), substitute "medicine".

21 Subsection 26A(6)

Omit "therapeutic goods", substitute "a medicine".

22 Subsection 26A(6)

Omit "goods" (second and third occurring), substitute "medicine".

23 Paragraph 26A(7)(a)

Omit "therapeutic goods were", substitute "a medicine was".

24 Paragraph 26A(7)(b)

Omit "goods been made in Australia, they", substitute "medicine been made in Australia, it".

25 Subsection 26A(7)

Omit "goods" (third occurring), substitute "medicine".

26 Subsection 26A(8)

Repeal the subsection.

27 Subsection 26A(9)

Omit "an applicant has been informed that therapeutic goods in respect of which an application was made are acceptable for listing", substitute "a medicine has been listed under this section".

28 Subsection 26A(9)

Omit "the goods" (wherever occurring), substitute "the medicine".

29 After subsection 28(5)

Insert:

(5A) In addition to any conditions imposed under subsection (1), (3) or (5), the listing of a medicine under section 26A is subject to a condition that the person in relation to whom the medicine is listed will deliver a reasonable number of samples of the medicine if the Secretary so requests:

(a)
within the period specified in the request; and

(b)
in accordance with any other requirements specified in the request.

The period specified in the request must include at least 10 working days.

30 Paragraph 30(1)(e)

Omit "goods", substitute "a medicine".

31 After subsection 30(1)

Insert:

(1A) The Secretary may, by notice in writing given to a person in relation to whom a medicine is listed under section 26A, cancel the listing of the medicine if:

(a)
the medicine is not eligible for listing; or

(b)
the medicine is exempt; or

(c)
there is a serious breach, involving the medicine, of the requirements relating to advertising applicable under the regulations, and the Secretary is satisfied that:

(i)
the breach is significant; and
(ii)
as a result of the breach, the presentation of the medicine is misleading to a significant extent.

(1B) However, paragraph (1A)(c) does not apply to medicines that are manufactured in Australia for export only, or are imported into Australia for export only.
(1C) The Secretary may, by notice in writing given to a person in relation to whom a medicine is listed under section 26A, cancel the listing of the medicine if:

(a)
the Secretary, under section 31, gives to the person a notice requiring the person to give to the Secretary information or documents relating to the medicine; and

(b)
the notice is given for the purposes of ascertaining whether the medicine should have been listed; and

(c)
the person fails to comply with the notice within 20 working days after the notice is given.

32 Paragraph 30(2)(ba)

Omit "goods", substitute "a medicine".

33 Paragraph 30(2)(ba)

Omit "or (h)", substitute ", (h), (i), (j) or (k)".

34 Subsection 30(5)

Omit "subsection (1)", substitute "subsection (1), (1A) or (1C)".

35 At the end of section 31

Add:

(6) A person in relation to whom a medicine is listed under section 26A must not, in purported compliance with a notice under this section relating to the medicine, intentionally or recklessly provide information that is false or misleading in a material particular.

Maximum penalty: 400 penalty units.

36 Application of amendments

(1) The amendments made by this Schedule do not apply, and the Therapeutic Goods Act 1989 as in force immediately before the commencement of this Schedule continues to apply, in relation to any application made under that Act, before that commencement, for listing of therapeutic goods.
(2) However, the amendment made by item 5 of this Schedule applies, after that commencement, to therapeutic goods that were listed before that commencement.
(3) The amendment made by item 31 of this Schedule applies, after that commencement, to medicines listed under section 26A before that commencement.


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