Commonwealth Numbered Regulations

THERAPEUTIC GOODS AMENDMENT REGULATIONS 2001 (NO. 3) 2001 NO. 252 - SCHEDULE 1

(regulation 3)

[1] Before regulation 10

insert

10A Characteristics that separate and distinguish certain medicines from other therapeutic goods
(1) For paragraph 16 (1A) (d) of the Act, different characteristics are:

(a)

a different name; or

(b)

different indications; or

(c)

a different excipient; or

(d) for medicines that contain any restricted ingredients:

(i)

a different quantity of a restricted ingredient that is an excipient; or

(ii)

if the restriction on a restricted ingredient relates to its concentration in a relevant medicine — a different concentration of the restricted ingredient; or

(iii)

if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine — different directions for use setting out a different recommended single or daily dose.

(2) A substance is a restricted ingredient if:

(a)

it is an ingredient in a relevant medicine; and

(b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:

(i)

Schedule 4;

(ii)

the Poisons Standard;

(iii)

a condition imposed under section 28 of the Act;

(iv)

a standard under section 10 of the Act;

(v)

any other provision in these Regulations or in the Act that deals with eligibility of medicines for listing.

(3) In this regulation:

"relevant medicine" means a medicine that is listable goods or listed goods and that is not an export only medicine.

[2] Regulation 23

omit

In this Part,

insert

(1)

In this Part,

[3] Regulation 23

insert

(2) For this Part, a sample of therapeutic goods is appropriately fastened and sealed if the sample is fastened and sealed:
(a) in a vessel or package that is marked with the name and address of:

(i)

the person from whom the sample was taken; or

(ii)

for a sample delivered under subsection 28 (5A) of the Act — the sponsor of the goods; and

(b)

so as to prevent the opening of the vessel or package, and the removal of the name and address, without breaking the seal.

[4] Paragraphs 25 (3) (b) and (c)

omit

the sample

insert

a sample taken under paragraph (a) or delivered under subsection 28 (5A) of the Act

[5] Subregulation 26 (1)

omit

Where an authorised officer takes a sample of therapeutic goods,

insert

When an authorised officer takes a sample of therapeutic goods (other than a further sample taken under the circumstances described in subregulation 30 (6)),

[6] Subregulations 26 (2) and (3)

substitute

(2) An authorised officer must ensure that any sample of goods taken (including further samples taken under the circumstances described in subregulation 30 (6)) is:

(a)

appropriately packaged, fastened and sealed; and

(b)

stored and transported in accordance with the instructions (if any) specified on the label of the goods.

[7] After regulation 26

insert

26A Receiving samples for testing
(1) When a sample of a medicine is delivered under subsection 28 (5A) of the Act, the Secretary must as soon as practicable:

(a)

determine whether the sample is appropriately packaged, fastened and sealed; and

(b) do either of the following:

(i)

if the sample is appropriately packaged, fastened and sealed — send the sample, in the form in which it was received, to the relevant laboratory operated by the Department for analysis;

(ii)

if the sample is not appropriately packaged, fastened and sealed — return the sample to the sponsor of the medicine, with a statement explaining in what way the sample is not appropriately packaged, fastened or sealed.

(2)

In complying with subregulation (1), the Secretary must ensure that the sample is stored and transported in accordance with the instructions (if any) specified on the label of the medicine.

[8] Paragraph 29 (2) (b)

before

the person

insert

if the sample was taken under subregulation 25 (3) —

[9] After subregulation 31 (1)

insert

(1A)

If a sample of a medicine delivered under subsection 28 (5A) of the Act is sent to a laboratory for analysis, the Commonwealth is liable to pay to the person in relation to whom the medicine is listed an amount equal to the value of the sample.

[10] Subregulation 31 (2)

omit

taken.

insert

taken by the authorised officer or delivered under subsection 28 (5A) of the Act.

[11] Schedule 2, Part 1, item 1, column 2

omit

about a disease, condition, ailment or defect specified in

insert

that is a prohibited representation under

[12] Schedule 2, Part 1, item 4, column 2

omit

paragraph 7.1 (a)

insert

paragraph 7.1.3 (a)

[13] Schedule 4, Part 2, column 1

after

Thiamine nitrate

insert

Thiamine phosphoric acid ester chloride

[14] Schedule 4, Part 3

after

Calcium lactate

insert

Calcium lactate gluconate

[15] Schedule 4, Part 3

omit

ferrous lactate

insert

Ferrous lactate

[16] Schedule 4, Part 5, Division 1

insert in appropriate alphabetical position

Chondroitin sulfate — bovine
Chondroitin sulfate — shark
Lycopene
Papain
Tocotrienols complex — palm

[17] Schedule 4, Part 5, Division 2, Subdivision 2, table

substitute

Note
Certain substances mentioned in this Division are also mentioned in Division 3.

[18] Schedule 4, Part 5, Division 3, before item 1

insert

[19] Schedule 4, Part 5, Division 3, after item 5

insert

[20] Schedule 4, Part 5, Division 3, after item 6

insert