Therapeutic Goods Amendment (Excluded Goods—Hand Sanitisers) Determination (No. 2) 2020

I, Jane Cook, as delegate of the Minister for Health, make the following determination.

Dated 1 May 2020

Dr Jane Cook

Contents

1  Name

2  Commencement

3  Authority

4  Schedules

Schedule 1—Amendments

Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020

1  Name

  This instrument is the Therapeutic Goods Amendment (Excluded Goods—Hand Sanitisers) Determination (No. 2) 2020.

2  Commencement

 (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

 (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

  This instrument is made under section 7AA of the Therapeutic Goods Act 1989.

4  Schedules

  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020

1  Before section 1

Insert:

Part 1—Preliminary

2  Section 4 (note)

Repeal the note, substitute:

Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:

(a)      advertise;

(b) batch;

(c) British Pharmacopoeia;

(d) default standard;

(e) European Pharmacopoeia;

(f) label;

(g) supply; and

(h) United States Pharmacopoeia-National Formulary.

3  Section 4

Insert:

acceptable microbiological quality, in relation to water, means a microbial count that is less than 100 colony forming units per mL.

other purification process, in relation to water, means a process, such as reverse osmosis, that meets the following requirements:

 (a) the process is validated to produce and distribute water that is of acceptable chemical quality and acceptable microbiological quality; and

 (b) regular microbiological testing of the water is undertaken, including sampling at the point of use, using one of the following methods:

 (i) filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating on a single plate at 30-35°C for not less than 5 days; or

 (ii) filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating on separate plates at 35-37°C and 20-22°C for not less than 5 days.

4  Before section 5

Insert:

Part 2—Excluded goods

5  After section 5

Insert:

Part 3—Application, saving and transitional provisions

6  Transitional provision

 (1) In this section:

Amendment Determination means the Therapeutic Goods Amendment (Excluded Goods—Hand Sanitisers) Determination (No. 2) 2020.

commencement date means the day on which the Amendment Determination commences.

Former Determination means the Therapeutic Goods (Excluded Goods—Hand Sanitiser) Determination 2020, as in force immediately before the commencement date.

transition period means the period beginning on the commencement date and ending on 30 June 2020.

 (2) Despite the amendments made by the Amendment Determination, the Former Determination continues to apply for the duration of the transition period in relation to the manufacture and supply of goods specified in items 1 and 2 of the table in Schedule 1 to the Former Determination.

6  Schedule 1 (table item 1, column 2, subparagraph (a)(i))

After “solution”, insert “that may contain a denaturant such as denatonium benzoate (NLT 5ppm), sucrose octaacetate (0.12%w/v) or tertiary butyl alcohol (0.25%v/v)”.

7  Schedule 1 (table item 1, column 2, subparagraph (a)(ii))

Repeal the subparagraph, substitute:

(ii) purified water derived from potable water that has been rendered sterile or otherwise purified by boiling, distillation or other purification process;

8  Schedule 1 (table item 1, column 2, subparagraph (a)(iii))

After “grade”, insert “or food standard grade”.

9  Schedule 1 (table item 1, column 2, after paragraph (b))

Insert:

(ba) the purified water specified in subparagraph (a)(ii) is used as soon as practicable following purification to maintain the acceptable chemical quality, and the acceptable microbiological quality, of the water;

10  Schedule 1 (table item 1, column 2, paragraph (d))

After “paragraphs (a), (b),”, insert “(ba)”.

11  Schedule 1 (cell at table item 1, column 3)

Repeal the cell, substitute:

12  Schedule 1 (table item 2, column 2, subparagraph (a)(ii))

Repeal the subparagraph, substitute:

(ii) purified water derived from potable water that has been rendered sterile or otherwise purified by boiling, distillation or other purification process;

13  Schedule 1 (table item 2, column 2, subparagraph (a)(iii))

After “grade”, insert “or food standard grade”.

14  Schedule 1 (table item 2, column 2, after paragraph (b))

Insert:

(ba) the purified water specified in subparagraph (a)(ii) is used as soon as practicable following purification to maintain the acceptable chemical quality, and the acceptable microbiological quality, of the water;

15  Schedule 1 (table item 2, column 2, paragraph (d))

After “paragraphs (a), (b),”, insert “(ba)”.

16  Schedule 1 (cell at table item 2, column 3)

Repeal the cell, substitute:

17  Schedule 2

Repeal the Schedule, substitute:

Schedule 2—Labels

Part 1—Ethanol hand sanitiser

Note: See item 1 of Schedule 1.

1  Front label

2  Back label

Part 2—Isopropyl alcohol hand sanitiser

Note: See item 2 of Schedule 1.

1  Front label

2  Back label