Therapeutic Goods Amendment Regulation 2012 (No. 3) (Cth)

Therapeutic Goods Amendment Regulation 2012 (No. 3)¹

Select Legislative Instrument 2012 No. 251

I, QUENTIN BRYCE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulation under the Therapeutic Goods Act 1989.

Dated 8 November 2012

QUENTIN BRYCE

Governor-General

By Her Excellency’s Command

CATHERINE KING

Parliamentary Secretary for Health and Ageing

1. Name of regulation

This regulation is the Therapeutic Goods Amendment Regulation 2012 (No. 3).

1. Commencement

This regulation commences on 10 November 2012.

1. Amendment of Therapeutic Goods Regulations 1990

Schedule 1 amends the Therapeutic Goods Regulations 1990.

Schedule 1          Amendments

(section 3)

[1]          Regulation 2, definition of generic medicine

omit

[2]          Regulation 2, definition of Standard AS/NZS

substitute

Standard AS/NZS means a joint Australian and New Zealand Standard published by, or on behalf of, Standards Australia and the body known as Standards New Zealand.

Note   Section 2B of the Acts Interpretation Act 1901 defines Standards Australia.

[3]          Regulation 2, definition of virucide, note

substitute

Note   For the definitions of the following terms, see subsection 3 (1) of the Act:

·medicine

·poison

·product information

·Secretary.

[4]          Regulation 15A

substitute

15AConditions of registration and listing of medicines

For paragraph 28 (5) (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the requirements, if any, set out in the document published by the Therapeutic Goods Administration titled Australian Requirements and Recommendations for Pharmacovigilance Responsibilities of Sponsors of Medicines, as in force from time to time.

[5]          Subregulations 34A (4), 35A (3), 36A (3), 37A (3), 38A (3), 38D (3), 39A (3) and 39D (3)

omit

[6]          Part 6, after Division 1EA

insert

Division 1EB          Advisory Committee on Safety of Vaccines

39FEstablishment

The Advisory Committee on the Safety of Vaccines is established.

39GFunctions

(1)The committee’s functions are to advise and make recommendations to the Minister or Secretary about the following matters:

(a)safety of vaccines;

(b)risk assessment and risk management of vaccines;

(c)any other matters referred to the committee by the Minister or Secretary (whether or not they relate to vaccine safety).

(2)The Minister or Secretary may require the committee to give its advice to other persons or bodies.

39HMembership

(1)The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (2), (3) and (4).

(2)The Minister must appoint one member from each of the following:

(a)the Australian Technical Advisory Group on Immunisation;

(b)the National Immunisation Committee;

(c)the Advisory Committee on the Safety of Medicines;

(d)the National Centre for Immunisation Research and Surveillance.

(3)The Minister may appoint up to 6 additional members, each with expertise in at least one of the following fields:

(a)immunology;

(b)virology;

(c)bacteriology;

(d)infectious diseases in adults;

(e)infectious diseases in children;

(f)public health;

(g)epidemiology;

(h)vaccine program implementation;

(i)biostatistics;

(j)consumer issues;

(k)the provision of immunisation treatment by a general medical practitioner;

(l)the provision of immunisation treatment by a nurse practitioner.

(4)Membership of the committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (3).

[7]          Regulation 40

omit

1E and 1EA.

insert

1E, 1EA and 1EB.

[8]          After subregulation 42 (11)

insert

Publication of recommendations of committees

1. The Secretary must publish the recommendations of each committee.

[9]          After Part 8

insert

Part 9                      Transitional

1. Transitional

Despite the amendments made by the Therapeutic Goods Amendment Regulation 2012 (No.   ):

(a)item 7 of Part 1 of Schedule 4, as in force on 9 November 2012, continues to apply in relation to therapeutic goods already included in the part of the Register for listed goods on that date; and

(b)paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply in relation to goods exempt from the operation of Parts 3-2 and 3-2A of the Act on that date; and

(c)paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply in relation to therapeutic goods exempt from the operation of Part 3-3 of the Act on that date.

[10]        Schedule 4, Part 1, item 7, paragraph (a)

omit

AS/NZS 2604:1998

insert

AS/NZS 2604:2012

[11]        Schedule 5, item 8, subparagraph (g) (i)

omit

AS/NZS 2604:1998

insert

AS/NZS 2604:2012

[12]        Schedule 5A, heading

substitute

Schedule 5A       Therapeutic goods exempt from operation of Parts 3-2 and 3-2A of Act subject to conditions

(subregulations 12 (2) and (3))

[13]        Schedule 7, item 14, paragraph (b)

omit

AS/NZS 2604:1998

insert

AS/NZS 2604:2012

[14]        Schedule 9, Part 1, subitem 1 (1)

insert

generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (previously registered medicine):

(a)has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the registered medicine or previously registered medicine; and

(b)has the same pharmaceutical form; and

(c)is bioequivalent; and

(d)has the same safety and efficacy properties.

[15]        Schedule 9, Part 2, item 4, paragraphs (g) and (h)

omit

(f)

insert

(d)

Note

1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See