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THERAPEUTIC GOODS AMENDMENT REGULATION 2012 (NO. 3) (SLI NO 251 OF 2012) - 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

15A          Conditions 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

39F          Establishment

                The Advisory Committee on the Safety of Vaccines is established.

39G          Functions

         (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.

39H          Membership

         (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

       (12)   The Secretary must publish the recommendations of each committee.

[9]           After Part 8

insert

Part 9                  Transitional

   

49             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)




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