Commonwealth Numbered Regulations

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Therapeutic Goods Committee
34. (1) The Therapeutic Goods Committee is established.

(2) The functions of the Committee are:

   (a)  to consider any matters referred to it by the Minister relating to the
        administration of the Act; and

   (b)  to consider and inquire into:

        (i)    the standards applicable to any therapeutic goods and any
               matter relating to those standards; and

        (ii)   the requirements with respect to labelling and packaging of
               goods; and

        (iii)  principles to be observed in the manufacture of therapeutic
               goods for use in humans; and to advise the Minister about those
               matters, standards, requirements and principles.

(3) The Committee consists of not fewer than 8 persons and not more than 11
persons, each of whom is to be appointed in writing by the Minister.

(4) The Committee is to consist of:

   (a)  persons, each of whom has expertise in one or more of the following

        (i)    pharmaceutics;

        (ii)   pharmaceutical chemistry;

        (iii)  pharmacology;

        (iv)   microbiology;

        (v)    virology;

        (vi)   therapeutic devices;

        (vii)  veterinary science;

        (viii) pharmacognosy; and

   (b)  4 persons, at least one of whom has experience of each of the
        following kinds:

        (i)    scientific experience in the manufacture of pharmaceutical

        (ii)   scientific experience in the manufacture of alternative

        (iii)  scientific experience in the manufacture of therapeutic

        (iv)   consumer affairs experience in respect of therapeutic goods;

   (c)  a person nominated by the Secretary to the Department of Primary
        Industries and Energy.

(5) The Minister is to appoint, in writing, a member of the Committee to be
its chairperson.

(6) The Committee may appoint sub-committees, consisting of members of the
Committee and other persons to inquire into, and report to the Committee on,
any matter that is within the functions of the Committee. 

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