Commonwealth Numbered Regulations

1990 No. 394 THERAPEUTIC GOODS REGULATIONS - REG 34

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
        fields:

        (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
               drugs;

        (ii)   scientific experience in the manufacture of alternative
               medicines;

        (iii)  scientific experience in the manufacture of therapeutic
               devices;

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

   (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.