Commonwealth Numbered Regulations

1995 No. 208 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 6

  6.1   Subregulations 34 (2), (3) and (4):
Omit the subregulations, substitute:

"(2) The Committee's functions are:

   (a)  to consider:

        (i)    the adoption of standards for therapeutic goods;

        (ii)   matters relating to standards for therapeutic goods; and

        (iii)  requirements for labelling and packaging of therapeutic goods;
               and

   (iv) principles to be observed in the manufacture of therapeutic goods for
        human use; and advise the Minister of the results of its
        consideration; and

   (b)  to advise the Minister on the likely impact that adoption of a
        proposed standard would have on Australian domestic and international
        trade; and

   (c)  to consider a matter that is referred to the Committee by the Minister
        and to advise the Minister of the results of its consideration.

"(3) The Committee must:

   (a)  give to the Minister the reasons for any advice of the Committee; and

   (b)  when considering a matter to which paragraph (2) (a) applies, have
        regard to:

        (i)    the desirability of adopting standards of the British
               Pharmacopoeia and other recognised international standards for
               therapeutic goods in the interests of international
               harmonisation of therapeutic goods standards; and

        (ii)   whether the application of those standards to Australian
               conditions is appropriate.

"(4) The Minister must appoint in writing 11 persons to the Committee in
accordance with subregulations (4A), (4B) and (4C).

"(4A) The Committee must comprise the following persons:

   (a)  a person who is nominated to the Minister in writing by a body that
        represents, or a combination of bodies that together represent, the
        interests of Australian manufacturers of prescription drug products;

   (b)  a person who is nominated to the Minister in writing by a body that
        represents, or a combination of bodies that together represent, the
        interests of Australian manufacturers of non-prescription drug
        products;

   (c)  a person who is nominated to the Minister in writing by a body that
        represents, or a combination of bodies that together represent, the
        interests of Australian manufacturers of alternative medicines;

   (d)  a person who is nominated to the Minister in writing by a body that
        represents, or a combination of bodies that together represent, the
        interests of Australian manufacturers of therapeutic devices;

   (e)  a person who is nominated to the Minister in writing by a body that
        represents, or a combination of bodies that together represent, the
        interests of consumers of health services;

   (f)  a person with expertise in microbiology and virology;

   (g)  a person with expertise in biomedical engineering;

   (h)  a person with expertise in the biological safety of biomaterials;

   (i)  a person with expertise in biotechnology;

   (j)  a person with expertise in pharmaceutical sciences;

   (k)  a member of the Health and Food Standards Advisory Committee of
        Standards Australia.

"(4B) At least 1 of the persons appointed to the Committee must be a medical
practitioner.

"(4C) At least 1 of the persons to whom paragraphs (4A) (f), (g), (h), (i),
(j) and (k) refer must be able to represent the interests of consumers of
health services.

"(4D) The chairperson of the Committee may invite a person who is nominated in
writing by the National Registration Authority for Agricultural and Veterinary
Chemicals to attend a meeting at which a matter that is relevant to the
function of the Authority is to be discussed.".