Commonwealth Numbered Acts

HEALTH LEGISLATION AMENDMENT ACT (No. 2) 1986 No. 94 of 1986 - SECT 44

44. After section 24 of the Principal Act the following section is inserted:
Regulations may provide for inspection of manufacture of goods for therapeutic
use

"24A. (1) The regulations may make provision for or in relation to the
inspection of procedures carried out, or documents relating to procedures
carried out, in the manufacture of goods for therapeutic use.

"(2) Without limiting the generality of sub-section (1), the regulations that
may be made by virtue of that sub-section include regulations making provision
for or in relation to-

   (a)  the authorisation of persons to inspect, and to enter upon premises
        for the purposes of inspecting, procedures carried out, or documents
        relating to procedures carried out, in the manufacture of goods for
        therapeutic use; and

   (b)  the taking of extracts from, or making copies of, a document relating
        to procedures carried out in the manufacture of goods for therapeutic
        use.

"(3) A reference in this section to prcedures carried out in the manufacture
of goods for therapeutic use is a reference to-

   (a)  procedures carried out by a prescribed corporation in the manufacture
        of goods for therapeutic use;

   (b)  procedures carried out by a person (not being a prescribed
        corporation) for export from Australia;

   (c)  procedures carried out by a person (not being a prescribed
        corporation) in the manufacture of goods for therapeutic use-

        (i)    for supply-

                (A)  in the course of trade and commerce among the States,
                     between a State and a Territory or between 2 Territories;

                (B)  under a law of the Commonwealth relating to the provision
                     of pharmaceutical benefits;

                (C)  to the Commonwealth or the Northern Territory or to an
                     authority of the Commonwealth or of a Territory; or

                (D)  in an internal Territory; or

        (ii)   in an internal Territory; or

   (d)  procedures carried out by a person (not being a prescribed
        corporation) in the manufacture in an internal Territory of goods for
        therapeutic use.".