Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 36

             (1)  The Minister may, from time to time, determine written principles to be observed in the manufacture of therapeutic goods for use in humans.

             (2)  The manufacturing principles may relate to:

                     (a)  the standards to be maintained, and the equipment to be used, at premises used for the manufacturing of therapeutic goods for use in humans; or

                     (b)  procedures for quality assurance and quality control to be employed in the manufacturing of therapeutic goods for use in humans; or

                     (c)  the qualifications and experience required of persons employed in the manufacture of therapeutic goods for use in humans; or

                     (d)  the manufacturing practices to be employed in the manufacturing of therapeutic goods for use in humans; or

                     (e)  other matters relevant to the quality, safety and efficacy of therapeutic goods for use in humans that are manufactured in Australia;

and may include codes of good manufacturing practice.

             (3)  The Minister may, before taking action under subsection (1) in relation to the manufacturing principles, obtain advice from a committee established by the regulations on the action that should be taken under that subsection as to the principles to be observed in the manufacture of therapeutic goods for use in humans.

             (4)  Manufacturing principles are disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901 .