(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.
(4) Manufacturing principles are legislative instruments.
(5) Despite subsection 14(2) of the Legislation Act 2003
, the manufacturing principles may make provision in relation to a matter by
applying, adopting or incorporating, with or without modification, any matter
contained in an instrument or other writing as in force or existing from time
to time.