Medicines and Allied Substances
[No.
of 2013 29
(b) that the advertisement was received in the ordinary course
of business and the person charged had no reason to
suspect that its publication would amount to an offence
under this Act; and
(c) that the advertisement was commissioned by a third party.
46. (1) The Authority may, where it determines that it is not in
the public interest that any medicine or allied substance should be
made available to the public, by notice, in writing, served on any
person or in the Gazette, direct that person to return the medicine
or allied substance which the person has in that person’s possession
to—
Recall of
medicine,
etc. from
circulation
(a) the manufacturer of the medicine or allied substance;
(b) in the case of any imported medicine or allied substance,
to the importer concerned;
(c) deliver it or send it to the Authority or such other person
as the Authority may designate.
(2) The Authority may, by notice, in writing, direct the
manufacturer or importer of the medicine or allied substance
referred to in subsection (1) or the person referred to in paragraph
(c) of subsection (1), who has in their possession any quantity of
the medicine or allied substance, including the returned quantity to
deal with or dispose of that quantity in such manner as the Authority
may determine.
(3) A person shall not sell any medicine or allied substance which
is the subject of a notice under subsection (1).
(4) A person who contravenes subsection (3) commits an offence
and is liable, upon conviction, to a fine not exceeding one million
penalty units or to imprisonment for a period not exceeding three
years, or to both.
47. The Minister may, on the recommendation of the Authority,
by statutory instrument, make regulations for monitoring the safety
of medicines and allied substances.
48. (1) The Authority shall keep and maintain a Register of
Marketing Authorisations issued under this Act.
(2) The Register referred to in subsection (1) shall be kept at the
offices of the Authority and shall be open to inspection by the public
at such times and on such conditions, including the payment of a
fee for inspection as the Board may determine.
PART VI
REGULATION OF CLINICAL TRIALS
Monitoring
medicine and
allied
substance
Register of
Marketing
Authorisations