28
No.
Labelling of
medicines
Sale of
medicine
of 2013]
Medicines and Allied Substances
instrument.
44. (1) A person shall not sell by retail or otherwise supply
medicine in a place other than a pharmacy, health facility or an
animal health facility, except with the written approval of the
Authority.
(2) Any medicine sold in a place other than a pharmacy, health
facility or animal health facility shall be sold in the original package
labelled by the manufacturer with—
(a) full instructions for use;
(b) indications, contra indications, warnings and precautions;
and
(c) any other information as the Minister may provide, by
statutory instrument, on the recommendation of the
Authority.
(3) A medical doctor, dental surgeon or any other authorised
prescriber shall not sell any medicine to any person unless it is in a
package for an individual patient’s use only.
(4) A wholesaler, manufacturer or importer shall not sell any
medicine to any person unless that person is duly authorised to
handle medicines and allied substances under this Act.
45.
(1)
An advertisement of any medicine or allied
substance shall conform to the information relating to the medicine
Advertising of or allied substance approved by the Authority and as specified in
medicines or
the marketing authorisation.
allied
substances
(2) A medicine or allied substance which is sold by prescription
only shall not be advertised to the general public without the prior
written approval of the Authority.
(3) In this section, “ advertisement ” means any representation
by any means whatsoever for the purpose of promoting, directly or
indirectly, the sale or disposal of any medicine or allied substance.
(4) A person who contravenes subsection (1) or (2) 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.
(5) Where a person has been charged with an offence under
this section, it shall be a defence for that person to prove—
(a) that the person’s business is to publish or arrange for the
publication of advertisements;