26
No.
of 2013]
Medicines and Allied Substances
(e)medicine imported or exported in response to a declared
health emergency;
(f)medicine imported by an authorised institution for
administration to patients under its care; and
(g) any medicine or allied substance used for purposes of a
clinical trial.
(5) The Minister may, on the recommendation of the Authority,
by statutory instrument, provide for—
(a) the criteria for the regulation of persons under subsection
(1);
(b) the procedure for applying for a marketing authorisation
and the grant, amendment, renewal, transfer and
revocation of a marketing authorisation;
(c) the terms and conditions attaching to an application, grant,
amendment, refusal, renewal, transfer or revocation of
a marketing authorisation; and
(d) such other matters as are necessary or incidental to the
effective regulation of marketing authorisations under
this Part.
(7) A holder of a marketing authorisation shall pay such annual
retention fee as the Minister may prescribe.
Categories of
medicines
Medicines
list
Prohibition
of sale of
prescription
only
medicines
without
prescription
40. (1) The categories of medicines to which this Part applies
are—
(a) prescription only medicine;
(b) pharmacy medicine; and
(c) general sale medicine.
(2) Medicines shall be dispensed in accordance with the
respective requirements applicable to the categories specified in
subsection (1) and as shall be prescribed by statutory instrument.
41. The Minister may, on the recommendation of the Authority,
by statutory instrument, provide for a list of substances to be
considered as medicines.
42. (1) A person shall not sell or supply medicine which is
required to be sold by prescription only to any person without a
prescription.
(2) For the purposes of this section, an authorised prescriber
shall prescribe medicines which under this Act are required to be
dispensed only under a prescription by issuing a prescription in the