Medicines and Allied Substances
[No.
of 2013 25
the person shall—
(a) in addition to obtaining an import or export permit, obtain
additional authorisation from the Authority; and
Additional
requirements
for import or
export of
narcotic drugs,
psychotropic
substances
and
precursors
(b) comply with additional requirements as may be provided
for under the Dangerous Drugs Act and Narcotic Drugs
and Psychotropic Substances Act and any other written
law.
Cap. 95
38. The Authority shall maintain a Register of Licences and Cap. 96
Permits, in the prescribed form, which shall contain such particulars
as the Authority may consider necessary for purposes of this Act. Register of
PART V
Licences and
Permits
REGULATION OF MEDICINES AND ALLIED SUBSTANCES
39. (1) A person shall not place on the market, advertise,
market, manufacture, sell, import, supply, administer or deal in any
manner with any medicine or allied substance without a marketing
authorisation issued by the Authority.
(2) A person who intends to place on the market, advertise,
market, manufacture, sell, import, supply, administer or deal in any
manner with any medicine or allied substance shall apply to the
Authority for a marketing authorisation in the prescribed manner
and form.
(3) A person who contravenes subsection (1) commits an offence
and is liable, upon conviction, to a fine not exceeding two million
penalty units or to imprisonment for a period not exceeding four
years, or to both.
(4) This section does not apply to—
(a) donated medicines;
(b) a person importing medicine for that person’s use or for
the use of that person’s relative, if the quantity of the
imported medicine is based on the prescription;
(c) a physician, dentist or veterinary surgeon importing
medicine on the physician’s, dentist’s or veterinary
surgeon’s order for administration to a person or animal,
if the quantity of the imported medicine is based on a
prescription;
(d) medicine manufactured under the supervision of a
pharmacist or by a pharmacist—
(i) for sale in the pharmacist’s own pharmacy; or
(ii) in a hospital for its use;
Marketing
authorisation