Act No. 13, 2003
(ii)
MEDICINES AND RELATED SUBSTANCES
CONTROL ACT, 2003
of the therapeutic efficacy and effect of the medicine;
(iii) of the purpose for which, the circumstances under which, and the
manner in which, the medicine should be used; and
(iv) regarding any other matter concerning the medicine, which, in the
opinion of the Council, may be of value to those persons;
(b)
after the registration of a medicine has been cancelled in terms of section
22, cause medical practitioners, dentists, pharmacists, veterinarians,
practitioners and the holder of the certificate of registration issued in respect
of that medicine to be informed of the cancellation of the registration.
Control of medicines and scheduled substances
29. (1) The Minister, on the recommendation of the Council and for the
purpose of the control of medicines and other substances
(a)
must classify medicines and other substances, by notice in the Gazette, as
Schedule 1, Schedule 2, Schedule 3, Schedule 4 or Schedule 5 substances;
and
(b)
may from time to time amend the Schedules referred to in paragraph (a) by
notice in the Gazette:
Provided that the Council must recommend only those medicines and other substances,
which it considers necessary to be classified.
(2) Subject to this section, a person may not sell a medicine or a scheduled
substance, except in accordance with the prescribed conditions.
(3) Except as provided under the regulations made under section 44(1)(u)
relating to own use, a person may not
(a)
(b)
in respect of medicines or scheduled substances
(i)
manufacture or pack and sell those medicines or scheduled substances,
unless the person holds a licence contemplated in section 31(5)(a) or
(b) for the manufacture or packing and selling and the person complies
with the specified conditions;
(ii)
import or export those medicines or scheduled substances, unless the
person holds a licence contemplated in section 31(5)(c) for the import
or export and the person complies with the conditions determined by
the Council;
in respect of a scheduled substance, which is a Schedule 3 substance or
Schedule 4 substance
(i)
manufacture or pack and sell the substance, unless the person holds a
licence contemplated in section 31(5)(a) or (b), and in addition, holds
a permit referred to in subsection (15)(a) or (23)(a), as the case may
be, for the manufacture or packing and selling of the Schedule 3
substance or Schedule 4 substance specified in the permit and the
person complies with the prescribed conditions;
(ii)
import or export the substance, unless the person holds a licence
contemplated in section 31(5)(c), and in addition, holds a permit