Act No. 13, 2003
MEDICINES AND RELATED SUBSTANCES
CONTROL ACT, 2003
(e)
prescribing the form of a certificate of registration of a medicine to be issued
under this Act;
(f)
prescribing the form and manner of an application for a permit or a licence
in terms of this Act, the manner of issuing a permit or a licence and the form
of every permit or licence;
(g)
prescribing the form in which the register of medicines, which are not
veterinary medicines or complementary medicines, the veterinary medicines
register, the complementary medicines register and any register required in
this Act must be kept and the particulars which must be entered in it;
(h)
prescribing the forms of registers, prescription books, records, and other
documents, which must be kept or used in respect of scheduled substances,
the manner in which they must be kept, the particulars which must be entered
in them and the place where, and the period for which, they must be retained;
(i)
prescribing the particulars which must appear on a prescription or an order
for a medicine or a scheduled substance, the number of issues of a medicine
or a scheduled substance that may be made on any such specified prescription
or order, the manner in which any such prescription or order must be issued
and the period for which any such prescription or order must be retained;
(j)
prescribing the samples of a medicine and the quantity of that medicine,
which must accompany an application for the registration of a medicine ;
(k) subject to section 29, prescribing the circumstances in which, the conditions
on which, and the persons or categories of persons by whom or to whom, a
medicine or a scheduled substance may be sold;
(l)
prescribing the manner in which a package containing a medicine or a
scheduled substance must be labeled, packed or sealed;
(m) prescribing the particulars to be furnished with a medicine or a scheduled
substance sold regarding its use, and the manner in which those particulars
must be furnished;
(n)
prescribing the particulars which must appear in an advertisement relating
to a medicine or a scheduled substance or prohibiting the inclusion of any
specified particulars in an advertisement relating to a medicine or a scheduled
substance, or the distribution of any such advertisement to a specified person
or specified category of persons or to a specified organisation or a specified
category of organisations;
(o)
prescribing the requirements with which a medicine or any component of
that medicine must comply in regard to composition, therapeutic suitability
and effect, purity or any other property;
(p)
prescribing the particulars which must be published in the Gazette in respect
of a notice required to be given in the Gazette in terms of this Act;
(q)
prescribing the procedure at meetings of the Council and of any committee,
other than the appeal committee appointed in terms of section 34, including
the quorum in the case of a committee, and the manner in which meetings
of a committee must be called;
(r)
requiring the furnishing of returns, reports and information in respect of
scheduled substances, and plants from which any such substance can be
extracted or manufactured, and in respect of a medicine or other substance
of which a scheduled substance is a component;