excluding any power, duty or function referred to in subsection (1), conferred or imposed on the
Director-General by or in terms of this Act.
[S. 34A inserted by s. 2 of Act No. 19 of 1976, substituted by s. 15 of Act No. 94 of 1991. Sub-s. (2)
amended by s. 22 (b) of Act No. 90 of 1997.]
Wording of Sections
35. Regulations.—(1) The Minister may, in consultation with the council, make regulations—
(i)
prescribing the categories of persons by whom application may be made for the
registration of any medicine or to whom a certificate of registration may be transferred;
(ii)
prescribing the forms which shall be used for any application for the registration of any
medicine and the particulars which shall be furnished with any such application (including particulars
regarding the method by which the medicine in question or any component of such medicine is
manufactured and the premises at which such medicine or any such component is manufactured);
(iii)
providing for the classification of medicines into classes or categories for the purposes
of this Act;
(iv)
prescribing the samples of any medicine and the quantity thereof which shall
accompany any application for the registration of a medicine;
(v)
prescribing the form in which the medicines register shall be kept and the particulars
which shall be entered therein in respect of any registered medicine;
(vi)
prescribing the form of any certificate of registration of any medicine;
(vii)
prescribing the circumstances in which, the conditions on which and the persons or
categories of persons to whom any medicine or Scheduled substance may be sold;
(viii)
prescribing the manner in which any package containing any medicine or Scheduled
substance shall be labelled, packed or sealed;
(ix)
prescribing the particulars in regard to the use thereof which shall be furnished with
any medicine or Scheduled substance sold, and the manner in which such particulars shall be furnished;
(x)
prescribing the particulars which shall appear in any advertisement relating to any
medicine or Scheduled substance, or prohibiting the inclusion of any specified particulars in such
advertisement, or the distribution of any such advertisement to a specified person or a specified
category of persons or to a specified organisation or a specified category of organisations;
(xi)
prescribing the requirements with which any medicine or any component thereof shall
comply in regard to composition, therapeutic suitability and effect, purity or any other property;
(xii)
prescribing the particulars which shall be published in the Gazette in respect of any
application for registration referred to in section 15 (11);
(xiii)
prescribing the procedure at meetings of the council and of any committee appointed
under section 9 (including the quorum in the case of committees) and the manner in which meetings of
any such committee shall be called;
(xiv)
prescribing the particulars which shall 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 shall be issued and the period for which any such prescription or order shall be retained;
(xv)
prescribing the forms of licences, registers, prescription books, records and other
documents which shall be kept or used in respect of Scheduled substances, the manner in which they
shall be kept, the particulars which shall be entered therein and the place where and the period for
which they shall be retained;
(xvi)
requiring the furnishing of returns, reports and information in respect of Scheduled
substances and plants from which any such substance can be extracted, derived, produced or
manufactured, and in respect of any medicine or other substance of which any such Scheduled
substance is a component;
(xvii)
as to the transshipment or the exportation from or importation into the Republic of any
Scheduled substance, specifying the ports or places at which such substance may be brought into the
Republic;
(xviii)
authorising and regulating or restricting the transmission through the Republic of
Scheduled substances;
(xix)
prescribing the manner in which packages containing Scheduled substances shall be
labelled when imported into or manufactured in the Republic and the persons by whom and the manner
in which they shall be kept;
(xx)
authorising and regulating the purchase, acquisition, keeping or use of preparations of
cocaine by managers or persons in charge of factories or workshops in connection with the treatment of
eye injuries or for other essential purposes;
(xxi)
authorising and regulating the purchase, acquisition, keeping or use of Scheduled
substances by particular persons or categories of persons;
(xxii)
authorising and regulating the possession by persons entering or departing from the
Republic of specified quantities of Scheduled substances for personal medicinal use;
(xxiii)
as to the disposal or destruction of a medicine or a Scheduled substance, and the
records which shall be kept in respect thereof;
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