(d)
any medicine or scheduled substance may be possessed for sale by a pharmacist, a
person licenced to own a pharmacy in terms of the Pharmacy Act, 1974, or a person who is the holder
of a licence as contemplated in section 22C.
(17) For the purposes of this section—
(a)
“authorised prescriber” means a medical practitioner, dentist, veterinarian,
practitioner, nurse or other person registered under the Health Professions Act, 1974; and
(b)
“medicinal purpose” means for the purposes of the treatment or prevention of a
disease or some other definite curative or therapeutic purpose, but does not include the satisfaction or
relief of a habit or craving for the substance used or for any other such substance, except where the
substance is administered or used in a hospital or similar institution maintained wholly or partly by the
Government or a provincial government or approved for such purpose by the Minister.
[S. 22A inserted by s. 21 of Act No. 65 of 1974, amended by s. 9 of Act No. 17 of 1979 and by s. 7 of
Act No. 71 of 1991, substituted, and subsequently re-substituted (after amendment), by s. 9 of Act No.
94 of 1991 and by s. 13 of Act No. 90 of 1997.]
Wording of Sections
22B. Publication of information relating to medicine, Scheduled substance or medical device.—
(1) Notwithstanding the provisions of section 34 the council may, if it deems it expedient and in the
public interest, disclose information in respect of the prescribing, dispensing, administration and use of a
medicine, Scheduled substance or medical device.
(2) The Director-General may publish the information referred to in subsection (1) or release it to the
public in a manner which he thinks fit.
[S. 22B inserted by s. 10 of Act No. 94 of 1991.]
22C. Licensing.—(1) Subject to the provisions of this section—
(a)
the Director-General may on application in the prescribed manner and on payment of
the prescribed fee issue to a medical practitioner, dentist, practitioner, nurse or other person registered
under the Health Professions Act, 1974, a licence to compound and dispense medicines, on the
prescribed conditions;
(b)
the council may, on application in the prescribed manner and on payment of the
prescribed fee, issue to a manufacturer, wholesaler or distributor of a medicine or medical device a
licence to manufacture, import or export, act as a wholesaler of or distribute, as the case may be, such
medicine or medical device, upon such conditions as to the application of such acceptable quality
assurance principles and good manufacturing and distribution practices as the council may determine.
[Para. (b) substituted by s. 6 (a) of Act No. 59 of 2002.]
Wording of Sections
(2) A licence referred to in subsection shall (1) (a) shall not be issued unless the applicant has
successfully completed a supplementary course determined by the South African Pharmacy Council
after consultation with the Health Professions Council of South Africa, the Allied Health Professions
Council of South Africa and the South African Nursing Council.
[Sub-s. (2) substituted by s. 6 (b) of Act No. 59 of 2002.]
Wording of Sections
(3) The Director-General or the council, as the case may be, may require an applicant contemplated in
subsection (1) to furnish such information, in addition to any information furnished by the applicant in
terms of the said subsection, as the Director-General or the council may deem necessary.
(4) When the Director-General or the council, as the case may be, grants or refuses an application for a
licence—
(a)
written notice shall be given of that fact to the applicant; and
(b)
in the event of the refusal of an application, the applicant shall be furnished with the
reasons for such refusal.
(5) No person shall compound or dispense a medicine unless he or she is authorised thereto in terms of
the Pharmacy Act, 1974, is a veterinarian or is the holder of a licence as contemplated in subsection
(1) (a).
[Sub-s. (5) substituted by s. 6 (c) of Act No. 59 of 2002.]
Wording of Sections
(6) No manufacturer, wholesaler or distributor referred to in subsection (1) (b) shall manufacture,
import, export, act as a wholesaler of or distribute, as the case may be, any medicine unless he or she is
the holder of a licence contemplated in the said subsection.
[Sub-s. (6) substituted by s. 6 (d) of Act No. 59 of 2002.]
Wording of Sections
(7) Subsections (5) and (6) shall come into operation twelve months from the date of commencement of
this section.
[S. 22C inserted by s. 14 of Act No. 90 of 1997. Sub-s. (7) substituted by s. 6 (e) of Act No. 59 of 2002.]
Wording of Sections
22D. Period of validity and renewal of licence.—A licence issued under section 22C shall be valid
for the prescribed period but may be renewed on application in the prescribed manner and before the