“veterinary medicine” means any substance or mixture of substances, other than a stock remedy or farm
feed to be registered in terms of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock
Remedies Act, 1947 (Act No. 36 of 1947), used or purporting to be suitable for use or manufactured or
sold for use in connection with vertebrates, for the treatment, diagnosis, prevention or cure of any
disease, infection or other unhealthy condition, or for the maintenance or improvement of health, growth,
production or working capacity, or for curing, correcting or modifying any somatic or organic function, or
for correcting or modifying behaviour.
[Definition of “veterinary medicine” added by s. 1 (h) of Act No. 17 of 1979.]
(2) Subject to section 15C, a medicine shall, notwithstanding the fact that its components are identical
to those of any other medicine as to physical characteristics, quantity and quality, for the purpose of this
Act not be regarded as being the same medicine as that other medicine if registration thereof is not
applied for by the holder of the certificate of registration issued in respect of that other medicine.
[Sub-s. (2) substituted by s. 1 (i) of Act No. 17 of 1979, by s. 1 (g) of Act No. 20 of 1981 and by s. 1 ( j)
of Act No. 90 of 1997.]
Wording of Sections
(3) In determining whether or not the registration or availability of a medicine is in the public interest,
regard shall be had only to the safety, quality and therapeutic efficacy thereof in relation to its effect on
the health of man or any animal, as the case may be.
[Sub-s. (3) substituted by s. 1 ( j) of Act No. 17 of 1979.]
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(4) International tendering for medicines shall be allowed in the prescribed manner and on the
prescribed conditions.
[S. 1 substituted by s. 1 (1) of Act No. 65 of 1974. Sub-s (4) added by s. 1 (k) of Act No. 90 of 1997.]
Wording of Sections
2. Establishment, powers and functions of Medicines Control Council.—(1) There is hereby
established a council to be known as the Medicines Control Council, which may exercise the powers
and shall perform the functions conferred upon or assigned to the council by this Act.
(2) The Council may advise the Minister or furnish a report to the Minister on any matter referred to the
council by the Minister for consideration and arising from the application of this Act.
[Sub-s. (2) added by s. 2 of Act No. 94 of 1991.]
(3) The council shall be a juristic person.
[S. 2 substituted by s. 2 (1) of Act No. 65 of 1974. Sub-s. (3) added by s. 2 of Act No. 90 of 1997.]
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3. Constitution of council.—The council shall consist of so many members, but not more than 24, as
the Minister may from time to time determine and appoint.
[S. 3 amended by s. 3 of Act No. 65 of 1974, by s. 1 of Act No. 36 of 1977, by s. 2 of Act No. 17 of 1979,
by s. 46 of Act No. 97 of 1986 and by s. 3 of Act No. 94 of 1991 and substituted by s. 3 of Act No. 90 of
1997.]
Wording of Sections
4. Period of office and remuneration of members of the council.—(1) A member of the council
shall, subject to the provisions of section 6 (3), be appointed for a period of five years but a new council
shall be appointed within six months after the date of commencement of the Medicines and Related
Substances Control Amendment Act, 1997.
[Sub-s. (1) substituted by s. 4 of Act No. 90 of 1997.]
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(2) Any person whose period of office as a member of the council has expired, shall be eligible for
reappointment: Provided that no person who has served two periods of five years as a member shall be
so eligible.
[Sub-s. (2) substituted by s. 4 of Act No. 90 of 1997.]
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(3) The Minister shall give notice in the Gazette of the appointment of any member of the council and
the date from which his membership commences and, in the case of a member appointed to fill a casual
vacancy on the council, the period for which he is appointed.
(4) A member of the council (other than a person who is in the full-time employment of the State) shall
receive such remuneration and such allowances in respect of his services as a member of the council or
of any committee thereof, as the Minister in consultation with the Minister of Finance may determine.
[Sub-s. (4) substituted by s. 4 (1) of Act No. 65 of 1974.]
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5. Chairman and vice-chairman.—(1) One of the members of the council shall be designated by the
Minister as chairman of the council and another member shall be designated by the Minister as vicechairman to act as chairman during the absence of the chairman.
[Sub-s. (1) amended by s. 46 of Act No. 97 of 1986.]
Wording of Sections

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