MEDICINES AND RELATED SUBSTANCES ACT NO 101 OF 1965, AS AMENDED
To provide for the registration of medicines and related substances intended for human and for
animal use; to provide for the establishment of a Medicines Control Council; to provide that such
council shall be a juristic person; to make other provision for the constitution of the council; to
provide that a member of the council or committee shall declare his or her commercial interest
related to the pharmaceutical or health care industry; to provide that the appointment of
members of the executive committee is subject to the approval of the Minister; to provide for the
control of medicines and scheduled substances and medical devices; to make further provision
for the prohibition on the sale of medicines which are subject to registration and are not
registered; to provide for procedures that will expedite the registration of essential medicines,
and for the re-evaluation of all medicines after five years; to provide for measures for the supply
of more affordable medicines in certain circumstances; to provide that labels be approved by the
council; to prohibit sampling and bonusing of medicines; to provide for the licensing of certain
persons to compound, dispense or manufacture medicines and medical devices and also to act
as wholesalers or distributors; to provide for the generic substitution of medicines; to provide
for the establishment of a pricing committee; to regulate the purchase and sale of medicines by
manufacturers, distributors, wholesalers, pharmacists and persons licensed to dispense
medicines; to make new provisions for appeals against decisions of the Director-General or the
council; to provide that the council may acquire and appropriate funds; to regulate the Minister’s
power to make regulations; to provide for the rationalization of certain laws relating to medicines
and related substances that have remained in force in various territories on the national territory
of the Republic by virtue of item 2 of Schedule 6 to the Constitution of the Republic of South
Africa, 1996; and to provide for matters connected therewith.
[Long title substituted by s. 37 of Act No. 65 of 1974, by s. 15 of Act No. 17 of 1979, by s. 22 of Act No.
94 of 1991, by s. 29 of Act No. 90 of 1997 and by s. 13 of Act No. 59 of 2002.]
1. Definitions.—(1) In this Act, unless the context otherwise indicates—
“advertisement”, in relation to any medicine or Scheduled substance, means any written, pictorial, visual
or other descriptive matter or verbal statement or reference—
(a)
appearing in any newspaper, magazine, pamphlet or other publication; or
[Para. (a) substituted by s. 1 (a) of Act No. 20 of 1981.]
Wording of Sections
(b)
distributed to members of the public; or
(c)
brought to the notice of members of the public in any manner whatsoever,
which is intended to promote the sale of that medicine or Scheduled substance; and “advertise” has a
corresponding meaning;
“analyst” means an analyst to whom authority has been granted under section 27;
“appeal board” . . . . . .
[Definition of “appeal board” deleted by s. 1 (a) of Act No. 94 of 1991.]
Wording of Sections
“approved name”, in relation to a medicine, means the international non-proprietary name (INN) of such
medicine or, where no such name exists, such other name as the council may determine, not being a
brand name or trade name registered in terms of the Trade Marks Act, 1993 (Act No. 194 of 1993);
[Definition of “approved name” substituted by s. 1 (a) of Act No. 90 of 1997.]
Wording of Sections
“certificate of registration” means a certificate of registration issued under section 15 (4), 15A (4) or
15B (4);
[Definition of “certificate of registration” inserted by s. 1 (b) of Act No. 20 of 1981.]
“council” means the Medicines Control Council established by section 2;
“dentist” means a person registered as such under the Health Professions Act, 1974;
[Definition of “dentist” substituted by s. 1 (b) of Act No. 90 of 1997.]
Wording of Sections
“Director-General” means the Director-General: Health;
[Definition of “Director-General” inserted by s. 1 (c) of Act No. 20 of 1981 and substituted by s. 1 (b) of
Act No. 94 of 1991 and by s. 1 (c) of Act No. 90 of 1997.]
Wording of Sections
“export” includes deliver or supply within the Republic for dispatch to any destination outside the
Republic;
[Definition of “export” inserted by s. 1 (a) of Act No. 17 of 1979.]
“hospital” means any institution established as a hospital or a nursing home or registered as such in
terms of any law;
“immediate container”, in relation to a medicine or Scheduled substance, means a container which is in
direct contact with the medicine or substance;
[Definition of “immediate container” inserted by s. 1 (b) of Act No. 17 of 1979.]
“inspector” means a person authorized as such under section 26;