Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)

1. Definitions

Purchase

(1)	In this Act, unless the context otherwise indicates—

"advertisement"

in relation to any medicine, Scheduled substance, medical device or IVD, means any written, pictorial, visual or other descriptive matter or verbal statement or reference—

(a)	appearing in any newspaper, magazine, pamphlet, electronic media (including radio and television) or other publication;

(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, Scheduled substance, medical device or IVD; and "advertise" has a corresponding meaning;

[Definition substituted by section 1(a) of Notice No. 19, GG 39585, dated 8 January 2016]

"advisory committee"

[Definition deleted by section 1(b) of Notice No. 19, GG 39585, dated 8 January 2016]

"analyst"

means an analyst to whom authority has been granted under section 27;

"appeal board"

[Definition deleted by section 1(a) of Act No. 94 of 1991]

"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 substituted by section 1(a) of Act No. 90 of 1997]

"Authority"

means the south African Health Products Regulatory Authority established by section 2;

[Definition inserted by section 1(b) of Notice No. 434, GG 32148, dated 21 April 2009]

"Board"

means the Board referred to in section 2;

[Definition inserted by section 1(c) of Notice No. 19, GG 39585, dated 8 January 2016]

"certificate of registration"

means a certificate of registration issued under section 15(4), 15A(4) or 15B(4);

[Definition inserted by section 1 of Act No. 20 of 1981]

"cosmetic"

[Definition deleted by section 1(d) of Notice No. 19, GG 39585, dated 8 January 2016]

"council"

[Definition deleted by section 1(d) of Notice No. 19, GG 39585, dated 8 January 2016]

"dentist"

means a person registered as such under the Health Professions Act, 1974;

[Definition substituted by section 1(b) of Act No. 90 of 1997]

"Director-General"

means the Director-General: Health;

[Definition substituted by section 1(c) of Act No. 90 of 1997]

"export"

includes deliver or supply within the Republic for dispatch to any destination outside the Republic;

[Definition inserted by section 1(a) of Act No. 17 of 1979]

"foodstuff"

[Definition deleted by section 1(e) of Notice No. 19, GG 39585, dated 8 January 2016]

"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 inserted by section 1(b) of Act No. 17 of 1979]

"inspector"

means a person authorized as such under section 26;

"interchangeable multi-source medicine"

means medicines that contain the same active substances which are identical in strength or concentration, dosage form and route of administration and meet the same or comparable standards, which comply with the requirements for therapeutic equivalence as prescribed;

[Definition inserted by section 1(d) of Act No. 90 of 1997]

"IVD"

(in vitro diagnostic) means a medical device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes;

[Definition substituted by section 1(f) of Notice No. 19, GG 39585, dated 8 January 2016]

"label"

when used as a verb, means brand, mark or otherwise designate or describe, and when used as a noun, means any brand or mark or any written, pictorial or other descriptive matter appearing on or attached to or packed with and referring to any article or the package containing any article;

"magistrate"

means a magistrate as defined in section 1 of the Magistrates Act, 1993 (Act No. 90 of 1993), and includes an additional magistrate and an assistant magistrate;

[Definition inserted by section 1(a) of Act No. 59 of 2002]

"Medical Act"

[Definition deleted by section 1(e) of Act No. 90 of 1997]

"medical device"

means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, including Group III and IV Hazardous Substances contemplated in the Hazardous Substances Act, 1973 (Act No. 15 of 1973)—

(a)	intended by the manufacturer to be used, alone or in combination, for humans or animals, for one or more of the following:

(i)	diagnosis, prevention, monitoring, treatment or alleviation of disease;

(ii)	diagnosis, monitoring, treatment, alleviation of or compensation for an injury;

(iii)

investigation, replacement, modification or support of the anatomy or of a physiological process;

(iv)	supporting or sustaining life;

(v)	control of conception;

(vi)	disinfection of medical devices; or

(vii)

providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and

(b)	which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human or animal body, but which may be assisted in its intended function by such means;

[Definition substituted by section 1(h) of Notice No. 19, GG 39585, dated 8 January 2016]

"medical device or IVD establishment"

means a facility used by a manufacturer, wholesaler, distributor, retailer, service provider or an importer of medical devices or IVDs for conducting business;

[Definition inserted by section 1(h) of Notice No. 434, GG 32148, dated 21 April 2009]

"medical practitioner"

means a person registered as such under the Health Professions Act, 1974, and includes an intern registered under that Act;

[Definition substituted by section 1(f) of Act No. 90 of 1997]

"medicinal purpose"

[Definition deleted by section 1(e) of Act No. 94 of 1991]

"medicine"

(a)	means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in—

(i)	the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in humans; or

(ii)	restoring, correcting or modifying any somatic or psychic or organic function in humans; and

(b)	includes any veterinary medicine;

[Definition substituted by section 1(g) of Notice No. 19, GG 39585, dated 8 January 2016]

"Minister"

means the Minister of Health;

[Definition substituted by section 1(g) of Act No. 90 of 1997]

"nurse"

means a person registered as such under the Nursing Act, 1978 (Act No. 50 of 1978);

[Definition inserted by section 1(g) of Act No. 94 of 1991]

"package"

means anything in or by which any medicine or Scheduled substance is enclosed, covered, contained or packed;

"pathologist"

means a pathologist to whom authority has been granted under section 27;

"pharmacist"

means a person registered as such under the Pharmacy Act, 1974;

[Definition substituted by section 1(h) of Act No. 94 of 1991]

"pharmacist intern"

means a person registered as such under the Pharmacy Act, 1974;

[Definition substituted by section 1(h) of Act No. 90 of 1997]

"pharmacist's assistant"

means a person registered as such under the Pharmacy Act, 1974;

[Definition inserted by section 1(h) of Act No. 90 of 1997]

"pharmacologist"

except for the purposes of section 24(1)(c), means a pharmacologist to whom authority has been granted under section 27;

[Definition substituted by section 1(j) of Act No. 94 of 1991]

"pharmacy Board"

[Definition deleted by section 1(k) of Act No. 94 of 1991]

"practitioner"

means a person registered as such under the Allied Health Professions Act, 1982 (Act No. 63 of 1982);

[Definition substituted by section 1(b) of Act No. 59 of 2002]

"prescribed"

means prescribed by or under this Act;

"product"

[Definition deleted by section 1(i) of Notice No. 19, GG 39585, dated 8 January 2016]

"public"

includes a section of the public concerned with manufacturing, dispensing, selling or administering, or the issue of prescriptions for, medicines or a Scheduled substance;

[Definition inserted by section 1(e) of Act No. 20 of 1981]

"register"

when used as a noun, means the register referred to in section 13, and when used as a verb, means to enter in such register;

"registered"

means entered in the register;

"registrar"

[Definition deleted by section 1(k) of Notice No. 434, GG 32148, dated 21 April 2009]

"regulation"

means a regulation made and in force under this Act;

"Scheduled substance"

means any medicine or other substance prescribed by the Minister under section 22A;

[Definition substituted by section 1(m) of Act No. 94 of 1991]