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Drugs Control Amendment Act


Published: 1974-10-30

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Drugs Control Amendment Act, 1974
REPUBLIC OF SOUTH AFRICA
GOVERNMENT GAZETTE
STAATSKOERANT VAN DIE REPUBLIEK VAN SUID-AFRIKA
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CAPE TOWN, 30 OCTOBER 1974
KAAPSTAD, 30 OKTOBER 1974 [No. 4469
DEPARTMENT OF THE PRIME MINISTER DEPARTEMENT VAN DIE EERSTE MINISTER
No. 2000. 30 October 1974. No. 2000. 30 Oktober 1974.
It is hereby notified that the State President has assented to the following Act which is hereby published for general information:-
No. 65 of 1974: Drugs Control Amendment Act, 1974.
Hierby word bekend gemaak dat die Staatspresident sy goedkeuring geheg bet aan die onderstaande Wet wat hierby ter algemene inligting gepubliseer word:-
No. 65 van 1974: Wysigingswet op die Beheer van Medisyne, 1974.
GOVERNMENT GAZETTE, 30 OCTOBER 1974
DRUGS CONTROL AMENDMENT ACT, 1974.
·ACT To amend the Drugs Control Act, 1965, so as to replace or define
or further define certain expressions; to substitute the ap- pellation "medicine" for the appellation "drug" in the English text, and to effect certain textual changes in that text ~sing out of such substitution; to further regulate the control of medicines; to further regulate the C!lnstitution of the Medicines Control Council and the remuneration of its members, of the members of its committees and of the members of the Medicines Control Appeal Board; to provide for the control of Scheduled substanceS; to make new pro- vision for inspectors, analysts, pharmacologists and patho- logists considered necessary for the proper enforcement of the said Act; and to effect. a change in relation to the power to make regulations; and to provide for matters connected therewith.
(English text signed by the State President.) (Assented to 23 October 1974.)
BE IT ENACTED by the State President, the Senate and the House of Assembly of the Republic of South Africa, as
follows:-
Act No. 65, 1974 ·
1. (1) The following section is hereby substituted for section 1 Sub~titution of of. th~ Drugs Control Act, 1965 (hereinafter referred to as the ~:~~gl ~f1965 pnnc1pal Act): c 0 • "Definitions. 1. (1) In this Act, unless the context otherwise
indicates- (i) '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 or other pub-
lication; or (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; (i)
(ii) 'analyst' means an analyst to whom authority has been granted under section 27; (xxix)
(iii) 'appeal board' means the Medicines Control Appeal Board established by section 10; (ii)
(iv) 'approved name', in relation to a medicine, means the internationally recognized name of such medicine or such other name as the council may determine, not being a brand name or trade name registered in terms of the Trade Marks Act, 1963 (Act No. 62 of 1963); (xxi)
(v) 'council' means the Medicines Control Council established by section 2; (xxxii)
(vi) 'dentist' means a person registered as such under the Medical Act; (xxxvii)
GOVERNMENT GAZETTE, 30 OCTOBER 1974
DRUGS CONTROL AMENDMENT ACT, 1974.
(vii) 'hospital' means any institution established as a hospital or· a nursing home or registered as such in terms of any law; (xxiii)
(viii) 'inspector' means a person authorized as such under section 26; (xxiv)
(ix) '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; (xvi)
(x) 'Medical Act' means the Medical, Dental and Supplementary Health Service Professions Act, 1974; (xli)
(xi) 'medical practitioner' means a person registered as such under the Medical Act, and includes an intern registered under that Act; (xix)
(xii) 'medicinal purpose', in relation to a Scheduled substance, means 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 ad- ministered or used in a hospital or similar institution maintained wholly or partly by the Government or a Provincial Administration or the Administration of the territory, or approved for this purpose by the Minister; (v)
(xiii) 'medicine' means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in- ( a) the diagnosis, treatment, mitigation, modi-
fication or prevention of disease, abnormal physical or mental state or the symptoms thereof in man; or
(b) restoring, correcting or modifying any somatic or psychic or organic function in man; (xxvi)
(xiv) 'Minister' means the Minister of Health; (xxvii) (xv) 'package' means anything in or by which any
medicine or Scheduled substance is enclosed, covered, contained or packed; (xxx)
(xvi) 'pathologist' means a pathologist to whom authority has been granted under section 27; (xxxi)
(xvii) 'pharmacist' means a person registered as such under the Pharmacy Act, 1974; (iii)
(xviii) 'pharmacologist', except for the purposes of paragraph (c) of subsection (I) of section 10, means a pharmacologist to whom authority has been granted under section 27; (xvii)
(xix) 'pharmacy Board' means the South African Pharmacy Board referred to in section 2 of the Pharmacy Act, 1974; (iv)
(xx) 'prescribed' means prescribed by or under this Act; (xl)
(xxi) '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; (xxxiii)
(xxii) 'registered' means entered in the register; (xx) (xxiii) 'registrar' means the Registrar of Medicines
appointed under section 12; (xxxiv) (xxiv) 'regulation' means a regulation made and in
force under this Act; (xxxv)
No. 4469 s
Act No. 65, 1974
GOVERNMENT GAZETTE, 30 OCTOBER 1974
DRUGS CONTROL AMENDMENT ACT, 1974.
(xxv) 'Scheduled substance' means any medicine or other substance included in any Schedule to this Act; (xviii)
(xxvi) 'Schedule I substance' means any medicine or other substance included in Schedule 1 to this Act; (vi)
(xxvii) 'Schedule 2 substance' means any medicine or other substance included in Schedule 2 to this Act; (vii)
(xxviii) 'Schedule 3 substance' means any medicine or other substance included in Schedule 3 to this Act; (viii)
(xxix) 'Schedule 4 substance' means any medicine or other substance included in Schedule 4 to this Act; (ix)
(xxx) 'Schedule 5 substance' means any medicine or other substance included in Schedule 5 to this Act; (x)
(xxxi) 'Schedule 6 substance' means any medicine or other substance included in Schedule 6 to this Act; (xi)
(xxxii) 'Schedule 7 substance' means any medicine or other substance included in Schedule 7 to this Act; (xii) .
(xxxiii) 'Schedule 8 substance' means any medicine or other substance included in Schedule 8 to this Act; (xiii)
(xxxiv) 'Schedule 9 substance' means any medicine or other substance included in Schedule 9 to this Act; (xiv)
(xxxv) 'Secretary' means the Secretary for Health; (xxxvi)
(xxxvi) 'sell' means sell by wholesale or retail and in- cludes import, offer, advertise, keep, expose, transmit, consign, convey or deliver for sale or authorize, direct or allow a sale or prepare or possess for purposes of sale, and barter or exchange or supply or dispose of to any person whether for a consideration or otherwise; and 'sale' and 'sold' have corresponding meanings; (xxxix)
(xxxvii) 'this Act' includes any regulation; (xxii) (xxxviii) 'the territory' means the territory of South-West
Africa; (xv) (xxxix) 'trainee pharmacist' means a trainee pharma-
cist as defined in the Pharmacy Act, 1974; (xxv) (xi) 'unqualified assistant' means an unqualified
assistant as defined in the Pharmacy Act, 1974; (xxviii)
(xli) 'veterinarian' means a person registered as such under the Veterinary Act, 1933 (Act No. 16 of 1933). (xxxviii)
(2) A medicine produced either within or outside the Republic shaH, notwithstanding the fact that its components are identical to those of any other medicine as to physical characteristics, quantity and quality, for the purposes of this Act not be regarded as being the same medicine as that other medicine if registration thereof is not applied for by the same applicant or if it is not presented in the same form as that other medicine.
(3) In determining whether or not the registration or availability of a medicine is in the public interest, regard shaH be had only to the safety, quality and therapeutic efficacy thereof in relation to its effect on the health of man.".
No. 4469 7
Act No. 65, 1974
GOVERNMENT GAZETTE, 30 OCTOBER 1974
DRUGS CONTROL AMENDMENT ACT, 1974.
(2) Any reference, in any law or elsewhere, to a drug as defined in section I of the principal Act prior to the substitution thereof by subsection (I) of this section, shall be deemed to be a reference to a medicine as defined in the said section I as so substituted.
No. 4469
Act No. 65, 1974
2. (I) The following section is hereby substituted for section Subti~titu2tionf of 2fh ""lA secono o t e pnnc1pa ct: Act 101 of 1965. "Establish- 2. There is hereby established a council to be ment, d known as the Medicines Control Council, which may f~~~fun~of exercise the powers and shall perform the functions Medicines conferred upon or assigned to the council by this Control Act.". Council.
(2) The Drugs Control Council established by section 2 of the principal Act prior to the substitution thereof by subsection (I) of this section, shall for all purposes be deemed to be and at all times to have been the Medicines Control Council referred to in the said section 2 as substituted by the said subsection (1), and any ·reference in any law or elsewhere to the Drugs Control Council shall be construed accordingly.
3. Section 3 of the principal Act is hereby amended- Am~ndment of (a) by the ~ubstitution for subsection (I) of the following ~~~g130~f1965.
subsectiOn: "(1) The council shall consist of not less than seven
or more than eleven members as may from time to time be determined by the State President.";
(b) by the substitution for paragraph (a) of subsection (2) of the following paragraph:
"(a) at least two persons who shall be medical practi- tioners who have a speciality in medicine entered in the appropriate register contemplated in section I9 of the Medical Act;";
(c) by the substitution, in paragraph (c) of that subsection, for the word "drugs" of the word "medicines"; and
(d) by the substitution for paragraph (d) of that subsection of the following paragraph:
"(d) at least one person who shall be a pharmacist;".
4. (I) Section 4 of the principal Act is hereby amended by the Am~ndment of substitution for subsection (4) of the following subsection: ~~~~g140~f1965
"(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.".
(2) Notwithstanding the provisions of section 4 (I) of the principal Act, any person who is at the commencement of this Act a member of the council referred to in that section, shall vacate his office as such on a date fixed by the State President by proclamation in the Gazette.
5. Section 6 of the principal Act is hereby amended- Am~ndi~;e~t of (a) by the substitution for paragraph (b) of subsection (I) ~~:'~81 0~ 1965.
of the following paragraph: "(b) who is disqualified under the Medical Act or the
Pharmacy Act, I974, from carrying on his pro- fession, while so disqualified;";
(b) by the substitution for paragraph (c) of that subsection of the following paragraph;
"(c) who has a direct or an indirect interest in the sale of any medicine; or";
(c) by the substitution for paragraph (c) of subsection (2) of the following paragraph:
9
GOVERNMENT GAZETTE, 30 OCTOBER 1974
DRUGS CONTROL AMENDMENT ACT, 1974.
"(c) if he becomes mentally ill, as defined in the Mental Health Act, 1973 (Act No. 18 of 1973);"; and
(d) by the substitution for subsection ( 4) of the following subsection:
"(4) For the purposes of paragraph (c) of subsection (1) a medical practitioner or a pharmacist shall not be deemed to have an interest in the sale of any medicine by reason only of the fact that-
(a) in the case of a medical practitioner, he sells the medicine in question in the course of carrying on his professional activities as a medical practitioner; or
(b) in the case of a pharmacist, he sells the medicine in question by retail in the course of carrying on his professional activities as a pharmacist.".
No.4469
Act No. 65, 1974
6. Section 7 of the principal Act is hereby amended by the Am~ndrnent of substitution for subsection (2) of the following subsection: ~~:·~g170~f1965 .
"(2) The chairman of the council may at any time call a special meeting of the council to be held at such time and place as he may determine, and shall, upon a written request by the Minister or a written request signed by not less than three members of the council, call a special meeting thereof to be held within thirty days after the date of receipt of such request, at such time and place as he may determine.".
7. Section 9 of the principal Act is hereby amended by the Amendment of substitution for subsection ( 4) of the following subsection: section 9 of
Act 101 of 1965. "( 4) There shall be payable to a member of a committee
of the council (other than a member of the council or a person who is in the full-time employment of the State) such remuneration and such allowances, while he is engaged in the carrying out of his duties as a member of such com- mittee, as the Minister may, in consultation with the Minister of Finance, determine.".
8. (I) The following section is hereby substituted for section Substitution of 10 of the principal Act: section 10 of
Act 101 of 1965. "Establish- ment of Medicines Control Appeal Board.
10. (I) There is hereby established a board to be known as the Medicines Control Appeal Board, which shall consist of three members to be appointed by the State President, of whom- ( a) one shall be a retired judge or an advocate of the
Supreme Court of South Mrica, who shall be the chairman of the board;
(b) one shall be a medical practitioner who has a speciality in medicine entered in the appropriate register contemplated in section 19 of the Medical Act; and
(c) one shall be a pharmacologist. (2) The provisions of section 4 shall mutatis
mutandis apply in respect of a member of the appeal board."
(2) The Drugs Control Appeal Board established by section IO of the principal Act prior to the substitution thereof by sub- section (1) of this section, shall for all purposes be deemed to be and at all times to have been the Medicines Control Appeal Board referred to in the said section 10 as substituted by the said subsection (I), and any reference in any law or elsewhere to the said Drugs Control Appeal Board shall be construed accor- dingly.
II
GOVERNMENT GAZETTE, 30 OCTOBER 1974 No. 4469
DRUGS CONTROL AMENDMENT ACT, 1974; Act No. 65, 1974
9. Section 11 of the principal Act is hereby amended- Amendment of section 11 of
(a) by the substitution for paragraph {f) of subsection (I) Act 101 of 1965. of the following paragraph:
"(f) if he has a direct or an indirect interest in the sale of any medicine;
(b) by the substitution for paragraph (g) of the said sub- section {l) of the following paragraph:
"(g) if he has been granted authority under section 27; or"
(c) by the substitution for paragraph (c) of subsection (2) of the following paragraph:
"(c) if he becomes mentally ill, as defined in the Mental Health Act, 1973 (Act No. 18 of 1973);"; and
(d) by the substitution, in subsection (4), for the word "drug", wherever it occurs, of the word "medicine".
10. {l) The following section is hereby substituted for section Substitution of 12 of the principal Act: section 12 of
Act 101 of 1965. "Appoint- 12. {l) The Minister may, subject to the laws ~en~ ff f governing the public service and after consultation Je~fcf!!s~ with the council, appoint an officer to be styled the
Registrar of Medicines who shall perform the functions and carry out the duties assigned to or imposed upon the registrar by or under this Act and such other functions and duties as may from time to time be assigned to or imposed upon him by the Minister or the Secretary.
{2) The registrar shall also act as secretary of the council.".
(2) (a) Any reference in any other law to the Registrar of Drugs referred to in section 12 of the principal Act prior to the substitution thereof by subsection {l) of this section, shall be construed as a reference to the Registrar of Medicines referred to in the said section 12 as substituted by the said subsection (1).
(h) Anything done by the said Registrar of Drugs prior to the commencement of this section in the administration of any law, shall be deemed to have been done by the said Registrar of Medicines.
(c) The person who held office as the said Registrar of Drugs immediately prior to the commencement of this section, shall be deemed to have been appointed as the said Registrar of Medicines under section 12 of the principal Act as substituted by subsection {l) of this section.
11. (l) Section 13 of the principal Act is hereby amended by Am~ndment of the su?,stitu~i?n for the word "drugs", wherever it occurs, of the ~~:'?81 1~f~f965 _ word med1cmes".
(2) The drugs register referred to in section l3 of the principal Act prior to the commencement of subsection (1) of this section shall be deemed to be the medicines register referred to in section 13 of the principal Act as amended by subsection (l) of this section, and any drug registered in the said drugs register prior to such commencement shall be deemed to be a medicine registered in the said medicines register.
13
GOVERNMENT GAZETTE, 30 OCTOBER 1974 No.4469
DRUGS CONTROL AMENDMENT ACT, 1974. Act No. 65, 1974
12. (1) The following section is hereby substituted for section Sub~titution of 14 of theprincipal Act· section 14 of · . Act 101 of 1965, .. . . . · . . . . . as substituted by ProhibitiOn 14. (1) Save as provided m this sectiOn or sectiOns section 1 of
onf the ~a,Ie 21 and 22A, no person shall sell any medicine which Act 29 of 1968. o me