medicines and related substances control act 101 of 1965

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12(5) The Minister may prescribe additional requirements for the labelling of medicines.18A. BonusingNo person shall supply any medicine according to a bonus system, rebate system or any other incentive scheme.18B. Sampling of medicines(1) No person shall sample any medicine.(2) For the purposes of this section 'sample' means the free supply of medicines by a manufacturer orwholesaler or its agent to a pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse orother person registered under the Health Professions Act, 1974, but does not include the free supply ofmedicines for the purposes of clinical trials, donations of medicines to the State, tendering to the State andquality control by inspectors.(3) The use of medicines or Scheduled substances for exhibition purposes shall be as prescribed.18C. Marketing of medicinesThe Minister shall, after consultation with the pharmaceutical industry and other stakeholders, make regulationsrelating to the marketing of medicines, and such regulations shall also provide for an enforceable Code ofPractice.19. Prohibition on sale of medicines which do not comply with prescribed requirements and furnishingof information regarding medicines to the council(1) No person shall sell any medicine unless it complies with the prescribed requirements.(2) The council may by notice in writing require any person who manufactures or sells or administers orprescribes any medicine or on whose direction any medicine is administered to furnish it, within a periodstipulated in such notice, with any information which such person has in his possession or which suchperson is in a position to obtain regarding such medicine.(3) The council may, if so requested by any person to whom a notice under subsection (2) is addressed,extend the period stipulated in such notice.20. Publication or distribution of false advertisements concerning medicines(1) No person shall-(a)(b)publish or distribute or in any other manner whatsoever bring to the notice of the public or cause orpermit to be published or distributed or to be so brought to the notice of the public any false ormisleading advertisement concerning any medicine; orin any advertisement make any claim to the effect that the therapeutic efficacy and effect of anymedicine is other than that stated by the council in terms of sub-paragraph (ii) of paragraph (a) ofsection twenty-two or state or suggest that any medicine should be used for a purpose or undercircumstances or in a manner other than that stated by the council in terms of sub-paragraph (iii) orparagraph (a) of that section.(2) It shall be a sufficient defence in any prosecution for an offence under paragraph (a) of sub-section (1) if itis proved to the satisfaction of the court that the accused, not being a person selling the medicine to which
13the false or misleading advertisement which is the subject of the prosecution relates, did not know, andcould not reasonably be expected to have known, that the advertisement was in any respect false ormisleading, unless it is proved that the accused failed on demand by the registrar or an inspector or amember of the South African Police to furnish the name and address of the person at whose instance theadvertisement was published, distributed or so brought to the notice of the public.21. Council may authorize sale of unregistered medicine for certain purposes(1) The council may in writing authorize any person to sell during a specified period to any specified personor institution a specified quantity of any particular medicine which is not registered.(2) Any medicine sold in pursuance of any authority granted under sub-section (1) may be used for suchpurposes and in such manner and during such period as the council may in writing determine.(3) The council may at any time by notice in writing withdraw any authority granted in terms of sub-section(1) if effect is not given to any determination made in terms of sub-section (2).22. Director-General to cause certain information to be furnished(1) The Director-General shall after consultation with the council, cause, in such manner as the Director-General considers most suitable-(a)as soon as practicable after any medicine, other than a veterinary medicine, has been registered,medical practitioners, dentists, pharmacists and the person who applied for the registration of suchmedicine to be informed-(i)(ii)(iii)(iv)of the name and number under which such medicine is registered and the conditions, if any,subject to which such medicine is registered;of the therapeutic efficacy and effect of such medicine;of the purpose for which, the circumstances under which and the manner in which suchmedicine should be used; andregarding any other matter concerning such medicine which, in the opinion of the council,may be of value to them;(b)as soon as practicable after the registration of any medicine, other than a veterinary medicine, hasbeen cancelled in terms of section 16, medical practitioners, dentists, pharmacists and the holder ofthe certificate of registration issued in respect of such medicine to be informed of the cancellationof such registration.(2) The provisions of subsection (1) shall apply mutatis mutandis in respect of any veterinary medicine, andfor the purposes of such application the reference in that subsection to medical practitioners and dentistsshall be deemed to be a reference to veterinarians.22AControl of medicines and Scheduled substances(1) Subject to this section, no person shall sell, have in his or her possession or manufacture any medicine orScheduled substance, except in accordance with the prescribed conditions.(2) The Minister may, on the recommendation of the council, prescribe the Scheduled substances referred toin this section.(3) Any Schedule 0 substance may be sold in an open shop.
Page 2 and 3: 21. Definitions(1) In this Act, unl
Page 4 and 5: 4'regulation' means a regulation ma
Page 6 and 7: 6(e)if the Minister is satisfied th
Page 8 and 9: 8(3) In the case of a medicine whic
Page 10 and 11: 1015A Amendment of entries in regis
Page 14 and 15: 14(4) Any Schedule 1 substance shal
Page 16 and 17: 16(j)in an emergency in which the h
Page 18 and 19: 18(i)(ii)(iii)(iv)(v)the Director-G
Page 20 and 21: 20(b)the council may, on applicatio
Page 22 and 23: 22(2) The Minister may, on the reco
Page 24 and 25: 2427. Analysts, pharmacologists and
Page 26 and 27: 26(m)manufactures, sells or uses a
Page 28 and 29: 28(6) The records and annual financ
Page 30 and 31: 30(xxi)(xxii)(xxiii)(xxiv)(xxv)(xxv
Page 32: 3236A Minister may prohibit the man

medicines and related substances control act 101 of 1965

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