The Ministerof Health intends to table the Medicines and Related Substances Amendment Bill, 2002, in Parliament this year, 2002.
Interestedpersonsareinvited to submit anysubstantiatedcomments or representations on the proposed Bill to the Director-General: Health, Private Bag X 828, Pretoria, 0001, within a period of onemonthfromthe date of publication of this Notice.
To amend the Medicines and Related Substances Act, 1965, as amended, so as to provide for some definitions, to provide for the appointment of a Deputy Registrar, to provide for a term of office of members of the Pricing Committee, to provide for the delay of the coming into operation manufacture, act as a wholesaler or distributor; to provide that appeals against the decisions of the Director-General and the council shall be to the Minister; to provide for a Marketing Code for pharmaceutical companies, to provide that the powers of inspectors shall be exercised pursuant to a warrant issued by a magistrate or a judge of the High Court or without a warrant in certain instances; and to provide for matters connected therewith.
(c)bythesubstitution in subsection (1) forthedefinition of"practitioner" of the following definition: "practitioner"meansapersonregistered as suchunderthe [Chiropractors, Homeopaths and] Allied Health [Service] Professions Act, 1982 (Act No.63 of 1982).
12. (1)The Minister may. after consultation with the Council. appoint a Reaistrar and one or more DeDutv Reaistrars.
2The Reaistrar shall perform the functions and carry out the duties assianed to or imposed upon the Reaistrar bv or under this Act and such other functions and duties as may from time to time be assianed to or imposed won him or her bv the Minister. council or Director-General.
18C. 11The Minister shall, after consultation with the pharmaceutical industry and other practices of pharmaceutical companies.
"(8) Subject to subsection (9) [a Schedule 7]or Schedule 8 substance shall not be acquired by any person other than the Director-General for the purpose of providinga medicalpractitionertherewith, ontheprescribedconditions for thetreatment of a particular patient of that medical practitioner upon such conditions as the Director-General, on the recommendations of the council, may determine."
"(a) No person shall import orexportaSchedule6, Schedule7orSchedule 8 substance or other substance or medicine prescribed for that purpose unless a permit has been issued to him or her by the Director-General in the prescribed manner and subject to [prescribed] conditions as may be determined bv the Director-General."
"(7) Subsections (5) and (6) shall comeintooperation [six monthsafterthe] twelve months from the date of commencement of this section."
"the [Director-General] Department or the council, as the case may be, may by way of a notice in writing call upon him or her to show cause within the period specified in the notice, which period shall not be less that 20 daysasfromthe revoked."
"(3) Any wholesaler may in the prescribed manner andon the prescribed conditions be exempted by the [Director-General] Deoartment from the provisions of subsection(l)."
"(1) Any personaggrieved by thedecision of theDirector-General, Le Departmentorthecouncil, asthecasemaybe, may, withintheprescribed period, in the prescribed manner and upon payment of the prescribed fee, appeal against such decision to [an appeal committee appointed by] the Minister for the purposes of the appeal concerned."
Amendment ofsection 25 of Act 101 of 1965 as substituted by section 32 of Act 88 of 1996 25.
9(1) or 226(1) or any member of the council or of any such committee shall not be liable in respectof anything done in good faith under this Act.
(1)For the purposes of the administration of this Act, a maaistrate or aiudae of the Hieh Court may, on application bv an insDector contemplated in section 26.
search any person Dresent on the premises. provided that such search is conducted bv an officer of the same aender as the person being searched, seize any such medicine, documents or thinas: and in carrvinq out any such search, open or cause to be oDened or removed and opened, anvthina in which such officer suspects any medicine. documents or thinasto be contained.
An application under subsection(1)shall be supported bv information SUDDlied under oath or solemn declaration, establishinn the facts on which the aDplication is based.
6 Anv inspector who executes a warrant mav seize, in addition to the medicines, documents or thinas referred to in the warrant, any other information, documents or thinas that such officer believes on reasonable arounds afford evidence of the non-compliance with the this Act.
18 The inspector, who shall take reasonable care to ensure that the medicines, documents or whichever event occurs last.
The person to whose affairs any medicine, documents or thinqs seized under this section relate, may examine and make extracts therefrom and obtain one copy thereof at the expense of the State durinq normal business hours under such SuDervision as the inspector may determine.
Amendment of section35 of Act 101 of 1965 as substituted by section 31 of Act 65 of 1974, as amended by section3 of Act19 of 1976, section 14 of Act 17 of 1979, section 7of Act 20 of 1981, section 7 of Act71 of 1991, section 16 of Act94 of 1991 and section 23 of Act 90 of 1997 15.
To provide for the reqistration of medicines intended for human and for animal use, for the reqistration of complementary medicines, for the registration of certain medical devices, for the establishment ofa Medicines Control Council:to provide that such Council shallbe a iuristic 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 industw, to provide that the appointment of members of the executive committee shall be subject of the approval of the Minister; to provide for the control of medicines. complementarv medicines, Scheduled substances and certain medical devices: to make further provision for the prohibition on the sale of evaluation of all medicines after five Years.
Repeal of Act132 of 1998 17. TheSouthAfricanMedicinesandMedicalDevicesRegulatoryAuthorityAct, 1998, (Act No.132 of 1998) is hereby repealed.
I come into operation on a date to be determined by the President by proclamation in the Gazette.