Skip to main content
(xxiv) as to the importation, exportation, conveyance, keeping, storage, processing and packing of medicines and Scheduled substances, and the manner in which medicines and Scheduled substances shall be kept and controlled in different categories of hospitals; [Para. (xxiv) substituted by s. 12 (a) of Act No. 59 of 2002.] Wording of Sections (xxv) prescribing the methods in accordance with which samples may be taken under this Act and the form of the certificates to be issued by inspectors in respect of such samples; (xxvi) prescribing the methods to be employed and the form of the certificates to be issued in connection with the testing, examination or analysis of samples taken under this Act; (xxvii) authorising, regulating, controlling, restricting or prohibiting the registration, manufacture, modification, importation, exportation, storage, transportation, sale or use of any medical device or class of medical devices or medicines in respect of its safety, quality and efficacy; [Para. (xxvii) substituted by s. 12 (b) of Act No. 59 of 2002.] Wording of Sections (xxviii) with regard to any matter to ensure the safety, quality and efficacy of medicines and medical devices; (xxix) as to the summary seizure and disposal of any Scheduled substance found in the possession or custody of any person not entitled under this Act to keep or use it; (xxx) as to the disposal or destruction of a Scheduled substance which has become unfit for use, and the report to be furnished in respect thereof; (xxxi) prescribing the fee to be paid to the registrar in respect of an application for the registration, and in respect of the registration of a medicine, Scheduled substance or medical device, the fee to be paid annually to the registrar in respect of the retention of the registration of a medicine, Scheduled substance or medical device and the date on which such annual fee shall be paid; (xxxii) prescribing the fee payable in respect of the authorisation of the use of unregistered medicines, the issuing of permits and certificates under this Act, the issuing or renewal of any licence under this Act, the performance of inspections to assess the quality of medicines, Scheduled substances or medical devices for the purpose of registration and the evaluation of changes to the particulars contained in registers; (xxxiii) relating to appeals against decisions of the Director-General or the council; (xxxiv) relating to the conditions under which medicines or Scheduled substances may be sold; (xxxv) relating to the repackaging of medicines in patient-ready packs; (xxxvi) relating to the safety, quality and efficacy of any interchangeable multi-source medicine; (xxxvii) relating to the scientific, pharmaceutical, clinical and other skills required by a member of the council or by a member of the executive committee of the council to evaluate the quality, efficacy and safety of medicines; (xxxviii) relating to the safety, quality and efficacy of imported medicines; (xxxix) relating to the control and conduct of clinical trials; (xl) with regard to any matter which in terms of this Act shall or may be prescribed; and (xli) generally for the efficient carrying out of the objects and purposes of this Act, and the generality of this provision shall not be limited by the preceding paragraphs of this subsection. (2) The Minister shall, not less than three months before any regulation is made under subsection (1), cause the text of such regulation to be published in the Gazette, together with a notice declaring his or her intention to make that regulation and inviting interested persons to furnish him or her with any comments thereon or any representations they may wish to make in regard thereto. (3) The provisions of subsection (2) shall not apply in respect of— (a) any regulation which, after the provisions of that subsection have been complied with, has been amended by the Minister in consequence of comments or representations received by him or her in pursuance of the notice issued thereunder; or (b) any regulation in respect of which the Minister is, after consultation with the council, of the opinion that the public interest requires it to be made without delay. (4) A regulation under subsection (1) (xxxi) and (xxxii) shall be made only in consultation with the Minister of Finance. (5) Regulations made under subsection (1) (xi) may prescribe that any medicine or any component thereof shall comply with the requirements set out in any publication which in the opinion of the council is generally recognised as authoritative. (6) Regulations may be made under this section in respect of particular medicines or Scheduled substances or classes or categories of medicines or Scheduled substances or in respect of medicines or Scheduled substances other than particular classes or categories of medicines or Scheduled substances, and different regulations may be so made in respect of different medicines or Scheduled substances or different classes or categories of medicines or Scheduled substances. (7) (a) Regulations made under this section may prescribe penalties for any contravention thereof or failure to comply therewith of a fine, or imprisonment for a period not exceeding 10 years. (b) Notwithstanding anything to the contrary in any law contained a magistrate’s court shall be competent to impose any penalty provided for in paragraph (a).

Select target paragraph3

Connect to a paragraph
Connect to an entity
Disable highlights
Add to table of contents