[Words preceding section 35(1)(i) substituted by section 41(a) of Notice No. 434, GG 32148, dated 21 April 2009]
[Section 35(1)(i) substituted by section 22(a) of Notice No. 19, GG 39585, dated 8 January 2016]
| (ii) | prescribing the forms which shall be used for any application for the registration of any medicine, medical device or IVD and the particulars which shall be furnished with any such application (including particulars regarding the method by which the medicine, medical device or IVD in question or any component of such medicine, medical device or IVD is manufactured and the premises in which such medicine, medical device or IVD or any such component is manufactured); |
[Section 35(1)(ii) substituted by section 22(a) of Notice No. 19, GG 39585, dated 8 January 2016]
| (iii) | providing for the classification of medicines, medical devices or IVDs into classes or categories for the purposes of this Act; |
[Section 35(1)(iii) substituted by section 22(a) of Notice No. 19, GG 39585, dated 8 January 2016]
| (iv) | prescribing the samples of any medicine, medical device or IVD and the quantity thereof which shall accompany any application for the registration of a medicine, medical device or IVD; |
[Section 35(1)(iv) substituted by section 22(a) of Notice No. 19, GG 39585, dated 8 January 2016]
| (v) | prescribing the form in which the medicines, medical devices or IVDs register shall be kept and the particulars which shall be entered therein in respect of any registered medicine, medical device or IVD, as the case may be; |
[Section 35(1)(v) substituted by section 22(a) of Notice No. 19, GG 39585, dated 8 January 2016]
| (vi) | prescribing the form of any certificate of registration of any medicine, medical device or IVD; |
[Section 35(1)(vi) substituted by section 22(a) of Notice No. 19, GG 39585, dated 8 January 2016]
| (vii) | prescribing the circumstances in which, the conditions on which and the persons or categories of persons to whom any medicine, Scheduled substance, medical device or IVD may be sold; |
[Section 35(1)(vii) substituted by section 22(a) of Notice No. 19, GG 39585, dated 8 January 2016]
| (viii) | prescribing the manner in which any package containing any medicine, Scheduled substance, medical device or IVD shall be labelled, packed or sealed; |
[Section 35(1)(viii) substituted by section 22(a) of Notice No. 19, GG 39585, dated 8 January 2016]
| (ix) | prescribing the particulars in regard to the use thereof which shall be furnished with any medicine, Scheduled substance, medical device or IVD sold, and the manner in which such particulars shall be furnished; |
[Section 35(1)(ix) substituted by section 22(a) of Notice No. 19, GG 39585, dated 8 January 2016]
| (x) | prescribing the particulars which shall appear in any advertisement relating to any medicine, Scheduled substance, medical device or IVD, or prohibiting the inclusion of any specified particulars in such advertisement, or the distribution of any such advertisement to a specified person or a specified category of persons or to a specified organisation or a specified category of organisations; |
[Section 35(1)(x) substituted by section 22(a) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xi) | prescribing the requirements with which any medicine, or any component thereof, medical device or IVD shall comply in regard to composition, therapeutic suitability and effect, purity or any other property; |
[Section 35(1)(xi) substituted by section 22(a) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xii) | prescribing the particulars which shall be published in the Gazette in respect of any application for registration referred to in section 15(10); |
[Section 35(1)(xii) substituted by section 41(b) of Notice No. 434, GG 32148, dated 21 April 2009]
| (xiii) | relating to the responsibilities of both medical device and IVD establishments and users of medical devices and IVDs, in relation to the use, training, maintenance, calibration, post-marketing surveillance, sterilization, disinfection, recall, decomposition, decommissioning or decontamination of medical devices and IVDs; |
[Section 35(1)(xiii) substituted by section 41(c) of Notice No. 434, GG 32148, dated 21 April 2009]
| (xiv) | prescribing the particulars which shall appear on a prescription or an order for a medicine or a Scheduled substance, the number of issues of a medicine or a Scheduled substance that may be made on any such specified prescription or order, the manner in which any such prescription or order shall be issued and the period for which any such prescription or order shall be retained; |
| (xv) | prescribing the forms of licences, registers, prescription books, records and other documents which shall be kept or used in respect of medicines, Scheduled substances, medical devices or IVDs, the manner in which they shall be kept, the particulars which shall be entered therein and the place where and the period for which they shall be retained; |
[Section 35(1)(xv) substituted by section 22(b) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xvi) | requiring the furnishing of returns, reports and information in respect of Scheduled substances and plants from which any substance can be extracted, derived, produced or manufactures, and in respect of any medicine or other substance of which any such Scheduled substance is a component; |
| (xvii) | as to the transhipment or the exportation from or importation into the Republic of any medicine, Scheduled substance, medical device or IVD, specifying the ports or places at which such medicine, Scheduled substance, medical device or IVD may be brought into the Republic; |
[Section 35(1)(xvii) substituted by section 22(c) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xviii) | authorising and regulating or restricting the transmission through the Republic of medicines, Scheduled substances, medical devices or IVDs; |
[Section 35(1)(xviii) substituted by section 22(c) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xix) | prescribing the manner in which packages containing medicines, Scheduled substances, medical devices or IVDs shall be labelled when imported into or manufactured in the Republic and the persons by whom and the manner in which they shall be kept; |
[Section 35(1)(xix) substituted by section 22(c) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xx) | authorising and regulating the purchase, acquisition, keeping or use of preparations of cocaine by managers or persons in charge of factories or workshops in connection with the treatment of eye injuries or for other essential purposes; |
| (xxi) | authorising and regulating the purchase, acquisition, keeping or use of Scheduled substances by particular persons or categories of persons; |
| (xxii) | authorising and regulating the possession by persons entering or departing from the Republic of specified quantities of medicines, Scheduled substances, medical devices or IVDs for personal medicinal use; |
[Section 35(1)(xxii) substituted by section 22(d) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xxiii) | as to the disposal or destruction of a medicine, Scheduled substance, medical device or IVD, and the records which shall be kept in respect thereof; |
[Section 35(1)(xxiii) substituted by section 22(d) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xxiv) | as to the importation, exportation, conveyance, keeping, storage, processing and packing of medicines, Scheduled substances, medical devices or IVDs, and the manner in which medicines, Scheduled substances, medical devices or IVDs shall be kept and controlled in different categories of hospitals; |
[Section 35(1)(xxiv) substituted by section 22(d) of Notice No. 19, GG 39585, dated 8 January 2016]
| (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, IVD or class of medical devices, IVDs or medicines in respect of its safety, quality and efficacy; |
[Section 35(1)(xxvii) substituted by section 22(e) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xxviii) | with regard to any matter to ensure the safety, quality and efficacy of medicines, medical devices or IVDs; |
[Section 35(1)(xxviii) substituted by section 22(e) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xxix) | as to the summary seizure and disposal of any medicine, Scheduled substance, medical device or IVD found in the possession or custody of any person not entitled under this Act to keep or use it; |
[Section 35(1)(xxix) substituted by section 22(e) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xxx) | as to the disposal or destruction of a medicine, Scheduled substance, medical device or IVD which has become unfit for use, and the report to be furnished in respect thereof; |
[Section 35(1)(xxx) substituted by section 22(e) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xxxi) | prescribing the fee to be paid to the Authority in respect of an application for the registration, and in respect of the registration of a medicine, medical device of IVD, the fee to be paid annually to the Authority in respect of the retention of the certification or the registration of a medicine, medical device or IVD and the date on which such annual fee shall be paid; |
[Section 35(1)(xxxi) substituted by section 22(e) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xxxii) | prescribing the fee payable in respect of the authorisation of the use of unregistered medicines, medical devices or IVDs, 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 safety, quality and efficacy of medicines, Scheduled substances, medical devices or IVDs for the purpose of registration, the evaluation of technical amendments and changes to the particulars contained in registers and the testing for batch release of biological medicines; |
[Section 35(1)(xxxii) substituted by section 22(e) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xxxiii) | relating to appeals against decisions of the Director-General or the Authority; |
[Section 35(1)(xxxiii) substituted by section 41(e) of Notice No. 434, GG 32148, dated 21 April 2009]
| (xxxiv) | relating to the conditions under which medicines, Scheduled substances, medical devices or IVDs may be sold; |
[Section 35(1)(xxxiv) substituted by section 22(f) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xxxv) | relating to the repackaging of medicines in patient-ready packs; |
| (xxxvii) | relating to the scientific, pharmaceutical, clinical, technical and other skills required by members of staff of the Authority to evaluate the quality, efficacy and safety of medicines, medical devices and IVDs; |
[Section 35(1)(xxxvii) substituted by section 41(f) of Notice No. 434, GG 32148, dated 21 April 2009]
| (xxxviii) | relating to the safety, quality and efficacy of imported medicines, Scheduled substances, medical devices and IVDs; |
[Section 35(1)(xxxviii) substituted by section 22(g) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xxxix) | relating to the control and conduct of clinical trails; |
| (xl) | relating to medicines, Scheduled substances, medical devices or IVDs in respect of matters contemplated in paragraphs (i) up to and including paragraph (xi) and paragraphs (xxiii), (xxiv), (xxxii), (xxxiv) and (xxxviii); |
[Section 35(1)(xl) substituted by section 22(h) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xli) | relating to the control of medicines, Scheduled substances, medical devices and IVDs in general; |
[Section 35(1)(xli) substituted by section 22(h) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xlii) | relating to the licensing for possessing or using certain medicines, Scheduled substances, medical devices or IVDs; |
[Section 35(1)(xlii) substituted by section 22(h) of Notice No. 19, GG 39585, dated 8 January 2016]
| (xliii) | relating to time frames for the consideration of applications by the Authority; |
[Section 35(1)(xliii) inserted by section 41(g) of Notice No. 434, GG 32148, dated 21 April 2009]
| (xliv) | with regard to any matter which in terms of this Act shall or may be prescribed; and |
[Section (1)(xl) renumbered to subsection (1)(xliv) by section 41(g) of Notice No. 434, GG 32148, dated 21 April 2009]
| (xlv) | 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. |
[Section (1)(xli) renumbered to subsection (1)(xlv) by section 41(g) of Notice No. 434, GG 32148, dated 21 April 2009]
| (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 Authority, of the opinion that the public interest requires it to be made without delay. |
[Section 35(3)(b) substituted by section 41(h) of Notice No. 434, GG 32148, dated 21 April 2009]
| (4) | A regulation under subsection (1)(xxxi) of (xxxii) shall be made only in consultation with the Minister of Finance. |
| (5) | Regulations made under subsection (1)(xi) may prescribe that any medicines, Scheduled substances, medical device or IVD or any component thereof shall comply with the requirements set out in any publication which in the opinion of the Authority is generally recognised as authoritative. |
[Section 35(5) substituted by section 22(i) of Notice No. 19, GG 39585, dated 8 January 2016]
| (6) | Regulations may be made under this section in respect of particular medicines, Scheduled substances, medical devices or IVDs or classes or categories of medicines, Scheduled substances or medical devices or IVDs or in respect of medicines, Scheduled substances, medical devices or IVDs other than particular classes or categories thereof, and different regulations may be so made in respect of different medicines, Scheduled substances, medical devices or IVDs or different classes or categories thereof. |
[Section 35(6) substituted by section 22(i) of Notice No. 19, GG 39585, dated 8 January 2016]
| (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). |
| (8) | Notwithstanding the provisions of subsection (1), the Minister may, if he or she deems it to be in the public interest, after consultation with the Authority, make regulations relating to any matter referred to in subsection (1) or to amend or repeal any regulation made in terms of that subsection. |
[Section 35(8) substituted by section 41(k) of Notice No. 434, GG 32148, dated 21 April 2009]
[Section 35 substituted by section 23 of Act No. 90 of 1997]
