[Section 14 heading substituted by section 24 of Notice No. 19, GG 39585, dated 8 January 2016]
| (1) | Save as provided in this section or sections 21 and 22A, no person shall sell any medicine, medical device or IVD which is subject to registration by virtue of a declaration published in terms of subsection (2) unless it is registered. |
| (a) | The Authority may from time to time determine that a medicine, medical device or IVD, or class or category of medicine, medical device or IVD or part of any class or category of medicine, medical devices or IVDs mentioned in the declaration shall be subject to registration in terms of this Act. |
| (b) | Any such declaration may also relate only to medicines, medical devices or IVDs which were available for sale in the Republic immediately prior to the date on which it comes into operation in terms of paragraph (c) or only to medicines, medical devices or IVDs which were not then so available. |
| (c) | Any such declaration shall be published in the Gazette by the Chief Executive Officer and shall come into operation on the date on which it is so published. |
| (3) | In the case of a medicine, medical device or IVD which was available for sale in the Republic immediately prior to the date of publication in the Gazette of the declaration by virtue of which it is subject to registration in terms of this Act, the provisions of subsection (1) shall come into operation— |
| (a) | if no application for the registration of such medicine, medical device or IVD is made within the period of six months immediately succeeding that date, on the expiration of that period; or |
| (b) | if an application for the registration of such medicine, medical device or IVD is made within the said period, on the date one month after the date on which a notice in respect of such medicine, medical device or IVD is published in the Gazette in terms of section 15(9) or section 17(a). |
[Section 14(3)(b) substituted by section 7 of Notice No. 19, GG 39585, dated 8 January 2016]
| (4) | The provisions of subsection (1) shall not apply in respect of the sale of any medicine— |
| (a) | compounded in the course of carrying on his or her professional activities by a pharmacist, veterinarian or person who is the holder of a licence contemplated in section 22C(1)(a), for a particular patient in a quantity not greater than the quantity required for treatment as determined by the medical practitioner, pharmacist, practitioner or veterinarian; or |
| (b) | compounded by a pharmacist in a quantity not greater than that prescribed by regulation for sale in the retail trade, subject to the conditions likewise prescribed or in a quantity for a particular person or animal as prescribed by a medical practitioner or a dentist or a veterinarian or a practitioner or a nurse or other person registered under the Health Professions Act, 1974, and referred to in section 22A, as the case may be, |
if such medicine does not contain any component the sale of which is prohibited by this Act or any component in respect of which an application for registration has been rejected, and is not or has not been advertised: Provided that the active components of such medicine appear in another medicine which has been registered under this Act.
[Section 14 substituted by section 24 of Act No. 14 of 2015]
