Intellectual Property Rights from Publicly Financed Research and
R 385
Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)22C. Licensing |
| (1) | Subject to the provisions of this section— |
| (a) | the Director-General may on application in the prescribed manner and on payment of the prescribed fee issue to a medical practitioner, dentist, practitioner, veterinarian, nurse or other person registered under the Health Professions Act, 1974, (Act No. 56 of 1974), a licence to compound and dispense medicines, on the prescribed conditions; |
| (b) | the Authority may, on application in the prescribed manner and on payment of the prescribed fee, issue to a medical device or IVD establishment, manufacturer, wholesaler or distributor of a medicine, Scheduled substance, medical device or IVD a licence to manufacture, import, export, act as a wholesaler of or distribute, as the case may be, such medicine, Scheduled substance, medical device or IVD upon such conditions as to the application of such acceptable quality assurance principles and good manufacturing and distribution practices as the Authority may determine. |
[Section 22C(1) substituted by section 16(a) of Notice No. 19, GG 39585, dated 8 January 2016]
| (2) | A licence referred to in subsection (1)(a) shall not be issued unless the applicant has successfully completed a supplementary course determined by the South African Pharmacy Council after consultation with the Health Professions Council of South Africa and the South African Nursing Council. |
[Section 22C(2) substituted by section 24(b) of Notice No. 434, GG 32148, dated 21 April 2009]
| (3) | The Director-General or the Authority, as the case may be, may require an applicant contemplated in subsection (1) to furnish such information, in addition to any information furnished by the applicant in terms of the said subsection, as the Director-General or the Authority may deem necessary. |
[Section 22C(3) substituted by section 24(c) of Notice No. 434, GG 32148, dated 21 April 2009]
| (4) | When the Director-General or the Authority, as the case may be, grants or refuses an application for a licence— |
[Words preceding section 22C(4)(a) substituted by section 24(d) of Notice No. 434, GG 32148, dated 21 April 2009]
| (a) | written notice shall be given of that fact to the applicant; and |
| (b) | in the event of the refusal of an application, the applicant shall be furnished with the reasons for such refusal. |
| (5) | No person shall compound or dispense a medicine unless he or she is authorised thereto in terms of the Pharmacy Act, 1974, is a veterinarian or is the holder of a licence as contemplated in subsection (1)(a). |
[Section 22C(5) substituted by section 6(c) of Act No. 59 of 2002]
| (6) | No medical device or IVD establishment, manufacturer, wholesaler or distributor referred to in subsection (1)(b) shall manufacture, act as a wholesaler of or distribute, as the case may be, any medicine, Scheduled substance, medical device or IVD unless he or she is the holder of a licence contemplated in the said subsection. |
[Section 22C(6) substituted by section 16(b) of Notice No. 19, GG 39585, dated 8 January 2016]
| (7) | Subsections (5) and (6) shall come into operation twelve months from the date of commencement of this section. |
[Section 22C(7) substituted by section 6(e) of Act No. 59 of 2002]
[Section 22C inserted by section 14 of Act No. 90 of 1997]
