Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)15C. Measures to ensure supply of more affordable medicines |
The Minister may prescribe conditions for the supply of more affordable medicines in certain circumstances so as to protect the health of the public, and in particular may—
| (a) | notwithstanding anything to the contrary contained in the Patents Act, 1978 (Act No. 57 of 1978), determine that the rights with regard to any medicine under a patent granted in the Republic shall not extend to acts in respect of such medicine which has been put onto the market by the owner of the medicine, or with his or her consent; |
| (b) | prescribe the conditions on which any medicine which is identical in composition, meets the same quality standard and is intended to have the same proprietary name as that of another medicine already registered in the Republic, but which is imported by a person other than the person who is the holder of the registration certificate of the medicine already registered and which originates from any site of manufacture of the original manufacturer as approved by the Authority in the prescribed manner, may be imported; |
[Section 15C(b) substituted by section 11 of Notice No. 434, GG 32148, dated 21 April 2009]
| (c) | prescribe the registration procedure for, as well as the use of, the medicine referred to in paragraph (b). |
[Section 15C inserted by section 10 of Act No. 90 of 1997]