The medicines register shall, in respect of any registered medicine, contain the following information:
(a) | The proprietary name of the medicine; |
(b) | the registration number allocated to the medicine; |
(c) | the approved name of each active ingredient of the medicine and the quantity thereof contained in a dosage unit or per suitable mass or volume or unit of the medicine; |
(d) | the dosage form of the medicine; |
(e) | the name of the holder of the certificate of registration; |
(f) | the name and address of the manufacturer(s) and the manufacturing facilities; |
(g) | the name of the final product release control; |
(h) | the name of the final product release responsibility; |
(i) | the date of registration of the medicine; |
(j) | the conditions of registration of the medicine, as may have been determined in terms of section 15(6) of the Act; |
(k) | category of the medicine; |
(I) | class of the medicine; and |
(m) | if falling under Category D a statement identifying the— |
(i) | sub-category of the medicine; and |
(ii) | the associated discipline where applicable. |