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. |
Statistics Act, 1999
