Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsRegistration of Medicines9. Categories and classification of medicines |
| (1) | Medicines shall be classified into categories as follows: |
| (a) | Category A = Medicines which are intended for use in humans and which are, without manipulation, ready for administration, including packaged preparations where only a vehicle is added to the effective medicine; |
| (b) | Category B = Medicines intended for use in humans and animals which cannot normally be administered without further manipulation; |
| (c) | Category C = Medicines intended for veterinary use which are, without further manipulation, ready for administration, including packaged preparations where only a vehicle is added to the effective medicine; and |
| (d) | Category D = Complementary medicines intended for use in humans and animals which are, without further manipulation, ready for administration, including packaged preparations where only a vehicle is added to the effective medicine. |
| (2) | Medicines in Category D shall be classified into the following sub-categories: |
| (a) | discipline-specific medicines with such disciplines as determined by the Authority; and |
| (b) | health supplements. |
| (3) | Medicines in Categories A and D (human complementary medicine) are subdivided into classes as per Annexure 1. |
| (4) | Medicines in categories C and D (veterinary complementary medicines) are subdivided into classes as per Annexure 2. |