Statistics Act, 1999
R 385
Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsSupply of Medicines2. Requirements for therapeutic equivalence |
| (1) | A medicine is considered therapeutically equivalent to another medicine if both medicines— |
| (a) | are— |
| (i) | pharmaceutically equivalent, in that they contain the same amount of active substances in the same dosage form, meet the same or comparable standards and are intended to be administered by the same route; or |
| (ii) | pharmaceutical alternatives, in that they contain the same active moiety but differ either in chemical form of that moiety or in the dosage form or strength; and |
| (b) | after administration in the same molar dose, their effects with respect to both efficacy and safety are essentially the same. |
| (2) | Therapeutic equivalence is determined from comparative bioavailability, pharmacodynamic, clinical or in vitro studies which meet the requirements and accepted criteria for bioequivalence as determined by the Authority. |
