3.7) Classification of Pharmaceutical Products Flashcards
(9 cards)
Why are pharmaceutical products grouped in categories
For ease of relevance
Classification of medicines are
legally prescribed in General regulations to Medicines and Related substances Act 101 of 1965 in Regulation 9
Define Category A medicine
Medicines which are intended for use in humans only and are without manipulation, ready for admin including packaged preparation where only a vehicle is added to the effective medicine
Define Category B medicne
Medicines intended for use in humans and animals which cannot normally be administered without further manipulation
Define Category C medicine
Medicines which are intended for use in veterinary use only and are without manipulation, ready for admin including packaged preparation where only a vehicle is added to the effective medicine
Define Category D medicine
Complementary medicine intended for use in humans and animals which are without further manipulations ready for admin including packaged preparations where only a vehicle is added to the effective medicine
Medicine in Cat D shall be classified into
- discipline-specific medicines with such disciplines as determined by Authority
- Health supplements
Annexure 1 is
medicines in Cat A and D
Annexure 2
Medicines in Cat C and D