In these Regulations, any word or expression to which a meaning has been assigned in the Act shall bear such meaning and, unless the context otherwise indicates:

"the Act"

means the Medicines and Related Substances Act, 1965, as amended (Act No, 1 of 1965).

API -Active Pharmaceutical Ingredient

BE - Bio Equivalence

CEP - Certificate of Suitability to the Monographs of the European Pharmacopoeia

CPQ - Confirmation of WHO API Prequalification

IVD - In vitro diagnostics

Pre-IND - Pre-investigational New Drug

WHO - World Health Organization