A phаrmаceuticаl cоmpany is preparing an applicatiоn fоr the registration of a medicine in South Africa. The company has three types of documents related to the active pharmaceutical ingredient (API):-Certificate of Analysis (CoA) – batch-specific document showing test results.-Certificate of Suitability (CEP) – issued by the EDQM, referencing the Ph. Eur. monograph. -- --Full API dossier – detailed submission including analytical methods, batch data, and chemical synthesis route. Which of the following statements correctly describes what needs to be submitted when the route of synthesis details are required?