definiens: means the principles and guidelines of good manufacturing practice in respectof medicinal products for human use and investigational medicinal products forhuman use as defined in : ( i ) the CTD ; ( ii ) European Community Directive2003/94 / EC ; ( iii ) European Community Directive 2005/28 / EC ; ( iv ) EudralexVolume 4 : ‘ EU Guidelines to Good Manufacturing Practice, Medicinal Productsfor Human and Veterinary Use, Part II Basic Requirements for ActiveSubstances used as Starting Materials ’, ICHQ7a Good Manufacturing PracticeGuidance for Active Pharmaceutical Ingredients and ‘ EU Guidelines to GoodManufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 13 : Investigational Medicinal Products ’ ; and ( v ) any national legislationimplementing the aforementioned Directives and any relevant guidance relatingthereto