definiens: means the principles and guidelines of good manufacturing practice in respect of medicinalproducts for human use and investigational medicinal products for human use as defined in:(i ) the CTD ; ( ii ) European Community Directive 2003/94 / EC ; ( iii ) European CommunityDirective 2005/28 / EC ; ( iv ) Eudralex Volume 4 : ‘ EU Guidelines to Good ManufacturingPractice, Medicinal Products for Human and Veterinary Use, Part II Basic Requirements forActive Substances used as Starting Materials ’, ICHQ7a Good Manufacturing PracticeGuidance for Active Pharmaceutical Ingredients and ‘ EU Guidelines to Good ManufacturingPractice Medicinal Products for Human and Veterinary Use, Annex 13 : InvestigationalMedicinal Products ’ ; and ( v ) any national legislation implementing the aforementionedDirectives and any relevant guidance relating thereto