definiens: means the chemistry, manufacturing and controls data or, as the case may be, the product specifications, manufacturing formulae and processing instructions required by Applicable Laws, including, ( i ) in the case of an application for a pproval to conduct clinical research under an IND, 21 C.F.R. Section 312.23(a)(7 ), and, to the extent that it is applicable, European Community Directive 2001/20 / EC ; or ( ii ) in relation to a NDA, 21 C.F.R.Section 314.50(d)(1 ) or, to the extent that they are applicabl e, the Quality Overall Summary section 2.3 of Module 2 and Module 3 of the Common Technical Document developed and agreed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ( ICH ) or Part I, Module 3 of Annex 1 to Directive 2001/83 / EC and the EC Guidelines