definiens: means the current and applicable laws and guidelin es on Good Manufacturing Practice for the manufacture of pharmaceutical products for human use in force applicable to the Parties or the manufacture of the Licensed Products, including, without limitation, the International Conference on Harmonisation of Techni cal Requirements for Registration of Pharmaceuticals For Human Use ( ICH ) Guideline Q7A G ood Manufacturing Practice for Active Pharmaceutical Ingredients, European Directive 2003 /94 / EC ( and any legislation implementing such Directive ) and any further guidance as published by the European Commission in Volume IV of ( each as may be amended from time to time ), the current and applicable directives and guidelines on current good manufacturing practices and standards promulgated or endorsed by the FDA, i ncluding the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 210 and 211, Part C, Div ision 2 of the Food and Drug Regulations, and the principles detailed in and the Good Manufacturing G uidelines published by Health Canada, in each case as they may be updated from time to time