definiens: or means all Laws and guidelines applicable to Manufacture of the Licensed Drug Candidate or Licen sed Product, including ( a ) the FD&C Act ( 21 U.S.C. 321 et seq . ) ; ( b ) relevant United States regulations in Title 21 of the United States Code of Federal Regu lations ( including Parts 11, 210, and 211 ) ; ( c ) European Co mmunity Directives 2001/83 / EC and 2003/94 / EC ; ( d ) t he EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, as set out in Volume 4 of the European Commission ’s Rules governi ng medicinal products in the EU ; ( e ) those standard s required by the MHLW ; ( f ) ICH, Q7 Good Manufacturin g Practice Guidance for Active Pharmaceutical Ingredients ; ( g ) similar standards and Laws to thos e in ( a ) through ( f ), as are in effect at the time of Manufacture of the Licensed Drug Candidate or Licensed Product ; and ( h ) all additional Regulatory Authority docume nts or regulations that replace, amend, modify, supplant o r complement any of the foregoing