definiens: means current Good Manufacturing Practices promul gated by the Regulatory Authorities in the jurisdictions included in Applicable Laws ( as appli cable to Client and [COMPANY] respectively ) . In the United States, this includes 21 C.F.R. Parts 210 and 211, as amend ed together with pertinent guidelines and guidance documents ; in the European Union, this includes 2003/94 / EEC Di rective ( as supplemented by Volume 4 of EudraLex published by the European Commission ), as amended, if and as implemented in the relevant constituent c ountry, together with pertinent guidelines and guidance doc uments, in Japan ( this includes the guidelines of g ood manufacturing control and quality control based on the requirements of the Pharmaceutical Affairs law of Japan as implemented in April of 2005 ), and in Canada ( in cluding the Food and Drugs Act, pertinent rules and regulations promulgated by Health Canada including Part C, Divi sion 2 of the Food and Drugs Regulations and the Go od Manufacturing Practices ( GMP ) Guidelines – 2009 Edi tion, Version 2 )