definiens: means current Good Manufacturing Practices promul gated by the Regulatory Authorities in the jurisdictions included in Applicable Laws ( as a pplicable to Client and [COMPANY] respectively ) . In the United States, this includes 21 C.F.R. Parts 210 and 211, as amended together with pertinent guidelines and g uidance documents ; in the European Union, this includes 200 3/94 / EEC Directive ( as supplemented by Volume 4 of EudraLex published by the European Commission ), as amended, if and as implemented in the relevant cons tituent country, together with pertinent guidelines and gui dance documents, in Japan ( this includes the guidel ines of good 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 )