definiens: or - shall mean goodlaboratory practice as set out in, as applicable:(a ) Rules Gov(b)g Medicinal Products in the EuropeanI ill, ISBN 92.825 9619 - 2 ( ex OECOeral Regulations, Title 21, Part 58 ( Good.ce for Nonclinical Labomtory Studies ) ; or(c ) the equivalen law or regulation in any Major Market1.1.4I or - shall mean goodin accordance with, as applicable:(a ) EC Directive 1I456 / EEC;or(b ) the current p . ciples and guidelines of good manufacturingpractice for .cinal products for human use and"substantial nformity with good manufacturingrequirements ( as sUchphmse is used mSection 802(f)(I ) ofthe Federal F d, Drug and Cosmetic Act, as such Act may betime to time ) ; or11 - CDrAIN txltUW&NiiALJ1lDIO~1ION cmrI'AlNID IN DOCII1GNT, MAaDD IYB&ACKnS, BJIILD ) WI'I'B ' J""_~PIIlIIIJANTTO 24.1 OP _ _ ExCIIANGIAcr OP 1934, /Jl_1EXECUfION COpy(c ) era!Regulations, Title 21, Part 210 ( CurrentGood Man turing Practice in Manufacturing, Processing, Packaging or olding of Drugs ; General ), Part 211 ( CurrentGood Man . g Practice for Finished Pbannaceuticals);or(d ) the equivalen law or regulation in any Major MaJket