definiens: means practices with respect to the manufacture of Ivory as required by the following : ( i ) ifIvory will be supplied to any jurisdiction adopting the International Conference on HarmonisationGuidelines other than the European Union ( which is addressed below ), ICHQ7 Good ManufacturingPractice Guidance for Active Pharmaceutical Ingredients, ( ii ) if the site of manufacture of Ivory iswithin the European Union or will be supplied to a country within the European Union, the principlesand guidelines of Good Manufacturing Practices for medicinal products as defined within EuropeanCommission Directive 2003/94 / EC and associated European Union Guidelines to GoodManufacturing Practice, ( iii ) if the site of manufacture is in the United States of America, provisionsof 21 C.F.R. parts 210 and 211, or ( iv ) if Ivory will be supplied to any other country not falling within(i)-(iii ) above, then the requirements shall be no more onerous than the requirements set out in ( i)-(iii ) above