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International Ripples The OECD Principles

Many countries with strong interests in chemicals, pesticides and pharmaceuticals and their trade started subsequently to adopt the OECD Principles of Good Laboratory Practice as the basis for safety testing in their industries. The European Union (then still named the European Community) also, by the Council Directive 67/18/EEC of 18 December 1986, formally adopted the OECD Principles, including them within its framework of guidelines governing the submission of safety data for the marketing of chemical substances. [Pg.14]

Therefore, in order to avoid differences in the interpretation of the GLP Principles, it was recognised that international harmonisation was needed in this field, too, and it was again the OECD which took the lead. A number of such issues were consequently addressed by the OECD in a series of so-called Consensus Conferences, where experts from industry and monitoring authorities of the OECD member countries discussed single issues and [Pg.15]

Although these documents do not have the same formal status as the Principles themselves, although they are therefore not applicable, or enforceable, to the same extent as the Principles themselves, and although they were thus not introduced to the same extent as the Principles themselves into legislative frameworks, they represent the current and considered thinking of all stakeholders, industry and regulators, with respect to the correct application of the GLP Principles to specific issues, and they have consequently to be followed in the same way as the Principles. [Pg.16]


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