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$SSURYDO RI 0RGLILFDWLRQV

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If ERP approves a method modification including extensions,

then the method begiŶƐ Ă ŶĞǁ ƚǁŽ ;ϮͿ LJĞĂƌ ƉĞƌŝŽĚ͘

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If the method modification is to correct an editorial error then ,

the method, then there is no change.

Method modifications require substantiation of the modification or

extension with proof of method performance as deemed suitable by the EPR.

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