When sponsors or manufacturers change their existing methods to the implemented Q4B-evaluated pharmacopoeial texts that are referenced in Section 2 of this annex , any change notification , variation .And/or prior approval procedures should be handled in accordance with established regional regulatory mechanisms pertaining to compendial changes .In accordance with the conditions set out in this annex , as fulfilling the requirements for compliance with the Ph . Eur . Chapte 5.1.4 . on the basis of the declaration of interchangeability made above .
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