4. CONSIDERATIONS FOR IMPLEMENTATION

When sponsors or manufacturers change their existing methods to the implemented Q4B-evaluated pharmacopoeial texts that are referenced in Section 2.1 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 2.9.40 . on the basis of the declaration of interchangeability made above .