RELATED DOCUMENTS EMA has issued guidance documents aligned with the revised Variations framework, which also apply to MRP/DCP procedures: EMA Post-authorisation guidance on classification of changesQ&A regarding medicines used in combination with medical devices and consultation procedures by notified bodiesQ&A on novel or complex manufacturing in Q.II.b.1 and Q.II.b.4Q&A on skip or periodic testingGuidance on stability testing for applications for variationsGuidance on Post-Approval Change Management Protocol (PACMP)Guidance on Product Lifecycle Management document (PLCM) (expected in January 2026)
