Consequential change Quality variation requiring approval SAP Nr.: Variations requiring notification Nr.: Scope / justification for the change Present Proposed Introduction of a Change Management Protocol related to the active pharmaceutical ingredient (ECMPWS) Introduction of a post approval change management protocol. (EU B.I.e.2) major SAP Nr. Medicines (2130) Veterinary medicines (2134) Complementary and herbal medicines (2131) Allergens (2132) Radiopharmaceuticals (2133) Advanced therapy products / justification for the change Present Proposed Consequential change Quality variation requiring approval SAP Nr.: Variations requiring notification Nr.: Scope / justification for the change Present Proposed
Consequential change Quality variation requiring approval SAP Nr.: Variations requiring notification Nr.: Scope / justification for the change Present Proposed Introduction of a Change Management Protocol related to the active pharmaceutical ingredient (ECMPWS) Introduction of a post approval change management protocol. (EU B.I.e.2) major SAP Nr. Medicines (2130) Veterinary medicines (2134) Complementary and herbal medicines (2131) Allergens (2132) Radiopharmaceuticals (2133) Advanced therapy products / justification for the change Present Proposed Consequential change Quality variation requiring approval SAP Nr.: Variations requiring notification Nr.: Scope / justification for the change Present Proposed
zl302_00_001e_foqualityvariationrequiringapproval.dotm.docx