Deletion of the solvent container of the finished product (LFP) Deletion of the solvent / diluent container from the pack. (EU B.II.a.6) minor SAP Nr. Human Medicines (2314) Veterinary medicines (2318) Complementary and herbal medicines (2315) Allergens (2316) Radiopharmaceuticals (2317) Advanced therapy products 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 Manufacturing site of the finished product (HSFP) Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished product. (EU B.II.b.1) major SAP Nr. minor SAP Nr. Human Medicines (2150) (2319) Veterinary medicines (2153) (2322) Complementary and herbal medicines (2151) (2320) Allergens (2842) (2856) Radiopharmaceuticals (2152) (2321) Advanced therapy products Scope / justification for the change Present Proposed
Deletion of the solvent container of the finished product (LFP) Deletion of the solvent / diluent container from the pack. (EU B.II.a.6) minor SAP Nr. Human Medicines (2314) Veterinary medicines (2318) Complementary and herbal medicines (2315) Allergens (2316) Radiopharmaceuticals (2317) Advanced therapy products 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 Manufacturing site of the finished product (HSFP) Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished product. (EU B.II.b.1) major SAP Nr. minor SAP Nr. Human Medicines (2150) (2319) Veterinary medicines (2153) (2322) Complementary and herbal medicines (2151) (2320) Allergens (2842) (2856) Radiopharmaceuticals (2152) (2321) Advanced therapy products Scope / justification for the change Present Proposed
zl302_00_001e_foqualityvariationrequiringapproval.dotm.docx