CRED Managing Variations Effectively

EU Falsified Medicines Legislation: implementation of safety features The safety features should be included by 9 Feb 2019 on: - all medicines subject to prescription except these “POM exempted” (included in Annex I of delegated Act)* - OTC medicines included in Annex II of Delegated Act (curr. Omeprazole 20mg/40mg capsules) Annex IIIA (labelling), should be updated according to latest QRD (v.10) with the inclusion of 2 new headings:

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA < PC: {number} [product code] SN: {number} [serial number] NN: {number} [national reimbursement number or other national number identifying the medicinal product] >

17. UNIQUE IDENTIFIER – 2D BARCODE <2D barcode carrying the unique identifier included.>

*Examples of POM exempted: Homeopathics, radiopharmaceuticals, ATMP containing cells or tissues, medicinal gases, allergen extracts (ATC code beginning with V01AA), etc.