guideline on the packaging information of medicinal products for human use authorised by the unionblue box human medicines

medication boxes, package inserts, and labels according to EMA regulations? to be indicated and/or “blue box” information as required by Member States.EMA/CMDv/391895/2012 Packaging 'blue-box' requirements for products authorised via national, mutual recognition, or decentralised or centralised procedures. Additional information on labelling/package leaflet that may be required 7 The "blue box" is a boxed area included in the labelling, with a blue border, aimed at . check are set-out in specific guidelines available on EMA website. 9. Quick Response (QR) codes in the labelling and/or package leaflet of . Packaging 'blue-box' requirements and additional information on labelling/package EMA/CMDv/391895/2012. Version 22/12/2014. Packaging 'blue-box' requirements and additional information on labelling/package leaflet for products However, if such a statement is included it should use the "blue box concept". uses, doctors will prescribe (in circumstances where guidelines permit for the 9 Sep 2012 Blue-box requirements: "Additional information on labeling/package leaflet that may be required nationally" Blue-box requirements different for DCP/MRP and Centralized procedures Labels: EMA, Labeling Requirements 'Blue box' labelling requirements have been updated for the second time this year. The EMA draft guideline on setting health based exposure limits will impact EMA/785529/2017 · List item. Quick Response (QR) codes in the labelling and/or package leaflet of veterinary medicinal products . Packaging 'blue-box' requirements and additional information on labelling/package leaflet for products 22 May 2017 Additional information on labelling/package leaflet that may be required nationally in accordance with Articles 57 and 62 of Directive