Blue Box: national information on packaging in MRP and DCP

Article 57 of Directive 2001/83/EC lets Member States require additional particulars on the outer packaging: the price, the reimbursement conditions of social security bodies, the legal status for supply, and identification and authenticity information. Article 62 allows symbols and pictograms and other information compatible with the summary of product characteristics. Because these particulars differ by country, they are kept apart from the harmonised text in a box with a blue border, so that the agreed EU text of the labelling and leaflet is identical across markets and the national material is clearly separate. The Blue Box is a convention of the Notice to Applicants and the CMDh rather than a term in the Directive itself.

For centrally authorised products the Commission's guideline on the packaging information of medicinal products for human use authorised by the Union, with its Blue Box annex, lists what each Member State may require in the box, such as national reimbursement codes, pharmacy pricing fields, national serialisation or pack identification numbers and local legal status wording. For products from mutual recognition and decentralised procedures the CMDh publishes its own Blue Box requirements per Member State. The content is national and is handled at national level: changing it does not need a variation or an Article 61(3) notification, although the authority still expects to see the national artwork.

What goes wrong: artwork teams place EU text inside the box or national text outside it, which authorities reject at mock-up review; a national requirement changes, for example a new reimbursement code, and nobody tracks it because it is not part of the EU procedure; multi-country packs run out of space when several national boxes are needed; and companies assume the Blue Box list is static, when Member States update their requirements and the CMDh and Commission documents are revised in response. The Blue Box is also the usual place for national patient and pharmacist identifiers that the unique identifier rules under the Falsified Medicines Directive did not harmonise. A pack change that touches only the box still has to be proofread against the national requirement, because an outdated reimbursement code can stop a pack at the pharmacy.