European pharmaceutical labels may require a “blue box”
Blue. Box. Label. Try to say that ten times fast. I somehow end up saying Blue. Blox. Label. (Or some variation of that). Now that you are probably giggling (and potentially confused), let’s get some facts straight in case you aren’t already a Blue Box Label Regulation expert.
Harmonization of labels in Europe has grown tremendously over the last decade under European Community auspices. However, there remain some instances in which European member states may exercise the option to develop their own unique labeling requirements.
Retail packaging of pharmaceutical products is one such area, and this is where the so-called “Blue Box” label comes into play. The Blue Box Label is a colour-coded label element wherein country-specific regulatory data must be printed.
Each European state is permitted to require the following additional information on pharmaceutical product labels:
- Name of the European state
- Price of the pharmaceutical product
- Reimbursement conditions of social security organisations
- Legal status for supply to the patient, in accordance with Directive 2001/83/EC as amended
- Product Identification and Authenticity (National Identification Number)
The preceding information should be printed on a label within a graphical blue box. The labels should be adhered to the side of the package. Text on the label should be written in the language of the European state which requires the additional information.
Multiple States, Multiple Blue Box Labels?
If a pharmaceutical product is to be sold in several European states which have individual labeling requirements, the individual requirements for each state are to be labeled separately. To accomplish this, the European Community suggests that a “blank” blue box be printed and that a “sticker” for each state be placed over the blank blue box.
Of course, a more efficient solution for pharmaceutical labelling requirements would be to digitally print a unique label for each blue box label required by any unique European state requirement. QuickLabel short run digital colour label printers have the capacity to print changing label content on the fly, while labels are being printed. In so doing, they eliminate the necessity to buy large quantities of pre-printed label packaging.
Digitally printing blue box labels with foreign language text, multicolor symbols and pictograms (in the required blue, red, green, and black colours), and barcodes using a QuickLabel printer can be a cost-effective solution to European requirements for state-specific blue box medicinal product packaging.
There are two QuickLabel printer solutions for blue box labeling: a simple 2-colour label printer that uses thermal transfer label printing technology to produce the required blue box and black text, or a full-colour inkjet label printer that can be used to print a blue box as well as all branding information.
Now, although you still may not be able to say Blue. Box. Label. Ten times fast, you do know plenty about this regulation and how QuickLabel Systems offers two fantastic printer solutions for this. Please share this with anyone who may find this helpful!
Resource for further information:
Guidelines on the Packaging of Medicinal Products for Human Use Authorized by the Community – http://ec.europa.eu/health/files/eudralex/vol-2/c/bluebox_02_2008_en.pdf