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In brief

On 6 April 2021, the Italian Medicines Agency (Agenzia Italiana del Farmarco or AIFA) published a document updating the requirements to be reported in the outer labelling of centralized medicinal products placed on the Italian market (so-called “Blue Box“). In this respect, it should be noted that the Blue Box is that area, marked by a blue border, included in the label of a medicinal product intended to contain specific information relevant for each Member State in whose territory the product is marketed.


In depth

Among the most important elements, we note the instructions for reporting prices for medicines reimbursed by the National Health Service (NHS), for those purchased in hospital settings, as well as for radiopharmaceuticals ready to use, radionuclide generators and precursors. As regards aspects related to the authenticity and traceability of drugs, it is required that all medicines, whether or not subject to prescription and notwithstanding their classification for reimbursement purposes, bear the sticker issued by the State Polygraphic Institute (Istituto Poligrafico e Zecca dello Stato) providing the unique identifier both in human-readable format and as two-dimensional barcode.

In addition, the document includes a scheme providing the specific texts to be reported in the Blue Box according to the supply regime applicable to the medicinal product and depending on whether the medicinal product is subject to prescription or not. Lastly, the document shows the mandatory pictograms that must be published on labels of non-prescription medicinal products and those containing doping substances.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

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