The amended Anti-Counterfeiting Directive 2011/62/EU explicitly states that from 2019 all drug packaging must be equipped with safety features. Prescription drugs must be labelled with a unique identifier from that date, permitting unambiguous traceability. It must contain the drug manufacturer’s code, a serial number, a national number for reimbursement, the batch number and the expiry date.
Furthermore, an anti-tampering feature must indicate that the packaging unit has not been opened. According to the Anti-Counterfeiting Directive, there will be four safe closing options available as secondary packaging materials for folding boxing from 2019: closing with glues, special folding glue constructions, closing with sealing labels and sealing with film.