Decommissioning: marking a unique identifier as supplied

Decommissioning is defined in Commission Delegated Regulation (EU) 2016/161 as the operation that changes the status of a unique identifier from active to a status that stops further verification of its authenticity. The core rule in Article 25 is that persons authorised or entitled to supply medicines to the public, in practice pharmacies, dispensing doctors and hospitals, verify the safety features and decommission the identifier at the time of supply. Hospitals may decommission earlier, at any point while the pack is in their possession, provided no wholesale sale takes place in between.

Wholesalers decommission in defined situations under Article 22: packs they intend to distribute outside the EU, samples requested by authorities, packs they cannot return to saleable stock, and packs that are recalled, withdrawn or stolen. The marketing authorisation holder decommissions, or asks the national organisation to update the status, when a batch is recalled or withdrawn, and sets the status of stolen packs so that they cannot re-enter the chain. Parallel traders who repackage decommission the original identifier under Article 16 before applying an equivalent new one.

Article 13 allows a decommissioned identifier to be reverted to active within ten days, by the same person at the same location, if the pack was not supplied, has not expired and was not marked as recalled, withdrawn, stolen or for destruction. Everything else is final. The repository records who changed the status and when, which is what gives investigators a trail when a pack is scanned twice or appears in two countries.

What goes wrong: hospital pharmacies that decommission at goods receipt and later return stock to a wholesaler, which then cannot sell it; export decommissioning missed for packs sold outside the EU; recalls where the holder does not update the status, so recalled packs still verify as active; and the ten-day reversal window used to cover errors it was not designed for. For holders, every one of these produces an alert whose investigation lands with regulatory and quality teams, and a pattern of alerts on one product can lead to an authority inquiry even when no falsified pack is involved.