Medicines Serialisation Explained: Unique Identifiers, Verification and Alerts

Serialisation is the obligation that turned every pharmacy counter and every wholesaler loading bay into a verification point. Since 9 February 2019, prescription medicines placed on the EU market have had to carry two safety features and be checked against a central database before they reach a patient. The rules sit in Delegated Regulation (EU) 2016/161, under the safety features provisions introduced into Directive 2001/83/EC by the Falsified Medicines Directive, and they allocate duties to manufacturers, wholesalers and the people who supply the public in quite different proportions.

Two safety features, doing different jobs

The unique identifier is a unique sequence carried in a two-dimensional Data Matrix barcode that identifies and authenticates an individual pack. It must contain a product code, a serial number, the batch number and the expiry date, plus the national reimbursement number where a Member State requires one. Article 4(b) governs the Data Matrix itself, Article 7 the human-readable text that has to accompany it, and Article 5 the technical requirements. Under Article 14 the manufacturer must verify before release that the barcode is readable, correct and complete.

The anti-tampering device does something the barcode cannot: it allows verification of whether the packaging has been tampered with, and that tamper evidence must hold for the whole shelf life of the product. The two features answer separate questions — is this pack genuine, and has this pack been opened — and a pack can fail either one independently.

Scope is narrower than “all medicines”. Safety features apply to prescription medicines other than those listed in Annex I, to non-prescription medicines listed in Annex II, and to any products a Member State has chosen to add. Radiopharmaceuticals are excluded.

Who verifies, and when

The architecture is risk-based rather than uniform, which is the part that causes confusion in practice.

Wholesalers operate under Articles 20 to 24. Article 20 requires verification of unique identifiers on products they physically hold that were returned to them, or received from a wholesaler outside the designated distribution chain — and Article 20(b) exempts direct shipments from the manufacturer or a designated wholesaler. In other words, the obligation targets the points where a pack could plausibly have left the legitimate chain and come back. Wholesalers are not required to verify the anti-tampering device under Articles 20 to 22. Article 22(a) requires decommissioning for products leaving the EU, performed by the wholesaler holding the product, and Article 23 covers decommissioning on behalf of certain recipients, including civil protection stocks and research supplies — a list that does not extend to healthcare institutions generally.

Persons authorised to supply the public — community pharmacies and hospitals — verify and decommission before supplying the pack. Article 25(2) gives hospitals useful latitude: verification and decommissioning may take place at any time while the product is in the institution’s possession, provided no sale occurs between delivery and supply. Article 28 deals with the practical case of a pack dispensed in parts, decommissioning the unique identifier when the pack is first opened.

Manufacturers verify and decommission before using products as investigational or auxiliary medicinal products under Articles 16 and 25(4)(c), and must keep records of their unique identifier operations.

The repositories system

The data layer is as regulated as the packaging. Under Article 31(1) a non-profit legal entity establishes and manages the repositories system, funded by manufacturers. Article 32 provides that each Member State is served by the European hub plus one national or supranational repository. Manufacturers and marketing authorisation holders upload the Article 33(2) data before a product is released for sale or distribution.

Two technical details matter operationally. Article 35(1)(f) imposes a 300 millisecond response limit on each repository, because verification happens while a patient waits. And Article 13 together with Article 35(1)(g) requires wholesalers operating from multiple sites to be uniquely identifiable within the system, so that a decommissioning event can be attributed to a location rather than a company.

When a check fails

The response obligations are immediate and personal to whoever is holding the pack. Article 30 prohibits supply to the public where there is reason to believe the packaging has been tampered with or the verification indicates the product may not be authentic. Article 24 prohibits a wholesaler from supplying a product whose unique identifier cannot be verified; where a code is permanently unreadable, the pack should not be supplied to the public.

Manufacturers, wholesalers and persons supplying the public must immediately inform the national competent authority of a suspected falsification, under Articles 18, 24 and 30 respectively, and manufacturers must also inform the competent authority and the marketing authorisation holder under Article 46 of the Directive. On the system side, Article 37(d) requires the national medicines verification organisation to ensure the authorities, the EMA and the Commission are informed once an alert cannot be explained by technical causes.

That last clause is the one that shapes day-to-day work. Most alerts are technical — a misread code, a duplicate scan, a data upload error — and the burden on pharmacy and wholesale staff is triage: deciding quickly whether this is an operational problem or the beginning of a falsification report. Training staff to make that distinction reliably is the difference between a functioning system and an alert queue nobody trusts.

Transitional stock and later starters

Products released for sale before 9 February 2019 without safety features could remain on the market until their expiry, which is why unserialised stock persisted for years after the start date. Repackaged or relabelled products must carry safety features, under Article 48. Italy and Greece operated on later timelines, with product released for sale before 9 February 2025 able to remain on the market.

Where this sits in a quality system

Serialisation is not a standalone project. For wholesalers it runs inside the Good Distribution Practice framework, whose training chapter expressly requires staff to be trained on product identification and on avoiding falsified medicines entering the supply chain — see our guide to the Responsible Person role and GDP training duties. For pharmacists, decommissioning is a point-of-supply clinical governance control, and sits alongside the wider professional record-keeping obligations covered in our guide to GPhC CPD records. Our CPD course library covers the quality management and audit foundations both rely on.

Frequently asked questions

Does a wholesaler have to scan every pack?

No. Article 20 requires verification for products physically held that were returned to the wholesaler or received from a wholesaler outside the designated distribution chain, and Article 20(b) exempts direct supply from the manufacturer or a designated wholesaler. The design targets re-entry points rather than imposing universal scanning.

Can a hospital decommission on delivery rather than at administration?

Article 25(2) permits verification and decommissioning at any time while the product is in the institution’s possession, provided no sale takes place between the time of delivery and supply to the public.

What happens if the barcode will not scan?

A wholesaler may not supply a product whose unique identifier cannot be verified under Article 24, and where a code is permanently unreadable the product should not be supplied to the public. The failure must be investigated rather than worked around.

Who pays for the repositories system?

Manufacturers. Article 31(1) requires the system to be set up and managed by a non-profit legal entity established by manufacturers and marketing authorisation holders, funded by them.