They come from the Falsified Medicines Directive (2011/62/EU), which amended Directive 2001/83/EC, with detailed rules in Delegated Regulation (EU) 2016/161. The unique identifier is a 2D Data Matrix carrying the product code, a serial number, the batch number and the expiry date, plus a national reimbursement number where a country requires it (see serialization). Pharmacies and wholesalers check it against a national verification system when the pack is dispensed. Most prescription medicines must carry both features, while most OTC medicines are exempt unless they are specifically listed, and some prescription medicines are exempt through a separate list. The rules have applied since February 9, 2019.
Why it matters for labeling
The packaging has to carry the Data Matrix, the human-readable data next to it, and space for the anti-tampering device. The regulation presumes that a print quality of at least 1.5 under ISO/IEC 15415 meets its requirement, and the manufacturer has to verify before release that the code is readable and holds the correct information. A good print grade doesn't prove the data is right.
Common mistakes
- Human-readable data that doesn't match the encoded data
- Artwork that leaves no space for the code or the seal
- A code that was graded but never decoded and compared with the approved data
- Applying the requirements to a product that is exempt, or missing them on one that isn't