Brubru EU Canon
Directive 2011/62/EU
The law that closed the legal supply chain to fake medicines, with pack-level safety features verified at the pharmacy counter.
After an alarming rise in fakes reaching patients through legitimate channels, Directive 2011/62/EU amended the Community Code to close the legal supply chain to falsified medicines. It introduces end-to-end controls: pack-level safety features, tighter active-substance rules, regulation of brokers, an online-pharmacy logo and stronger inspections.
A "falsified medicinal product" is one with a false representation of its identity, source or history. The definition deliberately excludes unintentional quality defects and intellectual-property infringements.
Every prescription medicine must carry two safety features (Articles 54(o) and 54a): a unique identifier (a 2D Data Matrix barcode) and an anti-tampering device. These let wholesalers and pharmacists verify authenticity and spot tampering. Over-the-counter products are excluded unless listed as at-risk. The detailed rules are in Commission Delegated Regulation (EU) 2016/161.
The unique identifier is checked against the European Medicines Verification System (EMVS), a repositories system that flags any pack scanned twice or out of sequence. The cost of the system is borne by marketing-authorisation holders. It went live across the EU on 9 February 2019.
Member States must run a system to stop suspect products reaching patients, with a rapid alert to all Member States and public announcements within 24 hours for serious risk (Article 117a). Penalties for trading falsified medicines must be effective, proportionate and dissuasive (Article 118a).
| Instrument | Directive 2011/62/EU (amends Directive 2001/83/EC) |
| Official Journal | L 174, 1 July 2011, p. 74 |
| Legal base | Articles 114 + 168(4)(c) TFEU |
| Adopted | 8 June 2011 |
| Transposition deadline | 2 January 2013 |
| Safety features applied | 9 February 2019 (Delegated Reg (EU) 2016/161) |
| Key tools | Unique identifier, anti-tampering device, EMVS, online-pharmacy logo |
A directive is not directly applicable: each Member State must write it into its own national law by a transposition deadline. For the Falsified Medicines Directive (Directive 2011/62/EU) the EU transposition deadline was 2 January 2013 (the safety-features provisions applied from 9 February 2019). The map shows, for each Member State, the principal national measure it notified to the Commission and its date. 25 of 27 Member States have notified measures parsed here; the full, authoritative list of national transposition measures for every Member State is on EUR-Lex (National transposition measures).
Click a Member State marker for the transposed national law and its publication date. Source: EUR-Lex National Implementing Measures, retrieved 26 May 2026. Where a marker reads "Notified via EUR-Lex", consult the EUR-Lex link above for that country's measures.
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