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Commission Delegated Regulation (EU) 2016/161 Article 7

Human-readable format

Article 7

1.   Manufacturers shall print the following data elements of the unique identifier on the packaging in human-readable format: (a) the product code; (b) the serial number; (c) the national reimbursement number or other national number identifying the medicinal product, if required by the Member State where the product is intended to be placed on the market and not printed elsewhere on the packaging. 2.   Paragraph 1 shall not apply where the sum of the two longest dimensions of the packaging equals or is less than 10 centimetres. 3.   Where the dimensions of the packaging allow it, the human-readable data elements shall be adjacent to the two-dimensional barcode carrying the unique identifier.

Read the full instrument → · Read this in context: CHAPTER II — TECHNICAL SPECIFICATIONS OF THE UNIQUE IDENTIFIER →

Other provisions in CHAPTER II — TECHNICAL SPECIFICATIONS OF THE UNIQUE IDENTIFIER

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 7 of Commission Delegated Regulation (EU) 2016/161 (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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