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Commission Delegated Regulation (EU) 2016/161 Article 12

Commission Delegated Regulation (EU) 2016/161 Article 12

Unique identifiers which have been decommissioned

Article 12

A medicinal product bearing a unique identifier which has been decommissioned shall not be further distributed or supplied to the public except in any of the following situations: (a) the unique identifier was decommissioned in accordance with Article 22(a) and the medicinal product is distributed for the purpose of exporting it outside the Union; (b) the unique identifier was decommissioned earlier than the time of supplying the medicinal product to the public, pursuant to Articles 23, 26, 28 or 41; (c) the unique identifier was decommissioned in accordance with Article 22(b) or (c) or Article 40, and the medicinal product is provided to the person responsible for its disposal; (d) the unique identifier was decommissioned in accordance with Article 22(d) and the medicinal product is provided to the national competent authorities.

Read the full instrument → · Read this in context: CHAPTER III — GENERAL PROVISIONS ON THE VERIFICATION OF THE SAFETY FEATURES →

Other provisions in CHAPTER III — GENERAL PROVISIONS ON THE VERIFICATION OF THE SAFETY FEATURES

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 12 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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