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Commission Delegated Regulation (EU) 2016/161 Article 21

Commission Delegated Regulation (EU) 2016/161 Article 21

Derogations from Article 20(b)

Article 21

Verification of the authenticity of the unique identifier of a medicinal product is not required under Article 20(b) in any of the following situations: (a) that medicinal product changes ownership but remains in the physical possession of the same wholesaler; (b) that medicinal product is distributed within the territory of a Member State between two warehouses belonging to the same wholesaler or the same legal entity, and no sale takes place.

Read the full instrument → · Read this in context: CHAPTER V — MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY WHOLESALERS →

Other provisions in CHAPTER V — MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY WHOLESALERS

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 21 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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