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Commission Delegated Regulation (EU) 2016/161 Article 26

Derogations from Article 25

Article 26

1.   Persons authorised or entitled to supply medicinal products to the public are exempted from the obligation to verify the safety features and decommission the unique identifier of medicinal products provided to them as free samples in accordance with Article 96 of Directive 2001/83/EC. 2.   Persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy are exempted from the obligation to verify the safety features and decommission the unique identifier of medicinal products where that obligation has been placed on wholesalers by national legislation in accordance with Article 23. 3.   Notwithstanding Article 25, Member States may decide, where necessary to accommodate the particular characteristics of the supply chain on their territory, to exempt a person authorised or entitled to supply medicinal products to the public operating within a healthcare institution from the obligations of verification and decommissioning of the unique identifier, provided that the following conditions are met: (a) the person authorised or entitled to supply medicinal products to the public obtains the medicinal product bearing the unique identifier through a wholesaler belonging to the same legal entity as the healthcare institution; (b) the verification and decommissioning of the unique identifier is performed by the wholesaler that supplies the product to the healthcare institution; (c) no sale of the medicinal product takes place between the wholesaler supplying the product and that healthcare institution; (d) the medicinal product is supplied to the public within that healthcare institution.

Read the full instrument → · Read this in context: CHAPTER VI — MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY PERSONS AUTHORISED OR ENTITLED TO SUPPLY MEDICINAL PRODUCTS TO THE PUBLIC →

Other provisions in CHAPTER VI — MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY PERSONS AUTHORISED OR ENTITLED TO SUPPLY MEDICINAL PRODUCTS TO THE PUBLIC

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 26 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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