My bookmarksSign up free

Commission Delegated Regulation (EU) 2016/161 Article 25

Commission Delegated Regulation (EU) 2016/161 Article 25

Obligations of persons authorised or entitled to supply medicinal products to the public

Article 25

1.   Persons authorised or entitled to supply medicinal products to the public shall verify the safety features and decommission the unique identifier of any medicinal product bearing the safety features they supply to the public at the time of supplying it to the public. 2.   Notwithstanding paragraph 1, persons authorised or entitled to supply medicinal products to the public operating within a healthcare institution may carry out that verification and decommissioning at any time the medicinal product is in the physical possession of the healthcare institution, provided that no sale of the medicinal product takes place between the delivery of the product to the healthcare institution and the supplying of it to the public. 3.   In order to verify the authenticity of the unique identifier of a medicinal product and decommission that unique identifier, persons authorised or entitled to supply medicinal products to the public shall connect to the repositories system referred to in Article 31 through the national or supranational repository serving the territory of the Member State in which they are authorised or entitled. 4.   They shall also verify the safety features and decommission the unique identifier of the following medicinal products bearing the safety features: (a) medicinal products in their physical possession that cannot be returned to wholesalers or manufacturers; (b) medicinal products that, while in their physical possession, are requested as samples by competent authorities, in accordance with national legislation; (c) medicinal products which they supply for subsequent use as authorised investigational medicinal products or authorised auxiliary medicinal products as defined in Articles 2(2)(9) and (10) of Regulation (EU) No 536/2014.

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 25 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.

What to look at next