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Commission Delegated Regulation (EU) 2016/161 Article 40

Products recalled, withdrawn or stolen

Article 40

The marketing authorisation holder or, in case of parallel imported or parallel distributed medicinal products bearing an equivalent unique identifier for the purposes of complying with Article 47a of Directive 2001/83/EC, the person responsible for placing those medicinal products on the market shall promptly take all the following measures: (a) ensure the decommissioning of the unique identifier of a medicinal product which is to be recalled or withdrawn, in every national or supranational repository serving the territory of the Member State or Member States in which the recall or the withdrawal is to take place; (b) ensure the decommissioning of the unique identifier, where known, of a medicinal product which has been stolen, in every national or supranational repository in which information on that product is stored; (c) indicate in the repositories referred to in points (a) and (b) that that product has been recalled or withdrawn or stolen, where applicable.

Read the full instrument → · Read this in context: CHAPTER VIII — OBLIGATIONS OF MARKETING AUTHORISATION HOLDERS, PARALLEL IMPORTERS AND PARALLEL DISTRIBUTORS →

Other provisions in CHAPTER VIII — OBLIGATIONS OF MARKETING AUTHORISATION HOLDERS, PARALLEL IMPORTERS AND PARALLEL DISTRIBUTORS

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 40 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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