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Commission Delegated Regulation (EU) 2016/161 Article 3

Definitions

Article 3

1.   For the purposes of this Regulation, the definitions in Article 1 of Directive 2001/83/EC shall apply. 2.   The following definitions shall apply: (a) ‘unique identifier’ means the safety feature enabling the verification of the authenticity and the identification of an individual pack of a medicinal product; (b) ‘anti-tampering device’ means the safety feature allowing the verification of whether the packaging of a medicinal product has been tampered with; (c) ‘decommissioning of a unique identifier’ means the operation changing the active status of a unique identifier stored in the repositories system referred to in Article 31 of this Regulation to a status impeding any further successful verification of the authenticity of that unique identifier; (d) ‘active unique identifier’ means a unique identifier which has not been decommissioned or which is no longer decommissioned; (e) ‘active status’ means the status of an active unique identifier stored in the repositories system referred to in Article 31; (f) ‘healthcare institution’ means a hospital, in- or outpatient clinic or health centre.

Read the full instrument → · Read this in context: CHAPTER I — SUBJECT MATTER AND DEFINITIONS →

Other provisions in CHAPTER I — SUBJECT MATTER AND DEFINITIONS

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 3 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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