Commission Delegated Regulation (EU) 2016/161 Article 18

Actions to be taken by manufacturers in case of tampering or suspected falsification

Article 18

Where a manufacturer has reason to believe that the packaging of the medicinal product has been tampered with, or the verification of the safety features shows that the product may not be authentic, the manufacturer shall not release the product for sale or distribution and shall immediately inform the relevant competent authorities.

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

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

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 18 of Commission Delegated Regulation (EU) 2016/161 (LawPlayer, data as of 2026-07-04)

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