Lists of derogations from bearing or not bearing the safety features
Article 45
1. The list of medicinal products or product categories subject to prescription which shall not bear the safety features are set out in Annex I to this Regulation.
2. The list of medicinal products or product categories not subject to prescription which shall bear the safety features are set out in Annex II to this Regulation.
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 45 of Commission Delegated Regulation (EU) 2016/161 (LawPlayer, data as of 2026-07-04)