EU Clinical Trials Regulation (CTR 536/2014) CTR-Art.66_67_68_69: Labelling of investigational medicinal products (Articles 66-69)

Articles 66-69 set the labelling requirements for IMPs (Annex VI to the Regulation): unauthorised IMPs, authorised IMPs used as IMPs, and radiopharmaceuticals. Article 69 governs the language of labelling (determined by the Member State concerned, with English permitted where the Member State so allows).

Maintained by Gerard BlokdykVerified against the published standard 31 May 2026Control text last updated 21 May 2026

Other controls in CTR - Conduct, Manufacturing and Labelling (Ch VIII-X)

CTR-Art.47 Compliance with the protocol and Good Clinical Practice (Article 47)
CTR-Art.48 Monitoring (Article 48)
CTR-Art.52 Reporting of serious breaches (Article 52)
CTR-Art.57_58 Clinical trial master file and archiving (Articles 57-58)
CTR-Art.61_62_63 Manufacturing and import of IMPs and the qualified person (Articles 61-63)

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MCP endpoint All EU Clinical Trials Regulation (CTR 536/2014) controls