Commission Directive 2005/28/EC of 8 April 2005 laying down… Article 3

Article 3

The available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the proposed clinical trial. Clinical trials shall be conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association (1996).

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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 Directive 2005/28/EC of 8 April 2005 laying down… (LawPlayer, data as of 2026-07-04)

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