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Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance · European Union

The following particulars shall appear on the immediate and the outer packaging: name of the main contact; name of the medicinal product, followed by its strength and pharmaceutical form; statement of the active substances expressed qualitatively and quantitatively per dosage unit; batch or code number identifying the contents and packaging operation; clinical trial reference code allowing identification of the clinical trial site, investigator and subject; directions for use (reference may be made to a leaflet or other explanatory document intended for the subject or person administering the product); ’For clinical trial use only’ or similar wording; the storage conditions; and period of use (expiry date or retest date as applicable).

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.