D. REPLACING OF INFORMATION

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 particulars listed in sections A, B and C, other than those particulars listed in paragraph 9, may be omitted from the label of a product and made available by other means, for example by use of a centralised electronic randomisation system, use of a centralised information system, provided that the safety of the subject and the reliability and robustness of data are not compromised. This shall be justified in the protocol. The particulars referred to in the following points shall not be omitted from the label of a product: paragraph 1, points (b), (c), (d), (f), (j) and (k); paragraph 4, points (b), (c), (e), and (f); paragraph 5, points (b), (c), (e), and (f); paragraph 6, points (b), (d), (e), (h), and (i).

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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.