9. — Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16…

9.

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 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.