Recital 161
Recital 161
(161) 為同意參與臨床試驗科學研究活動之目的，歐洲議會及歐盟理 事會之歐盟規則第 536/2014 號[15]應適用之。
(161) For the purpose of consenting to the participation in scientific research activities in clinical trials, the relevant provisions of Regulation (EU) No 536/2014 of the European Parliament and of the Council [15] should apply.
[15] 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 (OJ L 158, 27.5.2014, p. 1). https://eur-lex.europa.eu/legal-content/EN/AUTO/?uri=OJ:L:2014:158:TOC
[15] 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 (OJ L 158, 27.5.2014, p. 1). https://eur-lex.europa.eu/legal-content/EN/AUTO/?uri=OJ:L:2014:158:TOC
Source: https://www.ndc.gov.tw/Content_List.aspx?n=F98A8C27A0F54C30
The latest consolidated version of the Regulation with corrections by Corrigendum, OJ L 127, 23.5.2018, p. 2 ((EU) 2016/679). Source: EUR-lex.