전문161조
Recital 161
(161) 임상 실험의 과학 연구 활동 참여에 동의할 목적으로, 유럽 의회 및 각료이사회 규정서 (EU) No 536/2014의 관련 조문이 적용되어야 한다 [15].
(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: http://www.pipc.go.kr/cmt/not/ntc/selectBoardArticle.do?nttId=5969&bbsId=BBSMSTR_000000000121&bbsTyCode=BBST03&bbsAttrbCode=BBSA03&authFlag=Y&pageIndex=6
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.