Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).’;
Treoir 2001/20/CE ó Pharlaimint na hEorpa agus ón gComhairle an 4 Aibreán 2001 maidir le comhfhogasú dhlíthe, rialacháin agus fhorálacha riaracháin na mBallstát maidir le dea-chleachtas cliniciúil a chur chun feidhme i stiúradh trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine (IO L 121, 1.5.2001, lch. 34).”.