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Fortalepunkt 161

Recital 161

161) Når det gjelder samtykke til å delta i vitenskapelige forskningsaktiviteter i forbindelse med kliniske utprøvinger, bør de relevante bestemmelsene i europaparlaments- og rådsforordning (EU) nr.

536/2014 få anvendelse.

(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