Eurecnet - Legislation: Finland

Legislation: Denmark

Legislation

• Act on Research Ethics Review of Health Research Projects ( LBK nr 1338 af 01/09/2020 in Danish only)



Clinical trials with medicinal products:

• REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC



The Danish Law on clinical trials with medicinal products (only in Danish):

• Bekendtgørelse af lov om kliniske forsøg med lægemidler, LBK nr. 1252 af 31/10/2018



Clinical investigations with medical device:

• REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC



The Danish Law on clinical investigations with medical device (only in Danish):

• Lov nr. 1853 af 09/12/2020 om videnskabsetisk behandling af kliniske afprøvning af medicinsk udstyr.

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