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Legislation changes for clinical trials in the Netherlands

July 01, 2015

A revised Decree for the mandatory insurance for medical research with human subjects has been published in the Official Dutch Journal (Staatsblad) on 9 December 2014.

Effective 1st July 2015, the legal requirements for Netherlands clinical trials policies are changing.
The new limits are:
- EUR 650,000 per patient (instead of EUR 450,000)
- EUR 5,000,000 per protocol (instead of EUR 3,500,000)

These changes do not apply to clinical trials that have been approved by Ethics Committee prior to 1st July 2015.

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