Netherlands

Netherlands Clinical Trial Quote Request

Clinical Trials Quote Request

Yes. www.ccmo.nl/en/insurance

450.000 €/patient
3.500.000 €/protocol

Effective July 1, 2015, new limits required are:
650.000 €/patient
5.000.000 €/protocol

4 years from the end of patient treatment

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Dutch

- There are TWO insurance requirements.
- Local admitted clinical trial insurance satisfies the G1 patient indemnity insurance requirement according to WMO
- The G2 is the liability insurance of Sponsor, which can be covered via a global product liability policy
- Therefore to satisfy G2, if the Sponsor has a Master Product Liability policy through Newfront, Newfront can provide a certificate

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Yes and No. Insurance is mandatory for drug testing via "Liability for Drugs Association" in Norway

Drug Sponsor must apply for insurance direct at the following site:
https://laf.no/

Device trials can be covered by the US Master Policy

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If the trial is Device-related as mentioned above, please submit an email request to our certificate team requesting a certificate at: techcertrequest@theabdteam.com and CC your ABD Team.

Include the following in your email:
o Include in your email the following: RE: Protocol #, Country
o Attach the Protocol and Informed Consent Form (ICF) documents, if not already provided to ABD