SSDataProtection object

Notification to DP Authority/ Ombudsmann is mandatory

Yes

Language of notification

Official National Language(s)

Notification format

Paper hardcopy
Electronically

Notification fee required

Yes

Fee

For all investigation on Medical Devices: 25€ (electronically), 125€ (paper version)

Guidance on notification requirements

Further details on the declaration procedure are provided on the Commission’s website in section “Privacy topics” (in French or Dutch only).

Data Protection Authority/ Agency - Contact Details

The Commission for the Protection of Privacy (CPP)

Contact Name 2

"The Privacy Commission”

Phone

+32 (0)2 274 48 79

Fax

+32 (0)2 274 48 35

Address

Rue de la Presse 35

ZIP/City

1000 Brussels

Country

Belgium (BE)

Additional Information

Clinical Trials must comply with data protection rules as specified in the Belgian Data Protection Act and its implementing Royal Decrees provided on the CPP website.

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