Penalty and Appeal Act

Both the CCMO and the accredited MREC are governmental bodies and the Penalty and Appeal Act applies on the timelines for the review of research files.

When the CCMO or the accredited MREC reach the end of the statutory timeline but the review has not yet resulted in a decision, they can request the sponsor for an extension of the review period. If the sponsor does not give permission for an extension, the CCMO or accredited MREC will finalize the review and will issue their positive or negative decision within the legal timelines.

If the CCMO or MREC do not reach a decision within the statutory timelines, there are two consequences:

1. After the applicant has informed the CCMO or accredited MREC in writing that the review timeline has expired without an decision, the committee has a grace period of two weeks. If the committee still fail to take a decision, the applicant is entitled to a receive a penalty payment for each day the decision period is exceeded. The height of the penalty payment depends on the number of days the CCMO or accredited MREC exceeded the timeline to a maximum of 42 days and €1442;
2. If the CCMO or accredited MREC does not take a decision within the above described grace period, the applicant can immediately – so without submitting first an objection at the CCMO or accredited MREC – appeal to the administrative court against the absence of the decision. For this the applicant is not required to hire a lawyer. When the court declares the appeal well-founded, then the CCMO or accredited MREC are required to reach the decision after all within two weeks. The court can impose an additional penalty payment should the CCMO or accredited MREC not comply to this.

More information in this issue can be found at the website Government information for entrepreneurs.