8. Possible actions taken by the EU/EEA Member States concerned (MSC): Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

Serious breaches will be notified by the sponsors via the secure module of CTIS. After submission in CTIS this information will be visible in the secure module of the Member States that can perform an assessment. The assessment of the serious breach done by the Member States will lead to the publication of the serious breach and the corresponding evaluation done by the MS via the CTIS public domain.

Some of the serious breaches reported will be managed in-house via acceptable Corrective and Preventive Actions (CAPA) and with the oversight of the MS. Some serious breaches may require either an inspection and/or regulatory actions being taken.

Inspection request - the serious breach may trigger an (urgent) inspection. The outcome of this inspection may lead on to further regulatory action or even prosecution.

In case an inspection is deemed necessary, the notice of a serious breach will be published at the same time as the inspection report in CTIS, in line with section 4.5.3 of the Appendix on disclosure rules, to the “Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014”.

Regulatory actions - in case a serious breach requires regulatory actions to be taken, as for example corrective measures described under Article 77 of Regulation (EU) 536/2014, including revocation or suspension of the authorisation to conduct the clinical trial(s) or requiring the sponsor to modify any aspect of the clinical trial(s), these will be managed by the MSC. Except where immediate action is required, the MSC will ask the sponsor for their opinion. That opinion shall be delivered within 7 days.

Furthermore, actions with reference to national legislation might be applicable as well.

© European Medicines Agency, 2021

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