1. Where an unexpected event is likely to seriously affect the benefit-risk balance, the sponsor and the investigator shall take appropriate urgent safety measures to protect the subjects.
2. The sponsor shall notify the Member States concerned, through the EU portal, of the event and the measures taken.
That notification shall be made without undue delay but no later than seven days from the date the measures have been taken.
3. This Article is without prejudice to Chapters III and VII.