http://www.legislation.gov.uk/id/eur/2014/536

CHAPTER VISTART, END, TEMPORARY HALT, AND EARLY TERMINATION OF A CLINICAL TRIAL

Article 36Notification of the start of a clinical trial and of the end of the recruitment of subjects

1.

The sponsor shall notify each Member State concerned of the start of a clinical trial in relation to that Member State through the EU portal.

That notification shall be made within 15 days from the start of the clinical trial in relation to that Member State.

2.

The sponsor shall notify each Member State concerned of the first visit of the first subject in relation to that Member State through the EU portal.

That notification shall be made within 15 days from the first visit of the first subject in relation to that Member State.

3.

The sponsor shall notify each Member State concerned of the end of the recruitment of subjects for a clinical trial in that Member State through the EU portal.

That notification shall be made within 15 days from the end of the recruitment of subjects. In case of re-start of recruitment, paragraph 1 shall apply.