Art. 10 Reports on inspections and study audits
1 The competent authority shall provide the establishment with the draft of the inspection report and allow it an appropriate period in which to state its position thereon. On receipt of a response from the establishment or on expiry of the period, the authority shall pass the inspection report to the notification authority. 2 The competent authority shall pass the report on the study audit to the notification authority. 3 The notification authority shall decide:
4 The provisions on study audits also apply to studies audited during an inspection. |