S.L. 483.4 Art. 9Annual reports. Re-numbered by: L.N. 304 of 2013.

(1) The Authority shall submit to the Commission an annual report, by the 30th June of the following year, on the notification of serious adverse reactions and events received by it. The Commission shall submit to the competent authorities of Member States a summary of the reports received. The Authority shall make this report available to tissue establishments.

(2) Data transmission shall comply with the data exchange format specifications as set out in Schedule V, Parts A and B, and shall provide all the information necessary to identify the sender and maintain its reference data.