1.Member States shall submit to the Commission an annual report, by 30 June of the following year, on the notification of serious adverse reactions and events received by the competent authority. The Commission shall submit to the competent authorities of Member States a summary of the reports received. The competent authority shall make this report available to tissue establishments.
2.Data transmission shall comply with the data exchange format specifications as set out in Annex V, part A and B, and shall provide all the information necessary to identify the sender and maintain its reference data.