CHAPTER V

HAEMOVIGILANCE

Notification of serious adverse events and reactions
Article 15
1
Member States shall ensure that:
- any serious adverse events (accidents and errors) related to the collection, testing, processing, storage and distribution of blood and blood components which may have an influence on their quality and safety, as well as any serious adverse reactions observed during or after transfusion which may be attributed to the quality and the safety of blood and blood components are notified to the competent authority,
- blood establishments have in place a procedure accurately, efficiently and verifiably to withdraw from distribution blood or blood components associated with the notification referred to above.
2
These serious adverse events and reactions shall be notified in accordance with the procedure and notification format referred to in Article 29(i).