S.L. 427.10 Art. 10European databank.

(1) Regulatory data in accordance with these regulations shall be stored in a European databank accessible to the competent authorities to enable them to carry out their tasks relating to these regulations on a well-informed basis.

(2) The databank shall contain the following:

(a) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures as laid down in Schedules II to V;

(b) data obtained in accordance with the vigilance procedure as defined in regulation 8(3) to (5);

(c) data relating to clinical investigations referred to in regulation 7(1) to (7).

(3) Data shall be forwarded in a standardised format by the Medicines Authority.