F1Article 10b
1.
Regulatory data in accordance with this Directive shall be stored in a European databank accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis.
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data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures as laid down in Annexes 2 to 5;
(b)
data obtained in accordance with the vigilance procedure as defined in Article 8;
(c)
data relating to clinical investigations referred to in Article 10.
2.
Data shall be forwarded in a standardised format.
3.
The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(c), shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).