S.L. 458.47 Art. 4Ethics Committees.

(1) Each Ethics Committee established under Article 6(1)

of Directive 2001/20/EC shall adopt the relevant rules of procedure necessary to implement the requirements set out in that Directive and, in particular, in Articles 6 and 7 thereof.

(2) The Ethics Committees shall, in every case, retain the essential documents relating to a clinical trial, as referred to in Article 15(5) of Directive 2001/20/EC, for at least three years after completion of that trial. They shall retain the documents for a longer period, where so required under other applicable requirements.

(3) Communication of information between the Ethics Committees and the Authority shall be ensured through appropriate and efficient systems.