The Medicines for Human Use (Clinical Trials) Regulations 2004 No. 1031

SCHEDULE 3 U.K. PARTICULARS AND DOCUMENTS THAT MUST ACCOMPANY AN APPLICATION FOR AN ETHICS COMMITTEE OPINION, A REQUEST FOR AUTHORISATION, A NOTICE OF AMENDMENT AND A NOTIFICATION OF THE CONCLUSION OF A TRIAL

PART 2 U.K. REQUEST FOR AUTHORISATION

1.  The name and address of— U.K.

(a) the sponsor,

(b) if the sponsor is not established in the European Community, his legal representative,

(c) if any person has been authorised by the sponsor to make the request on his behalf, that person,

(d) if the persons taking responsibility for the initiation, management and financing (or arranging the financing) of the clinical trial have allocated responsibility in accordance with regulation 3(4), any person responsible for carrying out the functions of the sponsor under Part 4 or 5 of these Regulations, and

(e) any other person to whom the sponsor has delegated any of his responsibilities in relation to the proposed trial.