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

12.  A description or sample of the labelling which is to appear on each investigational medicinal product when supplied to a subject in the trial. U.K.