SCHEDULE 3PARTICULARS 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 2REQUEST FOR AUTHORISATION
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The name and address of the person responsible for the manufacture or importation of any finished investigational medicinal product to be used in the trial and the details of any authorisation referred to in Article 13 of the Directive held by that person.