Paragraph 6 F1

proof that the applicant has at the applicant’s disposal an appropriately qualified person responsible for pharmacovigilance F2who resides and operates in the United Kingdom;

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

the contact details of the appropriately qualified person;

a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Part 11; and

a reference to the location where the pharmacovigilance system master file for the medicinal product is kept F4or, if kept in electronic form, from which it can be accessed, which in either case, must be in the United Kingdom.