SCHEDULE 2Persons not required to comply with regulation 3 or regulation 4

PART 2Persons not required to comply with regulation 6

I134

A person who is—

a

a “qualified person” within the meaning of regulation 41(2) of the Human Medicines Regulations 2012,

b

a “responsible person” within the meaning of regulation 45(1) of those Regulations, or

c

“an appropriately qualified person responsible for pharmacovigilance” within the meaning of regulation 182(2)(a) of those Regulations, where they have travelled to the United Kingdom in order to undertake activities in relation to their role as such a person.