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

PART 2Persons not required to comply with regulation 4

I134

1

A person who is—

a

a “qualified person” within the meaning of regulation 41(2) of the Human Medicines Regulations 2012 M1,

b

a “responsible person” within the meaning of regulation 45(1) of those Regulations, F1...

c

“an appropriately qualified person responsible for pharmacovigilance” within the meaning of regulation 182(2)(a) of those Regulations, F2or

F3d

a “qualified person (manufacture)” as referred to in paragraph 8(2) of Schedule 2 to the Veterinary Medicines Regulations 2013,

where they have travelled to the United Kingdom in order to undertake activities in relation to their role as such a person.