45 
the Veterinary Medicines Regulations 2013( a), and who has travelled to the United Kingdom to 
undertake activities in relation to their role as such a person. 
36. —(1) A person who— 
(a)  has travelled to the United Kingdom to— 
(i)  conduct a clinical trial within the meaning of “con ducting a clinical trial” in 
regulation 2(1) of the Medicines for Human Use (Cli nical Trials) Regulations 
2004(b), 
(ii)  undertake such activities as are necessary or expedient to prepare for the conduct of a 
clinical trial, or 
(iii)  carry out any necessary compliance activity in rela tion to a clinical trial that cannot 
be conducted remotely; 
(b)  is a “qualified person” within the meaning of regul ation 43 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; or 
(c)  is a “sponsor” within the meaning given in regulati on 2(1) of those Regulations, or carries 
out the functions or duties of a sponsor, of a clin ical trial and has travelled to the United 
Kingdom to undertake activities in relation to a clinical trial. 
(2)  For the purposes of sub-paragraph (1), “clinical tr ial” has the meaning given in regulation 
2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004. 
37.  A person who has travelled to the United Kingdom t o conduct a “clinical investigation” 
within the meaning of the Medical Devices Regulations 2002(c), or to undertake such activities as 
are necessary or expedient to prepare for the condu ct of a clinical investigation or carry out any 
other necessary compliance activity in relation to a clinical investigation that cannot be conducted 
remotely. 
38.  A person who is— 
(a)  a “qualified person” within the meaning of regulati on 41(2) of the Human Medicines 
Regulations 2012; 
(b)  a “responsible person” within the meaning of regula tion 45(1) of those Regulations; 
(c)  “an appropriately qualified person responsible for pharmacovigilance” within the 
meaning of regulation 182(2)(a) of those Regulations; or 
(d)  a “qualified person (manufacture)” as referred to i n 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. 
39. —(1) A person who has travelled to the United Kingd om for the purposes of their work in 
essential infrastructure industries including— 
(a)  a person involved in essential maintenance and repa ir of data infrastructure required to 
reduce and resolve outages, or in the provision of goods and services to support these 
activities; and 
(b)  an information technology or telecommunications pro fessional (including information 
technology consultant, quality analyst, software te ster, systems tester, and 
telecommunications planner), whose expertise is required to— 
(i)  provide an essential or emergency response to threa ts and incidents relating to the 
security of any network and information system, and 
(ii)  ensure the continued operation of any network and information system. 
                                                                                                                                            
(a) S.I. 2013/2033. 
(b) S.I. 2004/1031, to which there are amendments not  relevant to these Regulations. 
(c) S.I. 2002/618.