F1PART 1AEligible vaccinated arrivals
Eligible vaccinated arrivals: Non-UK or US clinical trial conditions3E
1
P meets the conditions of this regulation if P—
a
has participated, or is participating in, phase 2 (therapeutic exploratory studies) or phase 3 (clinical efficacy and safety studies) of a clinical trial of a vaccine for vaccination against coronavirus which is regulated by—
i
the European Medicines Agency, or
ii
a regulatory authority (other than such an authority in the United Kingdom or the United States of America) which is designated as a Stringent Regulatory Authority by the World Health Organization,
b
is able, if requested to do so by an immigration officer or the operator of the relevant service on which P travels to Scotland, to provide proof of such participation through a participation document, and
c
has declared on the Passenger Locator Form that P meets the COVID-19 vaccination eligibility criteria.
2
For the purposes of this regulation, “participation document” means a document in English, French or Spanish issued by a relevant person which confirms—
a
P’s full name,
b
P’s date of birth,
c
the name and manufacturer of the vaccine,
d
the country or territory in which the clinical trial is taking, or took, place,
e
the regulatory authority responsible for the regulation of the clinical trial,
f
the phase of the clinical trial in which P is participating or participated.
3
For the purposes of paragraph (2) “relevant person” means—
a
the competent health authority of the country or territory in which the relevant clinical trial is being, or was, carried out, or
b
the person who is conducting, or conducted, the relevant clinical trial.
Pt. 1A substituted for reg. 3 (22.11.2021 at 4.00 a.m.) by The Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Amendment (No. 7) Regulations 2021 (S.S.I. 2021/425), regs. 1, 4 (with reg. 13)