- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made).
3. In regulation 2A (eligible vaccinated arrivals)—
(a)in paragraph (2)—
(i)in sub-paragraph (b), after “United Kingdom” insert “or a relevant country”,
(ii)after sub-paragraph (b) insert—
“(ba)if the course of doses was received in the United States of America, is ordinarily resident in the United States of America,”,
(iii)in sub-paragraph (c), for the words “by way of letter of certification” to “pass” substitute—
“through—
(i)letter of certification issued by NHS Scotland, or equivalent certification issued, in paper or electronic form, by NHS England, NHS Wales or the Department of Health in Northern Ireland, including through the NHS COVID pass,
(ii)the EU Digital COVID certificate, or
(iii)the Centers for Disease Control and Prevention vaccination card”,
(iv)in sub-paragraph (c), at end, omit “and”,
(v)after sub-paragraph (c), insert—
“(ca)is able to provide proof if required by an immigration officer or the operator of the relevant service on which P travels to Scotland of meeting the requirement in sub-paragraph (ba), and”,
(b)after paragraph (3) insert—
“(3A) P—
(a)has participated or is participating in a clinical trial regulated in the United States of America by the Food and Drugs Administration of a vaccine for vaccination against coronavirus,
(b)is able to provide proof of such participation through the Centers for Disease Control and Prevention vaccination card,
(c)has declared on the Passenger Locator Form that P has completed a course of doses of an authorised vaccine, and
(d)is ordinarily resident in the United States of America and is able to provide proof of that residence.”,
(c)in sub-paragraph (b) of paragraph (4), after “United Kingdom” insert “or a relevant country”,
(d)in paragraph (10)—
(i)for the definition of “authorised vaccine” substitute—
““authorised vaccine” means a medicinal product for vaccination against coronavirus authorised—
in relation to doses received in the United Kingdom—
for supply in the United Kingdom in accordance with a marketing authorisation, or
by the licensing authority on a temporary basis under regulation 174 of the Human Medicines Regulations 2012,
in relation to doses received in a relevant country, for supply in that country following evaluation by the relevant regulator for that country,”,
(ii)for the definition of “marketing authorisation” substitute—
““marketing authorisation”—
in relation to a vaccine authorised for supply in the United Kingdom or in a member State, has the meaning given in regulation 2 (medicinal products) of the Human Medicines Regulations 2012,
in relation to a vaccine authorised for supply in a relevant country other than a member State, means a marketing authorisation granted by the relevant regulator for the country,”,
(iii)after the definition of “NHS Wales” insert—
““relevant country” means a country listed in the first column of the table in paragraph (11),
“relevant regulator”, in relation to a relevant country, means the regulator identified in the corresponding row of the second column of the table in paragraph (11), and a reference to a regulator in that table is a reference to the regulatory authority of that name designated as a Stringent Regulatory Authority by the World Health Organization pursuant to the operation of the COVAX Facility(1),”,
(e)after paragraph (10) insert—
“(11) The table referred to in the definitions of “relevant country” and “relevant regulator” follows—
Relevant country | Relevant regulator |
---|---|
a member State | European Medicines Agency |
Andorra | European Medicines Agency |
Iceland | European Medicines Agency |
Liechtenstein | European Medicines Agency |
Monaco | European Medicines Agency |
Norway | European Medicines Agency |
San Marino | European Medicines Agency |
Switzerland | Swissmedic |
the United States of America | United States Food and Drug Administration |
Vatican City State | European Medicines Agency”. |
A list of the national regulatory authorities designated as Stringent Regulatory Authorities has been published by the World Health Organization and is available online at https://extranet.who.int/pqweb/sites/default/files/documents/Product-Eligibility_COVAX-Facility_Dec2020_0.pdf.
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