Legislation – The Health Protection (Coronavirus, International Travel and Operator Liability) (Wales) (Miscellaneous Amendments) (No. 3) Regulations 2021

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Introduction

1 Title and coming into force

2 Amendments to the Health Protection (Coronavirus, International Travel) (Wales) Regulations 2020

3 Amendments to regulation 2A

4 Amendments to the Health Protection (Coronavirus, International Travel, Pre-Departure Testing and Operator Liability) (Wales) (Amendment) Regulations 2021

5 Amendment to regulation 4

6 Amendment to regulation 5B

7 New regulations 5C and 5D

8 Amendments to regulation 6

9 Amendment to regulation 10

Signature

Explanatory note

Amendments to regulation 2A3.

(1)

Regulation 2A (exemptions for vaccinated travellers and others) is amended as follows.

(2)

In paragraph (3)—

(a)

in sub-paragraph (b), after “United Kingdom” insert “or a relevant country”;

(b)

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.”;

(c)

in sub-paragraph (c)—

(i)

after “immigration officer” insert “or the operator of a commercial service on which P travels to Wales from outside the common travel area”;

(ii)

for “through the NHS COVID pass” to the end substitute—

“through—

(i)

the NHS COVID pass, or equivalent from NHS Scotland, NHS Wales or the Department of Health in Northern Ireland,

(ii)

the EU Digital COVID certificate, or

(iii)

the Centers for Disease Control and Prevention vaccination card,”;

(d)

after sub-paragraph (c), insert—

“(ca)

is able to provide proof if required by an immigration officer or the operator of a commercial service on which P travels to Wales from outside the common travel area of meeting the requirement in sub-paragraph (ba), and”.

(3)

In paragraph (4)(b), after “participation” insert “if required by an immigration officer or the operator of a commercial service on which P travels to Wales from outside the common travel area”.

(4)

After paragraph (4) insert—

“(4A)

P—

(a)

has participated or is participating in a clinical trial 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 if required by an immigration officer or the operator of a commercial service on which P travels to Wales from outside the common travel area;

(c)

has declared that P meets the COVID-19 vaccination eligibility criteria for reduced isolation and testing requirements using a facility referred to in regulation 4(1); and

(d)

is ordinarily resident in the United States of America and is able to provide proof of that residence if required by an immigration officer or the operator of a commercial service on which P travels to Wales from outside the common travel area.”.

(5)

In paragraph (5)(a), after “United Kingdom” insert “or a relevant country”.

(6)

In paragraph (10)—

(a)

for the definition of “authorised vaccine” substitute—

““authorised vaccine” (“brechlyn awdurdodedig”) means a medicinal product for vaccination against coronavirus authorised—

(a)

in relation to doses received in the United Kingdom—

  1. (i)

    for supply in the United Kingdom in accordance with a marketing authorisation, or

  2. (ii)

    by the licensing authority on a temporary basis under regulation 174 of the Human Medicines Regulations 2012;

(b)

in relation to doses received in a relevant country, for supply in that country following evaluation by the relevant regulator for the country;”;

(b)

for the definition of “marketing authorisation” substitute—

““marketing authorisation” (“awdurdodiad marchnata”)—

(a)

in relation to a vaccine authorised for supply in the United Kingdom or in a member State, has the meaning given in regulation 8(1) (general interpretation) of the Human Medicines Regulations 2012;

(b)

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;”;

(c)

after the definition of “NHS Wales” insert—

““relevant country” (“gwlad berthnasol”) means a country listed in the first column of the table in paragraph (11);

“relevant regulator” (“rheoleiddiwr perthnasol”), 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 Facility3;”;

(d)

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”.