2021 No. 926 (W. 211)
The Health Protection (Coronavirus, International Travel and Operator Liability) (Wales) (Miscellaneous Amendments) (No. 4) Regulations 2021
Made
Laid before Senedd Cymru
Coming into force in accordance with regulation 1(2) and (3)
The Welsh Ministers, in exercise of the powers conferred on them by sections 45B and 45P(2) of the Public Health (Control of Disease) Act 19841, make the following Regulations.
Title and coming into forceI1I11
1
The title of these Regulations is the Health Protection (Coronavirus, International Travel and Operator Liability) (Wales) (Miscellaneous Amendments) (No. 4) Regulations 2021.
2
Except for regulation 7, these Regulations come into force at 4.00 a.m. on 8 August 2021.
3
Regulation 7 comes into force on 23August 2021.
Amendments to the Health Protection (Coronavirus, International Travel) (Wales) Regulations 2020I2I22
The Health Protection (Coronavirus, International Travel) (Wales) Regulations 20202 are amended in accordance with regulations 3 to 7.
Amendment to regulation 2AI3I33
In regulation 2A(2), omit “or Metropolitan France”.
Amendments to Schedule 3I4I44
In Schedule 3 (exempt countries and territories outside the common travel area), in Part 1, at the appropriate places insert—
Austria
Germany
Latvia
Norway
Romania
Slovakia
Slovenia
Amendments to Schedule 3AI5I55
In Schedule 3A (countries and territories subject to additional measures)—
a
at the appropriate places insert—
Georgia
Mayotte
Mexico
Réunion
b
omit—
Bahrain
India
Qatar
United Arab Emirates
Amendment to Schedule 1EI6I66
In Schedule 1E (specified testing events), at the appropriate place insert “R & A – The Curtis Cup”.
Amendments to Schedule 1CI77
1
Schedule 1C (mandatory testing after arrival in Wales) is amended as follows.
2
In sub-paragraph (b)(ii) of paragraph 1 (day 2 test requirements)—
a
after “greater than” insert “or equal to”;
b
for “with” substitute “or”.
3
For paragraph 2 (day 8 test requirements) substitute—
2Day 8 test requirements
A day 8 test complies with this sub-paragraph where—
a
it is a semi-quantitative test for the detection of coronavirus which—
i
targets a minimum of two distinguishable SARS-CoV-2 genes other than the S gene and performance reference controls,
ii
includes routine in silico assurance against every variant of concern, and
iii
produces a test solution that provides extracted nucleic acid that is suitable for whole genome sequencing using a specified method,
b
the manufacturer of any device used for the purposes of the test states that the device—
i
uses an established molecular detection method,
ii
has a specificity greater than or equal to 97% (or a 95% two-sided confidence interval entirely above 95%),
iii
has a sensitivity greater than or equal to 95% (or a 95% two-sided confidence interval entirely above 90%),
iv
has a limit of detection of less than or equal to 1000 SARS-CoV-2 copies per millilitre, and
v
is suitable for identifying every variant of concern, and
c
any device used for the purposes of the test—
i
can be put into service in accordance with Part 4 of the Medical Devices Regulations 20023, other than solely by virtue of regulation 39(2) of those Regulations, and
ii
has been validated no more than 18 months before the test is administered or provided to P.
Amendment to the Health Protection (Coronavirus, International Travel, Pre-Departure Testing and Operator Liability) (Wales) (Amendment) Regulations 2021I8I88
In regulation 5C of the Health Protection (Coronavirus, International Travel, Pre-Departure Testing and Operator Liability) (Wales) (Amendment) Regulations 20214, omit paragraph (4).
(This note is not part of the Regulations)