Citation and Commencement

1.  These Regulations may be cited as the Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Amendment (No. 7) Regulations 2021 and come into force at 4.00 a.m. on 22 November 2021.

Amendment of the Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Regulations 2021

2.  The Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Regulations 2021( 2) are amended in accordance with regulations 3 to 12.

Amendment of regulation 2

3.  In regulation 2 (interpretation: general)—

(a) in the definition of “COVID-19 vaccination eligibility criteria”, for “paragraphs (2) to (7) of regulation 3”, substitute “regulations 3B to 3H”,

(b) in the definition of “eligible vaccinated arrival”, for “regulation 3”, substitute “regulation 3A”,

(c) after the definition of “eligible vaccinated arrival” insert—

““ EU Digital COVID Certificate ” means a certificate of COVID-19 records issued by either a member state of the European Union, European Economic Area or the European Free Trade Association, or a European microstate,

“ European microstate ” means Andorra, Liechtenstein, Monaco, San Marino, the Sovereign Order of St John or the Vatican City State, ”.

Amendment of regulation 3

4.  For regulation 3 (interpretation: eligible vaccinated arrivals), substitute—

“PART 1A Eligible vaccinated arrivals

Interpretation of Part

3.— (1)  In this Part—

“ authorised vaccine ” means a medicinal product for vaccination against coronavirus which—

“ clinical trial ” has the meaning given in regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004 (interpretation)( 4) ,

“ Crown servant ” has the meaning given in section 12(1)(a) to (e) of the Official Secrets Act 1989( 5) ,

“ government contractor ” has the meaning given in section 12(2) of the Official Secrets Act 1989,

“ the licensing authority ” has the meaning given in regulation 6(2) (the licensing authority and the Ministers) of the Human Medicines Regulations 2012,

“marketing authorisation”—

“ medicinal product ” has the meaning given in regulation 2 (medicinal products) of the Human Medicines Regulations 2012,

“ NHS COVID pass ” means the COVID-19 records available on the NHS smartphone app developed and operated by the Secretary of State, through NHS.uk or in a COVID-19 post-vaccination status letter obtained from the NHS,

“ NHS England ” means the health service continued under section 1(1) of the National Health Service Act 2006( 7) ,

“ NHS Scotland ” means the health service continued under section 1(1) of the National Health Service (Scotland) Act 1978( 8) ,

“ NHS Wales ” means the health service continued under section 1(1) of the National Health Service (Wales) Act 2006( 9) ,

“ North American Certificate ” means, in relation to a state, district or province listed in the table in paragraph (6), the certificate identified in the corresponding row of the second column of that table,

“ relevant country ” means a country, territory or part of a country or territory listed in the first column of the table in paragraph (2) or a country, territory or part of a country or territory listed in schedule 1A (relevant countries),

“ relevant regulator ”, in relation to a relevant country listed in the table in paragraph (2), means the regulator identified in the corresponding row of the second column of the table in paragraph (2), 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 Organisation pursuant to the operation of the COVAX Facility( 10) ,

“ United Kingdom vaccine roll-out overseas ” means the administration of vaccine against coronavirus to—

“ vaccine certificate ” in relation to a passenger (“ P ”), means a certificate in English, French or Spanish issued by the competent health authority of a relevant country, other than a European country listed in the table in paragraph (2) or the United States of America, which contains—

“ WHO List vaccine ” means a vaccine which is—

(2)  The table referred to in the definitions of “relevant country” and “relevant regulator” follows—

(3)  Where a course of doses of an authorised vaccine or of a WHO List vaccine has been administered to a person (“ P ”) by a person acting on behalf of the United Nations and authorised to administer the vaccination in that capacity, P is to be treated as if they have received those doses in a relevant country listed in schedule 1A, and any reference to doses received in a relevant country, or to the competent health authority of a relevant country in these Regulations is to be construed as a reference to doses administered by the United Nations, and to the person acting on behalf of the United Nations.

(4)  For the purposes of this Part, a child is to be treated as making a declaration on the Passenger Locator Form, and possessing any evidence required, if that declaration is made, and that evidence possessed, by a person who is travelling with, and has responsibility for, that child.

(5)  For the purpose of this Part the following countries and territories are approved third countries or territories—

• Albania,

• Armenia,

• Faroe Islands,

• Israel,

• Morocco,

• North Macedonia,

• Panama,

• Turkey,

• Ukraine.

(6)  The table referred to in the definition of “North American Certificate” in paragraph (2) follows—

Eligible vaccinated arrivals

3A.   A person (“ P ”) is an eligible vaccinated arrival if P—

(a) is not a red list arrival, and

(b) meets any of the descriptions in regulations 3B to 3H.

Eligible vaccinated arrivals: vaccination conditions

3B.— (1)  P meets the conditions of this regulation if P—

(a) has completed a course of doses of an authorised vaccine or a WHO List vaccine with the final dose having been received before the start of the period beginning with the 14th day before the date of P’s arrival in Scotland,

(b) is able to provide proof, if requested to do so by an immigration officer or the operator of the relevant service on which P travels to Scotland, of meeting the requirement in sub-paragraph (a), through—

(i) certification in paper or electronic form issued by NHS Scotland, or equivalent certification issued 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,

(iii) the Centers for Disease Control and Prevention vaccination card,

(iv) a vaccine certificate,

(v) a North American Certificate, or

(vi) a certificate of COVID-19 records issued by an approved third country or territory, and

(c) has declared on P’s Passenger Locator Form that P meets the COVID-19 vaccination eligibility criteria.

(2)  For the purposes of this regulation—

(a) P has completed a course of doses if P has received the complete course of doses specified—

(i) in the summary of product characteristics approved as part of the marketing authorisation for the authorised vaccine or a WHO List vaccine, as the case may be, or

(ii) in the instructions for usage approved as part of the authorisation by the licensing authority on a temporary basis under regulation 174 (supply in response to spread of pathogenic agents etc.) of the Human Medicines Regulations 2012 for the authorised vaccine,

(b) if P has received a dose of one authorised vaccine or one WHO List vaccine and a dose of a different authorised vaccine or WHO List vaccine, P is deemed to have completed a course of doses of an authorised vaccine.

Eligible vaccinated arrivals: UK clinical trial conditions

3C.   P meets the conditions of this regulation if P—

(a) has participated, or is participating, in a clinical trial of a vaccine for vaccination against coronavirus carried out in accordance with the requirements of the Medicines for Human Use (Clinical Trials) Regulations 2004( 12) ,

(b) is able to provide proof of such participation if requested to do so by an immigration officer or the operator of the relevant service on which P travels to Scotland, and

(c) has declared on P’s Passenger Locator Form that P meets the COVID-19 vaccination eligibility criteria.

Eligible vaccinated arrivals: US clinical trial conditions

3D.   P meets the conditions of this regulation if 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, 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 the Centers for Disease Control and Prevention vaccination card, and

(c) has declared on the Passenger Locator Form that P meets the COVID-19 vaccination eligibility criteria.

Eligible vaccinated arrivals: Non-UK or US clinical trial conditions

3E.— (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( 13) ,

(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.

Eligible vaccinated arrivals: UK clinical exemptions conditions

3F.   P meets the conditions of this regulation if P—

(a) is a person who cannot be vaccinated against coronavirus for medical reasons with an authorised vaccine or a WHO List vaccine,

(b) is able to provide proof of that if requested to do so by an immigration officer or the operator of the relevant service on which P travels to Scotland, and

(c) has declared on P’s Passenger Locator Form that P meets the COVID-19 vaccination eligibility criteria.

Eligible vaccinated arrivals: age conditions

3G.   P meets the conditions of this regulation if P is under the age of 18 years upon arrival in Scotland.

Eligible vaccinated arrivals: UK vaccine rollout overseas conditions

3H.— (1)  P meets the conditions of this regulation if P is either—

(a) a person who—

(i) has completed a course of doses of a vaccine under the United Kingdom vaccine roll-out overseas, with the final dose having been received before the start of the period beginning with the 14th day before the date of P’s arrival in Scotland,

(ii) is able to provide proof, if requested to do so by an immigration officer or the operator of the relevant service on which P travels to Scotland, of meeting the requirement in head (i), and

(iii) has declared on P’s Passenger Locator Form that P meets the COVID-19 vaccination eligibility criteria.

(2)  For the purposes of this regulation—

(a) P has completed a course of doses of a vaccine if P has received the complete course of doses specified—

(i) in the summary of product characteristics approved as part of the marketing authorisation for the authorised vaccine or a WHO List vaccine, as the case may be, or

(ii) in the instructions for usage approved as part of the authorisation by the licensing authority on a temporary basis under regulation 174 (supply in response to spread of pathogenic agents etc.) of the Human Medicines Regulations 2012 for the authorised vaccine or WHO List vaccine,

(b) where P has received a dose of an authorised vaccine or WHO List vaccine and a dose of a vaccine under the United Kingdom vaccine roll-out overseas, P is deemed to have completed a course of doses of a vaccine under the United Kingdom vaccine roll-out overseas,

(c) where P has received a dose of one vaccine under the United Kingdom vaccine roll-out overseas, and a dose of a different vaccine under the United Kingdom vaccine roll-out overseas, P is deemed to have completed a course of doses of a vaccine under the United Kingdom vaccine roll-out overseas.

(3)  Where P is a person described in paragraph (2)(b), the proof which P provides for the purposes of paragraph (1)(a)(ii) must include proof of having received the dose of an authorised vaccine or WHO List vaccine through—

(a) certification in paper or electronic form issued by NHS Scotland, or equivalent certification issued by NHS England, NHS Wales or the Department of Health in Northern Ireland, including through the NHS COVID pass,

(b) the EU Digital COVID certificate,

(c) the Centers for Disease Control and Prevention vaccination card,

(d) a vaccine certificate,

(e) a North American Certificate,

(f) a certificate of COVID-19 records issued by an approved third country or   territory. ”.

Amendment of regulation 6

5.  In regulation 6 (Part 2: persons not required to comply)—

(a) after paragraph (1)(b), insert—

“(ba) a person who, on arrival in the United Kingdom, passes through to another country or territory outside the common travel area without entering the United Kingdom, ”,

(b) in paragraph (1)(c)—

(i) in head (i), omit “or” at the end,

(ii) after head (ii), insert—

“, or

(iii) paragraph 15 (road haulage worker), ”,

(c) in paragraph (1)(e)—

(i) in the opening text, after “in”, insert “any”,

(ii) for head (ii) substitute—

“(ii) paragraph 9(1) and (2) (seamen and masters etc.) who has travelled to the United Kingdom on a vessel in the course of their work,

(iia) paragraph 9(3) (inspector or surveyor of ships), ”,

(iii) omit “, where the condition in paragraph 16 of that schedule is met”,

(d) for paragraph (2), substitute—

“(2)  Paragraph (1)(b) and (c)(i) do not apply where P is a red list arrival in the case of a person described in paragraphs 1(1) of schedule 4. ”.

Amendment of regulation 7

6.  In regulation 7(2)(b)(i) (Part 3: interpretation) for “Covid” substitute “COVID”.

Amendment of regulation 14

7.  In regulation 14 (requirement to undertake tests)—

(a) for paragraph (9A) substitute—

“(9A)  For the purposes of paragraph (9)(b)(i), a test complies with this paragraph if—

(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) it is, in relation to a red list arrival, a test that can be self-administered,

(c) the manufacturer of any device used for the purposes of the test states that the device—

(i) uses an established molecular detection method,

(ii) in relation to a day 2 test, has a specificity and a sensitivity greater than or equal to 99% (or a 95% two-sided confidence interval entirely above 97%),

(iii) in relation to a day 8 test, has a specificity greater than or equal to 97% (or a 95% two-sided confidence interval entirely above 95%),

(iv) in relation to a day 8 test, has a sensitivity greater than or equal to 95% (or a 95% two-sided confidence interval entirely above 90%),

(v) has a limit of detection of less than or equal to 1000 SARS-CoV-2 copies per millilitre, and

(vi) is suitable for identifying every variant of concern, and

(d) 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 2002( 14) , 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. ”,

(b) after paragraph (11), insert—

“(12)  For the purposes of paragraph (9A)—

(a) “ specified method ” means a targeted sequence method specific to SARS-CoV-2 or an equivalent—

(i) amplicon method, or

(ii) sequence bait capture method,

(b) “ validated ”, in relation to a device, means confirmed as having the required sensitivity and specificity using at least 150 positive clinical samples and 250 negative clinical samples against a laboratory-based RT-PCR test that is itself within the performance specification of the target product profile published by the Medicines and Healthcare Products Regulatory Agency for laboratory based SARS-CoV-2 PCR tests, by—

(i) the Secretary of State, or

(ii) a laboratory which is accredited to ISO standard 15189 or ISO/IEC standard 17025( 15) by—

(aa) the United Kingdom Accreditation Service( 16) , or

(bb) an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (“ ILAC ”) Mutual Recognition Arrangement( 17) or the European co-operation for Accreditation (“ EA ”) Multilateral Agreement( 18) ,

other than a laboratory which processes tests provided by the test provider for the purposes of this Part or which is owned by the test provider or the device manufacturer( 19) .

(c) “ variant of concern ” means a variant of SARS-CoV-2 identified in a designation published by the UK Health Security Agency for the purposes of this   paragraph( 20) . ”.

Amendment of regulation 18

8.  In regulation 18 (Part 4: persons not required to comply)—

(a) for paragraph (1)(d), substitute—

“(d) a person who, on arrival in the United Kingdom—

(i) passes through to another country or territory outside the common travel area without entering the United Kingdom, or

(ii) enters the United Kingdom for the sole purpose of continuing a journey to a country or territory outside the common travel area and—

(aa) remains within their port of entry until their departure from Scotland, or

(bb) travels directly from their port of entry to another port of departure in Scotland, ”.

Amendment of regulation 27

9.  In regulation 27 (Part 6: persons not required to comply)—

(a) in paragraph (1)(c) substitute—

“(c) a person who, on arrival in the United Kingdom—

(i) passes through to another country or territory outside the common travel area without entering the United Kingdom, or

(ii) enters the United Kingdom for the sole purpose of continuing a journey to a country or territory outside the common travel area and—

(aa) remains within their port of entry until their departure from Scotland, or

(bb) travels directly from their port of entry to another port of departure in Scotland, ”.

(b) in paragraph (d) omit “within the meaning of regulation 3”.

Amendment of schedule 1A

10.  In schedule 1A (relevant countries), in the appropriate places in alphabetical order insert—

“Belarus ”,

“British Antarctic Territory ”,

“British Indian Ocean Territory ”,

“British Virgin Islands ”,

“Bolivia ”,

“Democratic Republic of the Congo ”,

“Dominican Republic ”,

“Ecuador ”,

“Falkland Islands ”,

“Guernsey ”,

“Isle of Man ”,

“Jersey ”,

“Laos ”,

“Libya ”,

“Malawi ”,

“Montserrat ”,

“Mozambique ”,

“Pitcairn, Henderson, Ducie and Oeno Islands ”,

“Saint Helena, Ascension and Tristan da Cunha ”,

“Samoa ”,

“Senegal ”,

“South Georgia and the South Sandwich Islands ”,

“The Sovereign Base Areas of Akrotiri and Dhekelia in the Island of Cyprus ”,

“Turks and Caicos Islands ”,

“Vanuatu ”,

“Zambia ”,

“Zimbabwe ”.

Amendment of schedule 3

11.  For paragraph 5 of schedule 3 (passenger information), substitute—

“5.   Where the passenger is an eligible vaccinated arrival, a declaration that the passenger meets the COVID-19 vaccination eligibility criteria. ”.

Amendment of schedule 6

12.  In Part 1 of schedule 6 (specified competitions), after paragraph 38A( 21), insert—

“38B.   Netball – international netball fixtures for the Scottish Thistles Netball Team. ”.

Saving

13.  The amendments made by these Regulations do not apply in relation to any person who arrived in Scotland before 4.00 a.m. on 22 November 2021, and the Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Regulations 2021 continue to apply to such persons as if the amendments made by these Regulations had not been made.

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Regulations 2021 (“ the International Travel Regulations”).

Regulations 4 introduces a new Part 1A and consolidates the previous regulation 3 of the International Travel Regulations, with amendments, which—

• expand the definition of “authorised vaccine” by removing the requirement that it be administered in a relevant country (new regulation 3);

• extend the scope of the scheme to recognise WHO emergency use vaccines;

• insert a new definition of EU Digital Covid Certificate;

• amend provision regarding the proof which may be provided of vaccination status in order to recognise certain certificates issued by a State or District of the USA;

• require persons vaccinated against coronavirus in Guernsey, Jersey, the Isle of Man or any of the United Kingdom Overseas Territories, and their dependents, to satisfy the conditions in new regulation 3B, rather than the conditions in new regulation 3H which apply in relation to the UK vaccine rollout overseas;

• expand the categories of “eligible vaccinated arrival” to include individuals who have participated, or are participating, in phase 2 or 3 of certain clinical trials taking place otherwise than in the United Kingdom or the United States of America (new regulation 3E);

• provide that the clinical exemptions which apply in relation to eligible vaccinated arrivals apply to persons who cannot be vaccinated against coronavirus for medical reasons (new regulation 3F);

• expand the scope of the eligible vaccinated arrival scheme so that all children under the age of 18 will be categorised as eligible, irrespective of vaccine status (new regulation 3G).

Regulation 3 makes consequential amendments following the insertion of new Part 1A.

Regulation 5 amends the exemptions from the requirement to complete a Passenger Locator Form for certain persons who have travelled to the UK. For persons travelling in the course of their work as a road passenger transport worker, seamen and masters (if travelling to the UK on a vessel in the course of their work), inspectors and surveyors of ships, aircraft crew, and tunnel system transport workers, the exemption will apply whether or not they have been in a red list country or travelled in a passenger carrying conveyance. New exemptions are inserted for passengers transiting through the UK and road haulage workers.

Regulation 7 amends the requirements of the type of test to be taken where a person is not an eligible vaccinated arrival following the persons arrival in Scotland.

Regulations 8 and 9 amend regulations 18 and 27 of the International Travel Regulations respectively. For the purposes of exemption from Part 4 (testing following arrival in Scotland) and Part 6 (self-isolation) of those Regulations, a person who on arrival in the UK travels onward to another country or territory without passing through border control into the UK are exempt, as well as persons who pass through the border into the UK for the sole purpose of continuing a journey to a country or territory outside the common travel area.

Regulation 10 adds to the list of countries which are “relevant countries” so persons who have a vaccine certificate from those countries can count as “ eligible vaccinated arrivals” for the purposes of the International Travel Regulations.

Regulation 11 makes consequential amendments to the passenger information specified in schedule 3 of the International Travel Regulations.

Regulation 12 adds international netball fixtures for the Scottish Thistles Netball Team to the specified competitions in relation to which elite sportspersons (defined in paragraph 42 of schedule 4 of the International Travel Regulations) may be exempt from certain requirements for testing and self-isolation (see regulations 25(1)(e) and 27(1)(h) of the International Travel Regulations).

Regulation 13 makes savings provision to the effect that a person arriving in Scotland before these Regulations come into effect must comply with the International Travel Regulations as they had effect at the time of the person’s arrival in Scotland. The amendments made by these Regulations apply only in relation to persons arriving in Scotland at or after 4.00 a.m. on 22 November 2021.

An impact assessment is being prepared and will be published online atwww.legislation.gov.uk.