
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.
2 
The Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Regulations 2021 are amended in accordance with regulations 3 to 12.
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,”.
4 
For regulation 3 (interpretation: eligible vaccinated arrivals), substitute—“
PART 1A
3. 

(1) In this Part—
 “authorised vaccine” means a medicinal product for vaccination against coronavirus which—
(a) in relation to doses received in the United Kingdom, is authorised—
(i) for supply in the United Kingdom in accordance with a marketing authorisation, or
(ii) 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,
(b) in relation to doses received in a relevant country listed in the table in paragraph (2), is authorised for supply in that country following evaluation by the relevant regulator for that country,
(c) in relation to doses received in any other country or territory (including a relevant country listed in schedule 1A (relevant countries)), is authorised in the United Kingdom in accordance with head (i) or (ii) of paragraph (a),
 “clinical trial” has the meaning given in regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004 (interpretation),
 “Crown servant” has the meaning given in section 12(1)(a) to (e) of the Official Secrets Act 1989,
 “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”—
(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 listed in the table in paragraph (2) other than a member State, means a marketing authorisation granted by the relevant regulator for the country,
 “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,
 “NHS Scotland” means the health service continued under section 1(1) of the National Health Service (Scotland) Act 1978,
 “NHS Wales” means the health service continued under section 1(1) of the National Health Service (Wales) Act 2006,
 “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,
 “United Kingdom vaccine roll-out overseas” means the administration of vaccine against coronavirus to—
(a) Crown servants, government contractors or other personnel posted or based overseas and their dependants under the scheme known as the Foreign, Commonwealth and Development Office staff COVID-19 vaccination programme, or
(b) military or civilian personnel, government contractors and their dependants at a military posting overseas, including the British overseas territories, the Channel Islands and the Isle of Man, under the vaccination scheme provided or approved by the UK Defence Medical Services,
 “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—
(a) P’s full name,
(b) P’s date of birth,
(c) the name and manufacturer of the vaccine that P received,
(d) the date that P received each dose of the vaccine, and
(e) details of either the identity of the issuer of the certificate or the country of vaccination, or both,
 “WHO List vaccine” means a vaccine which is—
(a) listed in lines 10, 11 or 13 of the Guidance Document “Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process” published by the World Health Organisation on 11th November 2021, and
(b) authorised or certified in a country or territory, or part of a country or territory, listed in schedule 1A.
(2) 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
Australia The Therapeutic Goods Administration
Canada Health Canada
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
(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—

State, District or Province Certificate Name
California Digital COVID-19 Vaccine Record
New York Excelsior Pass Plus
Washington State WA Verify
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.
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.
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,
(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.
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.
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,
(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.
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.
3G. 
P meets the conditions of this regulation if P is under the age of 18 years upon arrival in Scotland.
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 orterritory.”.
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.”.
6 
In regulation 7(2)(b)(i) (Part 3: interpretation) for “Covid” substitute “COVID”.
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, 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 by—(aa) the United Kingdom Accreditation Service, or(bb) an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (“ILAC”) Mutual Recognition Arrangement or the European co-operation for Accreditation (“EA”) Multilateral Agreement,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.
(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 thisparagraph.”.
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,”.
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”.
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”.
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.”.
12 
In Part 1 of schedule 6 (specified competitions), after paragraph 38A, insert—“
38B. 
Netball – international netball fixtures for the Scottish Thistles Netball Team.”.
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.
MICHAEL MATHESON
A member of the Scottish Government
St Andrew’s House,
Edinburgh
18th November 2021