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The Health Protection (Coronavirus, International Travel) Regulations (Northern Ireland) 2021

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Regulation 3A(2)

[F1SCHEDULE 2BN.I.Criteria to be [F2an eligible] arrival

This schedule has no associated Explanatory Memorandum

Textual Amendments

1.  P is [F3an “eligible”] arrival if P complies with any of paragraphs 2 to 6.N.I.

Textual Amendments

2.  P complies with this paragraph if P—N.I.

(a)has completed a course of doses of an authorised 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 Northern Ireland,

(b)received that course of doses in the United Kingdom or a relevant country,

F4(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)is able to provide proof, if required by an immigration officer or the operator of the relevant service on which P travels to Northern Ireland, of meeting the requirement in sub-paragraph (a) through—

(i)the NHS COVID pass, certification issued by the Department of Health, or equivalent from NHS Scotland or NHS Wales,

(ii)the EU Digital COVID Certificate, F5...

(iii)the Centres for Disease Control and Prevention vaccination card, [F6or]

[F7(iv)a vaccine certificate,]

(e)is able to provide proof, if required by an immigration officer or the operator of the relevant service on which P travels to Northern Ireland, of meeting the requirement in sub-paragraph (c), and

(f)has declared on the Passenger Locator Form that P meets the COVID-19 vaccination eligibility criteria F8....

Textual Amendments

3.  P complies with this paragraph if P [F9is ordinarily resident in Northern Ireland and]—N.I.

(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 required by an immigration officer or the operator of the relevant service on which P travels to Northern Ireland, and

(c)has declared on the Passenger Locator Form that P meets the COVID-19 vaccination eligibility criteria F10....

Textual Amendments

4.  P complies with this paragraph if P—N.I.

(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 required by an immigration officer or the operator of the relevant service on which P travels to Northern Ireland, to provide proof of such participation through the Centres for Disease Control and Prevention vaccination card,

(c)has declared on the Passenger Locator Form that P meets the COVID-19 vaccination eligibility criteria F11..., 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 the relevant service on which P travels to Northern Ireland.

Textual Amendments

[F124A.—(1) P meets the conditions of this regulation if P—N.I.

(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 Organisation;

(b)if required by an immigration officer or the operator of the relevant service on which P travels to Northern Ireland is able 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.]

Textual Amendments

5.  P complies with this paragraph if P is—N.I.

(a)under the age of 18 years upon arrival in Northern Ireland, and

(b)ordinarily resident in the United Kingdom or a relevant country.

6.  P complies with this paragraph if P is either—N.I.

(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 their arrival in Northern Ireland,

(ii)is able to provide proof, if required by an immigration officer or the operator of the relevant service on which P travels to Northern Ireland, of meeting the requirements in paragraph (i), and

(iii)has declared on the Passenger Locator Form that P meets the COVID-19 vaccination eligibility criteria F13..., or

(b)a dependent of a person of the description in any of paragraphs (a) to (c) of the definition of “United Kingdom vaccine roll-out overseas” and is under the age of 18 years upon arrival in Northern Ireland.

Textual Amendments

[F147.—(1) For the purposes of paragraph 2—N.I.

(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

(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 and a dose of a different authorised vaccine, P is deemed to have completed a course of doses of an authorised vaccine.]

Textual Amendments

F157A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .N.I.

Textual Amendments

[F167B.—(1) For the purposes of paragraph 6—N.I.

(a)P has completed a course of doses of a vaccine if P has received the complete course of doses of the vaccine as specified in the manufacturer’s guidance for that vaccine;

[F17(aa)if P has received a dose of an authorised vaccine in a relevant country, 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 an authorised vaccine;]

(b)where P has received a dose of an authorised vaccine F18... 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.]

[F19(2) Where P is a person described in paragraph (1)(b), the proof which P provides for the purposes of paragraph 6(1)(a)(ii) must include proof of having received the dose of an authorised vaccine through—

(a)the NHS COVID pass, certification issued by the Department of Health, or equivalent from NHS Scotland or NHS Wales;

(b)the EU Digital COVID certificate;

(c)the Center for Disease Control and Prevention vaccination card; or

(d)a vaccine certificate.]

Textual Amendments

F208.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .N.I.

Textual Amendments

F218A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .N.I.

Textual Amendments

9.  For the purposes of this Schedule a child is to be treated as making a declaration on a Passenger Locator Form, and providing any proof required, if that declaration is made, and the proof provided, by a person who is travelling with and has responsibility for that child.N.I.

10.  In this Schedule—N.I.

“authorised vaccine” means a medicinal product for vaccination against coronavirus [F22which—]

(a)

in relation to doses received in the United Kingdom [F23, 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 of the Human Medicines Regulations 2012;

(b)

[F24in relation to doses received in a relevant country listed in the table in paragraph 11, is authorised for supply in that relevant country following evaluation by the regulator for that relevant country,

(c)

in relation to doses received [F25any other country or territory (including a relevant country listed in paragraph 12)], would be authorised as described in paragraph (a)(i) or (ii) if the doses were received in the United Kingdom,]

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

[F26“the COVID-19 vaccination eligibility criteria” means the conditions in any of paragraphs 2 to 6,]

“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 [F27listed in the table in paragraph 11] other than a member State, means a marketing authorisation granted by [F28the regulator for that relevant 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 on the NHS smartphone app developed and operated by the Secretary of State, through the website at NHS.uk or a COVID-19 post vaccination letter obtained from the NHS,

“NHS” 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,

[F29“regulator”, in relation to a relevant country listed in the table in paragraph 11, means the regulator identified in the corresponding row of the second column of the table in that paragraph, 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,]

“relevant country” means a country listed in the first column of the table in paragraph 11 [F30or a country or territory listed in paragraph 12],

F31...

“relevant service” means a commercial transport service carrying passengers to Northern Ireland from outside the common travel area,

“United Kingdom vaccine roll-out overseas” means the administration of vaccination 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;[F32or]

(b)

F33...

(c)

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.

[F34“vaccine certificate” means a certificate in English, French or Spanish issued by the competent health authority of a relevant country [F35, other than a European country listed in the table in paragraph 11 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;

(e)

details of either the identity of the issuer of the certificate or the country of vaccination, or both.]

Textual Amendments

11.  The table referred to in [F36paragraph 10] follows—N.I.

Relevant countryRelevant regulator
a member StateEuropean Medicines Agency
AndorraEuropean Medicines Agency
[F37Australia The Therapeutic Goods Administration]
[F37CanadaHealth Canada]
IcelandEuropean Medicines Agency
LichtensteinEuropean Medicines Agency
MonacoEuropean Medicines Agency
NorwayEuropean Medicines Agency
San MarinoEuropean Medicines Agency
SwitzerlandSwissmedic
the United States of AmericaUnited States Food and Drug Administration
Vatican City StateEuropean Medicines Agency

Textual Amendments

[F3812.  The countries and territories referred to in the definitions of “authorised vaccine” and “relevant country” [F39in paragraph 10] are—N.I.

[F40Albania]

[F41Angola]

[F41Anguilla]

Antigua and Barbuda

[F41Argentina]

[F41Armenia]

[F41Azerbaijan]

[F40Bahamas]

Bahrain

[F40Bangladesh]

Barbados

[F41Belize]

[F41Bermuda]

[F40Bosnia and Herzegovina]

[F41Botswana]

[F40Brazil]

Brunei

[F41Cambodia]

[F41Cayman Islands]

[F40Chile]

[F40Colombia]

[F41Costa Rica]

[F41Djibouti ]

Dominica

[F40Egypt]

[F41Eswatini]

[F40Georgia]

[F40Ghana]

[F41Gibraltar]

[F40Grenada]

[F41Guyana]

[F41Honduras]

[F40Hong Kong]

[F40India]

[F40Indonesia]

Israel

[F40Jamaica]

Japan

[F40Jordan]

[F40Kenya]

[F40Kosovo]

Kuwait

[F41Lebanon]

[F41Lesotho]

[F41Madagascar]

Malaysia

[F40Maldives]

[F41Mauritius]

[F40Moldova]

[F41Mongolia]

[F40Montenegro]

[F40Morocco]

[F40Namibia]

[F41Nepal]

New Zealand

[F40Nigeria]

[F40North Macedonia]

[F41Occupied Palestinian Territories]

[F40Oman]

[F40Pakistan]

[F41Panama]

[F41Peru]

[F40the Philippines]

Qatar

[F41Rwanda]

Saudi Arabia

[F40Serbia]

[F41Seychelles]

[F41Sierra Leone]

Singapore

[F40South Africa]

South Korea

[F41Sri Lanka]

[F41Suriname]

[F40St Kitts and Nevis]

[F40St Lucia]

[F40St Vincent and the Grenadines]

Taiwan

[F41Tanzania]

[F40Thailand]

[F41Trinidad and Tobago]

[F41Tunisia]

[F40Turkey]

[F41Uganda]

[F40Ukraine]

United Arab Emirates

[F41Uruguay]

[F40Vietnam]]

Textual Amendments

[F4213.—(1) In the definition of “authorised vaccine” in paragraph 10, the reference to doses received in a relevant country listed in paragraph 12 includes doses administered to a person, otherwise than in a relevant country, by a person acting on behalf of the United Nations and authorised to administer the vaccination in that capacity.N.I.

(2) Where a course of doses of an authorised vaccine has been administered to a person, otherwise than in a relevant country, by a person acting on behalf of the United Nations and authorised to administer the vaccination in that capacity—

(a)the person to whom the doses have been administered is to be treated for the purposes of paragraph 2 as having received those doses in a relevant country listed in paragraph 12, and

(b)the reference in the definition of “vaccine certificate” in paragraph 10 to the competent health authority of a relevant country is to be construed as including the person acting on behalf of the United Nations.]]

Textual Amendments

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