SCHEDULES

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

10.  In this Schedule—N.I.

“authorised vaccine” means a medicinal product for vaccination against coronavirus [F3which—]

(a)

in relation to doses received in the United Kingdom [F4, 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)

[F5in 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 [F6any other country or territory (including a relevant country listed in paragraph 12)], [F7

(i)

would be authorised as provided for in sub-paragraph (a)(i) or (ii) if the doses were received in the United Kingdom, or

(ii)

are listed in lines [F810, 11, 12, 13 or 14] of the guidance document “Status of COVID-19 Vaccines within WHO EUL/PQ Evaluation Process” published by the World Health Organisation on [F923rd December]F10, and authorised or certified in a regulated country listed in paragraph 12,]]

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

[F11“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 [F12listed in the table in paragraph 11] other than a member State, means a marketing authorisation granted by [F13the 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 [F14available] on the NHS smartphone app developed and operated by the Secretary of State, through the website at NHS.uk or [F15in] 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,

[F16”North American Certificate” means, in relation to a State, District or Province listed in the table in paragraph 10B, the certificate identified in the corresponding row of the second column of that table;]

[F17“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 [F18or a country or territory listed in paragraph 12],

F19...

“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;[F20or]

(b)

F21...

(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.

[F22“vaccine certificate” means a certificate in English, French or Spanish issued by the competent health authority of a relevant country [F23, 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

F10The date refers to the day on which the relevant version of the Guidance Document “Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process” was published. A copy of the relevant version may be downloaded from https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_23Dec2021.pdf. A hard copy may be obtained from the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU.