# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 14

Extent: E+W+S+N.I.

In regulation 20 (amendment of Schedule 4 (standard provisions of licences under Part 3))—
(a) for paragraph (2) substitute—
“(2) For paragraph 13(b) substitute—
“(b) in the case of a product for sale or supply—
(i) in Great Britain, a UK marketing authorisation, certificate of registration or traditional herbal registration, or
(ii) in Northern Ireland, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration,
contains provisions relating to them,”.”;
(b) after paragraph (2) insert—
“(2A) After paragraph 14 insert—
“14A A licence holder—
(a) in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and
(b) in Northern Ireland may only supply a special medicinal product to a person in Great Britain,
in response to an order which satisfies the requirements of regulation 167.”.”;
(c) for paragraph (3) substitute—
“(3) In the heading of Part 2, after “State Other Than an EEA State” insert “ / Country other than an Approved Country for Import ”.”;
(d) for paragraph (4) substitute—
“(4) In paragraph 15, for “from a state other than an EEA State” substitute—
“from—
(a) in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import, or
(b) in the case of an import into Northern Ireland, a country other than an EEA State”.
(4A) In paragraphs 22(1) and 23, for “a state other than an EEA State” substitute “ , in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import and in the case of an import into Northern Ireland, a country other than an EEA State ”.
(4B) After paragraph 23, insert—
“23A A licence holder—
(a) in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and
(b) in Northern Ireland may only supply a special medicinal product to a person in Great Britain,
in response to an order which satisfies the requirements of regulation 167.”.”;
(e) for paragraph (6) substitute—
“(6) In paragraph 33, for “another EEA State” substitute “ , in the case of an import into Great Britain, an approved country for import and in the case of an import into Northern Ireland, an EEA State ”.”;
(f) after paragraph (6) insert—
“(7) After paragraph 41 insert—
“41A A licence holder—
(a) in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and
(b) in Northern Ireland may only supply a special medicinal product to a person in Great Britain,
in response to an order which satisfies the requirements of regulation 167.”.”.

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Source: https://www.legislation.gov.uk/uksi/2020/1488/schedule/2/paragraph/14 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-14
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.