The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

14.  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.”.”.