SCHEDULES

SCHEDULE 2U.K.Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 2 U.K.Amendment of Part 3 (amendment of Part 3 (manufacture and distribution of medicinal products and active substances))

14.  In regulation 20 (amendment of Schedule 4 (standard provisions of licences under Part 3))—U.K.

(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.”.”.

Commencement Information