SCHEDULES

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

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

25.  In regulation 35 (amendment of regulation 44 (requirement for wholesale dealers to deal only with specified persons))—

(a) in paragraph (2)—

(i) for sub-paragraph (a) substitute—

“(a) in sub-paragraph (b), for “another EEA State” substitute “an approved country for import (in the case of a licence holder in Great Britain) or by an EEA State (in the case of a licence holder in Northern Ireland)”; and”;

(ii) for sub-paragraph (b) substitute—

“(b) for sub-paragraph (c) substitute—

“(c) where the medicinal product is directly received—

(i) in the case of a licence holder in Great Britain, from a country that is not an approved country for import (“A”), for export to a country that is not an approved country for import (“B”), and

(ii) in the case of a licence holder in Northern Ireland, from a country other than an EEA State (“A”) for export to another country other than an EEA State (“B”) ,

the supplier of the medicinal product in country A is a person who is authorised or entitled to supply such medicinal products in accordance with the legal and administrative provisions in country A.”.”;

(b) for paragraph (3) substitute—

“(3) For paragraph (5)(b) substitute—

“(b) the holder of an authorisation granted by—

(i) in the case of a licence holder in Great Britain, the appropriate authority of an approved country for import;

(ii) in the case of a licence holder in Northern Ireland, the competent authority of an EEA State,

that is responsible for authorising the supply of those products by way of wholesale dealing;”.”;

(c) for paragraph (4) substitute—

“(4) For paragraph (5)(e) substitute—

“(e) in relation to supply—

(i) in the case of a licence holder in Great Britain to persons in countries other than approved countries for import, a person who is authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the country to which the product is supplied;

(ii) in the case of a licence holder in Northern Ireland to persons in a country other than an EEA State, a person who is authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the country other than an EEA State concerned.”.”;

(d) for paragraph (5)(b) substitute—

“(b) in sub-paragraph (e) after “of the 2001 Directive” insert “, in the case of a licence holder in Northern Ireland.”.”;

(e) after paragraph (5) insert—

“(6) After paragraph (7) insert—

“(8) A licence holder in Great Britain may only obtain a medicinal product in respect of which a UKMA(GB) was granted under the unfettered access route if the product satisfies the definition of qualifying Northern Ireland goods.

(9) Paragraph (2)(c) does not apply to—

(a) in the case of a licence holder in Great Britain, products received from Northern Ireland, and

(b) in the case of a licence holder in Northern Ireland, products received from Great Britain.

(10) Paragraph (5)(e) does not apply to—

(a) in the case of a licence holder in Great Britain, products supplied to Northern Ireland, and

(b) in the case of a licence holder in Northern Ireland, products supplied to Great Britain.”.”.