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

23.  In regulation 33 (amendment of regulation 43 (obligations of licence holder))— U.K.

(a) for paragraph (2) substitute—

“(2) For paragraph (1), substitute—

“43.— (1) The licence holder must comply with the guidelines on good distribution practice—

(a) in the case of a licence holder in Great Britain, published under, or that apply by virtue of, regulation C17;

(b) in the case of a licence holder in Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive.”.”;

(b) for paragraph (3) substitute—

“(3) For paragraph (5)(a) substitute—

“(a) in the case of a product for sale or supply—

(i) in Great Britain, there is a UKMA(GB), UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”), or

(ii) in Northern Ireland, there is a UKMA(NI), UKMA(UK), a COR(NI), a COR(UK), a THR(NI), a THR(UK), and EU marketing authorisation or an Article 126a authorisation (an “authorisation”),

in force in relation to the product; and”.”;

(c) after paragraph (4)(a) insert—

“(aa) in sub-paragraph (b), after “the export” insert “ from Northern Ireland ”;”;

(d) in paragraph (4)(b)—

(i) for “for sub-paragraph (b), substitute” substitute “ after sub-paragraph (b), insert ”;

(ii) in the text inserted by that paragraph—

(aa) renumber the paragraph to be inserted as “(ba)”;

(bb) after “the export” insert “ from Great Britain ”;

(e) after paragraph (4)(b) insert—

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

“(d) the wholesale distribution of medicinal products—

(i) from Northern Ireland to a person in a country other than Great Britain or a country other than an EEA State; or

(ii) from Great Britain to a person in a country other than Northern Ireland or a country other than an approved country for import.”.”;

(f) in paragraph (5)(a)—

(i) for paragraph (i) substitute—

“(i) for sub-paragraph (i) substitute—

“(i) ordered by the licensing authority or—

(aa) in the case of a licence holder in Great Britain, by an appropriate authority for the licensing of medicinal products in an approved country for import;

(bb) in the case of a licence holder in Northern Ireland, by the competent authority of any EEA State, or”;”;

(ii) for paragraph (ii) substitute—

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

“(ii) carried out in co-operation with the manufacturer of, or the holder of—

(aa) in the case of a product for sale or supply in Great Britain, the UKMA(GB) or UKMA(UK), certificate of registration or traditional herbal registration, or

(bb) in the case of a product for sale or supply in Northern Ireland, the UKMA(NI) or UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration,

for, the product; and”;”;

(g) for paragraph (5)(b) substitute—

“(b) in sub-paragraph (c)(vii), before “the batch number” insert “ where the receipt, dispatch or brokering of medicinal products takes places in Northern Ireland, ”;”;

(h) after paragraph (5) insert—

“(5A) In paragraph (8)—

(a) after “A licence holder” insert “ in Northern Ireland ”;

(b) for “third country” substitute “ “country other than an EEA State”.”;

(i) in paragraph (6)—

(i) for “For paragraph (8) substitute” substitute “ After paragraph (8) insert ”;

(ii) renumber the paragraphs to be inserted as (8A) and (8B) respectively;

(iii) in the newly renumbered paragraph (8A)—

(aa) for “Paragraph (8A)” substitute “ Paragraph (8B) ”;

(bb) in sub-paragraph (a), after “imports” insert “ into Great Britain ”;

(j) for paragraph (7) substitute—

“(7) In paragraph (10), after “The holder” insert “ of a licence relating to wholesale dealings in Northern Ireland ”.”;

(k) for paragraph (8) substitute—

“(8) In paragraph (13), for “marketing authorisation holder” substitute “ UK marketing authorisation holder or EU marketing authorisation holder ”.”;

(l) for paragraph (9) substitute—

“(9) For paragraph (14) substitute—

“(14) Where the medicinal product is obtained through brokering—

(a) a licence holder in Great Britain must verify that the broker involved fulfils the requirements set out in regulation 45A(1)(b);

(b) a licence holder in Northern Ireland must verify that the broker involved is validly registered with the licensing authority or the competent authority of an EEA State.”.

(10) In paragraph (15), after “In this regulation” insert “ as it applies in the case of a product for sale or supply in Northern Ireland ”.”.

Commencement Information

I1 Sch. 2 para. 23 in force at 31.12.2020 immediately before IP completion day, see reg. 1