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

Amendment of regulation 18 (wholesale dealing in medicinal products) U.K.

15.—(1) Regulation 18 M1 is amended as follows.

(2) In paragraph (1)—

(a) in sub-paragraph (a), omit “or”;

(b) in sub-paragraph (b) for “distribution.” substitute “ distribution; or ”;

(c) insert at the end—

“(c) import a medicinal product [F1 into Great Britain] from an approved country for import F2 ....”.

[F3 (2A) After paragraph (2) insert—

“(2A) Paragraph (1)(c) does not apply to imports into Great Britain from an EEA State of medicinal products that have been released for sale, supply or distribution in an EEA State or the United Kingdom before IP completion day.

(2B) For the purposes of paragraph (2A) a medicinal product has been released for sale, supply or distribution where, after the stage of manufacturing has taken place, the product is the subject matter of a written or verbal agreement between two or more persons for the transfer of ownership, any other property right, or possession concerning the product, or where the product is the subject matter of an offer to a person to conclude such an agreement.”.]

[F4 (3) For paragraph (6) substitute—

“(6) A wholesale dealer’s licence does not authorise the distribution of a medicinal product by way of wholesale dealing, or possession of a medicinal product for the purpose of such distribution, unless—

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

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

but this is subject to the exceptions in regulation 43(6).”.]

[F5 (4) In paragraph (7) for “paragraph (6)” substitute “paragraph (6)(b)”.]

Textual Amendments

F1 Words in reg. 15(2)(c) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 10(a)(i)

F2 Words in reg. 15(2)(c) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 10(a)(ii)

F3 Reg. 15(2A) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 10(b)

F4 Reg. 15(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 10(c)

F5 Reg. 15(4) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 10(d)

Commencement Information

I1 Reg. 15 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M1 Regulation 18 was substituted by S.I. 2013/1855 and further amended by S.I. 2016/186.