The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Amendment of Schedule 8 (material to accompany an application for a UK marketing authorisation) U.K.

50.—(1) Schedule 8 M1 is amended as follows.

(2) In paragraph 12—

(a) in sub-paragraph (a), after “pharmacovigilance” insert “ who is ordinarily resident, and operates, in the United Kingdom [F1 or a member State]”;

[F2 (b) for sub-paragraph (b) substitute—

“(b) the country (which must be either the United Kingdom or a member State) in which the appropriately qualified person resides and carries out his or her tasks;”;]

[F3 (c) for paragraph (e) substitute—

“(e) a reference to the physical location where the pharmacovigilance system master file for the medicinal product can be accessed electronically, which must be in the United Kingdom.”.]

(3) For paragraph 18 substitute—

[F4 “18.   Where—

(a) in the case of a UKMA(NI) or a UKMA(UK), an application for authorisation for the medicinal product to be placed on the market is under consideration in one or more member States—

(i) a list of the member State or States concerned, and

(ii) in relation to each such application, a copy of the summary of the product characteristics, and the package leaflet, proposed by the applicant;

(b) in the case of a medicinal product for sale or supply in Great Britain, an application for authorisation for the medicinal product to be placed on the market is under consideration in a country other than the United Kingdom, or by the EMA, notification of that fact.”].

[F5 (4) In paragraph 19, for “a member State or by a third country” substitute “, in the case of a medicinal product for sale or supply in Northern Ireland, a member State or by a country other than an EEA State, or in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom or by the European Commission”.]

[F6 (5) In paragraph 20, after “Where” insert “, in the case of a medicinal product for sale or supply in Northern Ireland,”.]

[F7 (6) For paragraph 21 substitute—

“21.   Where an authorisation for the medicinal product to be placed on the market has been refused—

(a) in the case of a medicinal product for sale or supply in Northern Ireland, by a member State or by a country other than an EEA State, or

(b) in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom,

details of that decision and of the reasons for it.”.]

[F8 (7) In paragraph 22 for “A copy of any” substitute “In the case of a medicinal product for sale or supply in Northern Ireland, a copy of any”.]

[F9 (8) For paragraph 23 substitute—

“23.   For medicinal products included on the list referred to—

(a) in the case of a medicinal product for sale or supply in Northern Ireland, in Article 23 of Regulation (EC) No 726/2004, the symbol and statement “▼ This medicinal product is subject to additional monitoring”, or

(b) in the case of a medicinal product for sale or supply in Great Britain, in regulation 202A, the symbol and statement “▼ This medicinal product is subject to additional monitoring”.”.]

(9) After paragraph 25, insert—

“25A.   In the case of an advanced therapy medicinal product [F10 for sale or supply in Great Britain] which contains cells or tissues, a detailed description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin.”.

(10) After paragraph 35, insert—

“36.   In the case of an advanced therapy medicinal product [F11 for sale or supply in Great Britain]—

(a) references in this Part of this Schedule to administration of a product include references to the advanced therapy medicinal product's use, application or implantation; and

(b) descriptions, instructions and warnings must include explanatory drawings and pictures where necessary.”.

Textual Amendments

F1 Words in reg. 50(2)(a) 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. 38(a)(i)

F2 Reg. 50(2)(b) 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. 38(a)(ii)

F3 Reg. 50(2)(c) 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. 38(a)(iii)

F4 Words in reg. 50(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. 38(b)

F5 Reg. 50(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. 38(c)

F6 Reg. 50(5) 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. 38(d)

F7 Reg. 50(6) 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. 38(e)

F8 Reg. 50(7) 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. 38(f)

F9 Reg. 50(8) 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. 38(g)

F10 Words in reg. 50(9) 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. 38(h)

F11 Words in reg. 50(10) 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. 38(i)

Commencement Information

I1 Reg. 50 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 Schedule 8 was amended by S.I. 2013/1855.