5. In regulation 8(1)(1), in the definition of “homoeopathic medicinal product”, in paragraph (b)(i), for “in an pharmacopoeia used officially in an country” substitute “in a pharmacopoeia used officially in a country”.
6. In regulation 43(6)(d)(2)—
(a)at the end of sub-paragraph (i), omit “or”;
(b)in sub-paragraph (ii), for “import.” substitute “import; or”; and
(c)at the end insert—
“(iii)from the United Kingdom to a person in an EEA State, if the distribution is specifically for purposes of placing the product on the market in that State and the medicinal product has—
(aa)a marketing authorisation,
(bb)Article 126a authorisation,
(cc)certificate of registration, or
(dd)traditional herbal registration for that EEA State.”
7. In regulation 45A(1A)(3)—
(a)in sub-paragraph (b)(i), omit “or a competent authority of a member State”; and
(b)in sub-paragraph (b)(ii), omit “except where the person is validly registered with the competent authority of an EEA state,”.
8.—(1) Regulation 49(4) is amended as follows.
(2) For paragraph (3)(a) substitute—
“(a)a UKMA(UK) or UKMA(NI), must be established in the United Kingdom or the European Union;”.
(3) In paragraph (3)(b)(ii), after “the United Kingdom” insert “or the European Union”.
(4) In paragraph (3)(c), for “UKMA(UK)” substitute “parallel import licence”.
9. In regulation 58(5), after paragraph (4C) insert—
“(4D) When considering an application for a UK marketing authorisation, the licensing authority may, if it considers appropriate, grant a UKMA(UK), UKMA(GB) or UKMA(NI), regardless of the indication given under regulation 49(9).”
10.—(1) Regulation 60A(6) is amended as follows.
(2) In paragraph (1), in the definition of “the batch testing exemption”, in paragraph (b)(ii), after “United Kingdom” insert “or, in the case of a product for sale or supply in Northern Ireland, the European Union”.
(3) In paragraph (2), in each place where it occurs, for “immunological product” substitute “immunological medicinal product”.
11.—(1) Regulation 60B(7) is amended as follows.
(2) In paragraph (1), in the definition of “the batch testing exemption”, in paragraph (b)(ii), after “United Kingdom” insert “or the European Union”
(3) In paragraph (2)(a), in each place where it occurs, for “immunological product” substitute “immunological medicinal product”.
12. In regulation 167(7)(8), omit “a country other than”.
13. In regulation 182(2)(a)(9), for “the EU or” substitute “an EEA State or the”.
14.—(1) Regulation 188(10) is amended as follows.
(2) In paragraph (1A)(a), after “15 days beginning on the day” insert “following the day”.
(3) In paragraph (1A)(b), after “90 days beginning on the day” insert “following the day”.
15.—(1) Regulation 193(11) is amended as follows.
(2) In paragraph (6A), for “paragraph (2)(a)” substitute “paragraph (2A)(a)”.
(3) In paragraph (6B), for “paragraph (2)” substitute “paragraph (2A)”.
16.—(1) Regulation 199(12) is amended as follows.
(2) For paragraph (2)(a), substitute—
“(a)the licensing authority; and”.
(3) For paragraph (2)(b), substitute—
“(b)where the authorisation is a UKMA(NI) or UKMA(UK) and the study is to be conducted in an EEA State, the Pharmacovigilance Risk Assessment Committee,”.
(4) Omit paragraph (3).
(5) In paragraph (4), for “paragraphs (2) and 3(a)” substitute “paragraph (2)(a)”.
17.—(1) Regulation 200(13) is amended as follows.
(2) For paragraph (2)(a), substitute—
“(a)the licensing authority; and”
(3) For paragraph (2)(b), substitute—
“(b)where the authorisation is a UKMA(NI) or UKMA(UK) and the study is being conducted in an EEA State, the Pharmacovigilance Risk Assessment Committee,”
(4) Omit paragraph (3).
(5) In paragraph (4), for “paragraphs (2) and (3)(a)” substitute “paragraph (2)(a)”.
(6) In paragraph (6), for “paragraphs (2) and (3)(b)” substitute “paragraph (2)(b)”.
18.—(1) Regulation 201(14) is amended as follows.
(2) For paragraph (2)(a), substitute—
“(a)the licensing authority; and”
(3) For paragraph (2)(b), substitute—
“(b)where the authorisation is a UKMA(NI) or UKMA(UK) and the study was conducted in an EEA State, the Pharmacovigilance Risk Assessment Committee,”
(4) Omit paragraph (3).
19. For regulation 202A(1)(15) substitute—
“(1) The licensing authority may establish a list of medicinal products that are subject to additional monitoring and that are authorised under—
(a)a UKMA(GB), and
(b)a UKMA(UK) where the medicinal product is not on the list referred to in Article 23 of Regulation (EC) No 726/2004.”
20.—(1) Schedule 8(16) is amended as follows.
(2) In paragraph 12, in the two places where it occurs, for “a member State” substitute “an EEA State”.
(3) For paragraph 23 substitute—
“23. For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004 or regulation 202A, as the case may be, the symbol and statement “▼ This medicinal product is subject to additional monitoring”. ”
21. In Schedule 11(17), in paragraph 1(2) (application of this part), after “UKMA(NI)” insert “, COR(NI)”.
22. In Schedule 27(18), in paragraph 13, for “in the case of products for sale or supply in Northern Ireland, or the list referred to in regulation in the case of products for sale or supply in Great Britain” substitute “or regulation 202A, as the case may be,”.
23. In Schedule 33A(19), omit Part 10 (transitional provisions in respect of pharmacovigilance).
Regulation 8 was amended by S.I. 2019/775 (as amended by S.I. 2020/1488); there are other amending instruments but none is relevant.
Regulation 43(6) was amended by S.I. 2016/186 and 2019/775 (as amended by S.I. 2020/1488).
Regulation 45A was inserted by S.I. 2013/1855 and amended by S.I. 2019/775 (as amended by S.I. 2020/1488).
Regulation 49(3) was amended by S.I. 2019/775 (as amended by S.I. 2020/1488).
Regulation 58 was amended by S.I. 2019/775 (as amended by S.I. 2020/1488).
Regulation 60A was inserted by S.I. 2019/775 (as amended by S.I. 2020/1488).
Regulation 60B was inserted by S.I. 2019/775 (as amended by S.I. 2020/1488).
Regulation 167(7) was amended by S.I. 2017/715 and 2019/775 (as amended by S.I. 2020/1488).
Regulation 182(2) was amended by S.I. 2019/775 (as amended by S.I. 2020/1488).
Regulation 188(1A) was amended by S.I. 2019/775 (as amended by S.I. 2020/1488).
Regulation 193 was amended by S.I. 2019/775 (as amended by S.I. 2020/1488).
Regulation 199 was amended by S.I. 2019/775 (as amended by S.I. 2020/1488).
Regulation 200 was amended by S.I. 2019/775 (as amended by S.I. 2020/1488).
Regulation 201 was amended by S.I. 2019/775 (as amended by S.I. 2020/1488).
Regulation 202A was inserted by S.I. 2019/775.
Schedule 8 was amended by S.I. 2013/1855 and 2019/775 (as amended by S.I. 2020/1488).
Schedule 11 was amended by S.I. 2019/775 (as amended by S.I. 2020/1488).
Schedule 27 was amended by S.I. 2014/1878 and 2019/775 (as amended by S.I. 2020/1488).
Schedule 33A was inserted by S.I. 2019/775 (as amended by S.I. 2020/1488).