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

Amendment of regulation 23 (applications for multiple variations) U.K.

3.—(1) Regulation 23 is amended as follows.

[F1 (2) For paragraph (3)(b)(i) substitute—

“(i) have agreed—

(aa) in the case of a UKMA(NI) or UKMA(UK), in consultation with member States concerned and in accordance with Article 7(2)(c) of Commission Regulation (EC) No 1234/2008, should be subject to the procedure for grouping of variations within the meaning of that Article;

(bb) in the case of a UKMA(GB), should be subject to the procedure for grouping of variations within the meaning of paragraph 5(2)(c) of Schedule 10A to the Human Medicines Regulations; and”.

(3) For paragraph (6) substitute—

“(6) In a case where a recommendation on the classification of a variation is made in accordance with—

(a) in the case of a UKMA(NI) or UKMA(UK), Article 5 of Commission Regulation (EC) No 1234/2008; or

(b) in the case of a UKMA(GB), paragraph 3 of Schedule 10A to the Human Medicines Regulations,

the fee payable for the application made in respect of that variation is the appropriate fee for the classification given to the variation or, as the case may be, the appropriate fee which arises as a consequence of the classification given to the variation.”.

(4) In paragraph (7)—

(a) in the definition of “Major Variation (Type II) Group Application”—

(i) for sub-paragraph (b) substitute—

“(b) subject to sub-paragraph (c), the variations fall—

(i) in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008;

(ii) in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations;”;

(ii) for sub-paragraph (c)(i) substitute—

“(i) of a kind referred to—

(aa) in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 (extension of the marketing authorisation) or paragraph 3 (minor variation of type IB and consequential variations) of Annex III to Commission Regulation (EC) No 1234/2008;

(bb) in the case of UKMA(GB), in paragraph 5(3)(a) or (c) of Schedule 10A to the Human Medicines Regulations;”;

(b) in the definition of “Major Variation (Type II) Complex Group Application”—

(i) for sub-paragraph (b) substitute—

“(b) subject to sub-paragraph (c), the variations fall—

(i) in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008;

(ii) in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations;”;

(ii) for sub-paragraph (c)(i) substitute—

“(i) of a kind referred to—

(aa) in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 (extension of the marketing authorisation) or paragraph 3 (minor variation of type IB and consequential variations) of Annex III to Commission Regulation (EC) No 1234/2008;

(bb) in the case of a UKMA(GB), in paragraph 5(3)(a) or (c) of Schedule 10A to the Human Medicines Regulations;”;

(c) in the definition of “Major Variation (Type II) Extended Complex Group Application”—

(i) for sub-paragraph (b) substitute—

“(b) subject to sub-paragraph (c), the variations fall—

(i) in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008;

(ii) in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations;”;

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

“(c) the variations do not include a variation of a kind referred to—

(i) in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 of Annex III to Commission Regulation (EC) No 1234/2008;

(ii) in the case of a UKMA(GB), in paragraph 5(3)(a) of Schedule 10A to the Human Medicines Regulations; and”;

(d) for the definition of “major variation of type II” substitute—

““major variation of type II”—

(a)

in the case of a UKMA(NI) or UKMA(UK), has the meaning given in Article 2(3) of Commission Regulation (EC) No 1234/2008; and

(b)

in the case of a UKMA(GB), has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations;”;

(e) in the definition of “Minor Variation (Type IB) Group Application”—

(i) for sub-paragraph (b) substitute—

“(b) subject to sub-paragraph (c), the variations fall—

(i) in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008;

(ii) in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations;”;

(ii) for sub-paragraph (c)(i) substitute—

“(i) a variation of a kind referred to—

(aa) in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 or paragraph 2 of Annex III of Commission Regulation (EC) No 1234/2008;

(bb) in the case of a UKMA(GB), in paragraph 5(3)(a) or (b) of Schedule 10A to the Human Medicines Regulations; or”;

(f) for the definition of “minor variation of type IA” substitute—

““minor variation of type IA”—

(a)

in the case of a UKMA(NI) or UKMA(UK), has the meaning given in Article 2(2) of Commission Regulation (EC) No 1234/2008; and

(b)

in the case of a UKMA(GB), has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations;”;

(g) for the definition of “minor variation of type IB” substitute—

““minor variation of type IB”—

(a)

in the case of a UKMA(NI) or UKMA(UK), has the meaning given in Article 2(5) of Commission Regulation (EC) No 1234/2008; and

(b)

in the case of a UKMA(GB), has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations; and”;

(h) in the definition of “work sharing”, after “means” insert “, in the case of a UKMA(NI) or UKMA(UK),”.]

Textual Amendments

F1 Sch. 1 para. 3(2)-(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. 188(d)

Commencement Information

I1 Sch. 1 para. 3 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1