Paragraph 3 Amendment of regulation 23 (applications for multiple variations)

(1)

Regulation 23 is amended as follows.

(2)

For paragraph (3)(b)(i) substitute—

“(i)
have agreed 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)

In paragraph (6), for “Article 5 of Commission Regulation (EC) No 1234/2008” substitute “paragraph 3 of Schedule 10A to the Human Medicines Regulations”.

(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 within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations;”, and

(ii)

for sub-paragraph (c)(i) substitute—

“(i)
of a kind referred to 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 within the scope of paragraphs 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations;”, and

(ii)

for sub-paragraph (c)(i) substitute—

“(i)
of a kind referred to in paragraph 5(3)(a) or (c) of Schedule 10A to the Human Medicines Regulations; or”;

(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 within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations;”, and

(ii)

for sub-paragraph (c) substitute—

“(c)
the variations do not include a variation of a kind referred to in paragraph 5(3)(a) of Schedule 10A to the Human Medicines Regulations; and”;

(d)

in the definition of “major variation of type II”, for “Article 2(3) of Commission Regulation (EC) No 1234/2008” substitute “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 within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations;”, and

(ii)

for sub-paragraph (c)(i) substitute—

“(i)
a variation of a kind referred to in paragraph 5(3)(a) or (b) of Schedule 10A to the Human Medicines Regulations; or”;

(f)

in the definition of “minor variation of type IA”, for “Article 2(2) of Commission Regulation (EC) No 1234/2008” substitute “paragraph 1 of Schedule 10A to the Human Medicines Regulations”;

(g)

in the definition of “minor variation of type IB”, for “Article 2(5) of Commission Regulation (EC) No 1234/2008” substitute “paragraph 1 of Schedule 10A to the Human Medicines Regulations”; and

(h)

omit the definition of “work sharing”.