Regulation 29 Amendment of Schedule 4

(1)

Schedule 4 (Periodic fees for licences) is amended as follows.

(2)

In paragraph 5 (marketing authorisations)^f1, in column 2 (fee payable) of the table (periodic fees for holding a marketing authorisation)—

(a)

in entry 1, for “£10,681” substitute “£11,627”;

(b)

in entry 2, for “£338” substitute “£368”;

(c)

in entry 3(a), for “£10,681” substitute “£11,627”;

(d)

in entry 3(b)(i), for “£2,671” substitute “£2,908”;

(e)

in entry 3(b)(ii), for “£1,332” substitute “£1,450”;

(f)

in entries 3(b)(iii), (c) and (d), for “£338”, in each place it occurs, substitute “£368”;

(g)

in entries 3(e) to (h), for “£84”, in each place it occurs, substitute “£92”.

(3)

In paragraph 6 (marketing authorisation: where Part 2 of the Act applies)^f2, for “£338” substitute “£368”.

(4)

In paragraph 7 (marketing authorisation: derivatives)^f3—

(a)

in sub-paragraph (a), for “£10,681” substitute “£11,627”;

(b)

in sub-paragraph (b), for “£7,209” substitute “£7,847”.

(5)

In paragraph 11(1) and (2) (manufacturer’s licences or manufacturing authorisations)^f4, for “£515”, in both places it occurs, substitute “£561”.

(6)

In paragraph 12 (wholesale dealer’s licences)^f5—

(a)

in sub-paragraph (1), for “£317” substitute “£346”;

(b)

in sub-paragraph (2), for “£189” substitute “£206”.

(7)

In paragraph 15(1)(b)^f6 (additional amount for manufacturer’s licences and wholesale dealer’s licences which relate to special medicinal products)—

(a)

for Table 1 (additional periodic fee in connection with notices for imported special medicinal products) substitute—

“

Table 1

Additional periodic fee in connection with notices for imported special medicinal products

Column 1 Column 2

Number of special import notices Additional amount
1 to 20 £86
21 to 100 £427
101 to 500 £2,131
501 to 1,000 £4,261
1,001 to 2,000 £8,521
2,001 to 5,000 £17,042
5,001 to 10,000 £34,083
10,001 to 15,000 £51,125
15,001 to 20,000 £68,166
20,001 to 25,000 £85,208
25,001 to 30,000 £102,249
30,001 to 35,000 £119,291
35,001 to 40,000 £136,333
40,001 to 45,000 £153,375
45,001 to 50,000 £170,417
Each additional 5,000 above 50,000 £170,417 plus £17,042 for each additional 5,000 special import notices

”;

Column 1	Column 2
Number of special import notices	Additional amount
1 to 20	£86
21 to 100	£427
101 to 500	£2,131
501 to 1,000	£4,261
1,001 to 2,000	£8,521
2,001 to 5,000	£17,042
5,001 to 10,000	£34,083
10,001 to 15,000	£51,125
15,001 to 20,000	£68,166
20,001 to 25,000	£85,208
25,001 to 30,000	£102,249
30,001 to 35,000	£119,291
35,001 to 40,000	£136,333
40,001 to 45,000	£153,375
45,001 to 50,000	£170,417
Each additional 5,000 above 50,000	£170,417 plus £17,042 for each additional 5,000 special import notices

(b)

in the second column (additional amount) of Table 2 (Additional periodic fee in connection with the number of different special medicinal products notified for import)—

(i)

in the entry “1 to 5”, for “£100” substitute “£122”;

(ii)

in the entry “6 to 10”, for “200” substitute “£244”;

(iii)

in the entry “11 to 20”, for “£400” substitute “£487”;

(iv)

in the entry “21 to 50”, for “£1,000” substitute “£1,218”;

(v)

in the entry “51 to 100, for “£2,000” substitute “£2,435”;

(vi)

in the entry “101 to 200”, for “£4,000” substitute “£,4,869”;

(vii)

in the entry “For each additional 100 special medicinal products notified for import above 200”, for “£2,000” substitute “£4,869 plus £2,435 for each additional 100 special medicinal products notified for import”.

(8)

In paragraph 16 (traditional herbal registrations)^f7, for “£84” substitute “£92”.

Annotations

Footnotes

f1: Amended by S.I. 2023/314.
f2: Amended by S.I. 2023/314.
f3: Amended by S.I. 2023/314.
f4: Amended by S.I. 2023/314.
f5: Amended by S.I. 2023/314.
f6: Amended by S.I. 2023/314.
f7: Amended by S.I. 2023/314.