# The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025, Regulation 29: Amendment of Schedule 4


(1) Schedule 4 (Periodic fees for licences) is amended as follows.
(2) In paragraph 5 (marketing authorisations), 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), for “£338” substitute “£368”.
(4) In paragraph 7 (marketing authorisation: derivatives)—
(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), for “£515”, in both places it occurs, substitute “£561”.
(6) In paragraph 12 (wholesale dealer’s licences)—
(a) in sub-paragraph (1), for “£317” substitute “£346”;
(b) in sub-paragraph (2), for “£189” substitute “£206”.
(7) In paragraph 15(1)(b) (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
”;
(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), for “£84” substitute “£92”.

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Source: https://www.legislation.gov.uk/uksi/2025/317/regulation/29 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-amendment-regulations-2025/regulation-29
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.