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The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025

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Change 1

What to do with it
As published

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”.

Your change, as a redline

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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