Citation, commencement and extent

1.—(1) These Regulations may be cited as the Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025.

(2) These Regulations come into force on 1st April 2025.

(3) These Regulations extend to England and Wales, Scotland and Northern Ireland.

Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016

2.The Medicines (Products for Human Use) (Fees) Regulations 2016(2) are amended in accordance with regulations 3 to 31.

New regulation 3A

3. After regulation 3 (interpretation of Part 2), insert—

“Fee for scientific or other advice

3A.—(1)Unless regulation 5 applies, the fee specified in paragraph (2) is payable by a person with whom the licensing authority holds a meeting in order to provide scientific or other advice relating to a medicinal product.

(2)The fee payable by a person in relation to a meeting referred to in paragraph (1) is—

(a)£17,516, if the advice provided at that meeting is on a matter of high complexity;

(b)£13,137, if the advice provided at that meeting is on a matter of medium complexity;

(c)£8,758, if the advice provided at that meeting is on a matter of low complexity;

(d)£986, if the advice provided at that meeting is on a matter of simple complexity.

(3)In paragraph (2), a matter is of—

(a)high complexity if it requires more than twelve assessor days;

(b)medium complexity if it requires more than seven, but not more than twelve, assessor days;

(c)low complexity if it requires more than three, but not more than seven, assessor days;

(d)simple complexity if it requires not more than three assessor days.

(4)If the person paying the fee in accordance with paragraph (1) consents, the licensing authority may provide any advice in writing instead of at a meeting.

(5)In this regulation—

“assessor day” means—

“medicinal product”, in paragraph (e) of the definition of scientific or other advice in this regulation, includes a substance incorporated in a device which, if used separately, may be considered to be a medicinal product as defined in Article 1(2) of the 2001 Directive;

“scientific or other advice” includes—

Omission of regulation 4

4. Omit regulation 4 (fee for scientific advice: application for, or variation to, EU marketing authorisation)(3).

Amendment of regulation 5

5. In regulation 5(1) (fee for scientific advice: classification of a medicinal product)(4)—

(a)in sub-paragraph (a), for “£3,039” substitute “£8,758”;

(b)in sub-paragraph (b), for “£3,986” substitute “£8,758”.

Omission of regulation 6

6. Omit regulation 6 (fee for advertising advice)(5).

Omission of regulation 7

7. Omit regulation 7 (fee for pharmacovigilance advice)(6).

Amendment of regulation 8

8. In regulation 8 (fee for advice on labelling or leaflets)(7), for “£2,421” substitute “£3,757”.

Omission of regulation 9

9. Omit regulation 9 (fee for regulatory advice)(8).

Omission of regulation 10

10. Omit regulation 10 (fee for advice for other purposes)(9).

Amendment of regulation 10A

11. In regulation 10A(1) (waiver for advice given to small and medium companies)(10), for “4 to 10” substitute “3A to 8”.

Amendment of regulation 11

12. In regulation 11 (time for payment of fees under regulations 4 to 10), for “4 to 10”, in each place it occurs (including the heading to the regulation), substitute “3A to 8”.

Amendment of regulation 14

13. In regulation 14 (fee for applications for additional copy certificates)(11), for “£75” substitute “£82”.

Amendment of regulation 15

14. In regulation 15 (fees for applications for certificates and copy certificates by exporters of medicinal products)(12)—

(a)in paragraph (1)(a), for “£167” substitute “£182”;

(b)in paragraph (1)(b), for “£75” substitute “£82”.

Amendment of regulation 19A

15. In regulation 19A (fees for certification of plasma master files)(13)—

(a)in paragraph (1), for “£9,140” substitute “£11,126”;

(b)in paragraph (2)(a), for “£344” substitute “£419”;

(c)in paragraph (2)(b), for “£1,308” substitute “£1,593”.

Amendment of regulation 19B

16. In regulation 19B (fee for certification of vaccine antigen master files)(14), for “£9,140” substitute “£11,126”.

Amendment of regulation 19C

17. In regulation 19C (fees for assessment of post-authorisation safety studies)(15) for “£9,140”, in both places it occurs, substitute “£9,949”.

Amendment of regulation 19E

18. In regulation 19E(2) (fee for assessment of periodic safety update reports)(16)—

(a)in sub-paragraph (a), for “£979” substitute “£1,066”;

(b)in sub-paragraph (b), for “£490” substitute “£534”.

Amendment of regulation 19EA

19. In regulation 19EA (fee for assessment of clinical trial annual safety reports)(17), for “£248” substitute “£343”.

Amendment of regulation 21

20. In regulation 21(1) (fees for notification of changes and reports for broker’s registrations)(18), for “£283” substitute “£345”.

Amendment of regulation 22

21. In regulation 22(1) (fees for notification of changes and compliance reports for active substance registrations)(19), for “£283” substitute “£309”.

Amendment of regulation 27

22. In regulation 27(1) (fees for renewals of certain manufacturer’s licences)(20), for “£196” substitute “£214”.

Amendment of regulation 41

23. In regulation 41 (fees for applications for membership and certificates)(21)—

(a)in paragraph (1), for “£129” substitute “£141”;

(b)in paragraph (2), for “£68” substitute “£75”.

Amendment of regulation 42

24. In regulation 42(1) (fee for a review upon oral representations or a person appointed hearing)(22), for “£11,000” substitute “£11,974”.

Amendment of regulation 44

25. In regulation 44(1) (interpretation), in the definition of “standard variation”—

(a)in sub-paragraph (o), at the end, omit “or”;

(b)in sub-paragraph (p), for “authorisation.” substitute “authorisation; or”;

(c)after sub-paragraph (p), insert—

“(q)a change to any packaging of the product, including the container or other form of packaging immediately in contact with the medicinal product, any packaging into which the container or other form of packaging immediately in contact with the product is placed, or to a leaflet that accompanies the product and contains information for the user of the product.”.

Amendment of regulation 47

26. In regulation 47 (fees for variations of certificates)—

(a)in paragraph (1)(a)—

(i)in paragraph (i), for “£123” substitute “£149”;

(ii)in paragraph (ii), for “£62” substitute “£75”;

(b)in paragraph (1)(b), for “£123” substitute “£149”;

(c)in paragraph (2)(a)—

(i)in paragraph (i), for “£243” substitute “£296”;

(ii)in paragraph (ii), for “£243” substitute “£296”;

(iii)in paragraph (iii), for “£123” substitute “£149”;

(iv)in paragraph (iv), for “£62” substitute “£75”;

(d)in paragraph (2)(b), for “£243” substitute “£296”.

Amendment of Schedule 2

27.—(1)Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates) is amended as follows.

(2) In paragraph 21 (standard variation application for a homoeopathic medicinal product)—

(a)in sub-paragraph (o), at the end, omit “or”;

(b)in sub-paragraph (p), for “Directive.” substitute “Directive; or”;

(c)after sub-paragraph (p), insert—

“(q)a change to any packaging of the product, including the container or other form of packaging immediately in contact with the medicinal product, any packaging into which the container or other form of packaging immediately in contact with the product is placed, or to a leaflet that accompanies the product and contains information for the user of the product.”.

(3) In paragraph 24(5) (marketing authorisations)(23), in the table (fees for marketing authorisation applications)—

(a)in item 1 (major application)—

(i)in entry (a), for “£32,705” substitute “£39,811”;

(ii)in entries (b) to (d), for “£68,663”, in each place it occurs, substitute “£83,580”;

(iii)in entry (e), for “£20,281” substitute “£24,688”;

(iv)omit entry (f);

(v)omit entry (g);

(vi)in entry (h), for “£102,028” substitute “£124,194”;

(b)in item 2 (complex application)—

(i)in entries (a) to (c), for “£19,063”, in each place it occurs, substitute “£23,205”;

(ii)in entry (d), for “£11,487” substitute “£13,983”;

(iii)omit entry (e);

(iv)omit entry (f);

(v)in entry (g), for “£28,207” substitute “£34,335”;

(c)in item 3 (standard application)—

(i)in entries (a) to (c), for “£6,985”, in each place it occurs, substitute “£8,503”;

(ii)in entry (d), for “£6,361” substitute “£7,743”;

(iii)omit entry (e);

(iv)omit entry (f);

(v)in entry (g), for “£10,342” substitute “£12,589”;

(d)in item 4 (simple application)—

(i)in entries (a) to (c), for “£2,820”, in each place it occurs, substitute “£3,433”;

(ii)omit entry (d);

(iii)omit entry (e);

(iv)in entry (f), for “£2,820” substitute “£3,433”;

(e)in item 5 (parallel import licence applications)—

(i)in entry (a), for “£1,971” substitute “£2,400”;

(ii)in entry (b), for “£8,722” substitute “£10,617”;

(iii)in entry (c), for “£19,998” substitute “£24,343”;

(f)in item 6 (change of ownership application), for “£486” substitute “£592”.

(4) In paragraph 25(1) (fees where application includes reclassification)(24)—

(a)in sub-paragraph (a), for “£33,003” substitute “£40,173”;

(b)in sub-paragraph (b), for “£8,978” substitute “£10,929”.

(5) In paragraph 28(4)(b) (application for multiple authorisations)(25), for “£1,308” substitute “£1,593”.

(6) In paragraph 28A (application by pre-assessment of modules)(26)—

(a)in sub-paragraphs (1)(a) to (c), for “£25,507”, in each place it occurs, substitute “£31,049”;

(b)in sub-paragraphs (2)(a) to (c), for “£4,766”, in each place it occurs, substitute “£5,802”.

(7) In paragraph 29 (authorisation for a national homoeopathic product)—

(a)in sub-paragraph (4), in the table (fees for homoeopathic marketing authorisation applications)—

(i)in the second column (fee for applications in respect of products prepared from not more than 5 homoeopathic stocks)—

(aa)in entry 1, for “£517” substitute “£630”;

(bb)in entry 2, for “£808” substitute “£984”;

(cc)in entry 3, for “£1,088” substitute “£1,325”;

(ii)in the third column (fee for other applications)—

(aa)in entry 1, for “£732” substitute “£892”;

(bb)in entry 2, for “£1,014” substitute “£1,235”;

(cc)in entry 3, for “£1,312” substitute “£1,598”;

(b)in sub-paragraph (6), for “£2,154” substitute “£2,622”;

(c)in sub-paragraph (7), for “£7,185” substitute “£8,746”;

(d)in sub-paragraph (8), for “£635” substitute “£773”.

(8) In paragraph 30(1) (manufacturer’s licences and authorisations)(27)—

(a)in sub-paragraph (a), for “£201” substitute “£245”;

(b)in sub-paragraph (b), for “£378” substitute “£461”;

(c)in sub-paragraph (c), for “£3,457” substitute “£4,209”.

(9) In paragraph 31 (wholesale dealer’s licences)(28)—

(a)in sub-paragraph (1), for “£1,983” substitute “£2,159”;

(b)in sub-paragraph (5), for “£439” substitute “£478”.

(10) In paragraph 33(1) (active substance registrations)(29)—

(a)in paragraph (a), for “£3,457” substitute “£3,763”;

(b)in paragraph (b), for “£1,983” substitute “£2,159”.

(11) In paragraph 34 (clinical trial authorisations)(30)—

(a)in sub-paragraph (a), for “£3,366” substitute “£4,656”;

(b)in sub-paragraph (b), for “£248” substitute “£343”.

(12) In paragraph 35 (traditional herbal registrations)(31)—

(a)in sub-paragraph (1), in the second column (fee payable) of the table (fee for application for traditional herbal registration)—

(i)in entry 1 (complex registration application)—

(aa)in entry (a), for “£4,846” substitute “£5,899”;

(bb)in entry (b), for “£7,269” substitute “£8,848”;

(ii)in entry 2 (standard registration application)—

(aa)in entry (a), for “£2,423” substitute “£2,950”;

(bb)in entry (b), for “£3,634” substitute “£4,424”;

(iii)in entry 3 (reduced registration application category II)—

(aa)in entry (a), for “£807” substitute “£983”;

(bb)in entry (b), for “£1,212” substitute “£1,476”;

(iv)in entry 4 (reduced registration application category I)—

(aa)in entry (a), for “£539” substitute “£657”;

(bb)in entry (b), for “£807” substitute “£983”;

(v)in entry 5 (change of ownership application), for “£486” substitute “£592”.

(b)in sub-paragraph (3)—

(i)in paragraph (a), for “£1,077” substitute “£1,311”;

(ii)in paragraph (b), for “£2,154” substitute “£2,622”;

(c)in sub-paragraph (4), for “£7,186” substitute “£8,748”;

(d)in sub-paragraph (5), for “£638” substitute “£777”;

(e)in sub-paragraph (6), for “£2,154” substitute “£2,622”.

(13) In paragraph 35A (early access to medicines scheme fees), in the second column (fee payable) of the table (fees for early access to medicines scheme applications)(32)—

(a)in entry 1, for “£3,986” substitute “£4,852”;

(b)in entry 2, for “£25,643” substitute “£31,214”;

(c)in entry 3, for “£12,821” substitute “£15,607”;

(d)in entry 4, for “£8,309” substitute “£10,115”;

(e)in entry 5, for “£4,154” substitute “£5,057”.

(14) In paragraph 38(6) (marketing authorisations)—

(a)in the second column (column 2 fee payable) of Table 1 (fees for applications for variations of marketing authorisations falling within the scope of Chapter II of Regulation (EC) No 1234/200833)—

(i)in item 1 (application for a single kind variation)—

(aa)in entries (a) and (b), for “£344”, in both places it occurs, substitute “£419”;

(bb)in entry (c), for “£2,742” substitute “£3,338”;

(cc)in entry (d), for “£8,462” substitute “£10,301”;

(ii)in item 2 (applications for a group)—

(aa)in entry (a), for “£344” substitute “£419”;

(bb)in entry (b), for “£1,255” substitute “£1,528”;

(cc)in entry (c), for “£2,973” substitute “£3,619”;

(dd)in entry (d), for “£8,671” substitute “£10,555”;

(b)in the second column (fee payable) of Table 2 (fees for applications for variations of marketing authorisations falling within the scope of Chapter IIa of Regulation (EC) No 1234/200834)—

(i)in item 1, for “£344” substitute “£419”;

(ii)in item 2, for “£1,308” substitute “£1,593”;

(iii)in item 3, for “£9,140” substitute “£11,126”;

(iv)in item 4, for “£33,003” substitute “£40,173”;

(v)in item 5, for “£684” substitute “£833”;

(vi)in item 6, for “£1,817” substitute “£2,212”;

(vii)in item 7, for “£9,911” substitute “£12,065”;

(viii)in item 8, for “£28,904” substitute “£35,184”;

(c)in the second column (fee payable) of Table 3 (fees for reclassification variation applications)(35)—

(i)in entry (a), for “£33,003” substitute “£40,173”;

(ii)in entry (b), for “£8,978” substitute “£10,929”.

(15) In paragraph 40(1) (reclassification of marketing authorisations)(36), for “£1,308” substitute “£1,593”.

(16) In paragraph 41 (variation of marketing authorisation: national homoeopathic products)—

(a)in sub-paragraph (a), for “£243” substitute “£296”;

(b)in sub-paragraph (b), for “£374” substitute “£456”;

(c)in sub-paragraph (c), for “£123” substitute “£149”.

(17) In paragraph 42(1) (variation of parallel import licence)(37)—

(a)in paragraph (a), for “£33,003” substitute “£40,173”;

(b)in paragraph (b), for “£8,978” substitute “£10,929”;

(c)in paragraph (c), for “£393” substitute “£479”.

(18) In paragraph 43 (manufacturer’s authorisations and licences)(38)—

(a)in sub-paragraph (a), for “£283” substitute “£345”;

(b)in sub-paragraph (b), for “£565” substitute “£688”.

(19) In paragraph 44 (variation of manufacturer’s authorisations and licences)(39), for “£283” substitute “£345”.

(20) In paragraph 45 (wholesale dealer’s licences)(40), for “£535” substitute “£652”.

(21) In paragraph 46 (variation of wholesale dealer’s licence)(41), for “£283” substitute “£345”.

(22) In paragraph 47 (variation of a broker’s registration)(42), for “£283” substitute “£345”.

(23) In paragraph 48 (variation of an active substance registration)(43), for “£283” substitute “£309”.

(24) In paragraph 49(1) (clinical trial authorisations)(44), for “£248” substitute “£302”.

(25) In paragraph 50 (traditional herbal registrations)—

(a)in sub-paragraph (a), for “£240” substitute “£293”;

(b)in sub-paragraph (b), for “£635” substitute “£773”;

(c)in sub-paragraph (c), for “£7,186” substitute “£8,748”;

(d)in sub-paragraph (d), for “£152” substitute “£186”.

(26) In paragraph 54 (a set of changes)(45)—

(a)in sub-paragraph (1)—

(i)in paragraph (a), for “£570” substitute “£992”;

(ii)in paragraph (b), for “£361” substitute “£440”;

(b)in sub-paragraph (2), for “£205” substitute “£224”.

(27) In paragraph 56 (renewal of a marketing authorisation)(46)—

(a)in sub-paragraphs (a) and (b), for “£822”, in both places it occurs, substitute “£1,239”;

(b)in sub-paragraph (c), for “£10,650” substitute “£16,042”.

(28) In paragraph 57(2) (renewal of multiple marketing authorisations)(47)—

(a)in paragraphs (a)(i) and (a)(ii), for “£822”, in both places it occurs, substitute “£1,239”;

(b)in paragraph (b)(i), for “£10,650” substitute “£16,042”.

(29) In paragraph 57A (capital fee for conducting a major safety review)(48)—

(a)in sub-paragraph (a), for “£56,415” substitute “£61,408”;

(b)in sub-paragraph (b), for “£65,555” substitute “£71,357”;

(c)in sub-paragraph (c), for “£74,694” substitute “£81,305”;

(d)in sub-paragraph (d), for “£83,834” substitute “£91,254”.

(30) For paragraph 57B (capital fee for testing of samples by the appropriate authority)(49) substitute—

“57B.—(1)The fee payable under regulation 19F(1) in connection with the submission of a sample of a batch of a medicinal product is £5,093 for each day taken to examine the sample for testing, the appropriate documentation (as defined in regulation 60A of the Human Medicines Regulations) or both (as the case may be), and the fee payable is to be adjusted pro rata for each period taken of less than 1 day.

(2)In this paragraph, a “day” means a period of 8 hours and 30 minutes.”.

Amendment of Schedule 3

28.—(1)Schedule 3 (fees for inspections) is amended as follows.

(2) In paragraph 2(1) (fees: general)(50)—

(a)in paragraph (1)(a), for “£3,651” substitute “£5,251”;

(b)in paragraph (1)(b), for “£1,825” substitute “£2,625”.

(3) In paragraph 5 (wholesale dealer’s licence: general)(51)—

(a)in sub-paragraphs (a) and (b), for “£2,662”, in both places it occurs, substitute “£4,136”;

(b)in sub-paragraph (b), for “£1,331” substitute “£2,068”.

(4) In paragraph 6(2) (wholesale dealer’s licence: traditional herbal medicinal products)(52)—

(a)in paragraph (a), for “£1,023” substitute “£1,114”;

(b)in paragraphs (b) and (c), for “£1,880”, in both places it occurs, substitute “£2,047”.

(5) In paragraph 7(3) (wholesale dealer’s licences: inspection of short duration)(53), for “£1,331” substitute “£2,068”.

(6) In paragraph 8 (broker’s registrations)(54)—

(a)in sub-paragraph (1)—

(i)in paragraphs (a) and (b), for “£2,662”, in both places it occurs, substitute “£3,241”;

(ii)in paragraph (b), for “£1,331” substitute “£1,621”;

(b)in sub-paragraph (3), for “£640” substitute “£780”.

(7) In paragraph 9 (active substance registrations)(55)—

(a)in sub-paragraph (1)(a)—

(i)in sub-paragraphs (i) and (ii), for “£3,651”, in both places it occurs, substitute “£3,975”;

(ii)in sub-paragraph (ii), for “£1,825” substitute “£1,988”;

(b)in sub-paragraph (1)(b)—

(i)in sub-paragraphs (i) and (ii), for “£2,662”, in both places it occurs, substitute “£2,898”;

(ii)in sub-paragraph (ii), for “£1,331” substitute “£1,449”;

(c)in sub-paragraph (3)—

(i)in paragraph (a), for “£871” substitute “£949”;

(ii)in paragraph (b), for “£640” substitute “£697”.

(8) In paragraph 10 (office-based inspections)(56)—

(a)in sub-paragraph (a), for “£2,562” substitute “£4,924”;

(b)in sub-paragraph (b), for “£1,862” substitute “£3,810”.

Amendment of Schedule 4

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

(2) In paragraph 5 (marketing authorisations)(57), 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)(58), for “£338” substitute “£368”.

(4) In paragraph 7 (marketing authorisation: derivatives)(59)—

(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)(60), for “£515”, in both places it occurs, substitute “£561”.

(6) In paragraph 12 (wholesale dealer’s licences)(61)—

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

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

(7) In paragraph 15(1)(b)(62) (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—

(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)(63), for “£84” substitute “£92”.

Amendment of Schedule 5

30.—(1)Schedule 5 (fees for certificates of registration) is amended as follows.

(2) In the table—

(a)in the second column (fees for applications in respect of products prepared from not more than 5 homoeopathic stocks)—

(i)in item 1, for “£159” substitute “£194”;

(ii)in item 2, for “£478” substitute “£582”;

(iii)in item 3, for “£501” substitute “£610”;

(iv)in item 5, for “£430” substitute “£524”;

(v)in item 7, for “£790” substitute “£962”;

(b)in the third column (fees for other applications)—

(i)in item 1, for “£393” substitute “£479”;

(ii)in item 2, for “£704” substitute “£857”;

(iii)in item 3, for “£638” substitute “£777”;

(iv)in item 5, for “£563” substitute “£686”;

(v)in item 7 for “£1,034” substitute “£1,259”.

Amendment of Schedule 7

31.—(1)Schedule 7 (waiver, reduction or refund of capital fees) is amended as follows.

(2) In paragraph 11(1) (scientific advice: paediatric indications), for “regulation 4” substitute “regulation 3A”.

Signed by authority of the Secretary of State for Health and Social Care

Karin Smyth

Minister of State

Department of Health and Social Care

at 10.02 a.m. on 11th March 2025

Sealed with the Official Seal of the Department of Health in Northern Ireland

Cathy Harrison

A senior officer of the Department of Health in Northern Ireland