The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023
S.I. 2023/314 · Made 9 March 2023
Medicines
Fees And Charges
Made 9th March 2023
Laid before Parliament 10th March 2023
Laid before the Northern Ireland Assembly 10th March 2023
Coming into force 1st April 2023
The Secretary of State in relation to England and Wales and Scotland, and the Department of Health in Northern Ireland and the Secretary of State acting jointly in relation to Northern Ireland make the following Regulations in exercise of the powers conferred by sections 2(1) and 6(1)(a) of the Medicines and Medical Devices Act 2021f1, after having considered the matters in section 2(2) to (4) of that Act.
The Secretary of State and the Department of Health in Northern Ireland have carried out a public consultation in accordance with section 45(1) of that Act.
Annotations to the whole text
Footnotes
- f1
Contents
- 1Citation, commencement and extent
- 2Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016
- 3Amendment of regulation 4
- 4Amendment of regulation 5
- 5Amendment of regulation 6
- 6Amendment of regulation 7
- 7Amendment of regulation 8
- 8Amendment of regulation 9
- 9Amendment of regulation 10
- 10Amendment of regulation 12
- 11Amendment of regulation 14
- 12Amendment of regulation 15
- 13Amendment of regulation 19A
- 14Amendment of regulation 19B
- 15Amendment of regulation 19C
- 16Amendment of regulation 19E
- 17New regulation 19EA
- 18Amendment of regulation 21
- 19Amendment of regulation 22
- 20Amendment of regulation 27
- 21Amendment of regulation 41
- 22Amendment of regulation 42
- 23Amendment of Schedule 1
- 24Amendment of Schedule 2
- 25Amendment of Schedule 3
- 26Amendment of Schedule 4
- Signature
- Explanatory note
1Citation, commencement and extent
These Regulations may be cited as the Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023.
These Regulations come into force on 1st April 2023.
These Regulations extend to England and Wales, Scotland and Northern Ireland.
2Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016
The Medicines (Products for Human Use) (Fees) Regulations 2016f1 are amended in accordance with regulations 3 to 26.
3Amendment of regulation 4
In regulation 4 (fee for scientific advice: application for, or variation to, EU marketing authorisation)—
in paragraph (a), for “£2,201” substitute “£2,421”,
in paragraph (b), for “£2,763” substitute “£3,039”,
in paragraph (c), for “£3,061” substitute “£3,367”,
in paragraph (d), for “£3,624” substitute “£3,986”, and
in paragraph (e), for “£4,487” substitute “£4,936”.
4Amendment of regulation 5
In regulation 5(1) (fee for scientific advice: classification of a medicinal product)—
in sub-paragraph (a), for “£2,763” substitute “£3,039”, and
in sub-paragraph (b), for “£3,624” substitute “£3,986”.
5Amendment of regulation 6
In regulation 6 (fee for advertising advice), for “£2,201” substitute “£2,421”.
6Amendment of regulation 7
In regulation 7(1) (fee for pharmacovigilance advice)—
in sub-paragraph (a), for “£3,624” substitute “£3,986”, and
in sub-paragraph (b), for “£3,061” substitute “£3,367”.
7Amendment of regulation 8
In regulation 8 (fee for advice on labelling or leaflets), for “£2,201” substitute “£2,421”.
8Amendment of regulation 9
In regulation 9 (fee for regulatory advice), for “£2,763” substitute “£3,039”.
9Amendment of regulation 10
In regulation 10(1) (fee for advice for other purposes), for “£4,451” substitute “£4,896”.
10Amendment of regulation 12
In regulation 12(1) (fees for applications for authorisations, registrations, licences or certificates etc.), after “a broker’s registration”, insert “, an application under the Early Access to Medicines Scheme”.
11Amendment of regulation 14
In regulation 14 (fee for applications for additional copy certificates), for “£68” substitute “£75”.
12Amendment of regulation 15
In regulation 15 (fees for applications for certificates and copy certificates by exporters of medicinal products)—
in paragraph (1)(a), for “£152” substitute “£167”,
in paragraph (1)(b), for “£68” substitute “£75”, and
in paragraph (3), for “£34” substitute “£37”.
13Amendment of regulation 19A
In regulation 19Af1 (fees for certification of plasma master files)—
in paragraph (1), for “£8,309” substitute “£9,140”,
in paragraph (2)(a), for “£277” substitute “£344”, and
in paragraph (2)(b), for “£734” substitute “£1,308”.
14Amendment of regulation 19B
In regulation 19Bf1 (fee for certification of vaccine antigen master files), for “£8,309” substitute “£9,140”.
15Amendment of regulation 19C
In regulation 19Cf1 (fees for assessment of post-authorisation safety studies)—
in paragraph (2)—
in sub-paragraph (a), for “£734” substitute “£1,308”,
in sub-paragraph (b), for “£8,309” substitute “£9,140”,
in sub-paragraph (c), for “£734” substitute “£1,308”, and
in paragraph (3)—
in sub-paragraph (a), for “£734” substitute “£1,308”,
in sub-paragraph (b), for “£8,309” substitute “£9,140”, and
in sub-paragraph (c), for “£734” substitute “£1,308”.
16Amendment of regulation 19E
In regulation 19E(2)f1 (fee for assessment of periodic safety update reports)—
in sub-paragraph (a), for “£890” substitute “£979”, and
in sub-paragraph (b), for “£445” substitute “£490”.
17New regulation 19EA
After regulation 19E, insert—
“Fee for assessment of clinical trial annual safety reports
19EA.The fee payable by a sponsor who submits an annual safety report to the licensing authority under regulation 35(1)(b) of the Clinical Trials Regulations is £248.”.
18Amendment of regulation 21
In regulation 21(1) (fees for notification of changes and reports for broker’s registrations), for “£257” substitute “£283”.
19Amendment of regulation 22
In regulation 22(1) (fees for notification of changes and compliance reports for active substance registrations), for “£257” substitute “£283”.
20Amendment of regulation 27
In regulation 27 (fees for renewals of certain manufacturer’s licences)—
in paragraph (1), for “£178” substitute “£196”, and
in paragraph (3), for “£295” substitute “£325”.
21Amendment of regulation 41
In regulation 41 (fees for applications for membership and certificates)—
in paragraph (1), for “£117” substitute “£129”, and
in paragraph (2), for “£62” substitute “£68”.
22Amendment of regulation 42
In regulation 42(1) (fee for a review upon oral representations or a person appointed hearing), for “£10,000” substitute “£11,000”.
23Amendment of Schedule 1
In Schedule 1 (general interpretation provisions), in paragraph 1f1 (interpretation), in the appropriate place insert—
““Early Access to Medicines Scheme” has the meaning given in regulation 8(1) of the Human Medicines Regulations;”.
24Amendment of Schedule 2
Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates) is amended as follows.
In paragraph 1f1 (interpretation)—
after the definition of “active ingredient from a new source”, insert—
““EAMS scientific opinion” has the meaning given in regulation 8(1) of the Human Medicines Regulations;”, and
after the definition of “Phase IV trial”, insert—
““Promising Innovative Medicines designation” means a designation issued by the licensing authority under the Early Access to Medicines Scheme in accordance with regulation 167C(2)(a) of the Human Medicines Regulations;”.
In paragraph 24(5)f2 (marketing authorisations), in the second column (fee payable) of the table (fees for marketing authorisation applications)—
in item 1 (major application)—
in entry (a), for “£29,732” substitute “£32,705”,
in entries (b) to (d), for “£62,421” substitute “£68,663”,
in entry (e), for “£18,437” substitute “£20,281”,
in entry (f), for “£62,421” substitute “£68,663”,
in entry (g), for “£18,437” substitute “£20,281”,
in entry (h), for “£92,753” substitute “£102,028”,
in item 2 (complex application)—
in entries (a) to (c), for “£17,330” substitute “£19,063”,
in entry (d), for “£10,443” substitute “£11,487”,
in entry (e), for “£17,330” substitute “£19,063”,
in entry (f), for “£10,443” substitute “£11,487”,
in entry (g), for “£25,643” substitute “£28,207”,
in item 3 (standard application)—
in entries (a) to (c), for “£6,350” substitute “£6,985”,
in entry (d), for “£5,783” substitute “£6,361”,
in entry (e), for “£6,350” substitute “£6,985”,
in entry (f), for “£5,783” substitute “£6,361”,
in entry (g), for “£9,402” substitute “£10,342”,
in item 4 (simple application), in entries (a) to (f), for “£2,564” substitute “£2,820”,
in item 5 (parallel import licence applications)—
in entry (a), for “£1,792” substitute “£1,971”,
in entry (b), for “£6,663” substitute “£8,722”,
in entry (c), for “£18,180” substitute “£19,998”, and
in item 6 (change of ownership application), for “£442” substitute “£486”.
In paragraph 25(1) (fees where application includes reclassification)—
in sub-paragraph (a), for “£11,992” substitute “£33,003”, and
in sub-paragraph (b), for “£8,162” substitute “£8,978”.
In paragraph 27f3 (joint development)—
in sub-paragraph (2)—
in paragraph (a)(i), for “£17,330” substitute “£19,063”,
in paragraph (b)(i), for “£6,350” substitute “£6,985”,
in paragraph (c)(i), for “£17,330” substitute “£19,063”,
in paragraph (d)(i), for “£6,350” substitute “£6,985”, and
in sub-paragraph (3)(a)(i), for “£6,350” substitute “£6,985”.
In paragraph 28f4 (application for multiple authorisations)—
in sub-paragraph (2)—
in paragraph (a)(i), for “£17,330” substitute “£19,063”,
in paragraphs (b)(i) and (c)(i), for “£6,350” substitute “£6,985”,
in sub-paragraph (3), in paragraphs (b)(i) and (c)(i), for “£6,350” substitute “£6,985”, and
in sub-paragraph (4)(b), for “£734” substitute “£1,308”.
In paragraph 28Af5 (application by pre-assessment of modules)—
in sub-paragraphs (1)(a) to (c), for each “£23,188.25” substitute “£25,507”, and
in sub-paragraphs (2)(a) to (c), for each “£4,332.50” substitute “£4,766”.
In paragraph 30(1) (manufacturer’s licences and authorisations)—
in paragraph (a), for “£183” substitute “£201”,
in paragraph (b), for “£344” substitute “£378”, and
in paragraph (c), for “£3,143” substitute “£3,457”.
In paragraph 31 (wholesale dealer’s licences)—
in sub-paragraph (1), for “£1,803” substitute “£1,983”,
in sub-paragraph (2), for “£902” substitute “£992”, and
in sub-paragraph (5), for “£399” substitute “£439”.
In paragraph 32 (broker’s registrations)—
in sub-paragraph (1), for “£1,803” substitute “£1,983”, and
in sub-paragraph (2), for “£399” substitute “£439”.
In paragraph 33 (active substance registrations)—
in sub-paragraph (1)—
in paragraph (a), for “£3,143” substitute “£3,457”,
in paragraph (b), for “£1,803” substitute “£1,983”, and
in sub-paragraph (2), for “£399” substitute “£439”.
In paragraph 34 (clinical trial authorisations)—
in sub-paragraph (a), for “£3,060” substitute “£3,366”, and
in sub-paragraph (b), for “£225” substitute “£248”.
In paragraph 35(1) (traditional herbal registrations), in the second column (fee payable) of the table (fee for application for traditional herbal registration), in entry 5 (change of ownership application), for “£442” substitute “£486”.
After paragraph 35, insert—
“Early Access to Medicines Scheme fees
35A.The fee payable under regulation 12(1)(a) in connection with an application submitted under the Early Access to Medicines Scheme of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 2 of that table.
Fees for Early Access to Medicines Scheme applications
Column 1 Column 2 Kind of Application Fee payable 1. Promising Innovative Medicine (PIM) designation £3,986 2. EAMS scientific opinion for new medicinal products £25,643 3. Renewal of an EAMS scientific opinion for new chemical or biological medicinal products £12,821 4. EAMS scientific opinion for new indications £8,309 5. Renewal of an EAMS scientific opinion for new indications £4,154 ”
In paragraph 38 (marketing authorisations)—
in the second column (fee payable) of Table 1f6 (fees for applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) No 1234/2008)—
in entries 1(a) and 1(b), for “£277” substitute “£344”,
in entry 1(c), for “£2,493” substitute “£2,742”,
in entry 1(d), for “£7,693” substitute “£8,462,
in entry 2(a), for “£277” substitute “£344”,
in entry 2(b), for “£496” substitute “£1,255”,
in entry 2(c), for “£2,703” substitute “£2,973”,
in entry 2(d), for “£7,883” substitute “£8,671”,
in the second column (fee payable) in Table 2 (fees for applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008 and of marketing authorisations in force in Great Britain)—
in entry 1, for “£277” substitute “£344”,
in entry 2, for “£734” substitute “£1,308”,
in entry 3, for “£8,309” substitute “£9,140”,
in entry 4, for “£25,643” substitute “£33,003”,
in entry 5, for “£622” substitute “£684”,
in entry 6, for “£1,652” substitute “£1,817”,
in entry 7, for “£9,010” substitute “£9,911”,
in entry 8, for “£26,276” substitute “£28,904”, and
in the second column (fee payable) in Table 3 (fees for reclassification variation applications)—
in entry (a), for “£11,992” substitute “£33,003”,
in entry (b), for “£8,162” substitute “£8,978”.
In paragraph 40(1) (reclassification of marketing authorisations), for “£734” substitute “£1,308”.
In paragraph 42(1) (variation of parallel import licence)—
in paragraph (a), for “£11,992” substitute “£33,003”,
in paragraph (b), for “£8,162” substitute “£8,978”, and
in paragraph (c), for “£357” substitute “£393”.
In paragraph 43 (manufacturer’s authorisations and licences)—
in sub-paragraph (a), for “£257” substitute “£283”, and
in sub-paragraph (b), for “£514” substitute “£565”.
In paragraph 44 (variation of manufacturer’s authorisations and licences), for “£257” substitute “£283”.
In paragraph 45 (wholesale dealer’s licences), for “£486” substitute “£535”.
In paragraph 46 (variation of wholesale dealer’s licence), for “£257” substitute “£283”.
In paragraph 47 (variation of a broker’s registration), for “£257” substitute “£283”.
In paragraph 48 (variation of an active substance registration), for “£257” substitute “£283”.
In paragraph 49(1) (clinical trial authorisations) for “£225” substitute “£248”.
In paragraph 53(a)(ii) (multiple reclassification variation applications), for “£734” substitute “£1,308”.
In paragraph 54 (a set of changes)—
in sub-paragraph (1)—
in paragraph (a), for “£518” substitute “£570”,
in paragraph (b), for “£328” substitute “£361”, and
in sub-paragraph (2), for “£186” substitute “£205”.
In paragraph 56f7 (renewal of a marketing authorisation)—
in sub-paragraphs (a) and (b), for “£747” substitute “£822”, and
in sub-paragraph (c), for “£9,682” substitute “£10,650”.
In paragraph 57(2)f8 (renewal of multiple marketing authorisations)—
in sub-paragraphs (a)(i) and (a)(ii), for “£747” substitute “£822”,
in sub-paragraph (b)(i), for “£9,682” substitute “£10,650”, and
in sub-paragraph (b)(ii), for “£747” substitute “£822”.
In paragraph 57Af9 (capital fee for conducting a major safety review)—
in sub-paragraph (a), for “£51,286” substitute “£56,415”,
in sub-paragraph (b), for “£59,595” substitute “£65,555”,
in sub-paragraph (c), for “£67,904” substitute “£74,694”, and
in sub-paragraph (d), for “£76,213” substitute “£83,834”.
In paragraph 57B(4)f10—
in the second column (fee payable where the licensing authority carries out a full assessment) of the table (fees for testing of samples)—
in entry 1(a), for “£180” substitute “£198”,
in entry 1(b), for “£215” substitute “£237”,
in entry 1(c), for “£230” substitute “£253”,
in entry 2, for “£1,660” substitute “£1,826”,
in entry 3, for “£1,910” substitute “£2,101”,
in entry 4, for “£2,340” substitute “£2,574”,
in entry 5, for “£3,690” substitute “£4,059”,
in entry 6, for “£6,410” substitute “£7,051”,
in entry 7, for “£10,350” substitute “£11,385”, and
in the third column (fee payable where the licensing authority carries out a paper-based assessment) of the table—
in entries 1(a), (b) and (c), for “£90” substitute “£99”,
in entries 2 and 3, for “£305” substitute “£367”,
in entry 4, for “£305” substitute “£992”,
in entry 5, for “£677” substitute “£992”,
in entries 6 and 7, for “£677” substitute “£1,849”.
25Amendment of Schedule 3
Schedule 3 (fees for inspections) is amended as follows.
In paragraph 2(1) (fees: general)—
in paragraph (a), for “£2,655” substitute “£3,651”, and
in paragraph (b), for “£1,328” substitute “£1,825”.
In paragraph 5 (wholesale dealer’s licence: general)—
in sub-paragraphs (a) and (b), for “£1,936” substitute “£2,662”, and
in sub-paragraph (b), for “£968” substitute “£1,331”.
In paragraph 6(2) (wholesale dealer’s licence: traditional herbal medicinal products)—
in paragraph (a), for “£744” substitute “£1,023”, and
in paragraphs (b) and (c), for “£1,367” substitute “£1,880”.
In paragraph 7(3) (wholesale dealer’s licences: inspection of short duration), for “£968”, substitute “£1,331”.
In paragraph 8 (broker’s registrations)—
in sub-paragraph (1)—
in paragraphs (a) and (b), for “£1,936” substitute “£2,662”,
in paragraph (b), for “£968” substitute “£1,331”, and
in sub-paragraph (3), for “£582” substitute “£640”.
In paragraph 9 (active substance registrations)—
in sub-paragraph (1)(a)—
in sub-paragraphs (i) and (ii), for “£2,655” substitute “£3,651”,
in sub-paragraph (ii), for “£1,328” substitute “£1,825”,
in sub-paragraph (1)(b)—
in sub-paragraphs (i) and (ii), for “£1,936” substitute “£2,662”,
in sub- paragraph (ii), for “£968” substitute “£1,331”, and
in sub-paragraph (3)—
in paragraph (a), for “£792” substitute “£871”,
in paragraph (b), for “£582” substitute “£640”.
In paragraph 10 (office-based inspections)—
in sub-paragraph (a), for “£1,863” substitute “£2,562”, and
in sub-paragraph (b), for “£1,354” substitute “£1,862”.
26Amendment of Schedule 4
Schedule 4 (periodic fees for licences) is amended as follows.
In paragraph 5 (marketing authorisations), in column 2 (fee payable) of the table (periodic fees for holding a marketing authorisation)—
in entry 1, for “£9,710” substitute “£10,681”,
in entry 2, for “£307” substitute “£338”,
in entry 3(a), for “£9,710” substitute “£10,681”,
in entry 3(b)(i), for “£2,428” substitute “£2,671”,
in entry 3(b)(ii), for “£1,211” substitute “£1,332”,
in entries 3(b)(iii), (c) and (d), for “£307” substitute “£338”, and
in entries 3(e) to (h), for “£76” substitute “£84”.
In paragraph 6 (marketing authorisation: where Part 2 of the Act applies), for “£307” substitute “£338”.
In paragraph 7 (marketing authorisation: derivatives)—
in sub-paragraph (a), for “£9,710” substitute “£10,681”, and
in sub-paragraph (b), for “£6,554” substitute “£7,209”.
In paragraph 11(1) and (2) (manufacturer’s licences or manufacturing authorisations), for “£468” substitute “£515”.
In paragraph 12 (wholesale dealer’s licences)—
in sub-paragraph (1), for “£288” substitute “£317”, and
in sub-paragraph (2), for “£172” substitute “£189”.
For paragraph 15(1), substitute—
“(1)The additional amount referred to in paragraphs 11(3) and 14 in relation to any fee period is—
(a)the fee specified in the entry in column 2 of Table 1 (additional periodic fee in connection with notices for imported special medicinal products) corresponding to the estimated number of special import notices for that fee period specified in column 1, and
(b)the fee specified in the entry in column 2 of Table 2 (additional periodic fee in connection with the number of different special medicinal products imported) corresponding to the estimated number of different special medicinal products imported for that fee period specified in column 1.
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 £70 21 to 100 £350 101 to 1,000 £2,400 1,001 to 5,000 £12,000 5,001 to 20,000 £30,000 20,001 to 50,000 £60,000 50,001 to 100,000 £120,000 100,001 or more £200,000 Table 2
Additional periodic fee in connection with the number of different special medicinal products notified for import
Column 1 Column 2 Number of different special medicinal products notified for import Additional amount 1 to 5 £100 6 to 10 £200 11 to 20 £400 21 to 50 £1,000 51 to 100 £2,000 101 to 200 £4,000 For each additional 100 special medicinal products notified for import above 200 £2,000 ”
After paragraph 15(2), insert—
“(3)For the purposes of this paragraph, the estimated number of different special medicinal products notified for import for any fee period shall be the number notified in writing to the licence holder by the licensing authority before the start of that fee period as the number of such notices which the authority estimate will be given by the holder during the fee period.”.
In paragraph 16 (traditional herbal registrations), for “£76” substitute “£84”.
Signature
Signed by authority of the Secretary of State for Health and Social Care
Will Quince
Minister of State,
Department of Health and Social Care
9th March 2023
Sealed with the Official Seal of the Department of Health in Northern Ireland 8th March 2023
L.S.
Cathy Harrison
A senior officer of the Department of Health in Northern Ireland
Explanatory note
(This note is not part of the Regulations)
These Regulations make amendments to the Medicines (Products for Human Use) (Fees) Regulations 2016 (S.I. 2016/190).
The Medicines (Products for Human Use) (Fees) Regulations 2016 make provision for the fees payable in relation to authorisations, licences, certificates and registrations in respect of medicinal products for human use, including those under the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004.
The fee amounts specified in these Regulations represent an increase in the existing fees of 10% or more and are set in line with a consultation response issued by the Medicines and Healthcare products Regulatory Agency (“MHRA”) on 31 January 2023. A summary of the consultation responses and the Government’s response to the consultation are published on the MHRA’s website (www.mhra.gov.uk).
A full impact assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available from the Medicines and Healthcare products Regulatory Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU and is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk.