Amendment of Schedule 224
1
Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates) is amended as follows.
2
In paragraph 18 (interpretation)—
a
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;
b
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;
3
In paragraph 24(5)9 (marketing authorisations), in the second column (fee payable) of the table (fees for marketing authorisation applications)—
a
in item 1 (major application)—
i
in entry (a), for “£29,732” substitute “£32,705”
,
ii
in entries (b) to (d), for “£62,421” substitute “£68,663”
,
iii
in entry (e), for “£18,437” substitute “£20,281”
,
iv
in entry (f), for “£62,421” substitute “£68,663”
,
v
in entry (g), for “£18,437” substitute “£20,281”
,
vi
in entry (h), for “£92,753” substitute “£102,028”
,
b
in item 2 (complex application)—
i
in entries (a) to (c), for “£17,330” substitute “£19,063”
,
ii
in entry (d), for “£10,443” substitute “£11,487”
,
iii
in entry (e), for “£17,330” substitute “£19,063”
,
iv
in entry (f), for “£10,443” substitute “£11,487”
,
v
in entry (g), for “£25,643” substitute “£28,207”
,
c
in item 3 (standard application)—
i
in entries (a) to (c), for “£6,350” substitute “£6,985”
,
ii
in entry (d), for “£5,783” substitute “£6,361”
,
iii
in entry (e), for “£6,350” substitute “£6,985”
,
iv
in entry (f), for “£5,783” substitute “£6,361”
,
v
in entry (g), for “£9,402” substitute “£10,342”
,
d
in item 4 (simple application), in entries (a) to (f), for “£2,564” substitute “£2,820”
,
e
in item 5 (parallel import licence applications)—
i
in entry (a), for “£1,792” substitute “£1,971”
,
ii
in entry (b), for “£6,663” substitute “£8,722”
,
iii
in entry (c), for “£18,180” substitute “£19,998”
, and
f
in item 6 (change of ownership application), for “£442” substitute “£486”
.
4
In paragraph 25(1) (fees where application includes reclassification)—
a
in sub-paragraph (a), for “£11,992” substitute “£33,003”
, and
b
in sub-paragraph (b), for “£8,162” substitute “£8,978”
.
5
In paragraph 2710 (joint development)—
a
in sub-paragraph (2)—
i
in paragraph (a)(i), for “£17,330” substitute “£19,063”
,
ii
in paragraph (b)(i), for “£6,350” substitute “£6,985”
,
iii
in paragraph (c)(i), for “£17,330” substitute “£19,063”
,
iv
in paragraph (d)(i), for “£6,350” substitute “£6,985”
, and
b
in sub-paragraph (3)(a)(i), for “£6,350” substitute “£6,985”
.
6
In paragraph 2811 (application for multiple authorisations)—
a
in sub-paragraph (2)—
i
in paragraph (a)(i), for “£17,330” substitute “£19,063”
,
ii
in paragraphs (b)(i) and (c)(i), for “£6,350” substitute “£6,985”
,
b
in sub-paragraph (3), in paragraphs (b)(i) and (c)(i), for “£6,350” substitute “£6,985”
, and
c
in sub-paragraph (4)(b), for “£734” substitute “£1,308”
.
7
In paragraph 28A12 (application by pre-assessment of modules)—
a
in sub-paragraphs (1)(a) to (c), for each “£23,188.25” substitute “£25,507”
, and
b
in sub-paragraphs (2)(a) to (c), for each “£4,332.50” substitute “£4,766”
.
8
In paragraph 30(1) (manufacturer’s licences and authorisations)—
a
in paragraph (a), for “£183” substitute “£201”
,
b
in paragraph (b), for “£344” substitute “£378”
, and
c
in paragraph (c), for “£3,143” substitute “£3,457”
.
9
In paragraph 31 (wholesale dealer’s licences)—
a
in sub-paragraph (1), for “£1,803” substitute “£1,983”
,
b
in sub-paragraph (2), for “£902” substitute “£992”
, and
c
in sub-paragraph (5), for “£399” substitute “£439”
.
10
In paragraph 32 (broker’s registrations)—
a
in sub-paragraph (1), for “£1,803” substitute “£1,983”
, and
b
in sub-paragraph (2), for “£399” substitute “£439”
.
11
In paragraph 33 (active substance registrations)—
a
in sub-paragraph (1)—
i
in paragraph (a), for “£3,143” substitute “£3,457”
,
ii
in paragraph (b), for “£1,803” substitute “£1,983”
, and
b
in sub-paragraph (2), for “£399” substitute “£439”
.
12
In paragraph 34 (clinical trial authorisations)—
a
in sub-paragraph (a), for “£3,060” substitute “£3,366”
, and
b
in sub-paragraph (b), for “£225” substitute “£248”
.
13
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”
.
14
After paragraph 35, insert—
Early Access to Medicines Scheme fees35A
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
15
In paragraph 38 (marketing authorisations)—
a
in the second column (fee payable) of Table 113 (fees for applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) No 1234/2008)—
i
in entries 1(a) and 1(b), for “£277” substitute “£344”
,
ii
in entry 1(c), for “£2,493” substitute “£2,742”
,
iii
in entry 1(d), for “£7,693” substitute “£8,462,
iv
in entry 2(a), for “£277” substitute “£344”
,
v
in entry 2(b), for “£496” substitute “£1,255”
,
vi
in entry 2(c), for “£2,703” substitute “£2,973”
,
vii
in entry 2(d), for “£7,883” substitute “£8,671”
,
b
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)—
i
in entry 1, for “£277” substitute “£344”
,
ii
in entry 2, for “£734” substitute “£1,308”
,
iii
in entry 3, for “£8,309” substitute “£9,140”
,
iv
in entry 4, for “£25,643” substitute “£33,003”
,
v
in entry 5, for “£622” substitute “£684”
,
vi
in entry 6, for “£1,652” substitute “£1,817”
,
vii
in entry 7, for “£9,010” substitute “£9,911”
,
viii
in entry 8, for “£26,276” substitute “£28,904”
, and
c
in the second column (fee payable) in Table 3 (fees for reclassification variation applications)—
i
in entry (a), for “£11,992” substitute “£33,003”
,
ii
in entry (b), for “£8,162” substitute “£8,978”
.
16
In paragraph 40(1) (reclassification of marketing authorisations), for “£734” substitute “£1,308”
.
17
In paragraph 42(1) (variation of parallel import licence)—
a
in paragraph (a), for “£11,992” substitute “£33,003”
,
b
in paragraph (b), for “£8,162” substitute “£8,978”
, and
c
in paragraph (c), for “£357” substitute “£393”
.
18
In paragraph 43 (manufacturer’s authorisations and licences)—
a
in sub-paragraph (a), for “£257” substitute “£283”
, and
b
in sub-paragraph (b), for “£514” substitute “£565”
.
19
In paragraph 44 (variation of manufacturer’s authorisations and licences), for “£257” substitute “£283”
.
20
In paragraph 45 (wholesale dealer’s licences), for “£486” substitute “£535”
.
21
In paragraph 46 (variation of wholesale dealer’s licence), for “£257” substitute “£283”
.
22
In paragraph 47 (variation of a broker’s registration), for “£257” substitute “£283”
.
23
In paragraph 48 (variation of an active substance registration), for “£257” substitute “£283”
.
24
In paragraph 49(1) (clinical trial authorisations) for “£225” substitute “£248”
.
25
In paragraph 53(a)(ii) (multiple reclassification variation applications), for “£734” substitute “£1,308”
.
26
In paragraph 54 (a set of changes)—
a
in sub-paragraph (1)—
i
in paragraph (a), for “£518” substitute “£570”
,
ii
in paragraph (b), for “£328” substitute “£361”
, and
b
in sub-paragraph (2), for “£186” substitute “£205”
.
27
In paragraph 5614 (renewal of a marketing authorisation)—
a
in sub-paragraphs (a) and (b), for “£747” substitute “£822”
, and
b
in sub-paragraph (c), for “£9,682” substitute “£10,650”
.
28
In paragraph 57(2)15 (renewal of multiple marketing authorisations)—
a
in sub-paragraphs (a)(i) and (a)(ii), for “£747” substitute “£822”
,
b
in sub-paragraph (b)(i), for “£9,682” substitute “£10,650”
, and
c
in sub-paragraph (b)(ii), for “£747” substitute “£822”
.
29
In paragraph 57A16 (capital fee for conducting a major safety review)—
a
in sub-paragraph (a), for “£51,286” substitute “£56,415”
,
b
in sub-paragraph (b), for “£59,595” substitute “£65,555”
,
c
in sub-paragraph (c), for “£67,904” substitute “£74,694”
, and
d
in sub-paragraph (d), for “£76,213” substitute “£83,834”
.
30
In paragraph 57B(4)17—
a
in the second column (fee payable where the licensing authority carries out a full assessment) of the table (fees for testing of samples)—
i
in entry 1(a), for “£180” substitute “£198”
,
ii
in entry 1(b), for “£215” substitute “£237”
,
iii
in entry 1(c), for “£230” substitute “£253”
,
iv
in entry 2, for “£1,660” substitute “£1,826”
,
v
in entry 3, for “£1,910” substitute “£2,101”
,
vi
in entry 4, for “£2,340” substitute “£2,574”
,
vii
in entry 5, for “£3,690” substitute “£4,059”
,
viii
in entry 6, for “£6,410” substitute “£7,051”
,
ix
in entry 7, for “£10,350” substitute “£11,385”
, and
b
in the third column (fee payable where the licensing authority carries out a paper-based assessment) of the table—
i
in entries 1(a), (b) and (c), for “£90” substitute “£99”
,
ii
in entries 2 and 3, for “£305” substitute “£367”
,
iii
in entry 4, for “£305” substitute “£992”
,
iv
in entry 5, for “£677” substitute “£992”
,
v
in entries 6 and 7, for “£677” substitute “£1,849”
.