Office of Public Sector Information

Office of Public Sector Information

Main menu and contents

Supplementary menus and contents

Regulation 11

SCHEDULE

Column (1)

Provision in the Medicines Fees Regulations

Column (2)

Subject Matter

Column (3)

Old Amount

Column (4)

New Amount

Regulation 3B Capital fees for pre-application meetings
Paragraph (a) £1,118 £2,108
Paragraph (c) £1,866 £3,474
Paragraph (d) £2,235 £4,300
Regulation 3BA Capital fees for advertising advice meetings £1,486 £2,108
Regulation 3BB Capital fees for pharmacovigilance meetings
Paragraph (a) £1,866 £3,474
Paragraph (b) £1,486 £2,934
Regulation 3BC Capital fees for advice meetings concerning labelling and leaflets £1,118 £2,108
Regulation 3BD Capital fees for post authorisation regulatory advice meetings £1,486 £2,648
Part II of Schedule 1

Capital fees for applications for

authorizations, licences and

certificates

Paragraph 1A(1) £7,824 £8,206
Paragraph 4(4)(b) £594 £738
In Column (2) of the table in paragraph 4A
Entry 1 £480 £503
Entry 2 £752 £788
Entry 3 £1,010 £1,060
In Column (3) of the table in paragraph 4A
Entry 1 £680 £713
Entry 2 £942 £988
Entry 3 £1,219 £1,278
Paragraph 4A(5) £2,000 £2,098
Paragraph 4A(6) £6,672 £6,998
Paragraph 4A(7) £590 £618
In Column 2 of the table in paragraph 7
Entry 1 £674 £707
Entry 2 £2,982 £3,128
Entry 3 £2,485 £2,607
Entry 4 £155 £163
Paragraph 7(3) £100 £105
Paragraph 7(4) £140 £147
In Column 2 of the table in paragraph 8(1)
Entry 1(a) £4,500 £4,720
Entry 1(b) £6,750 £7,081
Entry 2(a) £2,250 £2,360
Entry 2(b) £3,375 £3,540
Entry 3(a) £750 £787
Entry 3(b) £1,125 £1,180
Entry 4(a) £500 £525
Entry 4(b) £750 £787
Entry 5 £366 £384
Paragraph 8(3)(a) £1,000 £1,049
Paragraph 8(3)(b) £2,000 £2,098
Paragraph 8(4) £6,672 £6,999
Paragraph 8(5) £590 £622
Paragraph 8(6) £2,000 £2,098
Part IIA of Schedule 1(32) Capital fees for assistance in obtaining marketing authorizations in other EEA states
Paragraph 2(a)(i) £37,989 £39,850
Paragraph 2(a)(ii) £24,953 £26,176
Paragraph 2(b)(i) £9,777 £10,256
Paragraph 2(b)(ii) £6,518 £6,837
Paragraph 2(c)(i) £3,910 £4,102
Paragraph 2(c)(ii) £3,259 £3,419
Paragraph 2(d) £2,340 £2,455
Part III of Schedule 1 Capital fees for applications for variations of authorizations, licences and certificates
Paragraph 5A(1) £594 £738
Paragraph 5B(a) £218 £237
Paragraph 5B(b) £350 £367
Paragraph 5B(c) £110 £120
Paragraph 6(a) £158 £166
Paragraph 6(b) £7,824 £8,206
Paragraph 6(c) £326 £342
Paragraph 11(1)(a) £110 £115
Paragraph 11(1)(b) £220 £231
Paragraph 11(1)(c) £330 £346
Paragraph 11A(a) £224 £234
Paragraph 11A(b) £590 £618
Paragraph 11A(c) £6,672 £6,998
Paragraph 11A(d) £142 £148
Paragraph 15(a)(ii) £594 £738
Paragraph 15(a)(iii) £297 £369
Paragraph 15(b)(ii) £297 £369
Part IIIA of Schedule 1(33) Capital fees for assessment of labels and leaflets
Paragraph 2(a) £472 £496
Paragraph 2(b) £300 £314
Part IV of Schedule 1(34) Capital fees for regulatory assistance given by the United Kingdom acting as reference Member State relating to the assessment of applications for the renewal of specified marketing authorizations
Paragraph 1(a) £8,847 £9,281
Paragraph 1(b) £722 £756
Paragraph 2(a)(ii) £722 £756
Paragraph 2(b)(ii) £361 £378
Schedule 2 Fees for inspections
Paragraph 2(a)(i) £3,618 £3,795
Paragraph 2(a)(ii) £6,645 £6,971
Paragraph 2(a)(iii) £8,010 £8,402
Paragraph 2(a)(iv) £13,676 £14,346
Paragraph 2(b)(i) £3,928 £4,120
Paragraph 2(b)(ii) £8,010 £8,402
Paragraph 2(b)(iii) £12,539 £13,153
Paragraph 2(b)(iv) £22,740 £23,854
Paragraph 2(c)(i) £1,563 £1,640
Paragraph 2(c)(ii) £3,879 £4,069
Paragraph 2(c)(iii) £5,761 £6,043
Paragraph 2(c)(iv) £10,726 £11,252
Paragraph 2(cc)(i) £2,243 £2,353
Paragraph 2(cc)(ii) £5,856 £6,143
Paragraph 2(cc)(iii) £10,914 £11,449
Paragraph 2(d) £240 £252
Paragraph 2A(a) £2,534 £3,795
Paragraph 2A(b) £4,654 £6,971
Paragraph 2A(c) £5,610 £8,402
Paragraph 2A(d) £9,578 £14, 346
Paragraph 4A(1)(a) £2,000 £2,996
Paragraph 4A(1)(b) £4,284 £4,494
Paragraph 4A(1)(c) £5,712 £5,992
Paragraph 4A(2)(a) £500 £750
Paragraph 4A(2)(b) £1,250 £1,875
Paragraph 4A(2)(c) £2,000 £3,000
Paragraph 5(1) £712 £747
Paragraph 5(1) £1,563 £1,640
Paragraph 5A(a) £5,057 £6,068
Paragraph 5A(b) £7,225 £8,670
Paragraph 5A(c) £14,450 £17,340
Paragraph 5B(1) (a) £800 £839
Paragraph 5B(1)(b) £1,300 £1,364
Paragraph 5B(1)(c) £1,300 £1,364
Paragraph 5C(1)(a) £600 £629
Paragraph 5C(1)(b) £1,100 £1,154
Paragraph 5C(1)(c) £1,100 £1,154
Paragraph 5D(1)(a) £800 £839
Paragraph 5D(1)(b) £1,300 £1,364
Paragraph 5D(1)(c) £1,300 £1,364
Paragraph 7(4)(a) £4,284 £5,141
Paragraph 7(4)(b) £7,139 £8,567
Paragraph 7(4)(c) £14,279 £17,135
Paragraph 7(4)(d) £21,418 £25,702
Paragraph 7(4) £4,284 £5,141
Part III of Schedule 3 Periodic fees for marketing authorizations and licences
In column 2 of the Table in paragraph 1
Entry 1 £17,278 £18,573
Entry 2(a) £7,114 £7,648
Entry 2(b)(i) £1,780 £1,913
Entry 2(b)(ii) £888 £955
Entry 2(b)(iii) £289 £310
Entry 2(c)(i) £779 £837
Entry 2(c)(ii) £390 £419
Entry 2(c)(iii) £144 £155
Entry 2(d)(i) £322 £346
Entry 2(d)(ii) £160 £172
Entry 2(d)(iii) £70 £75
Entry 2(e) £88 £95
Entry 2(g) £63 £68
Paragraph 2(a) £395 £425
Paragraph 2(b) £195 £210
Paragraph 2(c) £83 £89
Paragraph 3(a) £7,114 £7,648
Paragraph 3(b) £4,803 £5,163
Paragraph 7(a) £356 £383
Paragraph 7(b) £356 £383
Paragraph 8(1) £219 £235
Paragraph 8(2) £131 £141
Paragraph 10 £234 £252
Paragraph 11 £75 £80
(32)

Part IIA was inserted by regulation 6 of S.I. 2000/2031. Back [32]

(33)

Part IIIA of Schedule 1 was inserted by regulation 4(1) and (6) of S.I. 2003/625. Back [33]

(34)

Part IV of Schedule 1 was inserted by regulation 5(7) of S.I. 2002/542. Back [34]