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Regulation 2(1)

SCHEDULEU.K.

Column (1)Column (2)Column (3)Column (4)
Provision in the General Fees RegulationsSubject MatterOld AmountNew Amount
Regulation 3B M1Capital fees for pre-application meetings  
Paragraph (a) £1,012£1,118
Paragraph (b) £1,346£1,486
Paragraph (c) £1,690£1,866
Paragraph (d) £2,024£2,235
Regulation 3BA M2Capital fees for advertising advice meetings£1,346£1,486
Regulation 3BB M3Capital fees for pharmacovigilance advice meeting  
Paragraph (a) £1,690£1,866
Paragraph (b) £1,346£1,486
Regulation 3BC M4Capital fees for advice meetings concerning labelling and leaflets£1,012£1,118
Regulation 3BD M5Capital fees for post authorisation regulatory advice meetings£1,346£1,486
Regulation 6Applications for certificates by exporters of medicinal products  
Paragraph (1)(a) £118£130
Paragraph (1)(b) £53£58
Paragraph (1)(c)(i) £53£58
Paragraph (1)(c)(ii) £26£29
Regulation 11Renewal of certain manufacturer's licences£127£152
Part II of Schedule 1Capital fees for applications for authorizations, licences and certificates  
In Column 2 of the Table in paragraph 1 M6   
Entry 1(a) £25,802£28,494
Entry 1(b) £56,218£61,959
Entry 1(c) £56,218£61,959
Entry 1(d) £80,698£88,993
Entry 1(e) £115,098£126,982
Entry 1(f) £80,698£88,993
Entry 2(a) £15,689£17,202
Entry 2(b) £15,689£17,202
Entry 2(c) £22,366£24,576
Entry 2(d) £31,219£34,353
Entry 2(e) £22,366£24,576
Entry 3(a) £5,820£6,304
Entry 3(b) £5,820£6,304
Entry 3(c) £8,272£9,011
Entry 3(d) £11,813£12,921
Entry 3(e) £8,272£9,011
Entry 4(a) £2,337£2,457
Entry 4(b) £2,337£2,457
Entry 5 £1,493£1,638
Entry 6 £366£404
Paragraph 1A(1) £6,558£7,824
Paragraph 4(4)(b) £500£594
Paragraph 5(1)(a) £142£156
Paragraph 5(1)(b) £268£295
Paragraph 5(1)(c) £2,444£2,688
Paragraph 6(1) £1,402£1,542
Paragraph 6(2) £600£660
Paragraph 6(4) £310£341
In Column 2 of the Table in paragraph 7 M7   
Entry 1 £610£674
Entry 2 £2,700£2,982
Entry 3 £2,250£2,485
Entry 4 £140£155
Part IIA of Schedule 1 M8Capital fees for assistance in obtaining marketing authorizations in other EEA States  
Paragraph 2(a)(i) £34,400£37,989
Paragraph 2(a)(ii) £22,596£24,953
Paragraph 2(b)(i) £8,853£9,777
Paragraph 2(b)(ii) £5,902£6,518
Paragraph 2(c)(i) £3,541£3,910
Paragraph 2(c)(ii) £2,951£3,259
Paragraph 2(d) £2,119£2,340
Part III of Schedule 1Capital fees for applications for variations of authorizations, licences and certificates  
Paragraph 2(a) £142£170
Paragraph 2(aa) £224£266
Paragraph 2(b) £590£704
Paragraph 2(c) £6,672£7,964
Paragraph 2(cc) £22,254£24,576
Paragraph 2(d) £6,558£7,824
Paragraph 3(a) £222£264
Paragraph 3(aa) £442£526
Paragraph 3(b) £714£852
Paragraph 3(c) £11,568£13,808
Paragraph 3(d) £31,106£34,353
Paragraph 5A(1) £500£594
Paragraph 6(a) £142£158
Paragraph 6(b) £6,558£7,824
Paragraph 6(c) £296£326
Paragraph 7(a) £200£220
Paragraph 7(b) £400£440
Paragraph 8 £200£220
Paragraph 9 £378£416
Paragraph 10 £200£220
Paragraph 11(1)(a) £100£110
Paragraph 11(1)(b) £200£220
Paragraph 11(1)(c) £300£330
Paragraph 15(a)(ii) £500£594
Paragraph 15(a)(iii) £250£297
Paragraph 15(b)(ii) £250£297
Part IIIA of Schedule 1 M9Capital fees for assessment of labels and leaflets  
Paragraph 2(a) £430£472
Paragraph 2(b) £273£300
Part IV of Schedule 1 M10Capital 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) £7,415£8,847
Paragraph 1(b) £605£722
Paragraph 2(a)(ii) £605£722
Paragraph 2(b)(ii) £303£361
Schedule 2Fees for inspections  
Paragraph 2(a)(i) £2,534£3,618
Paragraph 2(a)(ii) £4,654£6,645
Paragraph 2(a)(iii) £5,610£8,010
Paragraph 2(a)(iv) £9,578£13,676
Paragraph 2(b)(i) £2,751£3,928
Paragraph 2(b)(ii) £5,610£8010
Paragraph 2(b)(iii) £8,782£12,539
Paragraph 2(b)(iv) £15,926£22,740
Paragraph 2(c)(i) £1,005£1,563
Paragraph 2(c)(ii) £2,717£3,879
Paragraph 2(c)(iii) £4,035£5,761
Paragraph 2(c)(iv) £7,512£10,726
Paragraph 2(cc)(i) £1,518£2,243
Paragraph 2(cc)(ii) £4,048£5,856
Paragraph 2(cc)(iii) £7,590£10,914
Paragraph 2(d) £221£240
In column 2 in the Table in paragraph 2(f) M11   
Entry for “none” £1,023£1,461
Entry for “1 to 4” £1,226£1,751
Entry for “5 to 20” £2,035£2,906
Entry for “21 to 100” £4,059£5,796
Entry for “101 to 500” £9,119£9,484
Entry for “more than 500” £16,203£16,850
Paragraph 4A(1)(b) £3,000£4,284
Paragraph 4A(1)(c) £4,000£5,712
Paragraph 5(1) £499£712
Paragraph 5(1) £1,095£1,563
In column 2 in the Table in paragraph 5(3) M12   
Entry for “none” £1,023£1,461
Entry for “1 to 4” £1,226£1,751
Entry for “5 to 20” £2,035£2,906
Entry for “21 to 100” £4,059£5,796
Entry for “101 to 500” £9,119£9,484
Entry for “more than 500” £16,203£16,850
Paragraph 5A(a) M13 £3,542£5,057
Paragraph 5A(b) £5,060£7,225
Paragraph 5A(c) £10,120£14,450
Paragraph 5D(1)(a) M14 £600£800
Paragraph 5D(1)(b) £1,100£1,300
Paragraph 5D(1)(c) £1,100£1,300
Paragraph 7(4)(a) M15 £3,000£4,284
Paragraph 7(4)(b) £5,000£7,139
Paragraph 7(4)(c) £10,000£14,279
Paragraph 7(4)(d) £15,000£21,418
Paragraph 7(4) £3,000£4,284
Part III of Schedule 3Periodic fees for marketing authorizations and licences  
In column 2 of the Table in paragraph 1   
Entry 1 £14,768£17,278
Entry 2(a) £6,080£7,114
Entry 2(b)(i) £1,521£1,780
Entry 2(b)(ii) £759£888
Entry 2(b)(iii) £247£289
Entry 2(c)(i) £666£779
Entry 2(c)(ii) £333£390
Entry 2(c)(iii) £123£144
Entry 2(d)(i) £275£322
Entry 2(d)(ii) £137£160
Entry 2(d)(iii) £60£70
Entry 2(e) £75£88
Paragraph 2(a) £338£395
Paragraph 2(b) £167£195
Paragraph 2(c) £71£83
Paragraph 3(a) £6,080£7,114
Paragraph 3(b) £4,105£4,803
Paragraph 7(2) £304£356
Paragraph 8(1) £187£219
Paragraph 8(2) £112£131
Paragraph 10 M16 £200£234

Marginal Citations

M1Regulation 3B was inserted by S.I. 2003/625 and amended by S.I. 2003/2321 and 2004/666.

M6The Table was substituted by S.I. 2005/2979.

M7Paragraph 7 was substituted by S.I. 2004/1157 and amended by S.I. 2005/1124.

M8Part IIA was inserted by S.I. 2000/3031 and amended by S.I. 2001/795, 2002/236 and 242, 2003/625 and 2004/666.

M9Part IIIA was inserted by S.I. 2003/625 and amended by S.I. 2004/666, 2005/1124 and 2979.

M10Part IV was inserted by S.I. 2002/542.