The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006

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.