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The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006
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Regulation 2(1)
SCHEDULE
This schedule has no associated Explanatory Memorandum
| Column (1) | Column (2) | Column (3) | Column (4) |
|---|---|---|---|
| Provision in the General Fees Regulations | Subject Matter | Old Amount | New Amount |
| Regulation 3B(1) | Capital 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(2) | Capital fees for advertising advice meetings | £1,346 | £1,486 |
| Regulation 3BB(3) | Capital fees for pharmacovigilance advice meeting | ||
| Paragraph (a) | £1,690 | £1,866 | |
| Paragraph (b) | £1,346 | £1,486 | |
| Regulation 3BC(4) | Capital fees for advice meetings concerning labelling and leaflets | £1,012 | £1,118 |
| Regulation 3BD(5) | Capital fees for post authorisation regulatory advice meetings | £1,346 | £1,486 |
| Regulation 6 | Applications 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 11 | Renewal of certain manufacturer’s licences | £127 | £152 |
| Part II of Schedule 1 | Capital fees for applications for authorizations, licences and certificates | ||
| In Column 2 of the Table in paragraph 1(6) | |||
| 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(7) | |||
| 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(8) | Capital 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 1 | Capital 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(9) | Capital fees for assessment of labels and leaflets | ||
| Paragraph 2(a) | £430 | £472 | |
| Paragraph 2(b) | £273 | £300 | |
| Part IV of Schedule 1(10) | 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) | £7,415 | £8,847 | |
| Paragraph 1(b) | £605 | £722 | |
| Paragraph 2(a)(ii) | £605 | £722 | |
| Paragraph 2(b)(ii) | £303 | £361 | |
| Schedule 2 | Fees 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)(11) | |||
| 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)(12) | |||
| 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)(13) | £3,542 | £5,057 | |
| Paragraph 5A(b) | £5,060 | £7,225 | |
| Paragraph 5A(c) | £10,120 | £14,450 | |
| Paragraph 5D(1)(a)(14) | £600 | £800 | |
| Paragraph 5D(1)(b) | £1,100 | £1,300 | |
| Paragraph 5D(1)(c) | £1,100 | £1,300 | |
| Paragraph 7(4)(a)(15) | £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 3 | Periodic 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(16) | £200 | £234 |
(2)
Regulation 3BA was inserted by S.I. 2004/666.
(3)
Regulation 3BB was inserted by S.I. 2004/666.
(4)
Regulation 3BC was inserted By S.I. 2004/666.
(5)
Regulation 3BD was inserted by S.I. 2004/666.
(6)
The Table was substituted by S.I. 2005/2979.
(8)
Part IIA was inserted by S.I. 2000/3031 and amended by S.I. 2001/795, 2002/236 and 242, 2003/625 and 2004/666.
(10)
Part IV was inserted by S.I. 2002/542.
(11)
Paragraph 2(f) was inserted by S.I. 2005/2979.
(12)
Paragraph 5(3) was inserted by S.I.2003/625.
(13)
Paragraph 5A was inserted by S.I. 2003/625.
(14)
Paragraph 5D was inserted by S.I. 2005/2979.
(15)
Paragraph 7 was inserted by S.I. 2004/1157.
(16)
Paragraph 10 was inserted by S.I. 2004/1157.
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