- Latest available (Revised)
- Original (As made)
The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004
You are here:
- UK Statutory Instruments
- 2004 No. 666
- Schedules only
What Version
More Resources
Status:
This is the original version (as it was originally made).
Regulation 15
SCHEDULE
| Column (1) | Column (2) | Column (3) | Column (4) |
|---|---|---|---|
| Provision in the General Regulations | Subject matter | Old amount | New amount |
| Regulation 3B(1) | Capital fees for pre-application meetings | ||
| Paragraph (a) | £1,000 | £1,012 | |
| Paragraph (b) | £1,330 | £1,346 | |
| Paragraph (c) | £1,670 | £1,690 | |
| Paragraph (d) | £2,000 | £2,024 | |
| Regulation 6 | Applications for certificates by Exporters of medicinal products | ||
| Paragraph (1)(a) | £117 | £118 | |
| Paragraph (1)(b) | £52 | £53 | |
| Paragraph (1)(c)(i) | £52 | £53 | |
| Regulation 10 | Renewal of clinical trial certificates | £2,199 | £2,225 |
| Regulation 11(1) | Renewals of certain manufacturer’s licences | £125 | £127 |
| Part II of Schedule 1(2) | Capital fees for applications for authorizations, licences and certificates | ||
| In column 2 of the Table in paragraph 1(1) | |||
| Entry 1(a) | £25,835 | £25,690 | |
| Entry 1(b) | £55,441 | £56,106 | |
| Entry 1(c) | £79,630 | £80,586 | |
| Entry 2(a) | £15,392 | £15,577 | |
| Entry 2(b) | £21,990 | £22,254 | |
| Entry 3(a) | £5,640 | £5,708 | |
| Entry 3(b) | £8,063 | £8,160 | |
| Entry 4 | £2,199 | £2,225 | |
| Entry 5 | £1,465 | £1,483 | |
| Entry 6 | £362 | £366 | |
| Paragraph 1A(1) | £6,480 | £6,558 | |
| Paragraph 4(4)(b) | £494 | £500 | |
| Paragraph 5(1)(a) | £140 | £142 | |
| Paragraph 5(1)(b) | £265 | £268 | |
| Paragraph 5(1)(c) | £2,415 | £2,444 | |
| Paragraph 6(1) | £949 | £1,402 | |
| Paragraph 6(2) | £698 | £600 | |
| Paragraph 6(4) | £306 | £310 | |
| Paragraph 7 | £17,215 | £17,422 | |
| Part IIA of Schedule 1(3) | Capital fees for assistance in obtaining marketing authorizations in other EEA states | ||
| Paragraph 2(a)(i) | £33,992 | £34,400 | |
| Paragraph 2(a)(ii) | £22,328 | £22,596 | |
| Paragraph 2(b)(i) | £8,748 | £8,853 | |
| Paragraph 2(b)(ii) | £5,832 | £5,902 | |
| Paragraph 2(c)(i) | £3,499 | £3,541 | |
| Paragraph 2(c)(ii) | £2,916 | £2,951 | |
| Paragraph 2(d) | £2,094 | £2,119 | |
| Part III of Schedule 1(4) | Capital fees for applications for variations of authorizations, licences and certificates | ||
| Paragraph 2(a) | £140 | £142 | |
| Paragraph 2(aa) | £214 | £224 | |
| Paragraph 2(b) | £494 | £590 | |
| Paragraph 2(c) | £7,326 | £6,672 | |
| Paragraph 2(cc) | £21,990 | £22,254 | |
| Paragraph 2(d) | £6,480 | £6,558 | |
| Paragraph 3(a) | £220 | £222 | |
| Paragraph 3(aa) | £334 | £442 | |
| Paragraph 3(b) | £598 | £714 | |
| Paragraph 3(c) | £11,432 | £11,568 | |
| Paragraph 3(d) | £30,738 | £31,106 | |
| Paragraph 5A(1) | £494 | £500 | |
| Paragraph 6(a) | £140 | £142 | |
| Paragraph 6(b) | £6,480 | £6,558 | |
| Paragraph 6(c) | £292 | £296 | |
| Paragraph 7(a) | £132 | £200 | |
| Paragraph 7(b) | £264 | £400 | |
| Paragraph 8 | £132 | £200 | |
| Paragraph 9 | £304 | £378 | |
| Paragraph 10 | £132 | £200 | |
| Paragraph 11 | £216 | £218 | |
| Paragraph 15(a)(ii) | £494 | £500 | |
| Paragraph 15(a)(iii) | £247 | £250 | |
| Paragraph 15(b)(ii) | £247 | £250 | |
| Part IIIA of Schedule 1(5) | Capital fees for assessment of labels and leaflets | ||
| Paragraph 2(a) | £350 | £319 | |
| Paragraph 2(b) | £270 | £273 | |
| Part IV of Schedule 1(6) | 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) | £7,327 | £7,415 | |
| Paragraph 1(b) | £598 | £605 | |
| Paragraph 2(a)(ii) | £598 | £605 | |
| Paragraph 2(b)(ii) | £299 | £303 | |
| Schedule 2 | Fees for inspections | ||
| Paragraph 2(a)(i) | £2,291 | £2,481 | |
| Paragraph 2(a)(ii) | £4,249 | £4,601 | |
| Paragraph 2(a)(iii) | £5,132 | £5,557 | |
| Paragraph 2(a)(iv) | £8,796 | £9,525 | |
| Paragraph 2(b)(i) | £2,492 | £2,698 | |
| Paragraph 2(b)(ii) | £5,132 | £5,557 | |
| Paragraph 2(b)(iii) | £8,061 | £8,729 | |
| Paragraph 2(b)(iv) | £14,659 | £15,873 | |
| Paragraph 2(c)(i) | £879 | £952 | |
| Paragraph 2(c)(ii) | £2,460 | £2,664 | |
| Paragraph 2(c)(iii) | £3,677 | £3,982 | |
| Paragraph 2(c)(iv) | £6,888 | £7,459 | |
| Paragraph 2(cc)(i) | £1,500 | £1,518 | |
| Paragraph 2(cc)(ii) | £4,000 | £4,048 | |
| Paragraph 2(cc)(iii) | £7,500 | £7,590 | |
| Paragraph 2(d) | £166 | £168 | |
| Paragraph 5(1) | £461 | £499 | |
| Paragraph 5(1) | £1,011 | £1,095 | |
| In column 2 of the Table in paragraph 5(3)(7) | |||
| Entry for “None” | £1,011 | £1,023 | |
| Entry for “1 to 4” | £1,211 | £1,226 | |
| Entry for “5 to 20” | £2,011 | £2,035 | |
| Entry for “21 to 100” | £4,011 | £4,059 | |
| Entry for “101 to 500” | £9,011 | £9,119 | |
| Entry for “More than 500” | £16,011 | £16,203 | |
| Paragraph 5A(a)(8) | £3,500 | £3,542 | |
| Paragraph 5A(b) | £5,000 | £5,060 | |
| Paragraph 5A(c) | £10,000 | £10,120 | |
| Part III of Schedule 3 | Periodic fees for marketing authorizations and licences | ||
| In column 2 of the Table in paragraph 1 | |||
| Entry 1 | £14,241 | £14,768 | |
| Entry 2(a) | £5,863 | £6,080 | |
| Entry 2(b)(i) | £1,467 | £1,521 | |
| Entry 2(b)(ii) | £732 | £759 | |
| Entry 2(b)(iii) | £238 | £247 | |
| Entry 2(c)(i) | £642 | £666 | |
| Entry 2(c)(ii) | £321 | £333 | |
| Entry 2(c)(iii) | £119 | £123 | |
| Entry 2(d)(i) | £265 | £275 | |
| Entry 2(d)(ii) | £132 | £137 | |
| Entry 2(d)(iii) | £58 | £60 | |
| Entry 2(e) | £72 | £75 | |
| Paragraph 2(a) | £326 | £338 | |
| Paragraph 2(b) | £161 | £167 | |
| Paragraph 2(c) | £68 | £71 | |
| Paragraph 3(a) | £5,863 | £6,080 | |
| Paragraph 3(b) | £3,959 | £4,105 | |
| Paragraph 7 | £293 | £304 | |
| Paragraph 8(1) | £180 | £187 | |
| Paragraph 8(2) | £108 | £112 |
(1)
Regulation 3B was inserted by regulation 4(1) and (3) of S.I. 2003/625 and amended by regulation 9 of S.I. 2003/2321.
(2)
Paragraphs 1A and 4(4) of Part II of Schedule 1 were inserted by regulation 5(5) of S.I. 2002/542.
(3)
Part IIA was inserted by regulation 6 of S.I. 2000/2031.
(4)
Paragraphs 2(d), 5A and 15 of Part III of Schedule 1 were inserted, and paragraph 6(b) and (c) of that Part was substituted, by regulation 5(6) of S.I. 2002/542
(5)
Part IIIA of Schedule 1 was inserted by regulation 4(1) and (6) of S.I. 2003/625.
(6)
Part IV of Schedule 1 was inserted by regulation 5(7) of S.I. 2002/542.
(7)
Paragraph 5(3) was inserted by regulation 4(1) and (7)(e)(ii) of S.I. 2003/625.
(8)
Paragraph 5A was inserted by regulation 4(1) and (7)(f) of S.I. 2003/625.
Options/Help
Print Options
PrintThe Whole Instrument
PrintThe Schedules only
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Opening Options
Different options to open legislation in order to view more content on screen at once
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as enacted version that was used for the print copy
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as made version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.