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The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004
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- Offerynnau Statudol y Deyrnas Unedig
- 2004 No. 666
- Schedules only
Pa Fersiwn
Rhagor o Adnoddau
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Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).
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.
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