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The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003
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- UK Statutory Instruments
- 2003 No. 625
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Regulation 4(9)
SCHEDULE
| Column (1) | Column (2) | Column (3) | Column (4) |
|---|---|---|---|
| Provision in the General Regulations | Subject matter | Old amount | New amount |
| Regulation 6 | Applications for certificates by exporters of medicinal products | ||
| Paragraph (1)(a) | £108 | £117 | |
| Paragraph (1)(b) | £48 | £52 | |
| Paragraph (1)(c)(i) | £48 | £52 | |
| Paragraph (1)(c)(ii) | £24 | £26 | |
| Regulation 10 | Renewal of clinical trial certificates | £2,036 | £2,199 |
| Regulation 11(1) | Renewals of certain manufacturer’s licences | £116 | £125 |
| Part II of Schedule 1(1) | Capital fees for applications for authorizations, licences and certificates | ||
| In column 2 of the Table in paragraph 1(1) | |||
| Entry 1(a) | £24,431 | £25,835 | |
| Entry 1(b) | £52,260 | £55,441 | |
| Entry 1(c) | £74,657 | £79,630 | |
| Entry 2(a) | £14,252 | £15,392 | |
| Entry 2(b) | £20,361 | £21,990 | |
| Entry 3(a) | £5,222 | £5,640 | |
| Entry 3(b) | £7,466 | £8,063 | |
| Entry 4 | £2,036 | £2,199 | |
| Entry 5 | £1,356 | £1,465 | |
| Entry 6 | £335 | £362 | |
| Paragraph 1A(1) | £6,000 | £6,480 | |
| Paragraph 4(4)(b) | £458 | £494 | |
| Paragraph 5(1)(a) | £130 | £140 | |
| Paragraph 5(1)(b) | £245 | £265 | |
| Paragraph 5(1)(c) | £2,236 | £2,415 | |
| Paragraph 6(1) | £879 | £949 | |
| Paragraph 6(2) | £646 | £698 | |
| Paragraph 6(4) | £283 | £306 | |
| Paragraph 7 | £15,940 | £17,215 | |
| Part IIA of Schedule 1(2) | Capital fees for assistance in obtaining marketing authorizations in other EEA states | ||
| Paragraph 2(a)(i) | £32,400 | £33,992 | |
| Paragraph 2(a)(ii) | £21,600 | £22,328 | |
| Paragraph 2(b)(i) | £8,100 | £8,748 | |
| Paragraph 2(b)(ii) | £5,400 | £5,832 | |
| Paragraph 2(c)(i) | £3,240 | £3,499 | |
| Paragraph 2(c)(ii) | £2,700 | £2,916 | |
| Paragraph 2(d) | £1,939 | £2,094 | |
| Part III of Schedule 1(3) | Capital fees for applications for variations of authorizations, licences and certificates | ||
| Paragraph 2(a) | £198 | £214 | |
| Paragraph 2(b) | £458 | £494 | |
| Paragraph 2(c) | £6,784 | £7,326 | |
| Paragraph 2(d) | £6,000 | £6,480 | |
| Paragraph 3(a) | £310 | £334 | |
| Paragraph 3(b) | £554 | £598 | |
| Paragraph 3(c) | £10,586 | £11,432 | |
| Paragraph 5A(1) | £458 | £494 | |
| Paragraph 6(a) | £130 | £140 | |
| Paragraph 6(b) | £6,000 | £6,480 | |
| Paragraph 6(c) | £270 | £292 | |
| Paragraph 7(a) | £122 | £132 | |
| Paragraph 7(b) | £245 | £264 | |
| Paragraph 8 | £122 | £132 | |
| Paragraph 9 | £282 | £304 | |
| Paragraph 10 | £122 | £132 | |
| Paragraph 11 | £200 | £216 | |
| Paragraph 12 | £103 | £110 | |
| Paragraph 15(a)(ii) | £458 | £494 | |
| Paragraph 15(a)(iii) | £229 | £247 | |
| Paragraph 15(b)(ii) | £229 | £247 | |
| Part IV of Schedule 1(4) | 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) | £6,784 | £7,327 | |
| Paragraph 1(b) | £554 | £598 | |
| Paragraph 2(a)(ii) | £554 | £598 | |
| Paragraph 2(b)(ii) | £277 | £299 | |
| Schedule 2 | Fees for inspections | ||
| Paragraph 2(a)(i) | £2,121 | £2,291 | |
| Paragraph 2(a)(ii) | £3,934 | £4,249 | |
| Paragraph 2(a)(iii) | £4,752 | £5,132 | |
| Paragraph 2(a)(iv) | £8,144 | £8,796 | |
| Paragraph 2(b)(i) | £2,307 | £2,492 | |
| Paragraph 2(b)(ii) | £4,752 | £5,132 | |
| Paragraph 2(b)(iii) | £7,464 | £8,061 | |
| Paragraph 2(b)(iv) | £13,573 | £14,659 | |
| Paragraph 2(c)(i) | £814 | £879 | |
| Paragraph 2(c)(ii) | £2,278 | £2,460 | |
| Paragraph 2(c)(iii) | £3,405 | £3,677 | |
| Paragraph 2(c)(iv) | £6,378 | £6,888 | |
| Paragraph 2(d) | £154 | £166 | |
| Paragraph 5(1) | £427 | £461 | |
| Paragraph 5(1) | £936 | £1,011 | |
| Part III of Schedule 3 | Periodic fees for marketing authorizations and licences | ||
| In column 2 of the Table in paragraph 1 | |||
| Entry 1 | £13,186 | £14,241 | |
| Entry 2(a) | £5,429 | £5,863 | |
| Entry 2(b)(i) | £1,358 | £1,467 | |
| Entry 2(b)(ii) | £678 | £732 | |
| Entry 2(b)(iii) | £220 | £238 | |
| Entry 2(c)(i) | £594 | £642 | |
| Entry 2(c)(ii) | £297 | £321 | |
| Entry 2(c)(iii) | £110 | £119 | |
| Entry 2(d)(i) | £245 | £265 | |
| Entry 2(d)(ii) | £122 | £132 | |
| Entry 2(d)(iii) | £54 | £58 | |
| Entry 2(e) | £67 | £72 | |
| Paragraph 2(a) | £302 | £326 | |
| Paragraph 2(b) | £149 | £161 | |
| Paragraph 2(c) | £63 | £68 | |
| Paragraph 3(a) | £5,429 | £5,863 | |
| Paragraph 3(b) | £3,666 | £3,959 | |
| Paragraph 7 | £271 | £293 | |
| Paragraph 8(1) | £167 | £180 | |
| Paragraph 8(2) | £100 | £108 |
(1)
Paragraphs 1A and 4(4) of Part II of Schedule 1 were inserted by regulation 5(5) of S.I. 2002/542
(2)
Part IIA was inserted by regulation 6 of S.I. 2000/2031.
(3)
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.
(4)
Part IV of Schedule 1 was inserted by regulation 5(7) of S.I. 2002/542.
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