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The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998
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Regulation 5
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 | ||
| Regulation 6(1)(a) | £110 | £80 | |
| Regulation 6(1)(b) | £55 | £30 | |
| Regulation 6(1)(c)(i) | £55 | £30 | |
| Regulation 10 | Renewals of clinical trial certificates | £1,925 | £1,500 |
| Part II of Schedule 1 | Capital fees for applications for authorizations, licences and certificates | ||
| In column 2 of the table in paragraph 1(1) | |||
| Entry 1(a) | £20,165 | £18,000 | |
| Entry 1(b) | £50,365 | £38,500 | |
| Entry 1(c) | £71,950 | £55,000 | |
| Entry 2(a) | £11,080 | £10,500 | |
| Entry 2(b) | £15,830 | £15,000 | |
| Entry 3(a) | £4,045 | £3,850 | |
| Entry 3(b) | £5,775 | £5,500 | |
| Entry 4 | £1,710 | £1,500 | |
| Entry 5 | £1,490 | £1,000 | |
| Entry 6 | £750 | £250 | |
| Paragraph 5(1)(c) | £1,690 | £1,650 | |
| Paragraph 6(1) | £780 | £650 | |
| Part III of Schedule 1 | Capital fees for applications for variations of authorizations, licences and certificates | ||
| Paragraph 2(a) | £190 | £150 | |
| Paragraph 2(b) | £342 | £340 | |
| Paragraph 2(c) | £8,766 | £5,000 | |
| Paragraph 3(c) | £10,520 | £7,800 | |
| Paragraph 6(b) | £310 | £200 | |
| Paragraph 11 | £195 | £150 | |
| Schedule 2 | Fees for inspections | ||
| Paragraph 2(a)(ii) | £2,945 | £2,900 | |
| Paragraph 2(a)(iii) | £4,750 | £3,500 | |
| Paragraph 2(a)(iv) | £8,125 | £6,000 | |
| Paragraph 2(b)(i) | £1,740 | £1,700 | |
| Paragraph 2(b)(ii) | £4,650 | £3,500 | |
| Paragraph 2(b)(iii) | £7,100 | £5,500 | |
| Paragraph 2(b)(iv) | £13,510 | £10,000 | |
| Part III of Schedule 3 | Periodic fees for marketing authorizations and licences | ||
| In column 2 of the table in paragraph 1 | |||
| Entry 1 | £11,300 | £10,200 | |
| Entry 2(a) | £4,800 | £4,000 | |
| Entry 2(b)(i) | £1,130 | £1,000 | |
| Entry 2(b)(ii) | £560 | £500 | |
| Entry 2(b)(iii) | £190 | £165 | |
| Entry 2(c)(i) | £535 | £440 | |
| Entry 2(c)(ii) | £270 | £220 | |
| Entry 2(c)(iii) | £120 | £80 | |
| Entry 2(d)(i) | £240 | £180 | |
| Entry 2(d)(ii) | £120 | £90 | |
| Entry 2(d)(iii) | £90 | £40 | |
| Entry 2(e) | £60 | £50 | |
| Paragraph 2(a) | £300 | £225 | |
| Paragraph 2(b) | £145 | £110 | |
| Paragraph 2(c) | £95 | £45 | |
| Paragraph 3(a) | £4,800 | £4,000 | |
| Paragraph 3(b) | £3,400 | £2,700 | |
| Paragraph 7 | £235 | £200 | |
| Paragraph 8(1) | £145 | £125 | |
| Paragraph 8(2) | £90 | £75 |
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