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This is the original version (as it was originally made).
Regulation 4(9)
SCHEDULE
Column (1) | Column (2) | Column (3) | Column (4) |
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Provision in the General Regulations | Subject matter | Old amount | New amount |
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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() | 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() | 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() | 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() | 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 |
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