SCHEDULE
Paragraphs 1A and 4(4) of Part II of Schedule 1 were inserted by regulation 5(5) of S.I. 2002/542.
Part IIA was inserted by regulation 6 of S.I. 2000/2031.
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
Part IIIA of Schedule 1 was inserted by regulation 4(1) and (6) of S.I. 2003/625.
Part IV of Schedule 1 was inserted by regulation 5(7) of S.I. 2002/542.
Paragraph 5(3) was inserted by regulation 4(1) and (7)(e)(ii) of S.I. 2003/625.
Paragraph 5A was inserted by regulation 4(1) and (7)(f) of S.I. 2003/625.
Column (1) | Column (2) | Column (3) | Column (4) |
|---|---|---|---|
Provision in the General Regulations | Subject matter | Old amount | New amount |
Regulation 3B M1 | 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 M2 | 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 M3 | 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 M4 | 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 M5 | Capital fees for assessment of labels and leaflets |
|
|
Paragraph 2(a) |
| £350 | £319 |
Paragraph 2(b) |
| £270 | £273 |
Part IV of Schedule 1 M6 | 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) M7 |
|
|
|
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) M8 |
| £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 |
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.