2006 No. 494
The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006
Made
Laid before Parliament
Coming into force
The Secretary of State for Health, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, acting jointly, make the following Regulations in exercise of the powers conferred on them by section 1(1) and (2) of the Medicines Act 1971 M1 or, as the case may be, the powers conferred by those provisions and now vested in them M2.
In so far as these Regulations are not made under section 1(1) and (2) of the Medicines Act 1971, the Secretary of State makes these Regulations in exercise of the powers conferred on her by section 2(2) of the European Communities Act 1972 M3 and section 56(1) and (2) of the Finance Act 1973 M4. The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products M5.
The Treasury has consented to the making of these Regulations as required by section 1(1) of the Medicines Act 1971 and section 56(1) of the Finance Act 1973.
In accordance with section 129(6) of the Medicines Act 1968 M6, the Secretary of State for Health, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development have consulted with such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations.
In the case of the Secretary of State, by virtue of article 2(1) of, and paragraph 1 of the Schedule to, S.I. 1999/3142 and article 3(1)(c) and (7) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794; and in the case of the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, by virtue of the powers vested in the Ministers in charge of those Departments by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47), which may now be exercised by the Departments by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c. 1); the Departments were renamed by virtue of Article 3(4) and (6) of S.I. 1999/283 (N.I. 1).
1968 c. 67; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.
Citation, commencement and interpretation1
1
These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006 and shall come into force on 1st April 2006.
2
In these Regulations—
“the Devices Regulations” means the Medical Devices (Consultation Requirements)(Fees) Regulations1995 M7;
“the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995 M8; and
“the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 M9.
Amendment of the General Fees Regulations2
1
The General Fees Regulations are amended as follows.
2
In each provision specified in the entries in column (1) of the Schedule to these Regulations (the content of which is described in column (2) of that Schedule), for the amount specified opposite that provision in column (3) of that Schedule substitute the amount specified opposite that provision in column (4) of that Schedule.
3
In Part II of Schedule 1 (capital fees for applications for authorizations, licences and certificates) M10, in paragraph 5, omit sub-paragraphs (1)(aa) and (3).
4
In Part III of Schedule 1 (capital fees for applications for variations of authorizations, licences and certificates) M11, in paragraph 7—
a
in sub-paragraph (a), at the end, insert “
and
”
; and
b
omit sub-paragraph (aa).
5
In Schedule 2 (fees for inspections) M12, in paragraph 2—
a
in sub-paragraph (d), at the end, insert “
and
”
; and
b
omit sub-paragraph (e).
6
In Part III of Schedule 3 (periodic fees for marketing authorizations and licences M13, for sub-paragraph (1) of paragraph 7, substitute—
1
The fee payable under regulation 14(3) in connection with the holding of a manufacturer's licence shall be £356.
Amendment of the Homoeopathic Products Regulations3
1
The Homoeopathic Products Regulations are amended as follows.
2
In regulation 14 (fees for variations of certificates)—
a
in paragraph (2)(a), for “£218” substitute “
£226
”
;
b
in paragraph (2)(b)(i), for “£218” substitute “
£226
”
;
c
in paragraph (2)(b)(ii), for “£218” substitute “
£226
”
;
d
in paragraph (2)(b)(iii), for “£110” substitute “
£114
”
; and
e
in paragraph (2)(b)(iv), for “£55” substitute “
£57
”
.
3
In the table in Schedule 2 (fees for applications for the grant of certificates of registration M14—
a
in column (2) (fees for applications in respect of products prepared from not more than 5 homoeopathic stocks)—
i
for “£134” substitute “
£148
”
;
ii
for “£402” substitute “
£444
”
; and
iii
for “£664” substitute “
£734
”
; and
b
in column (3) (fees for other applications)—
i
for “£330” substitute “
£365
”
;
ii
for “£592” substitute “
£654
”
;
iii
for “£869” substitute “
£960
”
.
Amendment of regulation 3 of the Devices Regulations4
1
In regulation 3 of the Devices Regulations (fees)—
a
in paragraph (1)(a), for “£3,575” substitute “
£3,948
”
;
b
in paragraph (1)(b), for “£8,333” substitute “
£9,202
”
;
c
in paragraph (2)(a), for “£707” substitute “
£781
”
;
d
in paragraph (2)(b), for “£1,978” substitute “
£2,184
”
;
e
in paragraph (3)(a), for “£3,575” substitute “
£3,948
”
;
f
in paragraph (3)(b), for “£8,333” substitute “
£9,262
”
;
g
in paragraph (4)(a), for “£707” substitute “
£781
”
;
h
in paragraph 4(b), for “£1,978” substitute “
£2,184
”
;
i
in paragraph (5)(a), for “£36,560” substitute “
£40,374
”
and
j
in paragraph (5)(b), for “£9,077” substitute “
£10,024
”
.
Signed by authority of the Secretary of State for Health
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
Sealed with the Official Seal of the Department of Agriculture and Rural Development
We consent,
SCHEDULE
Regulation 3B was inserted by S.I. 2003/625 and amended by S.I. 2003/2321 and 2004/666.
Regulation 3BA was inserted by S.I. 2004/666.
Regulation 3BB was inserted by S.I. 2004/666.
Regulation 3BC was inserted By S.I. 2004/666.
Regulation 3BD was inserted by S.I. 2004/666.
The Table was substituted by S.I. 2005/2979.
Paragraph 7 was substituted by S.I. 2004/1157 and amended by S.I. 2005/1124.
Part IIA was inserted by S.I. 2000/3031 and amended by S.I. 2001/795, 2002/236 and 242, 2003/625 and 2004/666.
Part IIIA was inserted by S.I. 2003/625 and amended by S.I. 2004/666, 2005/1124 and 2979.
Part IV was inserted by S.I. 2002/542.
Paragraph 2(f) was inserted by S.I. 2005/2979.
Paragraph 5(3) was inserted by S.I.2003/625.
Paragraph 5A was inserted by S.I. 2003/625.
Paragraph 5D was inserted by S.I. 2005/2979.
Paragraph 7 was inserted by S.I. 2004/1157.
Paragraph 10 was inserted by S.I. 2004/1157.
Column (1) | Column (2) | Column (3) | Column (4) |
|---|---|---|---|
Provision in the General Fees Regulations | Subject Matter | Old Amount | New Amount |
Regulation 3B M15 | Capital fees for pre-application meetings |
|
|
Paragraph (a) |
| £1,012 | £1,118 |
Paragraph (b) |
| £1,346 | £1,486 |
Paragraph (c) |
| £1,690 | £1,866 |
Paragraph (d) |
| £2,024 | £2,235 |
Regulation 3BA M16 | Capital fees for advertising advice meetings | £1,346 | £1,486 |
Regulation 3BB M17 | Capital fees for pharmacovigilance advice meeting |
|
|
Paragraph (a) |
| £1,690 | £1,866 |
Paragraph (b) |
| £1,346 | £1,486 |
Regulation 3BC M18 | Capital fees for advice meetings concerning labelling and leaflets | £1,012 | £1,118 |
Regulation 3BD M19 | Capital fees for post authorisation regulatory advice meetings | £1,346 | £1,486 |
Regulation 6 | Applications for certificates by exporters of medicinal products |
|
|
Paragraph (1)(a) |
| £118 | £130 |
Paragraph (1)(b) |
| £53 | £58 |
Paragraph (1)(c)(i) |
| £53 | £58 |
Paragraph (1)(c)(ii) |
| £26 | £29 |
Regulation 11 | Renewal of certain manufacturer's licences | £127 | £152 |
Part II of Schedule 1 | Capital fees for applications for authorizations, licences and certificates |
|
|
In Column 2 of the Table in paragraph 1 M20 |
|
|
|
Entry 1(a) |
| £25,802 | £28,494 |
Entry 1(b) |
| £56,218 | £61,959 |
Entry 1(c) |
| £56,218 | £61,959 |
Entry 1(d) |
| £80,698 | £88,993 |
Entry 1(e) |
| £115,098 | £126,982 |
Entry 1(f) |
| £80,698 | £88,993 |
Entry 2(a) |
| £15,689 | £17,202 |
Entry 2(b) |
| £15,689 | £17,202 |
Entry 2(c) |
| £22,366 | £24,576 |
Entry 2(d) |
| £31,219 | £34,353 |
Entry 2(e) |
| £22,366 | £24,576 |
Entry 3(a) |
| £5,820 | £6,304 |
Entry 3(b) |
| £5,820 | £6,304 |
Entry 3(c) |
| £8,272 | £9,011 |
Entry 3(d) |
| £11,813 | £12,921 |
Entry 3(e) |
| £8,272 | £9,011 |
Entry 4(a) |
| £2,337 | £2,457 |
Entry 4(b) |
| £2,337 | £2,457 |
Entry 5 |
| £1,493 | £1,638 |
Entry 6 |
| £366 | £404 |
Paragraph 1A(1) |
| £6,558 | £7,824 |
Paragraph 4(4)(b) |
| £500 | £594 |
Paragraph 5(1)(a) |
| £142 | £156 |
Paragraph 5(1)(b) |
| £268 | £295 |
Paragraph 5(1)(c) |
| £2,444 | £2,688 |
Paragraph 6(1) |
| £1,402 | £1,542 |
Paragraph 6(2) |
| £600 | £660 |
Paragraph 6(4) |
| £310 | £341 |
In Column 2 of the Table in paragraph 7 M21 |
|
|
|
Entry 1 |
| £610 | £674 |
Entry 2 |
| £2,700 | £2,982 |
Entry 3 |
| £2,250 | £2,485 |
Entry 4 |
| £140 | £155 |
Part IIA of Schedule 1 M22 | Capital fees for assistance in obtaining marketing authorizations in other EEA States |
|
|
Paragraph 2(a)(i) |
| £34,400 | £37,989 |
Paragraph 2(a)(ii) |
| £22,596 | £24,953 |
Paragraph 2(b)(i) |
| £8,853 | £9,777 |
Paragraph 2(b)(ii) |
| £5,902 | £6,518 |
Paragraph 2(c)(i) |
| £3,541 | £3,910 |
Paragraph 2(c)(ii) |
| £2,951 | £3,259 |
Paragraph 2(d) |
| £2,119 | £2,340 |
Part III of Schedule 1 | Capital fees for applications for variations of authorizations, licences and certificates |
|
|
Paragraph 2(a) |
| £142 | £170 |
Paragraph 2(aa) |
| £224 | £266 |
Paragraph 2(b) |
| £590 | £704 |
Paragraph 2(c) |
| £6,672 | £7,964 |
Paragraph 2(cc) |
| £22,254 | £24,576 |
Paragraph 2(d) |
| £6,558 | £7,824 |
Paragraph 3(a) |
| £222 | £264 |
Paragraph 3(aa) |
| £442 | £526 |
Paragraph 3(b) |
| £714 | £852 |
Paragraph 3(c) |
| £11,568 | £13,808 |
Paragraph 3(d) |
| £31,106 | £34,353 |
Paragraph 5A(1) |
| £500 | £594 |
Paragraph 6(a) |
| £142 | £158 |
Paragraph 6(b) |
| £6,558 | £7,824 |
Paragraph 6(c) |
| £296 | £326 |
Paragraph 7(a) |
| £200 | £220 |
Paragraph 7(b) |
| £400 | £440 |
Paragraph 8 |
| £200 | £220 |
Paragraph 9 |
| £378 | £416 |
Paragraph 10 |
| £200 | £220 |
Paragraph 11(1)(a) |
| £100 | £110 |
Paragraph 11(1)(b) |
| £200 | £220 |
Paragraph 11(1)(c) |
| £300 | £330 |
Paragraph 15(a)(ii) |
| £500 | £594 |
Paragraph 15(a)(iii) |
| £250 | £297 |
Paragraph 15(b)(ii) |
| £250 | £297 |
Part IIIA of Schedule 1 M23 | Capital fees for assessment of labels and leaflets |
|
|
Paragraph 2(a) |
| £430 | £472 |
Paragraph 2(b) |
| £273 | £300 |
Part IV of Schedule 1 M24 | 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) |
| £7,415 | £8,847 |
Paragraph 1(b) |
| £605 | £722 |
Paragraph 2(a)(ii) |
| £605 | £722 |
Paragraph 2(b)(ii) |
| £303 | £361 |
Schedule 2 | Fees for inspections |
|
|
Paragraph 2(a)(i) |
| £2,534 | £3,618 |
Paragraph 2(a)(ii) |
| £4,654 | £6,645 |
Paragraph 2(a)(iii) |
| £5,610 | £8,010 |
Paragraph 2(a)(iv) |
| £9,578 | £13,676 |
Paragraph 2(b)(i) |
| £2,751 | £3,928 |
Paragraph 2(b)(ii) |
| £5,610 | £8010 |
Paragraph 2(b)(iii) |
| £8,782 | £12,539 |
Paragraph 2(b)(iv) |
| £15,926 | £22,740 |
Paragraph 2(c)(i) |
| £1,005 | £1,563 |
Paragraph 2(c)(ii) |
| £2,717 | £3,879 |
Paragraph 2(c)(iii) |
| £4,035 | £5,761 |
Paragraph 2(c)(iv) |
| £7,512 | £10,726 |
Paragraph 2(cc)(i) |
| £1,518 | £2,243 |
Paragraph 2(cc)(ii) |
| £4,048 | £5,856 |
Paragraph 2(cc)(iii) |
| £7,590 | £10,914 |
Paragraph 2(d) |
| £221 | £240 |
In column 2 in the Table in paragraph 2(f) M25 |
|
|
|
Entry for “none” |
| £1,023 | £1,461 |
Entry for “1 to 4” |
| £1,226 | £1,751 |
Entry for “5 to 20” |
| £2,035 | £2,906 |
Entry for “21 to 100” |
| £4,059 | £5,796 |
Entry for “101 to 500” |
| £9,119 | £9,484 |
Entry for “more than 500” |
| £16,203 | £16,850 |
Paragraph 4A(1)(b) |
| £3,000 | £4,284 |
Paragraph 4A(1)(c) |
| £4,000 | £5,712 |
Paragraph 5(1) |
| £499 | £712 |
Paragraph 5(1) |
| £1,095 | £1,563 |
In column 2 in the Table in paragraph 5(3) M26 |
|
|
|
Entry for “none” |
| £1,023 | £1,461 |
Entry for “1 to 4” |
| £1,226 | £1,751 |
Entry for “5 to 20” |
| £2,035 | £2,906 |
Entry for “21 to 100” |
| £4,059 | £5,796 |
Entry for “101 to 500” |
| £9,119 | £9,484 |
Entry for “more than 500” |
| £16,203 | £16,850 |
Paragraph 5A(a) M27 |
| £3,542 | £5,057 |
Paragraph 5A(b) |
| £5,060 | £7,225 |
Paragraph 5A(c) |
| £10,120 | £14,450 |
Paragraph 5D(1)(a) M28 |
| £600 | £800 |
Paragraph 5D(1)(b) |
| £1,100 | £1,300 |
Paragraph 5D(1)(c) |
| £1,100 | £1,300 |
Paragraph 7(4)(a) M29 |
| £3,000 | £4,284 |
Paragraph 7(4)(b) |
| £5,000 | £7,139 |
Paragraph 7(4)(c) |
| £10,000 | £14,279 |
Paragraph 7(4)(d) |
| £15,000 | £21,418 |
Paragraph 7(4) |
| £3,000 | £4,284 |
Part III of Schedule 3 | Periodic fees for marketing authorizations and licences |
|
|
In column 2 of the Table in paragraph 1 |
|
|
|
Entry 1 |
| £14,768 | £17,278 |
Entry 2(a) |
| £6,080 | £7,114 |
Entry 2(b)(i) |
| £1,521 | £1,780 |
Entry 2(b)(ii) |
| £759 | £888 |
Entry 2(b)(iii) |
| £247 | £289 |
Entry 2(c)(i) |
| £666 | £779 |
Entry 2(c)(ii) |
| £333 | £390 |
Entry 2(c)(iii) |
| £123 | £144 |
Entry 2(d)(i) |
| £275 | £322 |
Entry 2(d)(ii) |
| £137 | £160 |
Entry 2(d)(iii) |
| £60 | £70 |
Entry 2(e) |
| £75 | £88 |
Paragraph 2(a) |
| £338 | £395 |
Paragraph 2(b) |
| £167 | £195 |
Paragraph 2(c) |
| £71 | £83 |
Paragraph 3(a) |
| £6,080 | £7,114 |
Paragraph 3(b) |
| £4,105 | £4,803 |
Paragraph 7(2) |
| £304 | £356 |
Paragraph 8(1) |
| £187 | £219 |
Paragraph 8(2) |
| £112 | £131 |
Paragraph 10 M30 |
| £200 | £234 |
1971 c. 69; as amended by section 21 of the Health and Medicines Act 1988 (c. 49). By virtue of section 1(3) of the 1971 Act, expressions used in that section have the same meaning as in the Medicines Act 1968 (c. 67); see therefore section 1(1) of the 1968 Act, as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388, by article 5 of, and the Schedule to, S.I. 1999/3142, and by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794, which contains a definition of “the Ministers” which is relevant to the powers being exercised in the making of these Regulations. See also regulation 9(12) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144), by virtue of which the references in section 1(1) and (2)(b) of the 1971 Act to a licence under Part II of the 1968 Act include reference to a marketing authorization under the 1994 Regulations.