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 19711 or, as the case may be, the powers conferred by those provisions and now vested in them2.
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 19723 and section 56(1) and (2) of the Finance Act 19734. The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products5.
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 19686, 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.
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) Regulations19957;
“the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 19958; and
“the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 19949.
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) 10, 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) 11, 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) 12, 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 licences13, 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 registration14—
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
Column (1) | Column (2) | Column (3) | Column (4) |
|---|---|---|---|
Provision in the General Fees Regulations | Subject Matter | Old Amount | New Amount |
Regulation 3B15 | 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 3BA16 | Capital fees for advertising advice meetings | £1,346 | £1,486 |
Regulation 3BB17 | Capital fees for pharmacovigilance advice meeting | ||
Paragraph (a) | £1,690 | £1,866 | |
Paragraph (b) | £1,346 | £1,486 | |
Regulation 3BC18 | Capital fees for advice meetings concerning labelling and leaflets | £1,012 | £1,118 |
Regulation 3BD19 | 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 120 | |||
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 721 | |||
Entry 1 | £610 | £674 | |
Entry 2 | £2,700 | £2,982 | |
Entry 3 | £2,250 | £2,485 | |
Entry 4 | £140 | £155 | |
Part IIA of Schedule 122 | 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 123 | Capital fees for assessment of labels and leaflets | ||
Paragraph 2(a) | £430 | £472 | |
Paragraph 2(b) | £273 | £300 | |
Part IV of Schedule 124 | 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)25 | |||
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)26 | |||
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)27 | £3,542 | £5,057 | |
Paragraph 5A(b) | £5,060 | £7,225 | |
Paragraph 5A(c) | £10,120 | £14,450 | |
Paragraph 5D(1)(a)28 | £600 | £800 | |
Paragraph 5D(1)(b) | £1,100 | £1,300 | |
Paragraph 5D(1)(c) | £1,100 | £1,300 | |
Paragraph 7(4)(a)29 | £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 1030 | £200 | £234 |
(This note is not part of the Regulations)