2000 No. 592
The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000
Made
Laid before Parliament
Coming into force
The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 19721 in relation to medicinal products2, in exercise of the powers conferred upon him by the said section 2(2), the Secretary of State, with the consent of the Treasury, in exercise of the powers conferred upon him by section 56(1) and (2) of the Finance Act 19733, the Secretary of State concerned with health in England, the Minister of Agriculture, Fisheries and Food, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, acting jointly and with the consent of the Treasury, in exercise of powers conferred upon them by section 1(1) and (2) of the Medicines Act 19714, or, as the case may be, powers conferred by those provisions and now vested in them5, and in each case in exercise of all other powers respectively enabling them in that behalf, after consultation in accordance with section 129(6) of the Medicines Act 19686, as extended by section 1(3)(b) of the Medicines Act 1971, with such organisations as appear to them to be representative of interests likely to be substantially affected, hereby make the following Regulations:–
Citation, commencement and interpretation1
1
These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000 and shall come into force on 1st April 2000.
Amendment of the Homoeopathic Products Regulations2
1
In regulation 14 of the Homoeopathic Products Regulations9 (fees for variations of certificates)–
a
in paragraph (1)(a), for “£80” there shall be substituted “ £90”;
b
in paragraph (1)(b)(i), for “£80” there shall be substituted “ £90”;
c
in paragraph (1)(b)(ii), for “£40” there shall be substituted “ £45”;
d
in paragraph (2)(a), for “£155” there shall be substituted “ £176”;
e
in paragraph (2)(b)(i), for “£155” there shall be substituted “ £176”;
f
in paragraph (2)(b)(ii), for “£155” there shall be substituted “ £176”;
g
in paragraph (2)(b)(iii), for “£77.50” there shall be substituted “ £88”; and
h
in paragraph (2)(b)(iv), for “£38.75” there shall be substituted “ £44”.
2
In regulation 15(1) of the Homoeopathic Products Regulations10 (fee payable by holders of certificates), for “£10” there shall be substituted “£11”.
3
In the Table in Schedule 2 to the Homoeopathic Products Regulations11 (fees for applications for the grant of certificates of registration)–
a
in column (2) (fees for applications in respect of products prepared from not more than 5 homoeopathic stocks)–
i
for “£95” there shall be substituted “£108”,
ii
for “£285” there shall be substituted “£325”, and
iii
for “£470” there shall be substituted “£535”; and
b
in column (3) (fees for other applications)–
i
for “£235” there shall be substituted “£267”,
ii
for “£420” there shall be substituted “£478”, and
iii
for “£615” there shall be substituted “£701”.
Amendment of regulation 3 of the Medical Devices (Consultation Requirements) (Fees) Regulations 19953
In regulation 3 of the Medical Devices (Consultation Requirements) (Fees) Regulations 199512 (fees)–
a
in paragraph (1)(a), for “£2,005” there shall be substituted “ £2,285”;
b
in paragraph (1)(b), for “£5,620” there shall be substituted “ £6,406”;
c
in paragraph (2)(a), for “£500” there shall be substituted “ £570”;
d
in paragraph (2)(b), for “£1,400” there shall be substituted “ £1,596”;
e
in paragraph (3)(a), for “£2,005” there shall be substituted “ £2,285”;
f
in paragraph (3)(b), for “£5,620” there shall be substituted “ £6,406”;
g
in paragraph (4)(a), for “£500” there shall be substituted “ £570”;
h
in paragraph (4)(b), for “£1,400” there shall be substituted “ £1,596”;
i
in paragraph (5)(a), for “£25,725” there shall be substituted “ £29,326”; and
j
in paragraph (5)(b), for “£6,425” there shall be substituted “ £7,324”.
Amendment of the General Fees Regulations4
1
In paragraph (1) of regulation 2 of the General Fees Regulations13 (interpretation), after the definition of “medicinal product” there shall be inserted the following definition–
“orphan medicinal product” has the meaning given in article 2(b) of Regulation (EC) No. 141/200014 of the European Parliament and of the Council of 16th December 1999 on orphan medicinal products;
2
In Column 1 of the Table set out in paragraph 1 of Part II of Schedule 1 to the General Fees Regulations (which contains a list of types of application for a marketing authorization in connection with which a capital fee is payable), for the words “any such application” in entry 1(a) there shall be substituted the words “any application relating to an orphan medicinal product or a product”.
3
In the following provisions–
a
paragraphs 4 and 5 of Part III of Schedule 1 to the General Fees Regulations (which relate to the capital fee payable for the first application for a variation of a marketing authorization granted in respect of a limited use drug); and
b
paragraph 1 of Part I of Schedule 3 to the General Fees Regulations16 (interpretation of Schedule 3),
after the words “Directive 75/318/EEC15 applies”, at each place where they occur, there shall be inserted the words “or which is in respect of an orphan medicinal product”.
4
In paragraph 4 of Part III of Schedule 3 to the General Fees Regulations17 (which relates to the periodic fees payable in connection with the holding of certain marketing authorizations)–
a
before sub-paragraph (3) there shall be inserted the following sub-paragraph–
2A
The fee payable in respect of–
a
a new active substance in accordance with entry 1 of the Table set out in paragraph 1; or
b
a derivative of a new active substance in accordance with paragraph 3,
shall only be payable for the five relevant fee periods following the fee period during which the marketing authorization was granted.
b
in sub-paragraph (4)(a), for the words “each fee period mentioned in sub-paragraph (1),” there shall be substituted the words “the five relevant fee periods following the fee period during which the marketing authorization was granted,”;
c
in sub-paragraph (5), for the words “sub-paragraphs (1), (2) and (3) ” there shall be substituted the words “sub-paragraphs (2A) to (4)”; and
d
for sub-paragraph (6) there shall be substituted the following sub-paragraph–
6
In connection with the holding of a marketing authorization in respect of a limited use drug or a derivative of a limited use drug–
a
where turnover exceeds £200,000, until the expiry of the five relevant fee periods following the fee period during which the marketing authorization was granted, the periodic fee payable shall be the fee that would be payable if the drug were, respectively, a new active substance or a derivative of a new active substance;
b
where turnover does not exceed £200,000 or where a periodic fee has been payable in respect of the limited use drug or derivative of a limited use drug for five relevant fee periods following the fee period during which the marketing authorization was granted, the periodic fee payable shall be the fee payable in respect of a prescription only medicine in accordance with entry 2(b)(i) of the Table set out in paragraph 1.
5
In each provision of the General Fees Regulations specified in the entries in column (1) (the content of which is described in column (2)) of the Schedule to these Regulations, for the amount specified opposite that provision in column (3) of that Schedule there shall be substituted the amount specified opposite that provision in column (4) of that Schedule.
Revocation5
Regulations 2(1)(a) to (e) and (2), 3 and 4(2) of Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 199918 are hereby revoked.
Signed by authority of the Secretary of State for Health
We consent,
SCHEDULE
Column (1) | Column (2) | Column (3) | Column (4) |
|---|---|---|---|
Provision in the General Fees Regulations | Subject matter | Old amount | New amount |
Regulation 6 | Applications for certificates by exporters of medicinal products | ||
Paragraph (1)(a) | £85 | £96 | |
Paragraph (1)(b) | £30 | £34 | |
Paragraph (1)(c)(i) | £30 | £34 | |
Paragraph (1)(c)(ii) | £15 | £17 | |
Regulation 10 | Renewals of clinical trial certificates | £1,575 | £1,795 |
Regulation 11(1) | Renewals of certain manufacturer’s licences | £90 | £102 |
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) | £18,900 | £21,545 | |
Entry 1(b) | £40,425 | £46,085 | |
Entry 1(c) | £57,750 | £65,835 | |
Entry 2(a) | £11,025 | £12,568 | |
Entry 2(b) | £15,750 | £17,955 | |
Entry 3(a) | £4,040 | £4,605 | |
Entry 3(b) | £5,775 | £6,584 | |
Entry 4 | £1,575 | £1,795 | |
Entry 5 | £1,050 | £1,196 | |
Entry 6 | £260 | £296 | |
Paragraph 5(1)(a) | £100 | £114 | |
Paragraph 5(1)(b) | £190 | £216 | |
Paragraph 5(1)(c) | £1,730 | £1,972 | |
Paragraph 6(1) | £680 | £775 | |
Paragraph 6(2) | £500 | £570 | |
Paragraph 6(4) | £220 | £250 | |
Paragraph 7 | £12,180 | £13,885 | |
Part III of Schedule 1 | Capital fees for applications for variations of authorizations, licences and certificates | ||
Paragraph 2(a) | £155 | £176 | |
Paragraph 2(b) | £355 | £404 | |
Paragraph 2(c) | £5,250 | £5,984 | |
Paragraph 3(a) | £240 | £274 | |
Paragraph 3(b) | £430 | £490 | |
Paragraph 3(c) | £8,190 | £9,336 | |
Paragraph 6(a) | £100 | £114 | |
Paragraph 6(b) | £210 | £239 | |
Paragraph 7(a) | £95 | £108 | |
Paragraph 7(b) | £190 | £216 | |
Paragraph 8 | £95 | £108 | |
Paragraph 9 | £220 | £250 | |
Paragraph 10 | £95 | £108 | |
Paragraph 11 | £155 | £176 | |
Paragraph 12 | £80 | £90 | |
Schedule 2 | Fees for inspections | ||
Paragraph 2(a)(i) | £1,640 | £1,870 | |
Paragraph 2(a)(ii) | £3,045 | £3,470 | |
Paragraph 2(a)(iii) | £3,675 | £4,190 | |
Paragraph 2(a)(iv) | £6,300 | £7,182 | |
Paragraph 2(b)(i) | £1,785 | £2,034 | |
Paragraph 2(b)(ii) | £3,675 | £4,190 | |
Paragraph 2(b)(iii) | £5,775 | £6,582 | |
Paragraph 2(b)(iv) | £10,500 | £11,970 | |
Paragraph 2(c)(i) | £630 | £718 | |
Paragraph 2(c)(ii) | £1,764 | £2,010 | |
Paragraph 2(c)(iii) | £2,635 | £3,003 | |
Paragraph 2(c)(iv) | £4,935 | £5,625 | |
Paragraph 2(d) | £120 | £136 | |
Paragraph 5(1) | £330 | £376 | |
Paragraph 5(1) | £725 | £826 | |
Part III of Schedule 3 | Periodic fees for marketing authorizations and licences | ||
In column 2 of the Table in paragraph 1 | |||
Entry 1 | £10,710 | £12,209 | |
Entry 2(a) | £4,200 | £4,788 | |
Entry 2(b)(i) | £1,050 | £1,197 | |
Entry 2(b)(ii) | £525 | £598 | |
Entry 2(b)(iii) | £170 | £194 | |
Entry 2(c)(i) | £460 | £524 | |
Entry 2(c)(ii) | £230 | £262 | |
Entry 2(c)(iii) | £85 | £97 | |
Entry 2(d)(i) | £190 | £216 | |
Entry 2(d)(ii) | £95 | £108 | |
Entry 2(d)(iii) | £42 | £48 | |
Entry 2(e) | £52 | £59 | |
Paragraph 2(a) | £235 | £268 | |
Paragraph 2(b) | £115 | £131 | |
Paragraph 2(c) | £48 | £55 | |
Paragraph 3(a) | £4,200 | £4,788 | |
Paragraph 3(b) | £2,835 | £3,232 | |
Paragraph 7 | £210 | £239 | |
Paragraph 8(1) | £130 | £148 | |
Paragraph 8(2) | £78 | £89 |
(This note is not part of the Regulations)