1999 No. 566
The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999
Made
Laid before Parliament
Coming into force
The Secretary of State and the Department of Health and Social Services in Northern Ireland, being a Minister and a government department 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 them 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 Secretaries of State concerned with health and agriculture in Wales and Scotland respectively, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, 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 1999 and shall come into force on 1st April 1999.
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 “£75” there shall be substituted “£80”;
b
in paragraph (1)(b)(i), for “£75” there shall be substituted “£80”;
c
in paragraph (1)(b)(ii), for “£37.50” there shall be substituted “£40”;
d
in paragraph (2)(a), for “£150” there shall be substituted “£155”;
e
in paragraph (2)(b)(i), for “£150” there shall be substituted “£155”; and
f
in paragraph (2)(b), for heads (ii) and (iii) there shall be substituted the following heads–
ii
in respect of each other application so considered, where further medical, technical or scientific assessment is required, a fee of £155,
iii
in respect of the second to thirtieth applications so considered, where no further medical, technical or scientific assessment is required, a fee of £77.50, and
iv
in respect of each other application so considered, where no further medical, technical or scientific assessment is required, a fee of £38.75.
2
In the Table in Schedule 2 to the Homoeopathic Products Regulations (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 “£90” there shall be substituted “£95”,
ii
for “£270” there shall be substituted “£285”, and
iii
for “£450” there shall be substituted “£470”; and
b
in column (3) (fees for other applications)–
i
for “£225” there shall be substituted “£235”,
ii
for “£400” there shall be substituted “£420”, and
iii
for “£585” there shall be substituted “£615”.
Amendment of regulation 3 of the Medical Devices (Consultation Requirements) (Fees) Regulations 19953
In regulation 3 of the Medical Devices (Consultation Requirements) (Fees) Regulations 199510 (fees)–
a
in paragraph (1)(a), for “£1,910” there shall be substituted “£2,005”;
b
in paragraph (1)(b), for “£5,355” there shall be substituted “£5,620”;
c
in paragraph (2)(a), for “£475” there shall be substituted “£500”;
d
in paragraph (2)(b), for “£1,335” there shall be substituted “£1,400”;
e
in paragraph (3)(a), for “£1,910” there shall be substituted “£2,005”;
f
in paragraph (3)(b), for “£5,355” there shall be substituted “£5,620”;
g
in paragraph (4)(a), for “£475” there shall be substituted “£500”;
h
in paragraph (4)(b), for “£1,335” there shall be substituted “£1,400”;
i
in paragraph (5)(a), for “£24,500” there shall be substituted “£25,725”; and
j
in paragraph (5)(b), for “£6,120” there shall be substituted “£6,425”.
Amendment of the General Fees Regulations4
1
In paragraph 6(a) of Part III of Schedule 1 to the General Fees Regulations (capital fees for applications for, and variations to, marketing authorizations, licences and certificates—fees payable in connection with an application for variation of a marketing authorization (parallel import)), after head (vi)11 there shall be inserted the following head–
vii
subject to paragraph 6(b) of Schedule 5, a change consequential upon any or any combination of the following–
aa
a change of ownership of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,
bb
a change to the number of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,
cc
a change to the name of the holder of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,
dd
a change to the address of the holder of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,
ee
a change of ownership of the marketing authorization for the product in the country where the product originates,
ff
a change to the number of the marketing authorization for the product in the country where the product originates,
gg
a change to the name of the holder of the marketing authorization for the product in the country where the product originates,
hh
a change to the address of the holder of the marketing authorization for the product in the country where the product originates,
where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise,
2
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
Regulation 2(5) and 3 of the Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 199812 are hereby revoked.
Signed by authority of the Secretary of State for Health
Signed by authority of the Secretary of State for Wales
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on
We consent,
SCHEDULE
Column (1) | Column (2) | Column (3) | Column (4) |
|---|---|---|---|
Provision in the General Regulations | Subject matter | Old amount | New amount |
Regulation 6 | Applications for certificates by exporters of medicinal products | ||
Regulation 6(1)(a) | £80 | £85 | |
Regulation 6(1)(c)(ii) | £14 | £15 | |
Regulation 10 | Renewals of clinical trial certificates | £1,500 | £1,575 |
Regulation 11(1) | Renewals of certain manufacturers' licences | £85 | £90 |
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) | £18,000 | £18,900 | |
Entry 1(b) | £38,500 | £40,425 | |
Entry 1(c) | £55,000 | £57,750 | |
Entry 2(a) | £10,500 | £11,025 | |
Entry 2(b) | £15,000 | £15,750 | |
Entry 3(a) | £3,850 | £4,040 | |
Entry 3(b) | £5,500 | £5,775 | |
Entry 4 | £1,500 | £1,575 | |
Entry 5 | £1,000 | £1,050 | |
Entry 6 | £250 | £260 | |
Paragraph 5(1)(a) | £95 | £100 | |
Paragraph 5(1)(b) | £180 | £190 | |
Paragraph 5(1)(c) | £1,650 | £1,730 | |
Paragraph 6(1) | £650 | £680 | |
Paragraph 6(2) | £475 | £500 | |
Paragraph 6(4) | £210 | £220 | |
Paragraph 7 | £11,600 | £12,180 | |
Part III of Schedule 1 | Capital fees for applications for variations of authorizations, licences and certificates | ||
Paragraph 2(a) | £150 | £155 | |
Paragraph 2(b) | £340 | £355 | |
Paragraph 2(c) | £5,000 | £5,250 | |
Paragraph 3(a) | £230 | £240 | |
Paragraph 3(b) | £410 | £430 | |
Paragraph 3(c) | £7,800 | £8,190 | |
Paragraph 6(a) | £95 | £100 | |
Paragraph 6(b) | £200 | £210 | |
Paragraph 7(a) | £90 | £95 | |
Paragraph 7(b) | £180 | £190 | |
Paragraph 8 | £90 | £95 | |
Paragraph 9 | £210 | £220 | |
Paragraph 10 | £90 | £95 | |
Paragraph 11 | £150 | £155 | |
Paragraph 12 | £75 | £80 | |
Schedule 2 | Fees for inspections | ||
Paragraph 2(a)(i) | £1,560 | £1,640 | |
Paragraph 2(a)(ii) | £2,900 | £3,045 | |
Paragraph 2(a)(iii) | £3,500 | £3,675 | |
Paragraph 2(a)(iv) | £6,000 | £6,300 | |
Paragraph 2(b)(i) | £1,700 | £1,785 | |
Paragraph 2(b)(ii) | £3,500 | £3,675 | |
Paragraph 2(b)(iii) | £5,500 | £5,775 | |
Paragraph 2(b)(iv) | £10,000 | £10,500 | |
Paragraph 2(c)(i) | £600 | £630 | |
Paragraph 2(c)(ii) | £1,680 | £1,764 | |
Paragraph 2(c)(iii) | £2,510 | £2,635 | |
Paragraph 2(c)(iv) | £4,700 | £4,935 | |
Paragraph 2(d) | £115 | £120 | |
Paragraph 5(1) | £315 | £330 | |
Paragraph 5(1) | £690 | £725 | |
Part III of Schedule 3 | Periodic fees for marketing authorizations and licences | ||
In column 2 of the table in paragraph 1 | |||
Entry 1 | £10,200 | £10,710 | |
Entry 2(a) | £4,000 | £4,200 | |
Entry 2(b)(i) | £1,000 | £1,050 | |
Entry 2(b)(ii) | £500 | £525 | |
Entry 2(b)(iii) | £165 | £170 | |
Entry 2(c)(i) | £440 | £460 | |
Entry 2(c)(ii) | £220 | £230 | |
Entry 2(c)(iii) | £80 | £85 | |
Entry 2(d)(i) | £180 | £190 | |
Entry 2(d)(ii) | £90 | £95 | |
Entry 2(d)(iii) | £40 | £42 | |
Entry 2(e) | £50 | £52 | |
Paragraph 2(a) | £225 | £235 | |
Paragraph 2(b) | £110 | £115 | |
Paragraph 2(c) | £45 | £48 | |
Paragraph 3(a) | £4,000 | £4,200 | |
Paragraph 3(b) | £2,700 | £2,835 | |
Paragraph 7 | £200 | £210 | |
Paragraph 8(1) | £125 | £130 | |
Paragraph 8(2) | £75 | £78 |
(This note is not part of the Regulations)