1999 No. 566

MEDICINES
FEES AND CHARGES

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 1972F1 in relation to medicinal productsF2, 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 1973F3, 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 1971F4, or, as the case may be, powers conferred by those provisions and now vested in themF5, 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 1968F6, 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:–

Annotations:
Amendments (Textual)
F4

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) as amended by the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388):see therefore section 1(1) of the 1968 Act, as so amended, 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 those Regulations.

F5

In the case of the Secretaries of State concerned with health in England and in Wales, by virtue of article 2(2) of and Schedule 1 to the Transfer of Functions (Wales) Order 1969; in the case of the Secretary of State concerned with agriculture in Wales, by virtue of article 2(3) of and Schedule 1 to the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272); in the case of the Northern Ireland Departments, by virtue of section 40 of and Schedule 5 to the Northern Ireland Constitution Act 1973 (c.36) and section 1(3) of and paragraph 2(1)(b) of Schedule 1 to the Northern Ireland Act 1974 (c.28).

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.

2

In these Regulations–

  • “the General Fees Regulations" means the Medicines (Products for Human Use—Fees) Regulations 1995 F7;

  • “the Homoeopathic Products Regulations" means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 F8.

Amendment of the Homoeopathic Products Regulations2

1

In regulation 14 of the Homoeopathic Products Regulations F9 (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 ”.

Annotations:
Amendments (Textual)
F9

See regulation 2(3) of S.I. 1998/574.

Amendment of regulation 3 of the Medical Devices (Consultation Requirements) (Fees) Regulations 19953

In regulation 3 of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 F10 (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) F11 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.

Annotations:
Amendments (Textual)
F11

Inserted by regulation 5(4) of S.I. 1996/683.

Revocation5

Regulation 2(5) and 3 of the Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998 F12 are hereby revoked.

Signed by authority of the Secretary of State for Health

HaymanParliamentary Under Secretary of State,Department of Health

Signed by authority of the Secretary of State for Wales

Jon Owen JonesParliamentary Under Secretary of State, Welsh Office
Sam GalbraithParliamentary Under Secretary of State, Scottish Office
Jeff RookerMinister of State, Ministry of Agriculture, Fisheries and Food

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on

D.C. GowdyPermanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on

P. SmallPermanent Secretary

We consent,

Bob Ainsworth Jim DowdTwo of the Lords Commissioners of Her Majesty’s Treasury

SCHEDULE

Regulation 4(2)

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)

These Regulations further amend the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Products Regulations"), the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (“the Consultation Requirements Regulations") and the Medicines (Products for Human Use—Fees) Regulations 1995 (“the General Fees Regulations").

The Homoeopathic Products Regulations implemented in part Council Directive 92/73/EECF13 by introducing a new registration procedure for the marketing of certain homoeopathic medicinal products for human use. Regulation 2 of these Regulations makes further amendments to the Homoeopathic Products Regulations: introducing further discounts in respect of the fees payable for multiple identical applications for standard variations of certificates of registration by providing for a reduction of 75% in certain cases; and otherwise increasing the level of the capital fees payable in respect of applications for the grant of certificates of registration and for variations by an average overall of 5%.

The Consultation Requirements Regulations prescribe the fees which are payable where a notified body consults the competent body in accordance with Council Directive 93/42/EECF14 concerning medical devices. Regulation 3 of these Regulations amends regulation 3 of the Consultation Requirements Regulations by increasing the amounts of all the fees specified in those Regulations by an average overall of 5%.

The General Fees Regulations make provision for the fees payable under the Medicines Act 1971 relating to marketing authorizations, licences and certificates in respect of medicinal products for human use. Regulation 4(1) of these Regulations amends Part III of Schedule 1 to the General Fees Regulations in order to widen the category of applications for variations of marketing authorizations (parallel import) which attract the lower level fee. There is also a package of changes relating to the levels of: the capital fees payable for applications for marketing authorizations, manufacturers’ licences, wholesale dealers’ licences, clinical trial certificates and export certificates; capital fees for variations and renewals of such authorizations, licences and certificates; periodic fees payable in connection with the holding of certain authorizations and licences; and fees payable in connection with site inspections (regulation 4(2) and the Schedule). Fees have been increased by an average overall of 5%.

Regulation 5 revokes two provisions which are spent as a result of the coming into force of these Regulations.

A Regulatory Impact Appraisal in relation to these Regulations has been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medicines Control Agency, Room 2102, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.