Statutory Instruments
2001 No. 3751

MEDICINES
Medicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001

Made
22nd November 2001

Laid before Parliament
23rd November 2001

Coming into force
15th December 2001

The Minister of Agriculture, Fisheries and Food, the Secretary of State concerned with health in England, the Minister of Health, Social Services and Public Safety and the Minister of Agriculture and Rural Development, acting jointly, with the consent of the Treasury, in exercise of the powers conferred by section 1(1), (2) and (3)(b) of the Medicines Act 1971(1) and now vested in them(2) and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations(3), and the Secretary of State and the Minister of Agriculture, Fisheries and Food, being Ministers designated for the purpose of section 2(2) of the European Communities Act 1972(4) in relation to medicinal products and the common agricultural policy of the European Community, acting jointly, in exercise of the powers conferred on them by the said section 2(2), make the following Regulations—

Title, commencement and interpretation

1.—(1) These Regulations may be cited as the Medicines (Products of Animal Use—Fees) (Amendment No. 2) Regulations 2001 and shall come into force on 15th December 2001.

(2) In these Regulations “the Principal Regulations” means the Medicines (Products for Animal Use—Fees) Regulations 1998(5).

Amendment of fees specified in the principal Regulations

2.—(1) In respect of each provision of the principal Regulations specified in the entries in column (1) (the subject matter of which is described in column (2)) of Part I of the Schedule to these Regulations, where a fee is specified opposite that provision in column (3) there shall be substituted the fee specified opposite that provision in column (4).

(2) Paragraphs 1 and 2 of Part IV of the principal Regulations shall be replaced with the provisions of Part II of the Schedule to these Regulations.

(3) In Schedule 3 to the principal Regulations—

(a)in Part II, paragraph 1 (calculation of annual fees) there shall be substituted the figure “£275” for the figure “£269”, the figure “£19,600” for the figure “£18,956”, and the figure “0.46%” for the figure “0.451%.”;

(b)in Part II, paragraph 2 (calculation of annual fees) there shall be substituted the figure “0.7%” for the figure “0.677%”; and

(c)in Part III (calculation of annual fee—emergency vaccines) there shall be substituted the figure “0.7%” for the figure “0.677%”.

Transitional provisions

3.—(1) Subject to paragraphs (2) and (3) below, these Regulations shall not apply in respect of any application made before the date these Regulations come into force.

(2) These Regulations shall apply in relation to any fee payable in respect of any inspection made after these Regulations come into force in connection with any application made before they come into force.

(3) Where, in connection with an application to renew a marketing authorisation, licence or certificate made before these Regulations come into force, the authorisation, licence or certificate is due to expire on or after the date these Regulations come into force, regulation 17(4) and (5) of the principal Regulations shall apply to that application on the basis that the fee payable for the application following the coming into force of these Regulations is the appropriate fee payable.

(4) Nothing in these Regulations shall have effect in relation to an annual fee relating to a calendar year earlier than 2000.

Whitty
Parliamentary Under Secretary of State Ministry of Agriculture, Fisheries and Food
22 November 2002

Signed by authority of the Secretary of State for Health

Hunt
Parliamentary Under Secretary of State
Department of Health
16 November 2001

Bairbre De Brún
Minister of Health, Social Services and Public Safety
21 November 2001

Brid Rodgers
Minister of Agriculture and Rural Development
19 November 2001

We consent

Nick Ainger
Tony McNulty
Two of the Lords Commissioners of Her Majesty’s Treasury
19 November 2001

Regulation 2
SCHEDULE

PART I

Column (1)
Column (2)
Column (3)
Column (4)

Provision in the principal Regulations
Subject matter
Old fee
New fee

£
£

Regulation 12
Manufacturer’s licences: annual fees
205
210

Regulation 13
Wholesale dealer’s licences: annual fees

Regulation 13(1)
Turnover of £40,000 or more
410
420

Regulation 13(2)
Turnover of less than £40,000
205
210

Regulation 14
Registration of Homoeopathic Veterinary Medicinal Products

Regulation 14(3)
Alteration of dossier
90
95

SCHEDULE 1, PART II

FEES RELATING TO APPLICATIONS FOR THE GRANT OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER'S LICENCES, WHOLESALE DEALER'S LICENCES AND ANIMAL TEST CERTIFICATES

Paragraph 1, Table A, Column (2)
Fee for an application for a type A marketing authorisation

Entry 1
Major application
19,595
20,085

Entry 2
Complex application
11,370
11,655

Entry 3
Standard application
4,910
5,035

Entry 4
Abridged standard application
3,835
3,930

Entry 5
Simple application
1,385
1,400

Paragraph 1, Table A, Column (3)
Fee for an application for a type B marketing authorisation

Entry 1
Major application
10,815
11,085

Entry 2
Complex application
6,490
6,655

Entry 3
Standard application
3,245
3,325

Entry 5
Simple application
865
885

Paragraph 1, Table A, Column (4)
Fee for an application for a product licence

Entry 1
Major application
19,595
20,085

Entry 2
Complex application
11,370
11,655

Entry 3
Standard application
4,910
5,035

Entry 5
Simple application
1,365
1,400

Paragraph 2, Table B, Column (2)
Fee for an application for an Article 15.2 marketing authorisation

Entry 1
Major application
11,370
11,655

Entry 2
Complex application
4,910
5,035

Paragraph 3
Application for a marketing authorisation by holder of Article 15.2 marketing authorisation

Paragraph 3(a)
Major application previously made
8,225
8,430

Paragraph 3(b)
Complex application previously made
6,460
6,620

Paragraph 6
Manufacturer’s licences

Paragraph 6(1)(b)
Other cases
2,205
2,260

Paragraph 7
Wholesale dealer’s licences

Paragraph 7(1)
Application fee where anticipated turnover £40,000 or more
1,280
1,310

Paragraph 7(2)
Application fee where anticipated turnover less than £40,000
520
535

Paragraph 8
Animal test certificate applications in relation to biological products or for administration to non food-producing animals
270
275

Paragraph 8
Other animal test certificate applications
650
665

Paragraph 9
Marketing authorisation (parallel import)
1,530
1,570

SCHEDULE 1, PART III

FEES RELATING TO APPLICATIONS FOR ASSISTANCE IN CONNECTION WITH MUTUAL RECOGNITION APPLICATIONS

Paragraph 4, Table C, Column (2)
Basic fee

Entry 1
Major
3,515
3,605

Entry 2
Complex
2,350
2,410

Entry 3
Standard
1,015
1,040

Entry 4
Simple
340
350

Paragraph 4, Table C, Column (3)
Additional fee for the sixth and each additional member State

Entry 1
Major
760
780

Entry 2
Complex
370
380

Entry 3
Standard
190
195

Paragraph 5, Table D, Column (2)
Basic Fee

Entry 1
Category I application
8,625
8,840

Entry 2
Category II application
5,755
5,900

Entry 3
Category III application
4,600
4,715

Paragraph 5, Table D, Column (3)
Additional fee for the sixth and each additional member State

Entry 1
Category I application
1,080
1,105

Entry 2
Category II application
720
740

Entry 3
Category III application
575
590

SCHEDULE 1, PART IV

FEES RELATING TO APPLICATIONS FOR THE VARIATION OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER'S LICENCES, WHOLESALE DEALER'S LICENCES AND ANIMAL TEST CERTIFICATES

Paragraph 3, Table F, Column (2)
United Kingdom acting as the Reference Member State

Entry 1
Type I variation—Administrative
575
590

Entry 2
Type I variation—Scientific
2,300
2,360

Entry 3
Type 1 variation, Scientific—Type II procedure
3,785
3,880

Entry 4
Type II variation
8,050
8,250

Entry 5
Variation with extras
9,205
9,435

Paragraph 3, Table F, Column (3)
United Kingdom not acting as the Reference Member State

Entry 1
Type I variation—Administrative
110
115

Entry 2
Type I variation—Scientific
545
560

Entry 3
Type I variation, Scientific—Type II procedure
1,080
1,105

Entry 4
Type II variation
2,165
2,220

Entry 5
Variation with extras
3,850
3,945

Paragraph 5
Manufacturer’s licences

Paragraph 5(b)
Variation in any other case

Paragraph 5(b)(i)
Requiring assessment
390
400

Paragraph 5(b)(ii)
Not requiring assessment
130
135

Paragraph 6
Wholesale dealer’s licences

Paragraph 6(a)
Variation requiring assessment
390
400

Paragraph 6(b)
Variation not requiring assessment
130
135

Paragraph 7
Variation of animal test certificate
215
220

SCHEDULE 1, PART V
FEES RELATING TO APPLICATIONS FOR THE RENEWAL OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER'S LICENCES AND ANIMAL TEST CERTIFICATES

Paragraph 1
Marketing authorisations and product licences

Paragraph 1(b)
Herbal products
325
335

Paragraph 1(c)
Other cases
975
1,000

Paragraph 2
Manufacturer’s licences
95
100

Paragraph 3
Animal test certificates
95
100

SCHEDULE 2
FEES RELATING TO SITE INSPECTIONS

Paragraph 2(1), Table A, Column (2)

Entry 1
Supersite inspection
9,070
9,295

Entry 2
Major inspection
4,770
4,890

Entry 3
Standard inspection
3,415
3,500

Entry 4
Minor inspection
1,845
1,890

Paragraph 2(2), Table B, Column (2)

Entry 1
Supersite inspection
15,035
15,410

Entry 2
Major inspection
8,305
8,515

Entry 3
Standard inspection covering immunological Veterinary Medicinal Products
5,420
5,555

Entry 4
Other standard inspection
4,085
4,185

Entry 5
Minor inspection covering immunological Veterinary Medicinal Products
2,730
2,800

Entry 6
Other minor inspection
2,730
2,800

Paragraph 2(3), Table C, Column (2)

Entry 1
Supersite inspection
6,585
6,750

Entry 2
Major inspection
4,450
4,560

Entry 3
Standard inspection
2,180
2,235

Entry 4
Minor inspection
1,125
1,155

Paragraph 3(1)
Either or both of premises and procedures for quality control of a biological product which is not a dormant product
1,305
1,335

SCHEDULE 5, PART II
FEES RELATING TO APPLICATIONS FOR REGISTRATION OF HOMOEOPATHIC VETERINARY MEDICINAL PRODUCTS

Paragraph 1, Table, Column (2)
Fees for applications in respect of products prepared from not more than 5 homoeopathic stocks

Entry 1
Product both prepared solely from repeat stock and being of repeat formulation
110
115

Entry 2
Product which is either prepared solely from repeat stock or is of a repeat formulation
325
335

Entry 3
Any other application
545
560

Paragraph 1, Table, Column (3)
Fees for applications in respect of products prepared from more than 5 homoeopathic stocks

Entry 1
Product both prepared solely from repeat stock and being of repeat formulation
270
275

Entry 2
Product which is either prepared solely from repeat stock or is of a repeat formulation
485
495

Entry 3
Any other application
700
720

Paragraph 2

Equivalent product registered under Part II of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 or in an EEA State

Paragraph 2 (i)
Product prepared from not more than 5 homoeopathic stocks
110
115

Paragraph 2(ii)
Product prepared from more than 5 homoeopathic stocks
270
275

SCHEDULE 6
MARKETING AUTHORISATIONS, PRODUCT LICENCES AND ANIMAL TEST CERTIFICATES: FEES FOR REFERENCES TO THE VETERINARY PRODUCTS COMMITTEE OR TO THE MEDICINES COMMISSION

Paragraph 1, Table, Column (2)

Entry 1
Major application
1,540
1,580

Entry 2
Complex application
885
905

Entry 3
Standard application
410
420

Entry 4
Simple application
155
160

Paragraph 2
Animal test certificate
535
550

PART IIREPLACEMENT OF PARAGRAPHS 1 AND 2 OF PART IV OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS

1.  The application fee for a minor variation (Type 1) to a marketing authorisation (other than a mutually recognised marketing authorisation) as referred to in Annex 1 to Commission Regulation (EC) No. 541/95 (concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a member State (6)) shall be as follows:—

Fee

Type of application
£

1.
Change following modification(s) to the manufacturing authorisation
560

2.
Change in the name of the medicinal product (either invented name or common name)
560

3.
Change in the name and/or address of the marketing authorisation holder
220

4.
Replacement of an excipient with a comparable excipient (excluding adjuvants for vaccines and biologically derived excipients)
560

5.
Change in the colouring system of the product (addition, deletion or replacement of colourant(s))
560

6.
Change in the flavouring system of the product (addition, deletion or replacement of flavour(s))
560

7.
Change in coating weight of tablets or change in weight of capsule shells
560

8.
Change in the qualitative composition of immediate packaging material
560

9.
Deletion of an indication
560

10.
Deletion of a route of administration
560

10a.
Addition or replacement of measuring device for dosage forms
560

11.
Change in the manufacturer(s) of active substance
560

11a.
Change in name of manufacturer of active substance
220

11b.
Change in supplier of intermediate compound used in the manufacture of the active substance
560

12
Minor change of manufacturing process of the active substance
560

12a.
Change in specification of starting material or intermediate used in the manufacture of the active substance
560

13.
Batch size of active substance
560

14.
Change in specification of active substance
560

15.
Minor change in manufacture of the medicinal product
560

15a.
Change in in-process controls applied during the manufacture of the product
560

16.
Change in the batch size of finished product
560

17.
Change in specification of the medicinal product
560

18.
Synthesis or recovery of non-pharmacopoeial excipients which had been described in the original dossier
560

19.
Change in specification of excipients in the medicinal product (excluding adjuvants for vaccines)
560

20.
Extension of shelf life as foreseen at time of authorisation
560

20a.
Extension of the shelf life or retest period of the active substance
560

21.
Change in shelf life after first opening
560

22.
Change in shelf life after reconstitution
560

23.
Change in the storage conditions
560

24.
Change in test procedure of active substance
560

24a.
Change in test procedure for a starting material or intermediate used in the manufacture of the active substance
560

25.
Change in the test procedures of the medicinal product
560

26.
Changes to comply with supplements to pharmacopoeias
560

27.
Change in test procedures of non-pharmacopoeial excipients
560

28.
Change in test procedure of immediate packaging
560

29.
Change in test procedure of administrative device
560

30.
Change in pack size for a medicinal product
560

31.
Change in container shape
560

32.
Change of imprints, bossing or other markings (except scoring) on tablets or printing on capsules, including addition or changes of inks used for product marking
560

33.
Change of dimensions of tablets, capsules, suppositories or pessaries without change of quantitive composition and mean mass
560

34.
Change in the manufacturing process of a non proteinaceous component due to the subsequent introduction of a biotechnology step
560

2.  The application fee for any other variation to a marketing authorisation (other than a mutually recognised marketing authorisation), or for any variation to a product licence, shall be £2,220 except in the following cases, where the fee shall be the amount specified:—

Fee

Type of application
£

a.
Change which is made where there is identical supporting data relating to another product which is also being changed, all the products are from the same marketing authorisation holder and the change is identical to the first change and is made at the same time
220

b.
Change of distributor where no other aspects of the dossier are changed and the marketing authorisation holder remains the same
220

c.
Change of marketing authorisation holder where no other aspects of the dossier are changed
220

d.

Simple dosage instruction changes where the change is not the result of safety concerns, no new studies are required to support the change and the dose rate inmg/kg body weight remains the same

560

e.
Addition or change to user safety warnings where no other aspects of the dossier are changed, no user safety warnings are removed, no new studies are required to support the change and the proposed warnings serve to increase the protection of the user
560

f.
Corrections or simple text lay out changes to summary of product characteristics and/or product literature where the changes are not a result of safety concerns, no new studies are required to support the change and no other aspects of the dossier are changed
560

2A.  Notwithstanding the above, the fee for a variation where the licence relates solely to an emergency vaccine shall be £40 for each variation.

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Medicines (Products for Animal Use—Fees) Regulations 1998 (S.I. 1998/2428) as amended by the Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2000 (S.I. 2000/2250) and the Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2001 (S.I. 2001/1669) (“the principal Regulations”). The principal Regulations prescribe fees in connection with applications and inspections relating to:—
(a)marketing authorisations under the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (S.I. 1994/3142);
(b)licences and certificates granted under the Medicines Act 1968 in so far as they apply to medicinal products for animal use; and
(c)the registration of homoeopathic veterinary medicinal products.
Regulation 2 prescribes new fees in relation to the provision of the principal Regulations set out in column (1) of the Schedule to these Regulations. The fees in the principal Regulations are set out in column (3) and the new fees prescribed by these Regulations in column (4) of the Schedule.
It also amends Part II and III of Schedule 3 (calculation of annual fees) to the principal Regulations by prescribing new fees and, where the fee is charged on a percentage of turnover, new percentage amounts.
The average level of fees payable under these Regulations is increased by 2.5% in comparison with the principal Regulations.
Regulation 3 provides that the Regulations, subject to the exceptions in regulation 3(2) and (3), apply to applications made after the Regulations come into force and do not affect annual fees relating to a calendar year earlier than 2000.
The fee structure relating to variations for national marketing authorisations has been restructured to reflect operational procedures (Part II of the Schedule).
A Regulatory Impact Assessment has been prepared and a copy has been placed in the library of each House of Parliament. Copies may be obtained from the Veterinary Medicines Directorate, Woodham Lane, Addlestone, Surrey, KT15 3LS.


(1)
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 in that section have the same meaning as in the Medicines Act 1968 (c. 67) as amended by article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388). The expression “the Ministers” is defined in section 1(1) of the 1968 Act as so amended.

(2)
In the case of the Minister of Agriculture, Fisheries and Food (so far as concerns functions previously vested in the Secretaries of State respectively concerned with agriculture in Scotland and—in consequence of S.I. 1978/272—Wales), by virtue of articles 2(2) and 5 of, and the Schedule to, the Transfer of Functions (Medicines and Poisons) Order 1999 (S.I. 1999/3142); in the case of the Secretary of State concerned with health in England (so far as concerns functions previously vested in the Secretaries of State respectively concerned with health in Scotland and—in consequence of S.I. 1969/388—Wales), by virtue of articles 2(1) and 5 of, and the Schedule to, the Transfer of Functions (Medicines and Poisons) Order 1999; in the case of the Minister of Health, Social Services and Public Safety and the Minister of Agriculture and Rural Development, by virtue of section 95(5) of, and paragraph 10(1)(b) of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) and article 3(4) and (6) of the Departments (Northern Ireland) Order 1999 (S.I. 1999/283 (N.I. 1)).

(3)
See section 129(6) of the Medicines Act 1968 as extended to include Regulations made under the Medicines Act 1971 by section 1(3)(b) of that latter Act.

(4)
S.I. 1972/1811.

(5)
S.I. 1998/2428 as amended by S.I. 2000/2250 and S.I. 2001/1669.

(6)
OJ No. L55, 11.3.95, p. 7 as last amended by Commission Regulation (EC) No. 1146/98, OJ No. L159, 3.6.98, p.31.