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

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Source: https://www.legislation.gov.uk/uksi/2001/3751/schedule/part/I (the official version)
Page: https://openlegislation.uk/medicines-products-for-animal-usefees-amendment-no-2-regulations-2001/schedule/part-I
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.