The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 1999

Regulation 2

SCHEDULE SUBSTITUTION OF FEES

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	£190	£200
regulation 13	Wholesale dealer’s licences: annual fees
regulation 13(1)	Turnover of £40,000 or more	£380	£400
regulation 13(2)	Turnover of less than £40,000	£185	£200
regulation 14	Registration of Homoeopathic Veterinary Medicinal Products
regulation 14(2)	Renewal of registration	£75	£80
regulation 14(3)	Alteration of dossier	£85	£90
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	£18,120	£19,115
entry 2	Complex application	£10,515	£11,095
entry 3	Standard application	£4,540	£4,790
entry 4	Abridged standard application	£3,545	£3,740
entry 5	Simple application	£1,260	£1,330
paragraph 1, Table A, Column (3)	Fee for an application for a type B marketing authorisation
entry 1	Major application	£10,000	£10,550
entry 2	Complex application	£6,000	£6,330
entry 3	Standard application	£3,000	£3,165
entry 5	Simple application	£800	£845
paragraph 1, Table A, Column (4)	Fee for an application for a product licence
entry 1	Major application	£18,120	£19,115
entry 2	Complex application	£10,515	£11,095
entry 3	Standard application	£4,540	£4,790
entry 5	Simple application	£1,260	£1,330
paragraph 2, Table B, Column (2)	Fee for an application for an Article 15.2 marketing authorisation
entry 1	Major application	£10,515	£11,095
entry 2	Complex application	£4,540	£4,790
paragraph 3	Application for a marketing authorisation by holder of Article 15.2 marketing authorisation
paragraph 3(a)	Major application previously made	£7,605	£8,020
paragraph 3(b)	Complex application previously made	£5,975	£6,305
paragraph 6	Manufacturer’s licences
paragraph 6(1)(a)	Applications in respect of which paragraph 6(2) applies	£95	£100
paragraph 6(1)(b)	Other cases	£2,040	£2,150
paragraph 7	Wholesale dealer’s licences
paragraph 7(1)	Application fee where anticipated turnover £40,000 or more	£1,185	£1,250
paragraph 7(2)	Application fee where anticipated turnover less than £40,000	£480	£505
paragraph 8	Animal test certificate applications in relation to biological products or for administration to non food-producing animals	£250	£265
paragraph 8	Other animal test certificate applications	£600	£635
paragraph 9	Marketing authorisation (parallel import)	£1,415	£1,495
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	£3,250	£3,430
entry 2	Complex	£2,175	£2,295
entry 3	Standard	£940	£990
entry 4	Simple	£315	£330
paragraph 4, Table C, Column (3)	Additional fee for the sixth and each additional member State
entry 1	Major	£700	£740
entry 2	Complex	£340	£360
entry 3	Standard	£175	£185
entry 4	Simple	£60	£65
paragraph 5, Table D, Column (2)	Basic fee
entry 1	Category I application	£7,975	£8,415
entry 2	Category II application	£5,320	£5,615
entry 3	Category III application	£4,255	£4,490
paragraph 5, Table D, Column (3)	Additional fee for the sixth and each additional member State
entry 1	Category I application	£1,000	£1,055
entry 2	Category II application	£665	£700
entry 3	Category III application	£530	£560
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 1	Marketing authorisations (other than mutually recognised marketing authorisations) and product licences—complex application for variation	£2,000	£2,110
paragraph 2, Table E, Column (2)	Marketing authorisations (other than mutually recognised marketing authorisations) and product licences—application for variation other than complex application
entry 1	Variation requiring assessment	£500	£530
entry 2	Variation not requiring assessment	£200	£210
paragraph 3, Table F, Column (2)	United Kingdom acting as the Reference Member State
entry 1	Type I variation—Administrative	£530	£560
entry 2	Type I variation, Scientific—	£2,130	£2,245
entry 3	Type I variation, Scientific—	£3,500	£3,695
	Type II procedure
entry 4	Type II variation	£7,445	£7,855
entry 5	Variation with extras	£8,510	£8,980
paragraph 3, Table F, Column (3)	United Kingdom not acting as the Reference Member State
entry 1	Type I variation—Administrative	£100	£105
entry 2	Type I variation—Scientific	£500	£530
entry 3	Type I variation, Scientific-Type II procedure	£1,000	£1,055
entry 4	Type II variation	£2,000	£2,110
entry 5	Variation with extras	£3,560	£3,755
paragraph 5	Manufacturer’s licences
paragraph 5(a)	Variation of manufacturer’s licence referred to in Schedule 1, Part II, paragraph 6(2)	£95	£100
paragraph 5(b)	Variation in any other case
paragraph 5(b)(i)	Requiring assessment	£360	£380
paragraph 5(b)(ii)	Not requiring assessment	£120	£125
paragraph 6	Wholesale dealer’s licences
paragraph 6(a)	Variation requiring assessment	£360	£380
paragraph 6(b)	Variation not requiring assessment	£120	£125
paragraph 7	Variation of animal test certificate	£200	£210
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	£300	£315
paragraph 1(c)	Other cases	£900	£950
paragraph 2	Manufacturer’s licences	£90	£95
paragraph 3	Animal test certificates	£90	£95
SCHEDULE 2	FESS REALTING TO SITE INSPECTIONS
paragraph 2(1), Table A, Column (2)
entry 1	Supersite inspection	£8,390	£8,850
entry 2	Major inspection	£4,415	£4,655
entry 3	Standard inspection	£3,155	£3,330
entry 4	Minor inspection	£1,705	£1,800
paragraph 2(2), Table B, Column (2)
entry 1	Supersite inspection	£13,905	£14,670
entry 2	Major inspection	£7,680	£8,100
entry 3	Standard inspection covering immunological Veterinary Medicinal Products	£5,010	£5,285
entry 4	Other standard inspection	£3,775	£3,985
entry 5	Minor inspection covering immunological Veterinary Medicinal Products	£2,580	£2,720
entry 6	Other minor inspection	£2,525	£2,665
paragraph 2(3), Table C, Column (2)
entry 1	Supersite inspection	£6,090	£6,425
entry 2	Major inspection	£4,115	£4,340
entry 3	Standard inspection	£2,015	£2,125
entry 4	Minor inspection	£1,035	£1,095
paragraph 2(4)(b)	Site limited solely to manufacture and assembly of emergency vaccines	£100	£105
paragraph 3(1)	Either or both of premises and procedures for quality control of a biological product which is not a dormant product	£1,210	£1,275
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	£100	£105
entry 2	Product which is either prepared solely from repeat stock or is of a repeat formulation	£300	£315
entry 3	Any other application	£500	£530
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	£250	£265
entry 2	Product which is either prepared solely from repeat stock or is of a repeat formulation	£450	£475
entry 3	Any other application	£650	£685
paragraph 2	Equivalent product registered under Part II of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(1) or in an EEA State
paragraph 2(i)	Product prepared from not more than 5 homoeopathic stocks	£100	£105
paragraph 2(ii)	Product prepared from more than 5 homoeopathic stocks	£250	£265
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	£1,420	£1,500
entry 2	Complex application	£820	£865
entry 3	Standard application	£380	£400
entry 4	Simple application	£140	£150
paragraph 2	Animal test certificate	£495	£520

(1)

S.I. 1994/105, amended by S.I. 1994/899, 1995/541, 1996/482, 1998/574.