
1 

(1) These Regulations may be cited as the Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2000 and shall come into force on 1st October 2000.
(2) In these Regulations “the principal Regulations” means the Medicines (Products for Animal Use—Fees) Regulations 1998.
(3) Unless the context otherwise requires, expressions used in these Regulations shall have the same meaning as in the principal Regulations.
2 
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 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).
3 

(1) In Schedule 3 to the principal Regulations—
(a) in Part II, paragraph 1 (calculation of annual fees) there shall be substituted the figure “£269” for the figure “£262”, the figure “ £18,956” for the figure “£18,480”, and the figure “ 0.451%” for the figure “0.44%”;
(b) in Part II, paragraph 2 (calculation of annual fees) there shall be substituted the figure “0.677%” for the figure “0.66%”; and
(c) in Part III (calculation of annual fee—emergency vaccines) there shall be substituted the figure “0.677%” for the figure “0.66%”.
4 

(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 1999.
Hayman
Minister of State, Ministry of Agriculture, Fisheries and Food
1st August 2000Signed by authority of the Secretary of State for Health
Hunt
Parliamentary Under Secretary of State,
Department of Health
5th August 2000Bairbre de Brún
Minister of Health, Social Services and Public Safety
8th August 2000Signed by authority of the Minister of Agriculture and Rural Development
Peter Small
Permanent Secretary,
Department of Agriculture and Rural Development
8th August 2000We consent,
Jim Dowd and Bob Ainsworth
Two of the Lords Commissioners of Her Majesty’s Treasury
10th August 2000
SCHEDULE
Regulation 2


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 £200 £205
regulation 13 Wholesale dealer’s licences: annual fees
regulation 13(1) Turnover of £40,000 or more £400 £410
regulation 13(2) Turnover of less than £40,000 £200 £205
regulation 14 Registration of Homoeopathic Veterinary Medicinal Products
regulation 14(2) Renewal of registration £80 £80
regulation 14(3) Alteration of dossier £90 £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 £19,115 £19,595
entry 2 Complex application £11,095 £11,370
entry 3 Standard application £4,790 £4,910
entry 4 Abridged standard application £3,740 £3,835
entry 5 Simple application £1,330 £1,365
paragraph 1, Table A, Column (3) Fee for an application for a type B marketing authorisation
entry 1 Major application £10,550 £10,815
entry 2 Complex application £6,330 £6,490
entry 3 Standard application £3,165 £3,245
entry 5 Simple application £845 £865
paragraph 1, Table A, Column (4) Fee for an application for a product licence
entry 1 Major application £19,115 £19,595
entry 2 Complex application £11,095 £11,370
entry 3 Standard application £4,790 £4,910
entry 5 Simple application £1,330 £1,365
paragraph 2, Table B, Column (2) Fee for an application for an Article 15.2 marketing authorisation
entry 1 Major application £11,095 £11,370
entry 2 Complex application £4,790 £4,910
paragraph 3 Application for a marketing authorisation by holder of Article 15.2 marketing authorisation
paragraph 3(a) Major application previously made £8,020 £8,225
paragraph 3(b) Complex application previously made £6,305 £6,460
paragraph 6 Manufacturer’s licences
paragraph 6(1)(a) Applications in respect of which paragraph 6(2) applies £100 £100
paragraph 6(1)(b) Other cases £2,150 £2,205
paragraph 7 Wholesale dealer’s licences
paragraph 7(1) Application fee where anticipated turnover £40,000 or more £1,250 £1,280
paragraph 7(2) Application fee where anticipated turnover less than £40,000 £505 £520
paragraph 8 Animal test certificate applications in relation to biological products or for administration to non food-producing animals £265 £270
paragraph 8 Other animal test certificate applications £635 £650
paragraph 9 Marketing authorisation (parallel import) £1,495 £1,530
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 £3,430 £3,515
entry 2 Complex £2,295 £2,350
entry 3 Standard £990 £1,015
entry 4 Simple £330 £340
paragraph 4, Table C, Column (3) Additional fee for the sixth and each additional member State
entry 1 Major £740 £760
entry 2 Complex £360 £370
entry 3 Standard £185 £190
entry 4 Simple £65 £65
paragraph 5, Table D, Column (2) Basic fee
entry 1 Category I application £8,415 £8,625
entry 2 Category II application £5,615 £5,755
entry 3 Category III application £4,490 £4,600
paragraph 5, Table D, Column (3) Additional fee for the sixth and each additional member State
entry 1 Category I application £1,055 £1,080
entry 2 Category II application £700 £720
entry 3 Category III application £560 £575
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 £2,110 £2,165
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 £530 £545
entry 2 Variation not requiring assessment £210 £215
paragraph 3, Table F, Column (2) United Kingdom acting as the Reference Member State
entry 1 Type 1 variation—Administrative £560 £575
entry 2 Type I variation—Scientific £2,245 £2,300
entry 3 Type I variation, Scientific—Type II procedure £3,695 £3,785
entry 4 Type II variation £7,855 £8,050
entry 5 Variation with extras £8,980 £9,205
paragraph 3, Table F, Column (3) United Kingdom not acting as the Reference Member State
entry 1 Type 1 variation—Administrative £105 £110
entry 2 Type I variation—Scientific £530 £545
entry 3 Type I variation, Scientific—Type II procedure £1,055 £1,080
entry 4 Type II variation £2,110 £2,165
entry 5 Variation with extras £3,755 £3,850
paragraph 5 Manufacturer’s licences
paragraph 5(a) Variation of manufacturer’s licence referred to in Schedule 1, Part II, paragraph 6(2) £100 £100
paragraph 5(b) Variation in any other case
paragraph 5(b)(i) Requiring assessment £380 £390
paragraph 5(b)(ii) Not requiring assessment £125 £130
paragraph 6 Wholesale dealer’s licences
paragraph 6(a) Variation requiring assessment £380 £390
paragraph 6(b) Variation not requiring assessment £125 £130
paragraph 7 Variation of animal test certificate £210 £215
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 £315 £325
paragraph 1(c) Other cases £950 £975
paragraph 2 Manufacturer’s licences £95 £95
paragraph 3 Animal test certificates £95 £95
SCHEDULE 2 FEES RELATING TO SITE INSPECTIONS
paragraph 2(1), Table A, Column (2)
entry 1 Supersite inspection £8,850 £9,070
entry 2 Major inspection £4,655 £4,770
entry 3 Standard inspection £3,330 £3,415
entry 4 Minor inspection £1,800 £1,845
paragraph 2(2), Table B, Column (2)
entry 1 Supersite inspection £14,670 £15,035
entry 2 Major inspection £8,100 £8,305
entry 3 Standard inspection covering immunological Veterinary Medicinal Products £5,285 £5,420
entry 4 Other standard inspection £3,985 £4,085
entry 5 Minor inspection covering immunological Veterinary Medicinal Products £2,720 £2,730
entry 6 Other minor inspection £2,665 £2,730
paragraph 2(3), Table C, Column (2)
entry 1 Supersite inspection £6,425 £6,585
entry 2 Major inspection £4,340 £4,450
entry 3 Standard inspection £2,125 £2,180
entry 4 Minor inspection £1,095 £1,125
paragraph 2(4)(b) Site limited solely to manufacture and assembly of emergency vaccines £105 £105
paragraph 3(1) Either or both of premises and procedures for quality control of a biological product which is not a dormant product £1,275 £1,305
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 £105 £110
entry 2 Product which is either prepared solely from repeat stock or is of a repeat formulation £315 £325
entry 3 Any other application £530 £545
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 £265 £270
entry 2 Product which is either prepared solely from repeat stock or is of a repeat formulation £475 £485
entry 3 Any other application £685 £700
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 £105 £110
paragraph 2(ii) Product prepared from more than 5 homoeopathic stocks £265 £270
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 £1,500 £1,540
entry 2 Complex application £865 £885
entry 3 Standard application £400 £410
entry 4 Simple application £150 £155
paragraph 2 Animal test certificate £520 £535