OpenLegislation

Part I

Column (1)Column (2)Column (3)Column (4)
Provision in the principal RegulationsSubject matterOld feeNew fee
££
Regulation 12Manufacturer’s licences: annual fees205210
Regulation 13Wholesale dealer’s licences: annual fees
Regulation 13(1)Turnover of £40,000 or more410420
Regulation 13(2)Turnover of less than £40,000205210
Regulation 14Registration of Homoeopathic Veterinary Medicinal Products
Regulation 14(3)Alteration of dossier9095
SCHEDULE 1, PART IIFEES 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 1Major application19,59520,085
Entry 2Complex application11,37011,655
Entry 3Standard application4,9105,035
Entry 4Abridged standard application3,8353,930
Entry 5Simple application1,3851,400
Paragraph 1, Table A, Column (3)Fee for an application for a type B marketing authorisation
Entry 1Major application10,81511,085
Entry 2Complex application6,4906,655
Entry 3Standard application3,2453,325
Entry 5Simple application865885
Paragraph 1, Table A, Column (4)Fee for an application for a product licence
Entry 1Major application19,59520,085
Entry 2Complex application11,37011,655
Entry 3Standard application4,9105,035
Entry 5Simple application1,3651,400
Paragraph 2, Table B, Column (2)Fee for an application for an Article 15.2 marketing authorisation
Entry 1Major application11,37011,655
Entry 2Complex application4,9105,035
Paragraph 3Application for a marketing authorisation by holder of Article 15.2 marketing authorisation
Paragraph 3(a)Major application previously made8,2258,430
Paragraph 3(b)Complex application previously made6,4606,620
Paragraph 6Manufacturer’s licences
Paragraph 6(1)(b)Other cases2,2052,260
Paragraph 7Wholesale dealer’s licences
Paragraph 7(1)Application fee where anticipated turnover £40,000 or more1,2801,310
Paragraph 7(2)Application fee where anticipated turnover less than £40,000520535
Paragraph 8Animal test certificate applications in relation to biological products or for administration to non food-producing animals270275
Paragraph 8Other animal test certificate applications650665
Paragraph 9Marketing authorisation (parallel import)1,5301,570
SCHEDULE 1, PART IIIFEES RELATING TO APPLICATIONS FOR ASSISTANCE IN CONNECTION WITH MUTUAL RECOGNITION APPLICATIONS
Paragraph 4, Table C, Column (2)Basic fee
Entry 1Major3,5153,605
Entry 2Complex2,3502,410
Entry 3Standard1,0151,040
Entry 4Simple340350
Paragraph 4, Table C, Column (3)Additional fee for the sixth and each additional member State
Entry 1Major760780
Entry 2Complex370380
Entry 3Standard190195
Paragraph 5, Table D, Column (2)Basic Fee
Entry 1Category I application8,6258,840
Entry 2Category II application5,7555,900
Entry 3Category III application4,6004,715
Paragraph 5, Table D, Column (3)Additional fee for the sixth and each additional member State
Entry 1Category I application1,0801,105
Entry 2Category II application720740
Entry 3Category III application575590
SCHEDULE 1, PART IVFEES 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 1Type I variation—Administrative 575 590
Entry 2Type I variation—Scientific 2,300 2,360
Entry 3Type 1 variation, Scientific—Type II procedure 3,785 3,880
Entry 4Type II variation 8,050 8,250
Entry 5Variation with extras 9,205 9,435
Paragraph 3, Table F, Column (3)United Kingdom not acting as the Reference Member State
Entry 1Type I variation—Administrative 110 115
Entry 2Type I variation—Scientific 545 560
Entry 3Type I variation, Scientific—Type II procedure 1,080 1,105
Entry 4Type II variation 2,165 2,220
Entry 5Variation with extras 3,850 3,945
Paragraph 5Manufacturer’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 6Wholesale dealer’s licences
Paragraph 6(a)Variation requiring assessment 390 400
Paragraph 6(b)Variation not requiring assessment 130 135
Paragraph 7Variation of animal test certificate 215 220
SCHEDULE 1, PART VFEES RELATING TO APPLICATIONS FOR THE RENEWAL OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES AND ANIMAL TEST CERTIFICATES
Paragraph 1Marketing authorisations and product licences
Paragraph 1(b)Herbal products 325 335
Paragraph 1(c)Other cases 975 1,000
Paragraph 2Manufacturer’s licences 95 100
Paragraph 3Animal test certificates 95 100
SCHEDULE 2FEES RELATING TO SITE INSPECTIONS
Paragraph 2(1), Table A, Column (2)
Entry 1Supersite inspection 9,070 9,295
Entry 2Major inspection 4,770 4,890
Entry 3Standard inspection 3,415 3,500
Entry 4Minor inspection 1,845 1,890
Paragraph 2(2), Table B, Column (2)
Entry 1Supersite inspection15,03515,410
Entry 2Major inspection 8,305 8,515
Entry 3Standard inspection covering immunological Veterinary Medicinal Products 5,420 5,555
Entry 4Other standard inspection 4,085 4,185
Entry 5Minor inspection covering immunological Veterinary Medicinal Products 2,730 2,800
Entry 6Other minor inspection 2,730 2,800
Paragraph 2(3), Table C, Column (2)
Entry 1Supersite inspection 6,585 6,750
Entry 2Major inspection 4,450 4,560
Entry 3Standard inspection 2,180 2,235
Entry 4Minor 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 IIFEES 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 1Product both prepared solely from repeat stock and being of repeat formulation 110 115
Entry 2Product which is either prepared solely from repeat stock or is of a repeat formulation 325 335
Entry 3Any other application 545 560
Paragraph 1, Table, Column (3)Fees for applications in respect of products prepared from more than 5 homoeopathic stocks
Entry 1Product both prepared solely from repeat stock and being of repeat formulation 270 275
Entry 2Product which is either prepared solely from repeat stock or is of a repeat formulation 485 495
Entry 3Any other application 700 720
Paragraph 2Equivalent 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 6MARKETING 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 1Major application 1,540 1,580
Entry 2Complex application 885 905
Entry 3Standard application 410 420
Entry 4Simple application 155 160
Paragraph 2Animal test certificate 535 550