http://www.legislation.gov.uk/uksi/2001/3751Medicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001texttext/xmlenStatute Law Database2019-12-07MEDICINES2001-12-15 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:— Medicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001RegulationsThe Medicines (Products for Animal Use—Fees) Regulations 2004reg. 18(e)reg. 19reg. 1(1) 2001 No. 3751MEDICINESMedicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001 Made22nd November 2001 Laid before Parliament23rd November 2001 Coming into force15th 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 and now vested in them 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, 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 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 interpretation11These 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 2001.2In these Regulations “the Principal Regulations” means the Medicines (Products for Animal Use—Fees) Regulations 1998 . Amendment of fees specified in the principal Regulations21In 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).2Paragraphs 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.3In Schedule 3 to the principal Regulations—ain 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%. ”;bin Part II, paragraph 2 (calculation of annual fees) there shall be substituted the figure “0.7%” for the figure “ 0.677% ”; andcin Part III (calculation of annual fee—emergency vaccines) there shall be substituted the figure “0.7%” for the figure “ 0.677% ”. Transitional provisions31Subject 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.2These 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.3Where, 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.4Nothing in these Regulations shall have effect in relation to an annual fee relating to a calendar year earlier than 2000. WhittyParliamentary Under Secretary of State Ministry of Agriculture, Fisheries and Food22 November 2002 Signed by authority of the Secretary of State for Health HuntParliamentary Under Secretary of StateDepartment of Health16 November 2001 Bairbre De BrúnMinister of Health, Social Services and Public Safety21 November 2001 Brid RodgersMinister of Agriculture and Rural Development19 November 2001 We consent Nick Ainger Tony McNultyTwo of the Lords Commissioners of Her Majesty’s Treasury19 November 2001SCHEDULERegulation 2PART 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
PART II REPLACEMENT OF PARAGRAPHS 1 AND 2 OF PART IV OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS1The 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 ) shall be as follows:—
Fee
Type of application£
1.Change following modification(s) to the manufacturing authorisation560
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 holder220
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 shells560
8.Change in the qualitative composition of immediate packaging material560
9.Deletion of an indication560
10.Deletion of a route of administration560
10a.Addition or replacement of measuring device for dosage forms560
11.Change in the manufacturer(s) of active substance560
11a.Change in name of manufacturer of active substance220
11b.Change in supplier of intermediate compound used in the manufacture of the active substance560
12Minor change of manufacturing process of the active substance560
12a.Change in specification of starting material or intermediate used in the manufacture of the active substance560
13.Batch size of active substance560
14.Change in specification of active substance560
15.Minor change in manufacture of the medicinal product560
15a.Change in in-process controls applied during the manufacture of the product560
16.Change in the batch size of finished product560
17.Change in specification of the medicinal product560
18.Synthesis or recovery of non-pharmacopoeial excipients which had been described in the original dossier560
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 authorisation560
20a.Extension of the shelf life or retest period of the active substance560
21.Change in shelf life after first opening560
22.Change in shelf life after reconstitution560
23.Change in the storage conditions560
24.Change in test procedure of active substance560
24a.Change in test procedure for a starting material or intermediate used in the manufacture of the active substance560
25.Change in the test procedures of the medicinal product560
26.Changes to comply with supplements to pharmacopoeias560
27.Change in test procedures of non-pharmacopoeial excipients560
28.Change in test procedure of immediate packaging560
29.Change in test procedure of administrative device560
30.Change in pack size for a medicinal product560
31.Change in container shape560
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 marking560
33.Change of dimensions of tablets, capsules, suppositories or pessaries without change of quantitive composition and mean mass560
34.Change in the manufacturing process of a non proteinaceous component due to the subsequent introduction of a biotechnology step560
2The 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 time220
b.Change of distributor where no other aspects of the dossier are changed and the marketing authorisation holder remains the same220
c.Change of marketing authorisation holder where no other aspects of the dossier are changed220
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 in mg/kg body weight remains the same560
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 user560
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 changed560
2ANotwithstanding the above, the fee for a variation where the licence relates solely to an emergency vaccine shall be £40 for each variation.

(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:—

amarketing authorisations under the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (S.I. 1994/3142);blicences and certificates granted under the Medicines Act 1968 in so far as they apply to medicinal products for animal use; andcthe 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.

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.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)).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.S.I. 1972/1811.S.I. 1998/2428 as amended by S.I. 2000/2250 and S.I. 2001/1669.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.