LegalizeThe Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2000
Made: 10th August 2000
Laid before Parliament: 5th September 2000
Coming into force: 1st October 2000
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Citation, commencement and interpretation
1
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Amendment of fees specified in the principal Regulations
2
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3
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Transitional provisions
4
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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 | £200 | £205 |
| regulation 13 | Wholesale dealer’s licences: annual fees | Wholesale dealer’s licences: annual fees | 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 | Registration of Homoeopathic Veterinary Medicinal Products | 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 | FEES RELATING TO APPLICATIONS FOR THE GRANT OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES, WHOLESALE DEALER’S LICENCES AND ANIMAL TEST CERTIFICATES | 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 | Fee for an application for a type A marketing authorisation | 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 | Fee for an application for a type B marketing authorisation | 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 | Fee for an application for a product licence | 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 | Fee for an application for an Article 15.2 marketing authorisation | 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 | Application for a marketing authorisation by holder of Article 15.2 marketing authorisation | 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 | Manufacturer’s licences | 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 | Wholesale dealer’s licences | 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 | FEES RELATING TO APPLICATIONS FOR ASSISTANCE IN CONNECTION WITH MUTUAL RECOGNITION APPLICATIONS | FEES RELATING TO APPLICATIONS FOR ASSISTANCE IN CONNECTION WITH MUTUAL RECOGNITION APPLICATIONS |
| paragraph 4, Table C, Column (2) | Basic fee | Basic fee | 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 | Additional fee for the sixth and each additional member State | 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 | Basic fee | 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 | Additional fee for the sixth and each additional member State | 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 | FEES RELATING TO APPLICATIONS FOR THE VARIATION OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES, WHOLESALE DEALER’S LICENCES AND ANIMAL TEST CERTIFICATES | 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 | Marketing authorisations (other than mutually recognised marketing authorisations) and product licences—application for variation other than complex application | 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 | United Kingdom acting as the Reference Member State | 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 | United Kingdom not acting as the Reference Member State | 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 | Manufacturer’s licences | 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 | Variation in any other case | 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 | Wholesale dealer’s licences | 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 | FEES RELATING TO APPLICATIONS FOR THE RENEWAL OF MARKETING AUTHORISATIONS, PRODUCT LICENCES, MANUFACTURER’S LICENCES AND ANIMAL TEST CERTIFICATES | 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 | Marketing authorisations and product licences | 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 | FEES RELATING TO SITE INSPECTIONS | FEES RELATING TO SITE INSPECTIONS |
| paragraph 2(1), Table A, Column (2) | paragraph 2(1), Table A, Column (2) | paragraph 2(1), Table A, Column (2) | 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) | paragraph 2(2), Table B, Column (2) | paragraph 2(2), Table B, Column (2) | 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) | paragraph 2(3), Table C, Column (2) | paragraph 2(3), Table C, Column (2) | 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 | FEES RELATING TO APPLICATIONS FOR REGISTRATION OF HOMOEOPATHIC VETERINARY MEDICINAL PRODUCTS | 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 | Fees for applications in respect of products prepared from not more than 5 homoeopathic stocks | 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 | Fees for applications in respect of products prepared from more than 5 homoeopathic stocks | 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 | Equivalent product registered under Part II of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 or in an EEA State | 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 | MARKETING AUTHORISATIONS, PRODUCT LICENCES AND ANIMAL TEST CERTIFICATES: FEES FOR REFERENCES TO THE VETERINARY PRODUCTS COMMITTEE OR TO THE MEDICINES COMMISSION | 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) | paragraph 1, Table, Column (2) | paragraph 1, Table, Column (2) | 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 |
Signed
Hayman — Minister of State, Ministry of Agriculture, Fisheries and Food — 1st August 2000
Signed by authority of the Secretary of State for Health
Hunt — Parliamentary Under Secretary of State, — Department of Health — 5th August 2000
Bairbre de Brún — Minister of Health, Social Services and Public Safety — 8th August 2000
Signed by authority of the Minister of Agriculture and Rural Development
Peter Small — Permanent Secretary, — Department of Agriculture and Rural Development — 8th August 2000
We consent,
Jim Dowd and Bob Ainsworth — Two of the Lords Commissioners of Her Majesty’s Treasury — 10th August 2000
Explanatory note
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Footnotes
[^f00001]: 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.
[^f00002]: In the case of the Minister of Agriculture, Fisheries and Food, 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 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)).
[^f00003]: 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.
[^f00004]: S.I. 1972/1811.
[^f00005]: 1972 c. 68.
[^f00006]: S.I. 1998/2428; amended by S.I. 1999/2512.
[^f00007]: S.I. 1994/105, amended by S.I. 1994/899, 1995/541, 1996/482, 1998/574, 1999/566, 2000/592.
Transitional provisions
Editorial notes
[^key-4a1a45ede63234343db38fae976bca0a]: Regulations revoked (17.11.2004 with application in accordance with reg. 1(2) of the amending S.I.) by The Medicines (Products for Animal Use—Fees) Regulations 2004 (S.I. 2004/2750), regs. 1(1), 18(c) (with reg. 19)
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