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There are outstanding changes not yet made by the legislation.gov.uk editorial team to Medicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001. Any changes that have already been made by the team appear in the content and are referenced with annotations.
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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 | 205 | 210 |
Regulation 13 | Wholesale dealer’s licences: annual fees | ||
Regulation 13(1) | Turnover of £40,000 or more | 410 | 420 |
Regulation 13(2) | Turnover of less than £40,000 | 205 | 210 |
Regulation 14 | Registration of Homoeopathic Veterinary Medicinal Products | ||
Regulation 14(3) | Alteration of dossier | 90 | 95 |
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 | 19,595 | 20,085 |
Entry 2 | Complex application | 11,370 | 11,655 |
Entry 3 | Standard application | 4,910 | 5,035 |
Entry 4 | Abridged standard application | 3,835 | 3,930 |
Entry 5 | Simple application | 1,385 | 1,400 |
Paragraph 1, Table A, Column (3) | Fee for an application for a type B marketing authorisation | ||
Entry 1 | Major application | 10,815 | 11,085 |
Entry 2 | Complex application | 6,490 | 6,655 |
Entry 3 | Standard application | 3,245 | 3,325 |
Entry 5 | Simple application | 865 | 885 |
Paragraph 1, Table A, Column (4) | Fee for an application for a product licence | ||
Entry 1 | Major application | 19,595 | 20,085 |
Entry 2 | Complex application | 11,370 | 11,655 |
Entry 3 | Standard application | 4,910 | 5,035 |
Entry 5 | Simple application | 1,365 | 1,400 |
Paragraph 2, Table B, Column (2) | Fee for an application for an Article 15.2 marketing authorisation | ||
Entry 1 | Major application | 11,370 | 11,655 |
Entry 2 | Complex application | 4,910 | 5,035 |
Paragraph 3 | Application for a marketing authorisation by holder of Article 15.2 marketing authorisation | ||
Paragraph 3(a) | Major application previously made | 8,225 | 8,430 |
Paragraph 3(b) | Complex application previously made | 6,460 | 6,620 |
Paragraph 6 | Manufacturer’s licences | ||
Paragraph 6(1)(b) | Other cases | 2,205 | 2,260 |
Paragraph 7 | Wholesale dealer’s licences | ||
Paragraph 7(1) | Application fee where anticipated turnover £40,000 or more | 1,280 | 1,310 |
Paragraph 7(2) | Application fee where anticipated turnover less than £40,000 | 520 | 535 |
Paragraph 8 | Animal test certificate applications in relation to biological products or for administration to non food-producing animals | 270 | 275 |
Paragraph 8 | Other animal test certificate applications | 650 | 665 |
Paragraph 9 | Marketing authorisation (parallel import) | 1,530 | 1,570 |
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 | 3,515 | 3,605 |
Entry 2 | Complex | 2,350 | 2,410 |
Entry 3 | Standard | 1,015 | 1,040 |
Entry 4 | Simple | 340 | 350 |
Paragraph 4, Table C, Column (3) | Additional fee for the sixth and each additional member State | ||
Entry 1 | Major | 760 | 780 |
Entry 2 | Complex | 370 | 380 |
Entry 3 | Standard | 190 | 195 |
Paragraph 5, Table D, Column (2) | Basic Fee | ||
Entry 1 | Category I application | 8,625 | 8,840 |
Entry 2 | Category II application | 5,755 | 5,900 |
Entry 3 | Category III application | 4,600 | 4,715 |
Paragraph 5, Table D, Column (3) | Additional fee for the sixth and each additional member State | ||
Entry 1 | Category I application | 1,080 | 1,105 |
Entry 2 | Category II application | 720 | 740 |
Entry 3 | Category III application | 575 | 590 |
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 3, Table F, Column (2) | United Kingdom acting as the Reference Member State | ||
Entry 1 | Type I variation—Administrative | 575 | 590 |
Entry 2 | Type I variation—Scientific | 2,300 | 2,360 |
Entry 3 | Type 1 variation, Scientific—Type II procedure | 3,785 | 3,880 |
Entry 4 | Type II variation | 8,050 | 8,250 |
Entry 5 | Variation with extras | 9,205 | 9,435 |
Paragraph 3, Table F, Column (3) | United Kingdom not acting as the Reference Member State | ||
Entry 1 | Type I variation—Administrative | 110 | 115 |
Entry 2 | Type I variation—Scientific | 545 | 560 |
Entry 3 | Type I variation, Scientific—Type II procedure | 1,080 | 1,105 |
Entry 4 | Type II variation | 2,165 | 2,220 |
Entry 5 | Variation with extras | 3,850 | 3,945 |
Paragraph 5 | Manufacturer’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 6 | Wholesale dealer’s licences | ||
Paragraph 6(a) | Variation requiring assessment | 390 | 400 |
Paragraph 6(b) | Variation not requiring assessment | 130 | 135 |
Paragraph 7 | Variation of animal test certificate | 215 | 220 |
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 | 325 | 335 |
Paragraph 1(c) | Other cases | 975 | 1,000 |
Paragraph 2 | Manufacturer’s licences | 95 | 100 |
Paragraph 3 | Animal test certificates | 95 | 100 |
SCHEDULE 2 | FEES RELATING TO SITE INSPECTIONS | ||
Paragraph 2(1), Table A, Column (2) | |||
Entry 1 | Supersite inspection | 9,070 | 9,295 |
Entry 2 | Major inspection | 4,770 | 4,890 |
Entry 3 | Standard inspection | 3,415 | 3,500 |
Entry 4 | Minor inspection | 1,845 | 1,890 |
Paragraph 2(2), Table B, Column (2) | |||
Entry 1 | Supersite inspection | 15,035 | 15,410 |
Entry 2 | Major inspection | 8,305 | 8,515 |
Entry 3 | Standard inspection covering immunological Veterinary Medicinal Products | 5,420 | 5,555 |
Entry 4 | Other standard inspection | 4,085 | 4,185 |
Entry 5 | Minor inspection covering immunological Veterinary Medicinal Products | 2,730 | 2,800 |
Entry 6 | Other minor inspection | 2,730 | 2,800 |
Paragraph 2(3), Table C, Column (2) | |||
Entry 1 | Supersite inspection | 6,585 | 6,750 |
Entry 2 | Major inspection | 4,450 | 4,560 |
Entry 3 | Standard inspection | 2,180 | 2,235 |
Entry 4 | Minor 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 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 | 110 | 115 |
Entry 2 | Product which is either prepared solely from repeat stock or is of a repeat formulation | 325 | 335 |
Entry 3 | Any other application | 545 | 560 |
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 | 270 | 275 |
Entry 2 | Product which is either prepared solely from repeat stock or is of a repeat formulation | 485 | 495 |
Entry 3 | Any other application | 700 | 720 |
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 | 110 | 115 |
Paragraph 2(ii) | Product prepared from more than 5 homoeopathic stocks | 270 | 275 |
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 | 1,540 | 1,580 |
Entry 2 | Complex application | 885 | 905 |
Entry 3 | Standard application | 410 | 420 |
Entry 4 | Simple application | 155 | 160 |
Paragraph 2 | Animal test certificate | 535 | 550 |
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