Regulation 2
SCHEDULEU.K.
PART IU.K.
| 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 |