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 | £190 | £200 |
| regulation 13 | Wholesale dealer’s licences: annual fees | ||
| regulation 13(1) | Turnover of £40,000 or more | £380 | £400 |
| regulation 13(2) | Turnover of less than £40,000 | £185 | £200 |
| regulation 14 | Registration of Homoeopathic Veterinary Medicinal Products | ||
| regulation 14(2) | Renewal of registration | £75 | £80 |
| regulation 14(3) | Alteration of dossier | £85 | £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 | ||
| paragraph 1, Table A, Column (2) | Fee for an application for a type A marketing authorisation | ||
| entry 1 | Major application | £18,120 | £19,115 |
| entry 2 | Complex application | £10,515 | £11,095 |
| entry 3 | Standard application | £4,540 | £4,790 |
| entry 4 | Abridged standard application | £3,545 | £3,740 |
| entry 5 | Simple application | £1,260 | £1,330 |
| paragraph 1, Table A, Column (3) | Fee for an application for a type B marketing authorisation | ||
| entry 1 | Major application | £10,000 | £10,550 |
| entry 2 | Complex application | £6,000 | £6,330 |
| entry 3 | Standard application | £3,000 | £3,165 |
| entry 5 | Simple application | £800 | £845 |
| paragraph 1, Table A, Column (4) | Fee for an application for a product licence | ||
| entry 1 | Major application | £18,120 | £19,115 |
| entry 2 | Complex application | £10,515 | £11,095 |
| entry 3 | Standard application | £4,540 | £4,790 |
| entry 5 | Simple application | £1,260 | £1,330 |
| paragraph 2, Table B, Column (2) | Fee for an application for an Article 15.2 marketing authorisation | ||
| entry 1 | Major application | £10,515 | £11,095 |
| entry 2 | Complex application | £4,540 | £4,790 |
| paragraph 3 | Application for a marketing authorisation by holder of Article 15.2 marketing authorisation | ||
| paragraph 3(a) | Major application previously made | £7,605 | £8,020 |
| paragraph 3(b) | Complex application previously made | £5,975 | £6,305 |
| paragraph 6 | Manufacturer’s licences | ||
| paragraph 6(1)(a) | Applications in respect of which paragraph 6(2) applies | £95 | £100 |
| paragraph 6(1)(b) | Other cases | £2,040 | £2,150 |
| paragraph 7 | Wholesale dealer’s licences | ||
| paragraph 7(1) | Application fee where anticipated turnover £40,000 or more | £1,185 | £1,250 |
| paragraph 7(2) | Application fee where anticipated turnover less than £40,000 | £480 | £505 |
| paragraph 8 | Animal test certificate applications in relation to biological products or for administration to non food-producing animals | £250 | £265 |
| paragraph 8 | Other animal test certificate applications | £600 | £635 |
| paragraph 9 | Marketing authorisation (parallel import) | £1,415 | £1,495 |
| 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 | £3,250 | £3,430 |
| entry 2 | Complex | £2,175 | £2,295 |
| entry 3 | Standard | £940 | £990 |
| entry 4 | Simple | £315 | £330 |
| paragraph 4, Table C, Column (3) | Additional fee for the sixth and each additional member State | ||
| entry 1 | Major | £700 | £740 |
| entry 2 | Complex | £340 | £360 |
| entry 3 | Standard | £175 | £185 |
| entry 4 | Simple | £60 | £65 |
| paragraph 5, Table D, Column (2) | Basic fee | ||
| entry 1 | Category I application | £7,975 | £8,415 |
| entry 2 | Category II application | £5,320 | £5,615 |
| entry 3 | Category III application | £4,255 | £4,490 |
| paragraph 5, Table D, Column (3) | Additional fee for the sixth and each additional member State | ||
| entry 1 | Category I application | £1,000 | £1,055 |
| entry 2 | Category II application | £665 | £700 |
| entry 3 | Category III application | £530 | £560 |
| 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 1 | Marketing authorisations (other than mutually recognised marketing authorisations) and product licences—complex application for variation | £2,000 | £2,110 |
| paragraph 2, Table E, Column (2) | Marketing authorisations (other than mutually recognised marketing authorisations) and product licences—application for variation other than complex application | ||
| entry 1 | Variation requiring assessment | £500 | £530 |
| entry 2 | Variation not requiring assessment | £200 | £210 |
| paragraph 3, Table F, Column (2) | United Kingdom acting as the Reference Member State | ||
| entry 1 | Type I variation—Administrative | £530 | £560 |
| entry 2 | Type I variation, Scientific— | £2,130 | £2,245 |
| entry 3 | Type I variation, Scientific— | £3,500 | £3,695 |
| Type II procedure | |||
| entry 4 | Type II variation | £7,445 | £7,855 |
| entry 5 | Variation with extras | £8,510 | £8,980 |
| paragraph 3, Table F, Column (3) | United Kingdom not acting as the Reference Member State | ||
| entry 1 | Type I variation—Administrative | £100 | £105 |
| entry 2 | Type I variation—Scientific | £500 | £530 |
| entry 3 | Type I variation, Scientific-Type II procedure | £1,000 | £1,055 |
| entry 4 | Type II variation | £2,000 | £2,110 |
| entry 5 | Variation with extras | £3,560 | £3,755 |
| paragraph 5 | Manufacturer’s licences | ||
| paragraph 5(a) | Variation of manufacturer’s licence referred to in Schedule 1, Part II, paragraph 6(2) | £95 | £100 |
| paragraph 5(b) | Variation in any other case | ||
| paragraph 5(b)(i) | Requiring assessment | £360 | £380 |
| paragraph 5(b)(ii) | Not requiring assessment | £120 | £125 |
| paragraph 6 | Wholesale dealer’s licences | ||
| paragraph 6(a) | Variation requiring assessment | £360 | £380 |
| paragraph 6(b) | Variation not requiring assessment | £120 | £125 |
| paragraph 7 | Variation of animal test certificate | £200 | £210 |
| 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 | £300 | £315 |
| paragraph 1(c) | Other cases | £900 | £950 |
| paragraph 2 | Manufacturer’s licences | £90 | £95 |
| paragraph 3 | Animal test certificates | £90 | £95 |
| SCHEDULE 2 | FESS REALTING TO SITE INSPECTIONS | ||
| paragraph 2(1), Table A, Column (2) | |||
| entry 1 | Supersite inspection | £8,390 | £8,850 |
| entry 2 | Major inspection | £4,415 | £4,655 |
| entry 3 | Standard inspection | £3,155 | £3,330 |
| entry 4 | Minor inspection | £1,705 | £1,800 |
| paragraph 2(2), Table B, Column (2) | |||
| entry 1 | Supersite inspection | £13,905 | £14,670 |
| entry 2 | Major inspection | £7,680 | £8,100 |
| entry 3 | Standard inspection covering immunological Veterinary Medicinal Products | £5,010 | £5,285 |
| entry 4 | Other standard inspection | £3,775 | £3,985 |
| entry 5 | Minor inspection covering immunological Veterinary Medicinal Products | £2,580 | £2,720 |
| entry 6 | Other minor inspection | £2,525 | £2,665 |
| paragraph 2(3), Table C, Column (2) | |||
| entry 1 | Supersite inspection | £6,090 | £6,425 |
| entry 2 | Major inspection | £4,115 | £4,340 |
| entry 3 | Standard inspection | £2,015 | £2,125 |
| entry 4 | Minor inspection | £1,035 | £1,095 |
| paragraph 2(4)(b) | Site limited solely to manufacture and assembly of emergency vaccines | £100 | £105 |
| paragraph 3(1) | Either or both of premises and procedures for quality control of a biological product which is not a dormant product | £1,210 | £1,275 |
| 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 | £100 | £105 |
| entry 2 | Product which is either prepared solely from repeat stock or is of a repeat formulation | £300 | £315 |
| entry 3 | Any other application | £500 | £530 |
| 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 | £250 | £265 |
| entry 2 | Product which is either prepared solely from repeat stock or is of a repeat formulation | £450 | £475 |
| entry 3 | Any other application | £650 | £685 |
| paragraph 2 | Equivalent product registered under Part II of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 M1 or in an EEA State | ||
| paragraph 2(i) | Product prepared from not more than 5 homoeopathic stocks | £100 | £105 |
| paragraph 2(ii) | Product prepared from more than 5 homoeopathic stocks | £250 | £265 |
| 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 | £1,420 | £1,500 |
| entry 2 | Complex application | £820 | £865 |
| entry 3 | Standard application | £380 | £400 |
| entry 4 | Simple application | £140 | £150 |
| paragraph 2 | Animal test certificate | £495 | £520 |
Annotations
Marginal citations
- M1
S.I. 1994/105, amended by S.I. 1994/899, 1995/541, 1996/482, 1998/574.