Statutory Instruments
2001 No. 3751
MEDICINES
Medicines (Products for Animal Use—Fees) (Amendment No. 2) Regulations 2001
Made
22nd November 2001
Laid before Parliament
23rd November 2001
Coming into force
15th 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 interpretation
1. —(1) These 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.
(2) In these Regulations “the Principal Regulations” means the Medicines (Products for Animal Use—Fees) Regulations 1998 .
Amendment of fees specified in the principal Regulations
2. —(1) In 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).
(2) Paragraphs 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.
(3) In Schedule 3 to the principal Regulations—
(a) in 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%. ” ;
(b) in Part II, paragraph 2 (calculation of annual fees) there shall be substituted the figure “0.7%” for the figure “ 0.677% ” ; and
(c) in Part III (calculation of annual fee—emergency vaccines) there shall be substituted the figure “0.7%” for the figure “ 0.677% ” .
Transitional provisions
3. —(1) Subject 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.
(2) These 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.
(3) Where, 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.
(4) Nothing in these Regulations shall have effect in relation to an annual fee relating to a calendar year earlier than 2000.
Whitty
Parliamentary Under Secretary of State Ministry of Agriculture, Fisheries and Food
22 November 2002
Signed by authority of the Secretary of State for Health
Hunt
Parliamentary Under Secretary of State
Department of Health
16 November 2001
Bairbre De Brún
Minister of Health, Social Services and Public Safety
21 November 2001
Brid Rodgers
Minister of Agriculture and Rural Development
19 November 2001
We consent
Nick Ainger
Tony McNulty
Two of the Lords Commissioners of Her Majesty’s Treasury
19 November 2001
Regulation 2
SCHEDULE
PART I
| 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 |
PART II REPLACEMENT OF PARAGRAPHS 1 AND 2 OF PART IV OF SCHEDULE 1 TO THE PRINCIPAL REGULATIONS
1. The 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
| Fee | ||
|---|---|---|
| Type of application | £ | |
| 1. | Change following modification(s) to the manufacturing authorisation | 560 |
| 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 holder | 220 |
| 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 shells | 560 |
| 8. | Change in the qualitative composition of immediate packaging material | 560 |
| 9. | Deletion of an indication | 560 |
| 10. | Deletion of a route of administration | 560 |
| 10a. | Addition or replacement of measuring device for dosage forms | 560 |
| 11. | Change in the manufacturer(s) of active substance | 560 |
| 11a. | Change in name of manufacturer of active substance | 220 |
| 11b. | Change in supplier of intermediate compound used in the manufacture of the active substance | 560 |
| 12 | Minor change of manufacturing process of the active substance | 560 |
| 12a. | Change in specification of starting material or intermediate used in the manufacture of the active substance | 560 |
| 13. | Batch size of active substance | 560 |
| 14. | Change in specification of active substance | 560 |
| 15. | Minor change in manufacture of the medicinal product | 560 |
| 15a. | Change in in-process controls applied during the manufacture of the product | 560 |
| 16. | Change in the batch size of finished product | 560 |
| 17. | Change in specification of the medicinal product | 560 |
| 18. | Synthesis or recovery of non-pharmacopoeial excipients which had been described in the original dossier | 560 |
| 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 authorisation | 560 |
| 20a. | Extension of the shelf life or retest period of the active substance | 560 |
| 21. | Change in shelf life after first opening | 560 |
| 22. | Change in shelf life after reconstitution | 560 |
| 23. | Change in the storage conditions | 560 |
| 24. | Change in test procedure of active substance | 560 |
| 24a. | Change in test procedure for a starting material or intermediate used in the manufacture of the active substance | 560 |
| 25. | Change in the test procedures of the medicinal product | 560 |
| 26. | Changes to comply with supplements to pharmacopoeias | 560 |
| 27. | Change in test procedures of non-pharmacopoeial excipients | 560 |
| 28. | Change in test procedure of immediate packaging | 560 |
| 29. | Change in test procedure of administrative device | 560 |
| 30. | Change in pack size for a medicinal product | 560 |
| 31. | Change in container shape | 560 |
| 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 marking | 560 |
| 33. | Change of dimensions of tablets, capsules, suppositories or pessaries without change of quantitive composition and mean mass | 560 |
| 34. | Change in the manufacturing process of a non proteinaceous component due to the subsequent introduction of a biotechnology step | 560 |
2. The 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 time | 220 |
| b. | Change of distributor where no other aspects of the dossier are changed and the marketing authorisation holder remains the same | 220 |
| c. | Change of marketing authorisation holder where no other aspects of the dossier are changed | 220 |
| 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 same | 560 |
| 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 user | 560 |
| 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 changed | 560 |
2A. Notwithstanding the above, the fee for a variation where the licence relates solely to an emergency vaccine shall be £40 for each variation.