LegalizeMedicines (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.
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 | Wholesale dealer’s licences: annual fees | 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 | Marketing authorisations and product licences | 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 (EC) No. 541/95 (concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a member State ) shall be as follows:—
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:—
2A
Notwithstanding the above, the fee for a variation where the licence relates solely to an emergency vaccine shall be £40 for each variation.
Signed
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
Explanatory note
(This note is not part of the Regulations)
amarketing authorisations under the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (S.I. 1994/3142);
blicences and certificates granted under the Medicines Act 1968 in so far as they apply to medicinal products for animal use; and
cthe registration of homoeopathic veterinary medicinal products.
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 (so far as concerns functions previously vested in the Secretaries of State respectively concerned with agriculture in Scotland and—in consequence of S.I. 1978/272—Wales), 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 (so far as concerns functions previously vested in the Secretaries of State respectively concerned with health in Scotland and—in consequence of S.I. 1969/388—Wales), 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]: S.I. 1998/2428 as amended by S.I. 2000/2250 and S.I. 2001/1669.
[^f00006]: OJ No. L55, 11.3.95, p. 7 as last amended by Commission Regulation (EC) No. 1146/98, OJ No. L159, 3.6.98, p.31.
Editorial notes
[^c15811341]: 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.
[^c15811351]: In the case of the Minister of Agriculture, Fisheries and Food (so far as concerns functions previously vested in the Secretaries of State respectively concerned with agriculture in Scotland and—in consequence of S.I. 1978/272—Wales), 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 (so far as concerns functions previously vested in the Secretaries of State respectively concerned with health in Scotland and—in consequence of S.I. 1969/388—Wales), 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)).
[^c15811361]: 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.
[^c15811371]: S.I. 1972/1811.
[^c15811381]: S.I. 1998/2428 as amended by S.I. 2000/2250 and S.I. 2001/1669.
[^c15811391]: OJ No. L55, 11.3.95, p. 7 as last amended by Commission Regulation (EC) No. 1146/98, OJ No. L159, 3.6.98, p.31.
Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.
This text is published under legislation.gov.uk's own terms of reuse, not a Legalize or public-domain licence.
legislation.gov.uk
Open Government Licence v3.0 (attribution required)
© Crown and database right. Derived from content available under the Open Government Licence v3.0 from legislation.gov.uk.