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United Kingdom Statutory Instruments |
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You are here: BAILII >> Databases >> United Kingdom Statutory Instruments >> The Medicines (Products for Animal Use-Fees) (Amendment) Regulations 1999 No. 2512 URL: http://www.bailii.org/uk/legis/num_reg/1999/uksi_19992512_en.html |
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Statutory Instruments
MEDICINES
Made
9th September 1999
Laid before Parliament
10th September 1999
Coming into force
1st October 1999
The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, 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(1) and now vested in them(2) 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(3), and the Secretary of State and the Minister of Agriculture, Fisheries and Food, being Ministers designated(4) for the purpose of section 2(2) of the European Communities Act 1972(5) 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), hereby make the following Regulations:
1.-(1) These Regulations may be cited as the Medicines (Products for Animal Use-Fees) Amendment Regulations 1999 and shall come into force on 1st October 1999.
(2) In these Regulations "the principal Regulations" means the Medicines (Products for Animal Use-Fees) Regulations 1998(6).
(3) Unless the context otherwise requires, expressions used in these Regulations shall have the same meaning as in the principal Regulations.
2. 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 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).
3.-(1) In Schedule 3 to the principal Regulations-
(a)in Part II, paragraph 1 (calculation of annual fees) there shall be substituted the figure "£262" for the figure "£248", the figure "£18,480" for the figure "£17,640", and the figure "0.44%." for the figure "0.42%.";
(b)in Part II, paragraph 2 (calculation of annual fees) there shall be substituted the figure "0.66%" for the figure "0.63%"; and
(c)in Part III (calculation of annual fee-emergency vaccines) there shall be substituted the figure "0.66%" for the figure "0.63%".
4.-(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 1998.
Signed by authority of Secretary of State for Health
Gisela Stuart
Parliamentary Under Secretary of State,
Department of Health
31st August 1999
Signed by authority of the Secretary of State for Wales
David Hanson
Parliamentary Under Secretary of State, Welsh Office
9th September 1999
John Reid
Parliamentary Under Secretary of State, Scottish Office
1st September 1999
Joyce Quin
Minister of State, Ministry of Agriculture, Fisheries and Food
26th August 1999
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this
D. C. Gowdy
Permanent Secretary
1st day of September 1999
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this
P. J. Small
Permanent Secretary
1st day of September 1999
We consent,
Bob Ainsworth
Jim Dowd
Two of the Lords Commissioners of Her Majesty's Treasury
1st September 1999
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 | £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(7) 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 |
(This note is not part of the Regulations)
These Regulations amend the Medicines (Products for Animal Use-Fees) Regulations 1998 ("the principal Regulations"). The principal Regulations prescribe fees in connection with applications and inspections relating to:
(a)marketing authorisations under the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (S.I. 1994/3142);
(b)licences and certificates granted under the Medicines Act 1968 in so far as they apply to medicinal products for animal use; and
(c)the registration of homoeopathic veterinary medicinal products.
In prescribing fees in relation to the 1994 Regulations, the principal Regulations as amended by these Regulations continue to supplement the 1994 Regulations in implementing Council Directive 93/40/EEC (OJ No. L214, 24.8.93, page 31) which contains amendments to Council Directive 81/851/EEC (OJ No. L317, 6.11.81, page 1).
Regulation 2 prescribes new fees in relation to the provisions of the principal Regulations set out in column (1) of the Schedule to these Regulations. The fees in the principal Regulations are set out in column (3) and the new fees prescribed by these Regulations in column (4) of the Schedule.
Regulation 3 amends Parts II and III of Schedule 3 (calculation of annual fees) to the principal Regulations by prescribing new fees and, where the fee is charged on a percentage of turnover, new percentage amounts.
The average level of fees payable under these Regulations is increased by 5.5% in comparison with the principal Regulations.
Regulation 4 provides that the Regulations, subject to the exceptions in regulation 4(2) and (3), apply to applications made after the Regulations come into force and do not affect annual fees relating to a calendar year earlier than 1998.
A Regulatory Impact Assessment has been prepared and a copy has been placed in the library of each House of Parliament. Copies may be obtained from the Veterinary Medicines Directorate, Woodham Lane, New Haw, Addlestone, Surrey, KT15 3LS.
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 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.
In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969; in the case of the Secretary of State concerned with agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No.1) Order 1978 (S.I. 1978/272); in the case of Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).
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.
S.I. 1972/1811.
S.I. 1998/2428.
