The Medicines (Products for Animal Use—Fees) Regulations 1997

any fee otherwise payable under these Regulations in connection with an application for a marketing authorisation, product licence or application for a variation or renewal of such authorisation or product licence or an inspection during the currency of that authorisation or licence may be reduced or, if such a fee has already been paid, be refunded in part in proportion to the difference between the maximum turnover of the product in any calendar year (during any of the first five years of the currency of the authorisation or product licence) and the sum of £40,000.

• (2) Before a marketing authorisation or product licence holder pays any reduced fee or receives any refund pursuant to sub-paragraph (1) above he shall furnish evidence to the satisfaction of the relevant authority of the amount of annual turnover, in respect of the particular product, in each calendar year of the first five years of the currency of the authorisation or product licence and, in the case of an application for renewal, the last five years of such currency.

• (3) Where a reduced fee is determined in accordance with sub-paragraph (1) above at the time of the application on the basis of the estimated likely maximum turnover of the product during the first five years of the currency of the authorisation or product licence, any fee so determined shall be regarded as a provisional payment on account.

• (4) Where a provisional payment on account is made in accordance with sub-paragraph (3) above and subsequently the turnover in any calendar year in the first five years of the currency of the marketing authorisation or product licence exceeds £40,000, the authorisation or product licence holder shall be liable to pay the balance of the full fee otherwise payable under these Regulations within 30 days of notification by the relevant authority.

• (5) Where any provisional payment on account is made in accordance with sub-paragraph (3) above, the reduced fee shall be recalculated in accordance with the provisions of sub-paragraph (1) above at the end of five years from the date of the grant of the marketing authorisation or product licence and any difference between the fee so calculated and the provisionsl payment on account shall be payable by the applicant or, as the case may be, refunded to the applicant by the relevant authority within 30 days of a request for such a refund.

4

• (1) Subject to sub-paragraph (2) below, where an application for a marketing authorisation or product licence or manufacturer’s or wholesale dealer’s licence is withdrawn before determination by the relevant authority, the following percentage of the fee otherwise payable (under regulation 3) in connection with that application shall be refunded or, if it has not yet been paid, shall be waived—

• (a) if the application has been received but no veterinary, scientific or pharmaceutical assessment thereof has begun, 90%;

• (b) except in a case to which sub-paragraph (c) below applies, veterinary, scientific or pharmaceutical assessment has begun but not been completed, 50%;

• (c) if a request for further information in connection with the application has been made by the licensing authority under section 44(1) of the Act, 25%.

• In the case of sub-paragraph (b) above, where an application has been withdrawn because it is deficient and a 50% refund of the fee has been made by the relevant authority any subsequent reapplication in respect of the same authorisation or licence by the same applicant shall be charged at 50% of the fee otherwise payable under regulation 3.

• (2) If an application for a marketing authorisation or product licence is withdrawn either after scientific or veterinary pharmaceutical assessment has been completed or following consideration of that application by a committee established under section 4 of the Act or by the Medicines Commission, no refund or waiver of the fee payable (under regulation 3 of these Regulations) in connection with that application shall be made under this paragraph.

Signed

Signed by authority of the Secretary of State for Health

Baroness Jay — Minister of State, — Department of Health — 4th June 1997

Signed by authority of the Secretary of State for Wales

Win Griffiths — Parliamentary Under Secretary of State, Welsh Office — 9th June 1997

Sewel — Parliamentary Under Secretary of State, Scottish Office — 5th June 1997

Jeff Rooker — Minister of State, Ministry of Agriculture, Fisheries and Food — 31st May 1997

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland

D.C. Gowdy — Permanent Secretary — 4th June 1997

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland

P.J. Small — Permanent Secretary — 3rd June 1997

We consent,

Graham Allen — Bob Ainsworth — Two of the Lords Commissioners of Her Majesty’s Treasury — 3rd June 1997

Explanatory note

(This note is not part of the Regulations)

These Regulations consolidate with some changes the Regulations revoked. They prescribe fees in connection with applications and inspections relating to:

• (a) marketing authorisations granted under the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (S.I. 1994/3142);

• (b) licences and certificates granted under the Medicines Act 1968 insofar as they apply to medicinal products for animal use; and

• (c) the registration of homoeopathic veterinary medicinal products.

The principal changes are:

• (a) the removal of the 15% low turnover relief for wholesale dealers’ licences;

• (b) the introduction of a fee for the assessment of an application for a marketing authorisation for parallel imports;

• (c) the introduction of a reduced fee for the renewal of a marketing authorisation or product licence for herbal products; and

• (d) a requirement that all fees should be payable within 30 days of demand.

The Regulations also provide for:

• (a) the method and time for payment of fees (regulations 16 to 18);

• (b) the suspension of licences and certificates where fees remain unpaid (regulation 19);

• (c) the waiver reduction or refund of fees (regulation 20 and Schedule 7); and

• (d) transitional provisions (regulation 22).

Fees for applications for product licences, marketing authorisations, manufacturer’s and wholesale dealer’s licences, fixed annual fees and fees for the renewal or variation of those licences and authorisations have all been increased by an average of 6%.

A Compliance Cost 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, Addlestone, Surrey, KT15 3NB.

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 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 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).

[^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]: 1972 c. 68.

[^f00006]: OJ No. L317, 6.11.81, p.1.

[^f00007]: 1968 c. 67.

[^f00008]: OJ No. L317, 6.11.81, p.1.

[^f00009]: OJ No. L373, 31.12.90, p.15.

[^f00010]: OJ No. L214, 24.8.93, p.31.

[^f00011]: OJ No. L373, 31.12.90, p.26

[^f00012]: OJ No. L297, 13.10.92, p.12.

[^f00013]: OJ No. L1, 3.1.94, p.3.

[^f00014]: OJ No. L1, 3.1.94, p.572.

[^f00015]: OJ No. L160, 28.6.94, p.1.

[^f00016]: OJ No. L214, 24.8.93, p.1.

[^f00017]: Section 130(3A) was inserted by section 13(2) of the Animal Health and Welfare Act 1984 (c. 40).

[^f00018]: OJ No. L55, 11.3.95, p.7.

[^f00019]: S.I. 1994/3142.

[^f00020]: S.I. 1997/322.

[^f00021]: S.I. 1995/2364.

[^f00022]: S.I. 1996/2196.

[^f00023]: S.I. 1997/321.

[^f00024]: OJ No. L55, 11.3.95, p.7.

[^f00025]: S.I. 1971/1450; the relevant amending instrument is S.I. 1972/1200.

[^f00026]: OJ No. L297, 13.10.92, p.12.

[^f00027]: S.I. 1994/105, amended by S.I. 1994/899, 1995/541, 1996/482.