The Medicines (Products for Animal Use—Fees) Regulations 1998

2

Where an application for registration relates to a product–

• (a) for which a certificate of registration has been granted in relation to a product which is equivalent to it under Part II of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994²³; or

• (b) which is registered or authorised in an EEA State under legislation which implements the provisions of Article 6 of the Homoeopathics Directive in such State,

the fee for such application shall be–

• (i) £100 in the case of a product prepared from not more than 5 homoeopathic stocks, and

• (ii) £250 in the case of a product prepared from more than 5 homoeopathic stocks.

PART III — WAIVER OR REFUND OF FEES

1

Subject to paragraph 2, where an application for registration is withdrawn before determination by the Ministers, the following percentage of the fee otherwise payable in connection with that application shall be refunded or, if it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%; and

• (b) if veterinary, scientific or pharmaceutical assessment has begun but has not been completed, 50%.

2

If an application for registration is withdrawn either after veterinary, scientific or pharmaceutical assessment has been completed, or following consideration of that application by the Board or by the Medicines Commission, no refund or waiver of the fee payable in connection with that application shall be made.

SCHEDULE 6 — MARKETING AUTHORISATIONS, PRODUCT LICENCES AND ANIMAL TEST CERTIFICATES: FEES FOR REFERENCES TO THE VETERINARY PRODUCTS COMMITTEE OR TO THE MEDICINES COMMISSION

1

The fee payable under regulation 15 for a reference to the Veterinary Products Committee or to the Medicines Commission in connection with an application for a marketing authorisation or licence of the kind described in column (1) of the Table below shall be that specified in the corresponding entry in column (2) of that Table.

2

The fee payable under regulation 15 for a reference to the Veterinary Products Committee or to the Medicines Commission in connection with an application for an animal test certificate shall be £495.

3

For the purposes of this Schedule, the terms–

• “complex application”;

• “major application”;

• “simple application”; and

• “standard application”

shall have the meanings respectively given to such terms in Part I of Schedule 1.

SCHEDULE 7 — WAIVER, REDUCTION OR REFUND OF FEES

1

Where the manufacture, assembly, sale or supply of products of a particular class or description will be, or is likely to be, interrupted for a period, and in consequence thereof the health of animals will be, or is likely to be put at risk, the relevant authority may determine that any fees otherwise payable under these Regulations–

• (a) in connection with an application for the grant, variation or renewal of a marketing authorisation or product licence relating to a product falling within that class or description; or

• (b) in respect of any inspection made during the currency of such a marketing authorisation or product licence,

shall be waived during that particular period or, if the period will or is likely to exceed 3 months, during the first 3 months of that period.

2

The relevant authority may waive or reduce the payment of any fee payable under these Regulations in circumstances where–

• (a) in its opinion the interests of human or animal health require a marketing authorisation, product licence or certificate to be granted or an inspection to be made; and

• (b) the product in respect of which an application for a marketing authorisation, product licence or certificate has been made–

• (i) it is not intended for sale; or

• (ii) is intended only for use in the treatment of rare conditions or in the treatment of a minor species of animal or as an emergency vaccine.

3

• (1) Subject to sub-paragraphs (2) to (5) below, where the relevant authority–

• (a) is satisfied that the annual turnover (as calculated in accordance with Schedule 3) relating to a particular product during any calendar year of the first five years of the currency of its actual or prospective marketing authorisation or product licence, has not exceeded, or is unlikely to exceed, £40,000; and

• (b) is of the opinion that the interests of human or animal health require a marketing authorisation or product licence for the products in question to be granted, varied or renewed (as the case may be),

a fee otherwise payable under these Regulations in connection with an application made during that five year period for a marketing authorisation or product licence or application for a variation or first application for a renewal of such authorisation or product licence in relation to the product or in connection with an inspection in relation to the product 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) as established or as anticipated by the relevant authority 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 actual or anticipated 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.

• (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 actual turnover relating to the product in question 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 from and including the date of written notice sent by the relevant authority in accordance with regulation 17(2).

• (5) Where any provisional payment on account is made in accordance with sub-paragraph (3) above, the reduced fee shall be recalculated on the basis of actual turnover 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 provisional payment on account shall be payable by the applicant within 30 days from and including the date of written notice sent by the relevant authority in accordance with regulation 17 or, as the case may be, refunded to the applicant by the relevant authority.

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 relevant authority shall refund, or where no payment has been made, waive the following percentage of the fee otherwise payable (under regulation 3) in connection with that application–

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

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

• (c) if, in a case to which paragraph (b) above applies, a request for further information in connection with the application has been made by the relevant authority under section 44(1) of the Act, or under Article 9 of Directive 81/851/EEC as applied by regulation 5 of the 1994 Regulations, 25%,

and, in the case of 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 the Veterinary Products Committee 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

Hayman — Parliamentary Under Secretary of State, — Department of Health — 24th September 1998

Signed by authority of the Secretary of State for Wales

Jon Owen Jones — Parliamentary Under Secretary of State, Welsh Office — 25th September 1998

Sewel — Parliamentary Under Secretary of State, Scottish Office — 25th September 1998

Nick Brown — Minister of Agriculture, Fisheries and Food — 29th September 1998

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this 24th day of September 1998

D.C. Gowdy — Permanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this 28th day of September 1998

P. Small — Permanent Secretary

We consent,

Clive Betts — Jim Dowd — Two of the Lords Commissioners of Her Majesty’s Treasury — 25th September 1998

Explanatory note

(This note is not part of the Regulations)

These Regulations revoke and re-enact with modifications the Medicines (Products for Animal Use—Fees) Regulations 1997. As in the case of the 1997 Regulations, 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.

In prescribing fees in relation to the 1994 Regulations, these Regulations continue to supplement the 1994 Regulations in implementing Council Directive 93/40/EEC (OJ No. L214, 24.8.93, p.31) which contains amendments to Council Directive 81/851/EEC (OJ No. L317, 6.11.81, p.1).

The average level of fees payable under the Regulations is increased by 10% in comparison with the 1997 Regulations.

The changes in these Regulations include–

• (a) the introduction of a separate fee for variations to marketing authorisations which have been mutually recognised and which relate to medicinal products (primarily immunological) falling within the scope of introductory statement A to Annex 1 of Commission Regulation 541/95/EC;

• (b) a reduction in the fee payable for a variation which is additional, consequential and in identical terms to the first variation of a mutually recognised marketing authorisation;

• (c) a reduction in the fee payable for manufacturers' licences and wholesale dealers' licences.

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).

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, Addlestone, Surrey, KT15 3LS.

Footnotes