The Medicines (Products for Animal Use—Fees) Regulations 2004 (revoked)

Regulation 17

SCHEDULE 6 U.K. 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 payable under these Regulations— U.K.

(a) in connection with an application for the grant, variation or renewal of a marketing authorisation or product licence relating to such products; or

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

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

2.  The relevant authority may waive or reduce the payment of any fee payable under these Regulations in circumstances where— U.K.

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

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

(i) 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) Where the relevant authority— U.K.

(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 payable under these Regulations for a marketing authorisation or product licence application or for a variation or first application for a renewal thereof or for an inspection in relation to the product during the currency of that authorisation or licence, made during that five year period application may be reduced or, if the fee has already been paid, 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 estimated by the relevant authority and the sum of £40,000.

(2) Before a marketing authorisation or product licence holder or applicant pays any reduced fee or receives any refund pursuant to sub-paragraph (1) he shall furnish evidence to the satisfaction of the relevant authority of the actual or estimated amount of annual turnover of the product for 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) at the time of the application on the basis of the estimated maximum turnover of the product during any of the first five years of the currency of the authorisation or product licence, that fee shall be regarded as a provisional payment on account.

(4) Where a provisional payment on account was made and evidence furnished to the relevant authority’s satisfaction pursuant to sub-paragraph (2) shows that the maximum turnover in any of those years—

(a) exceeded £40,000, the 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 14(3);

(b) was less than the estimated maximum turnover, the relevant authority may refund the balance between the amount so paid and that payable calculated in accordance with sub-paragraph (1).

4.—(1) 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 in connection with that application: U.K.

(a) if no assessment (veterinary, scientific or pharmaceutical) has begun, 90%;

(b) if such assessment has begun but not been completed, 50%, except where paragraph (c) applies;

(c) if such assessment has begun but not been completed and 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 23 of Directive 2001/82/EC as applied by regulation 5 of the 1994 Regulations, 25%.

(2) In the case where an application has been withdrawn under sub-paragraph (1)(b), and a 50% refund of the fee has been made, any re-application in respect of the same product by the same applicant shall be charged at 50% of the fee otherwise payable under these Regulations.

(3) 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 shall be made under this paragraph.