The Registration of Homoeopathic Veterinary Medicinal Products (Fees) Regulations 1997

• Citation: S.I. 1997/321
• Sections: 13

Section 1 Title and commencement

These Regulations may be cited as the Registration of Homoeopathic Veterinary Medicinal Products (Fees) Regulations 1997 and shall come into force on 31st March 1997.

Section 2 Interpretation

(1) For the purposes of these Regulations the terms—

“Article 8 dossier”;

“the Board”;

“the Commission”;

“the Ministers”;

“product”; and

“registered”,

shall have the meanings respectively given to such terms by regulation 2(1) of the Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997 , as read, in the case of the expression “the Ministers”, with regulation 2(5) of those Regulations.

(2) In these Regulations, unless the context otherwise requires—

(a) any reference to a numbered regulation, or to a numbered Schedule, is a reference to the regulation of, or the Schedule to, these Regulations so numbered in these Regulations, and

(b) any reference in a Schedule, or Part of a Schedule, to a numbered paragraph is a reference to the paragraph so numbered in the Schedule, or Part of a Schedule, in which the reference occurs.

(3) Part I of Schedule 1 shall have effect for the purpose of the interpretation of Schedule 1.

Section 3 Fees relating to applications for registration

Subject to regulations 6 and 7, the relevant fee prescribed in Part II of Schedule 1 shall be payable by a person who applies to the Ministers to register a product.

Section 4 Fee relating to renewal applications

Subject to regulation 6, a fee of £75 shall be payable by a person who applies to the Ministers to renew the registration of a product.

Section 5 Fee relating to the authorisation of Article 8 dossier alterations

Subject to regulation 6, a fee of £85 shall be payable by a person who applies to the Ministers for authorisation to alter an Article 8 dossier relating to a registered product.

Section 6 Registrations, renewals and alterations made at the invitation of the Ministers

No fee shall be payable in connection with the registration of a product, the renewal of a registration of a registered product, or the alteration of an Article 8 dossier relating to a registered product, which is made or carried out at the express written invitation of the Ministers.

Section 7 Waiver or refund of fees

The Ministers shall waive or refund payment of any fee otherwise payable under regulation 3 in the circumstances and to the extent specified in Schedule 2.

Section 8 Time for payment of fees

Any fee payable under these Regulations shall be payable to the Ministers within 30 days following written notice from the Ministers requiring the payment of the fee.

Section 9 Civil proceedings to recover unpaid fees

All unpaid sums due by way of any fees payable under these Regulations shall be recoverable as debts due to the Crown.

Section 1

Subject to paragraph 2, the fee for an application of a kind described in column (1) of the Table below shall be—

(a) the fee specified in the corresponding entry of column (2) of that Table in the case of a product prepared from not more than 5 homoeopathic stocks, and

(b) the fee specified in the corresponding entry of column (3) of that Table in the case of a product prepared from more than 5 homoeopathic stocks.

(1) An application in respect of a product which is both prepared solely from a repeat stock or stocks and is of a repeat formulation

(2) An application in respect of a product which is either—

(a) prepared solely from a repeat stock or stocks; or

(b) is of a repeat formulation

(3) Any other application

Section 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 1994 , 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.

Section 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 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 per cent, and

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

Section 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 Commission, no refund or waiver of the fee payable under regulation 3 in connection with that application shall be made.