Statutory Instrument 1997 No. 321

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

---

© Crown Copyright 1997

Statutory Instruments printed from this website are printed under the superintendence and authority of the Controller of HMSO being the Queen's Printer of Acts of Parliament.

The legislation contained on this web site is subject to Crown Copyright protection. It may be reproduced free of charge provided that it is reproduced accurately and that the source and copyright status of the material is made evident to users.

It should be noted that the right to reproduce the text of Statutory Instruments does not extend to the Queen's Printer imprints which should be removed from any copies of the Statutory Instrument which are issued or made available to the public. This includes reproduction of the Statutory Instrument on the Internet and on intranet sites. The Royal Arms may be reproduced only where they are an integral part of the original document.

The text of this Internet version of the Statutory Instrument which is published by the Queen's Printer of Acts of Parliament has been prepared to reflect the text as it was Made. A print version is also available and is published by The Stationery Office Limited as the The Registration of Homoeopathic Veterinary Medicinal Products (Fees) Regulations 1997 , ISBN 0 11 063947 2. The print version may be purchased by clicking here. Braille copies of this Statutory Instrument can also be purchased at the same price as the print edition by contacting TSO Customer Services on 0870 600 5522 or e-mail:customer.services@tso.co.uk.

Further information about the publication of legislation on this website can be found by referring to the Frequently Asked Questions.

To ensure fast access over slow connections, large documents have been segmented into "chunks". Where you see a "continue" button at the bottom of the page of text, this indicates that there is another chunk of text available.

shall have the meanings respectively given to such terms by regulation 2(1) of the Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997[3], 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.

Fees relating to applications for registration
     3 . 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.

Fee relating to renewal applications
     4 . 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.

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

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

Waiver or refund of fees
     7 . 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.

Time for payment of fees
     8 . 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.

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

Angela Browning
Parliamentary Secretary, Ministry of Agriculture, Fisheries and Food

11th February 1997

Lindsay
Parliamentary Under-Secretary of State, Scottish Office

12th February 1997

"EEA Agreement" means the Agreement on the European Economic Area[4] signed at Oporto on 2nd May 1992 as adjusted by the Protocol[5] signed at Brussels on 17th March 1993 and as amended by the Decision of the EEA Joint Committee No 7/94[6];

"EEA State" means a State which is a Contracting Party to the EEA Agreement other than the United Kingdom;

"formulation" means the formulation of a product but does not include the formulation of a homoeopathic stock contained in such a product;

"the Homoeopathics Directive" means Council Directive 92/74/EEC widening the scope of Directive 81/851/EEC on the approximation of the provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products[7] as adapted by the EEA Agreement;

"homoeopathic stock" has the same meaning as in the Homoeopathics Directive;

"identical" means - 

(a) in relation to the formulation of a product, identical as regards the requirements in respect of the qualitative composition, preparation and testing,

(b) in relation to a homoeopathic stock, identical as regards the source, composition and preparation of the stock and the tests which it is required to undergo;

"product" includes a series of products which are all dilutions prepared from an identical homoeopathic stock or stocks and each of which has the same pharmaceutical dosage form;

"repeat formulation" means - 

(a) the formulation of a product which is identical to the formulation of a registered product - 


(i) which the applicant is responsible for marketing; or

(ii) to which the applicant has been authorised in writing to make reference for the purposes of his application by the person responsible for marketing that product, or



(b) the formulation of a product which is identical to another product in respect of which an applicant has made a simultaneous application;

"repeat stock" means - 

(a) a homoeopathic stock which is used in the preparation of a product (either on its own or in combination with another homoeopathic stock or stocks), and which is identical to another homoeopathic stock which is used (whether on its own or in combination with any other homoeopathic stocks or stocks) in the preparation of a registered product - 


(i) which the applicant is responsible for marketing; or

(ii) which another person is responsible for marketing and to which the applicant has been authorised in writing to make reference for the purposes of his application by the person (or, if more than one, each of such persons) who supplied information to the Ministers in connection with the application made to register that registered product; or



(b) a homoeopathic stock which is used in the preparation of a product (either on its own or in combination with another homoeopathic stock or stocks), and which is identical to a homoeopathic stock which is used (whether on its own or in combination with any other homoeopathic stocks or stocks) in the preparation of a product in respect of which an applicant has made a simultaneous application; and

"simultaneous application" means an application which is made by an applicant at the same time as making another application or applications, and which is the first of such applications to be considered by the Ministers.

(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[8], 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.