Medicines (Products for Animal Use - Fees) Regulations 1998

JurisdictionUK Non-devolved
CitationSI 1998/2428
Year1998

1998 No. 2428

MEDICINES

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

Made 29th September 1998

Laid before Parliament 8th October 1998

Coming into force 1st November 1998

The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, with the consent of the Treasury, in exercise of the powers conferred by section 1(1), (2) and (3)(b) of the Medicines Act 19711and now vested in them2and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations3, and the Secretary of State and the Minister of Agriculture, Fisheries and Food, being Ministers designated4for the purpose of section 2(2) of the European Communities Act 19725in relation to medicinal products and the common agricultural policy of the European Community, acting jointly, in exercise of the powers conferred on them by the said section 2(2), hereby make the following Regulations:

S-1 Citation, commencement and scope

Citation, commencement and scope

1.—(1) These Regulations may be cited as the Medicines (Products for Animal Use—Fees) Regulations 1998 and shall come into force on 1st November 1998.

(2) These Regulations apply only to fees relating to products for animal use.

S-2 Interpretation

Interpretation

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

“the Act” means the Medicines Act 19686;

“the 1971 Act” means the Medicines Act 1971;

“assistance in connection with a mutual recognition application” means the preparation of an assessment report of the type required by virtue of the second paragraph of Article 17.3 of Directive 81/851/EEC in order for an application to be made to a member State for mutual recognition of a marketing authorisation, or the updating of an existing assessment report for the purpose of enabling such an application to be made, and includes any assistance given of the type specified in Articles 18.2 and 18.3 of that Directive in connection with the application for mutual recognition in relation to which the assessment report or updated assessment report has been prepared;

“Directive 81/851/EEC” means Council Directive 81/851/EECon the approximation of the laws of the Member States relating to veterinary medicinal products7as amended by Council Directives 90/676/EEC8and 93/40/EEC9and as extended by Directive 90/677/EEC10and widened by Directive 92/74/EEC11;

“Directive 90/677/EEC” means Council Directive 90/677/EECextending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products;

“Directive 92/74/EEC” means Council Directive 92/74/EECwidening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homoeopathic veterinary medicinal products;

“EEA Agreement” means the Agreement on the European Economic Area12signed at Oporto on 2nd May 1992 as adjusted by the Protocol13signed at Brussels on 17th March 1993 and as amended by the Decision of the EEA Joint Committee No. 7/9414;

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

“marketing authorisation” means an authorisation to place on the market in the United Kingdom a Veterinary Medicinal Product but does not include a marketing authorisation granted by the Community in accordance with the provisions of Council Regulation (EEC) No. 2309/93laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products15;

“the Ministers” has the meaning given by regulation 1(4) of the 1994 Regulations;

“pay”, when used in the context of a requirement, means pay subject to any exception, waiver or reduction provided for in these Regulations, and related expressions shall be construed accordingly;

“product” means a medicinal product as defined in the 1971 Act save that–

(a) it includes–

(i) any substance or article to be administered in a medicinal test on animals under section 32(6)(c) of the Act; and

(ii) any Veterinary Medicinal Product which would not otherwise count as a medicinal product, and

(b) it excludes medicated feedingstuffs.

“Regulation (EC) No. 541/95” means Commission Regulation (EC) No. 541/95concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State16;

“the 1994 Regulations” means the Marketing Authorisations for Veterinary Medicinal Products Regulations 199417;

“the 1997 Regulations” means the Medicines (Products for Animal Use—Fees) Regulations 199718;

“relevant authority” insofar as it is used in relation to a marketing authorisation, or an application for, or relating to, such an authorisation, means the Ministers, and otherwise means the licensing authority;

“third country” means a country other than an EEA State or the United Kingdom;

“variation with extras”, in respect of a marketing authorisation, means changes falling within Annex II to Regulation (EC) No. 541/95;

“Veterinary Medicinal Product” means a veterinary medicinal product of the type specified in Article 1.2 of Directive 81/851/EEC and to which the provisions of that Directive apply; and

“Veterinary Products Committee” means the committee established by the Medicines (Veterinary Products Committee) Order 197019.

(2) Other expressions used in these Regulations have, in so far as the context admits, the same meanings as in Directive 81/851/EEC, Regulation (EC) No. 541/95, the Act and the 1971 Act.

(3) In these Regulations, unless the context otherwise requires–

(a)

(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;

(b)

(b) any reference in a regulation or a Schedule or Part of a Schedule to a numbered paragraph is a reference to the paragraph so numbered in the regulation or Schedule or Part of a Schedule in which the reference occurs; and

(c)

(c) any reference in a Schedule or Part of a Schedule to a lettered table is a reference to the table so lettered in the Schedule or Part of a Schedule in which the reference occurs.

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

S-3 Applications for the grant of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences and animal test certificates

Applications for the grant of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences and animal test certificates

3.—(1) Where a person applies for the grant of a marketing authorisation, a product licence, a manufacturer’s licence, a wholesaler dealer’s licence, or an animal test certificate, he shall pay the relevant fee prescribed in Part II of Schedule 1.

(2) Paragraph (1) shall not be taken to impose any obligation on an applicant for a new marketing authorisation or product licence falling within regulation 11(2), or on an applicant for a variation with extras.

S-4 Applications for assistance in connection with mutual recognition

Applications for assistance in connection with mutual recognition

4. Where a person applies for assistance in connection with a mutual recognition application, he shall pay the relevant fee prescribed in Part III of Schedule 1.

S-5 Applications for variation of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences and animal test certificates

Applications for variation of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences and animal test certificates

5.—(1) Where a person applies to vary a marketing authorisation, a product licence, a manufacturer’s licence, a wholesale dealer’s licence or an animal test certificate, he shall pay the relevant fee prescribed in Part IV of Schedule 1.

(2) This regulation extends to applications for a variation with extras.

S-6 Multiple variations

Multiple variations

6. Where a person applies to vary a provision of a marketing authorisation, licence or certificate, no fee is payable in respect of any variation which is consequential upon another variation of a provision of the same marketing authorisation, licence or certificate applied for in the same application.

S-7 Variation at the invitation of the relevant authority

Variation at the invitation of the relevant authority

7. No fee is payable for a variation made at the express written invitation of the relevant authority.

S-8 Applications for renewal of marketing authorisations, product licences, manufacturers' licences and animal test certificates

Applications for renewal of marketing authorisations, product licences, manufacturers' licences and animal test certificates

8. Where a person applies–

(a) for the renewal of a marketing authorisation, a product licence, a manufacturer’s licence or an animal test certificate, or

(b) for a new marketing authorisation or product licence falling within regulation 11(2),

he shall pay the relevant fee prescribed in Part V of Schedule 1.

S-9 Applications for renewal of marketing authorisations, product licences, manufacturer’s licences and animal test certificates in terms which are not identical to the existing marketing authorisation, licence or certificate

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