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

Interpretation

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

“the Act” means the Medicines Act 1968(1);

“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/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products(2) as amended by Council Directives 90/676/EEC(3) and 93/40/EEC(4) and as extended by Directive 90/677/EEC(5) and widened by Directive 92/74/EEC(6);

“Directive 90/677/EEC” means Council Directive 90/677/EEC extending 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/EEC widening 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 Area(7) signed at Oporto on 2nd May 1992 as adjusted by the Protocol(8) signed at Brussels on 17th March 1993 and as amended by the Decision of the EEA Joint Committee No. 7/94(9);

“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. 2309/93 laying 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 Products(10);

“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. 541/95 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State(11);

“the 1994 Regulations” means the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994(12);

“the 1997 Regulations” means the Medicines (Products for Animal Use—Fees) Regulations 1997(13);

“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 1970(14).

(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) 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) 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) 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.

(1)

1968 c. 67.

(2)

OJ No. L317, 6.11.81, p.1.

(3)

OJ No. L373, 31.12.90, p.15.

(4)

OJ No. L214, 24.8.93, p.31.

(5)

OJ No. L373, 31.12.90, p.26.

(6)

OJ No. L297, 13.10.92, p.12.

(7)

OJ No. L1, 3.1.94, p.3.

(8)

OJ No. L1, 3.1.94, p.572.

(9)

OJ No. L160, 28.6.94, p.1.

(10)

OJ No. L214, 24.8.93, p.1.

(11)

OJ No. L55, 11.3.95, p.7.

(12)

S.I. 1994/3142 to which there are amendments not relevant to these Regulations.

(13)

S.I. 1997/1469.

(14)

S.I. 1970/1304.