Medicines (Products for Animal Use - Fees) Regulations 1998
|Publication Date:||January 01, 1998|
The Medicines (Products for Animal Use - Fees) Regulations 1998
Laid before Parliament
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 1971( a) and now vested in them( b) and 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 Regulations( c), and the Secretary of State and the Minister of Agriculture, Fisheries and Food, being Ministers designated( d) for the purpose of section 2(2) of the European Communities Act 1972( e) in 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:
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.
2. - (1) In these Regulations, unless the context requires otherwise-
"the Act" means the Medicines Act 1968( f);
"the 1971 Act" means the Medicines Act 1971;
(a) 1971 c. 69 as amended by section 21 of the Health and Medicines Act 1988 (c. 49); by virtue of section 1(3) of the 1971 Act expressions in that section have the same meaning as in the Medicines Act 1968 (c. 67) as amended by the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388). The expression "the Ministers" is defined in section 1(1) of the 1968 Act as so amended.
(b) In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969; in the case of the Secretary of State concerned with agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272); in the case of Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).
(c) See section 129(6) of the Medicines Act 1968 as extended to include Regulations made under the Medicines Act 1971 by section 1(3)(b) of that latter Act.
(d) S.I. 1972/1811.
(e) 1972 c. 68.
(f) 1968 c. 67.
"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( a) as amended by Council Directives 90/676/EEC( b) and 93/40/EEC( c) and as extended by Directive 90/677/EEC( d) and widened by Directive 92/74/EEC( e);
"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( f) signed at Oporto on 2nd May 1992 as adjusted by the Protocol( g) signed at Brussels on 17th March 1993 and as amended by the Decision of the EEA Joint Committee No. 7/94( h);
"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( i);
"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( j);
"the 1994 Regulations" means the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994( k);
"the 1997 Regulations" means the Medicines (Products for Animal Use - Fees) Regulations 1997( l);
(a) OJ No. L317, 6.11.81, p.1.
(b) OJ No. L373, 31.12.90, p.15.
(c) OJ No. L214, 24.8.93, p.31.
(d) OJ No. L373, 31.12.90, p.26.
(e) OJ No. L297, 13.10.92, p.12.
(f) OJ No. L1, 3.1.94, p.3.
(g) OJ No. L1, 3.1.94, p.572.
(h) OJ No. L160, 28.6.94, p.1.
(i) OJ No. L214, 24.8.93, p.1.
(j) OJ No. L55, 11.3.95, p.7.
(k) S.I. 1994/3142 to which there are amendments not relevant to these Regulations.
(l) S.I. 1997/1469.
"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( a).
(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.
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.
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.
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.
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...
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