The Medicines (Products for Animal Use-Fees) Regulations 2004
|Publication Date:||January 01, 2004|
The Medicines (Products for Animal Use-Fees) Regulations 2004
The Secretary of State, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, acting jointly, with the consent of the Treasury, in exercise of the powers conferred upon them by section 1(1), (2) and (3)(b) of the Medicines Act 1971( 1) and now vested in them( 2);
And the Secretary of State, being designated for the purposes of section 2(2) of the European Communities Act 1972( 3) in relation to medicinal products( 4), in exercise of the powers conferred on her by that section;
And in exercise of the powers conferred by section 56 of the Finance Act 1973( 5), and with the consent of the Treasury;
After carrying out a consultation with such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations in accordance with section 129(6) of the Medicines Act 1968( 6);
And after carrying out the consultation required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council (laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety)( 7);
Make the following Regulations:
Citation, commencement and scope
1. - (1) These Regulations may be cited as the Medicines (Products for Animal Use - Fees) Regulations 2004 and shall come into force on 17th November 2004.
(2) These Regulations apply only to fees relating to products for animal use.
2. - (1) In these Regulations -
"the Act" means the Medicines Act 1968;
"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 32.1 of Directive 2001/82/EC 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 Article 33 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 2001/82/EC" means Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products( 8);
"EEA Agreement" means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992( 9) , amended as at the date of making these Regulations( 10) );
"EEA State" means a State which is a Contracting Party to the EEA Agreement other than the United Kingdom;
"export certificate" means a certificate issued under section 50 of the Act;
"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( 11);
"product" means a medicinal product as defined in the 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;(ii) any article or substance in relation to which provisions of Part II of the Act have effect by virtue of an order under section 104 or 105 of that Act; and(iii) 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 the competent authority of a Member State( 12), as it was immediately before repeal;
"Regulation (EC) No 1084/2003" means Commission Regulation (EC) No 1084/2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State( 13);
"the 1994 Regulations" means the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994( 14);
"the relevant authority" insofar as it is used in relation to a marketing authorisation or an application therefor, means the Secretary of State, and otherwise means the licensing authority as defined in section 6 of the Act;
"specific batch control" means consideration by the relevant authority of a marketing authorisation or animal test certificate holder's documentation relating to a specific batch of a veterinary medicinal product (other than an immunological product) where the quality characteristics of that product or of a material used during its manufacture or its packaging to produce the finished product for sale differ from those detailed in the marketing authorisation or animal test certificate, so that the relevant authority may decide whether action under Article 84 of Directive 2001/82/EC either to instigate a recall or to prohibit the placing on the market of the veterinary medicinal product would be required;
"variation with extras" means changes to a marketing authorisation falling within Annex II to Regulation (EC) No 541/95 except in the case of a mutually recognised marketing authorisation, where it means changes falling within Annex II to Regulation (EC) 1084/2003;
"veterinary medicinal product" has the same meaning as in Article 1.2 of Directive 2001/82/EC; and
"Veterinary Products Committee" means the committee established by the Medicines (Veterinary Products Committee) Order 1970( 15).
(2) Expressions used in relation to variations to marketing authorisations (other than mutually recognised marketing authorisations) have the same meaning as in Directive 851/81/EC on the approximation of the laws of the Member States relating to veterinary medicinal products( 16), as it was immediately before repeal, and Regulation (EC) No 541/95.
(3) Expressions used in relation to mutually recognised marketing authorisations have the same meaning as in Directive 2001/82/EC and Regulation (EC) No 1084/2003.
(4) Part 1 of Schedule 1 shall have effect for the purposes of interpretation of Schedule 1.
(5) Save as otherwise provided other expressions used in these Regulations have the same meaning as in the Act and the Medicines Act 1971.
Applications for authorisations, licences and certificates
3. - (1) Part 2 of Schedule 1 (application fees for a marketing authorisation, manufacturer's licence, product licence wholesale dealer's licence, an animal test certificate or export certificate) shall have effect.
(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 9(2) or on an applicant for a variation with extras.
Specific batch control
4. Where the holder of a marketing authorisation (other than a mutually recognised marketing authorisation) or an animal test certificate requests the relevant authority to undertake specific batch control he shall pay a fee of £500.
Applications for assistance in connection with mutual recognition
5. Part 3 of Schedule 1 (fees for assistance in connection with a mutual recognition application) shall have effect.
Applications for variation of authorisations, licences and certificates
6. - (1) Part 4 of Schedule 1 (fees for an application to vary a marketing authorisation, product licence, manufacturer's licence, wholesale dealer's licence or an animal test certificate) shall have effect.
(2) Paragraph (1) extends to applications for a variation with extras.
(3) Paragraph (1) shall not apply to -(a) a variation of a marketing authorisation, licence or certificate consequential upon another variation of the same marketing authorisation, licence or certificate applied for in the same application;(b) a variation application made at the express written invitation of the relevant authority;(c) a TSE variation application,
for which no fee is payable.
(4) For the purposes of paragraph (3), "TSE variation application" means an application (other than a complex application as defined in Schedule 1 or an application which seeks to demonstrate compliance by cross-referring to data held by the relevant authority) to vary -(a) a marketing authorisation to comply with regulation 6(1)(d) of the 1994 Regulations; or(b) a product licence to reduce the risk of revocation under section 28(3) of the Act by reason of the relevant authority not being satisfied that the product was manufactured in the manner carrying the least risk of transmitting animal spongiform encephalopathy agents.
Applications for renewal of authorisations, licences and certificates
7. - (1) The fee -(a) for the renewal of a marketing authorisation, a product licence, a manufacturer's licence or an animal test certificate;(b) to terminate a marketing authorisation or product licence and for it to be replaced with a new marketing authorisation or product licence in respect of the same product,
is that prescribed in Part 5 of Schedule 1.
(2) Where a person applies for renewal of a marketing authorisation, a product licence, a manufacturer's licence or an animal test certificate so as to contain variations, he shall pay the fee payable pursuant to paragraph (1) plus the fee which would have been payable had the application been an application to vary the authorisation, licence or certificate in question.
8. - (1) Fees for inspections in connection with an application for the grant, variation or renewal of a manufacturer's...
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