The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

means a ground specified in— (a) sub-paragraph 1 or 3 of the first paragraph, or (b) the second paragraph, of Article 11 of Directive 81/851;

means a dossier of the type specified in Article 15.1 of Directive 81/851;

means an authorisation of the type specified in Article 24.1 of Directive 81/851;

means particulars which meet the requirements of sub-paragraphs (a) to (c) of Article 25 of Directive 81/851, and— (a) where an Article 24 authorisation has been issued, it shall mean the Article 25 particulars on which such authorisation is based, and (b) where, following the issue of an Article 24 authorisation, an Article 25 particular is changed in accordance with regulation 15, it shall mean the Article 25 particulars as so changed;

means the particulars and documents specified in Article 8 of the Homoeopathics Directive;

means the Article 8 documents on which a registration relating to a product is based, and— (a) where the registration relating to a product has been renewed in accordance with regulation 7, the expression shall mean the Article 8 documents as updated by the Article 15 dossier provided in connection with the renewal application, and (b) where the documents have been altered in accordance with regulation 8, the expression shall mean the Article 8 documents as so altered;

means Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products;

means Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products as amended by Council Directives 90/676/EEC and 93/40/EEC as widened by the Homoeopathics Directive and as adapted by the EEA Agreement;

has the meaning given by Article 1 of the Homoeopathics Directive;

includes the activities specified in the first paragraph of Article 24.2 of Directive 81/851 but does not include the activities specified in the second paragraph of that provision;

means notice in writing;

means a product to which these Regulations apply by virtue of regulation 3(1);

means a person, other than a person in respect of whom a suspension notice served under regulation 27(4) is in force, who— (a) fulfils the conditions laid down in Article 31 of Directive 81/851, or (b) is eligible to act as a qualified person by virtue of Article 32 of that Directive;

means registered by the Ministers under these Regulations;

means the Medicines Act 1968;

means the Advisory Board on the Registration of Homoeopathic Products established by the Medicines (Advisory Board on the Registration of Homoeopathic Products) Order 1995;

means the Medicines Commission established by the Act;

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 as adapted by the EEA Agreement;

means the Minister of Agriculture, Fisheries and Food, the Secretary of State concerned with health in England and the Secretaries of State for Wales and Scotland, the Department of Agriculture for Northern Ireland and the Department of Health and Social Services for Northern Ireland;

means— (a) in relation to England, the Minister of Agriculture, Fisheries and Food, (b) in relation to Scotland and Wales, the Secretary of State, and (c) in relation to Northern Ireland, the Department of Health and Social Services for Northern Ireland.