Council Directive 92/74/EEC of 22 September 1992 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 homeopathic veterinary medicinal products

COUNCIL DIRECTIVE 92/74/EEC of 22 September 1992 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 homeopathic veterinary medicinal products
THE COUNCIL OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas differences currently existing between the provisions laid down by law, regulation or administrative action in the Member States may hinder trade in homeopathic veterinary medicinal products within the Community and lead to discrimination and  distortion of competition between manufacturers of these products;
Whereas the essential aim of any rules governing the production, distribution and use of veterinary medicinal products must be to safeguard human and animal health;
Whereas, despite considerable differences in the status of alternative medicines in the Member States, free choice of treatment should be guaranteed, provided all precautions are taken to ensure the quality of products;
Whereas the provisions of Directive 81/851/EEC (4) are not always appropriate for homeopathic veterinary medicinal products;
Whereas homeopathic medicine is officially recognized in certain Member States but is only tolerated in other Member States;
Whereas, even if homeopathic medicinal products are not always officially recognized, they are nevertheless prescribed and used in most Member States;
Whereas it is desirable in the first instance to provide users of these medicinal products with a very clear indication of their homeopathic character and with sufficient guarantees of their quality and safety;
Whereas the rules relating to the manufacture, control and inspection of homeopathic veterinary medicinal products must be harmonized to permit the circulation throughout the Community of medicinal products which are safe and of good quality;
Whereas, having regard to the particular characteristics of these medicinal products, such as the very low level of active principles they contain and the difficulty of applying to them the conventional statistical methods relating to clinical trials,  it is desirable to provide a special, simplified registration procedure for those traditional homeopathic medicinal products which are placed on the market without specific therapeutic indications in a pharmaceutical form and dosage which do not present  a risk for the animal;
Whereas in the light of current knowledge it appears difficult to allow according to a special, simplified registration procedure the marketing of medicinal products intended to be administered to animals whose flesh or products are intended for human  consumption; whereas, however, this question should be re-examined during the preparation of the overall report on the application of this Directive which has to be submitted by the Commission not later than 31 December 1995;
Whereas, however, the usual rules governing the authorization to market veterinary medicinal products must be applied to homeopathic veterinary medicinal products marketed with therapeutic indications or in a form which may present risks which must be  balanced against the desired therapeutic effect; whereas Member States should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products for pet  animals and exotic species, provided that they notify them to the Commission,