Council Directive 92/73/EEC of 22 September 1992 widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to medicinal products and laying down additional provisions on homeopathic medicinal products

COUNCIL DIRECTIVE 92/73/EEC of 22 September 1992 widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down  additional provisions on homeopathic 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 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 medicinal products must be to safeguard public health;
Whereas, despite considerable differences in the status of alternative medicines in the Member States, patients should be allowed access to the medicinal products of their choice, provided all precautions are taken to ensure the quality and safety of  the said products;
Whereas the anthroposophic medicinal products described in an official pharmacopoeia and prepared by a homeopathic method are to be treated, as regards registration and marketing authorization, in the same way as homeopathic medicinal products;
Whereas the provisions of Directive 65/65/EEC (4) and the Second Directive 75/319/EEC (5), are not always appropriate for homeopathic 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 all 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 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 therapeutic indications in a pharmaceutical form and dosage which do not present a risk  for the patient;
Whereas, however, the usual rules governing the authorization to market medicinal products should be applied to homeopathic medicinal products placed on the market with therapeutic indications or in a form which may present risks which must be balanced  against the desired therapeutic effect; whereas, in particular, those Member States which have a homeopathic tradition 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 provided that they notify them to the Commission,