Together with the introduction of Directive 92/73/EEC on homeopathic medicinal products for human use, a special directive on veterinary homeopathic medicinal products was adopted: Directive 92/74/EEC.¹ The adoption of Directive 2004/28/EC amending the consolidated veterinary Directive 2001/82/EC can result in some interesting changes to the rules on veterinary homeopathic medicinal products in the Member States. Most important is probably the introduction of the possibility of a simplified registration procedure for homeopathic medicinal products for the treatment of food-producing animals in Article 17(1)(b) of the amended Directive 2001/82/EC.

There is a basic division between homeopathic medicinal products used in food-producing animals, and those used in non food-producing animals. Both groups can be subject to special simplified registration if concentrations do not exceed 1:10.000 of the mother tincture, there is no specific indication on the label, and the route of administration is described in the European Pharmacopoeia or a pharmacopoeia currently used officially in one of the Member States. For food-producing species there is the additional requirement that the active substance used is listed in Annex II of Regulation (EEC) No 2377/90.²

Veterinary homeopathic medicinal products in potencies lower than D4 need to be authorized under the ‘normal’ authorization procedure.³ Only for non food-producing species, may Member States retain or adopt territory specific rules for the safety tests and pre-clinical and clinical trials of homeopathic medicinal products.⁴

The complex structure of the amended Directive 2001/82/EC with respect to the ‘Cascade System’ has on more than one occasion led to the misconception that in accordance with Articles 10 and 11, a veterinarian always needs to prescribe a conventional medicinal product before being allowed to use a homeopathic remedy. The newly introduced Article 16, allows the primary use of veterinary homeopathic medicinal products by way of derogation to Articles 10 and 11(1) and (2) of Directive 2001/82/EC. Therefore, a veterinarian is free to prescribe homeopathy on the condition that the following criteria are met:

1) administration must be done under the responsibility of a veterinarian;

2) for food-producing animals the active constituents in the products must be mentioned in Annex II of Regulation (EEC) No 2377/90.

In essence, this means that all veterinary homeopathic medicinal products can be used in non food-producing animals with a few minor exceptions.⁵ For food producing animals the number of remedies that may be used is more limited since they need to be mentioned in and comply with the positive list of Annex II of Regulation (EEC) No 2377/90.

In case a veterinary homeopathic medicinal product used in food-producing animals is not listed among the principles allowed in Annex II, it may be that a veterinarian is required to prescribe an allopathic medicinal product before being allowed to prescribe a homeopathic medicinal product in a food producing species. This would however not necessarily be the case if the product contains more than 1:10.000 of the mother tincture, since those products may be authorised as conventional medicinal products.⁶

All in all the currently applicable legislation does not meet the demands of the veterinary sector, since the practical impact on availability and allowed use remain too restricted. This has especially negative consequences for organic farmers and the availability of low cost and safe treatments for animals.