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European Coalition on Homeopathic & Anthroposophic Medicinal Products

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Homeopathic medicinal products for veterinary use

In 1992, Council Directive 92/74/EEC was adopted, widening the scope of Directive 81/851/EEC on the approximation of provisions relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products.

The adoption of Directive 2004/28/EC amending the consolidated veterinary Directive 2001/82/EC resulted in some interesting changes to the rules on veterinary homeopathic medicinal products in the Member States. Most important was 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) of the amended Directive 2001/82/EC.

Medicinal products used in food-producing animals as well as those used in non food-producing animals 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 Table 1 in the Annex of Regulation No. 37/2010.

Veterinary homeopathic medicinal products in potencies lower than D4 need to be authorised under the ‘normal’ authorisation procedure.1 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.2

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:

  • administration must be done under the responsibility of a veterinarian;
  • for food-producing animals the active constituents in the products must be mentioned in table 1 in the Annex of Regulation No. 37/2010.

In essence, this means that all veterinary homeopathic medicinal products can be used in non food-producing animals with a few minor exceptions.3 For food producing animals the number of remedies that may be used is more limited since they need to be mentioned in Table 1 in the Annex of Regulation No. 37/2010.

In summary 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.

However, the legal framework for veterinary medicinal products is currently under revision. An online public consulation on the key issues of an envisaged legal proposal was carried out between 13 April and 15 July 2010. On 10 September 2014 the European Commission adopted two proposals on veterinary medicinal products and medicated feed. The proposal on veterinary medicinal products (2014/0257 (COD)) aims to:

  • Increase the availability of veterinary medicinal products
  • Reduce administrative burden
  • Stimulate competitiveness and innovation
  • Improve the functioning of the internal market
  • Address the public health risk of antimicrobial resistance. 

The proposal shall repeal and replace Directive 2001/82/EC.

[1]See Article 19(1) of Directive 2001/82/EC.
[2]See Article 19(2) of Directive 2001/82/EC.
[3]Immunological homeopathic medicinal products are excluded on the basis of Article 20 of Directive 2001/82/EC.
[4]See Article 19(2) of Directive 2001/82/EC.

Last updated on 07 Oct 2015