Herbal veterinary medicines must be authorised by us following the same procedures as for other veterinary medicines. In accordance with our Guide to the Definition of an Animal Remedy, herbal substances which form a minor component of a product intended for oral administration to healthy animals, as part of the animals' diet, are not regarded as a veterinary medicine requiring authorisation provided that:
no indication for use of the product as a veterinary medicine is made;
none of the herbal substances has pharmacological action or affects physiological function at the dose administered to the target animal.
Homeopathic veterinary medicines can be registered in one of two ways:
1. By registration under the so-called “simplified registration scheme”. This procedure is regarded as “simplified” because although the safety and quality of products has to be demonstrated, products are not permitted to make therapeutic claims and therefore studies or data that demonstrate their effectiveness are unnecessary.
In order to qualify for registration the products must:
• Be administered by a route of administration described in the European Pharmacopoeia/other official Pharmacopoeia
• Be prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described in the European Pharmacopoeia/other official Pharmacopoeia
• Be sufficiently dilute to guarantee safety (they must not contain more than one part per 10,000 of the mother tincture)
• Make no therapeutic claims
2. Where appropriate, homeopathic products can also be submitted for standard marketing authorisation, i.e. for a veterinary product authorisation (VPA). In this case, the applicant must provide full information on the quality, safety and efficacy of the product in accordance with the requirements of Regulation (EU) 2019/6 as amended, as for standard veterinary medicinal products.
Further information can be found in the Guide to the Registration of Homeopathic Veterinary Medicinal Products and Application for a Registration Certificate for a Homeopathic Veterinary Medicinal Product.