Guide to the Registration of Homeopathic Veterinary Medicinal Products
15 November 2012
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 medical claims and therefore no efficacy data are necessary. The scheme is restricted to products that are administered by a route described in the European Pharmacopoeia.
In order to qualify for registration the products must:
- Be administered by a route described in the European Pharmacopoeia
- Be sufficiently dilute to guarantee their 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 a 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 Directive 2001/82/EC as amended, as for standard veterinary medicinal products.
Further information can be found in the IMB Guide to the Registration of Homeopathic Veterinary Medicinal Products and Application for a Registration Certificate for a Homeopathic Veterinary Medicinal Product.
For details of recent changes to the guide to the registration of homeopathic veterinary medicinal products, click on the link below.
Guide to the registration of homeopathic veterinary medicinal products with changes tracked
All IMB guidance documents are available from the Publications section of the IMB website.