Herbal medicines

Herbal veterinary medicines are authorised using the same regulatory procedures as for traditional veterinary medicines. However, if herbal substances are administered only:

• by mouth,
• to healthy animals,
• as part of the animals' normal diet, where they are a minor component of the food,

and in accordance with our Guide to the Definition of a Veterinary Medicinal Product,

• no indication for use of the product as a veterinary medicine is made on the product labelling or promotional material,
• none of the herbal substances has pharmacological action or affects physiological function at the dose administered to the target animal.
  

Then the product concerned will normally not be regarded by the HPRA as a veterinary medicine requiring a marketing authorisation for sale in Ireland. For queries on whether a product is a veterinary medicine or not use the Request for Classification form.

Homeopathic medicines

Homeopathic veterinary medicines can be registered in one of two ways:

Using the “simplified registration scheme”. This procedure is regarded as “simplified” because although the safety and quality of products has to be demonstrated, no efficacy studies are needed. Consequently, the products are not permitted to make therapeutic claims.

In order to qualify for the simplified registration scheme the products must:

• Use a route of administration described in an official pharmacopoeia,
• Be prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described in an official pharmacopoeia,
• Must not contain more than one part per 10,000 of the mother tincture,
• Make no therapeutic claims.

Using the standard marketing authorisation procedure, where full information on the quality, safety and efficacy of the product is provided in accordance with the requirements of EU veterinary medicines’ legislation.

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.