The Health Products Regulatory Authority (HPRA) has recently updated its guidance on the registration of homeopathic veterinary medicinal products.

According to the HPRA, this guidance is intended for companies wishing to obtain registration for the marketing of homeopathic medicinal products for veterinary use in Ireland.

It covers the criteria for registration as set out in Regulation (EU) 2019/6, includes information taken from other EU Directives as appropriate, and is applicable from January 28, 2022.

The HPRA's document provides advice on the administrative aspects of a registration scheme and gives guidance on how applications should be made.

The homeopathic veterinary medicines registration scheme is a simplified regulatory procedure which enables companies to market certain homeopathic veterinary medicinal products in Ireland.

Homeopathy broadly is a type of alternative medicine, based on the use of highly diluted substances.

According to the HPRA, homeopathic medicines are "distinct from other medicines".

"The difference is in their method of preparation and the principles on which they are prescribed."

Homeopathic medicines

Homeopathic medicines represent special types of veterinary medicines for which particular rules apply, in accordance with the requirements of Regulation (EU) 2019/6.

To be eligible for the homeopathic registration scheme, a homeopathic veterinary medicinal product must satisfy criteria.

The HPRA outlined that it must be prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence of such a description, by any pharmacopoeia used officially in an EU member state.

Other criteria includes: "There must be no specific therapeutic indication included in the labelling or in any information relating to the product (i.e. promotional material).

"The product must bear the scientific name of the stock or stocks from which it is prepared; if the product is composed of two or more stocks, the scientific names of the stocks may be supplemented by an invented name.

"It must be sufficiently dilute to guarantee safety; it must contain no more than one part per 10,000 of the mother tincture."

The HPRA said that if a homeopathic medicinal product is to be marketed in Ireland under the registration scheme, a "registration certificate must be held by the person responsible for placing it on the market".

In Ireland, it is unlawful for any veterinary medicinal product to be placed on the market except in accordance with a product authorisation or registration granted by the HPRA or the European Commission or, in exceptional cases, by the Department of Agriculture, Food and the Marine.