A homeopathic veterinary medicinal product is prepared in accordance with a homoeopathic manufacturing process. This process is described in the European Pharmacopoeia, or in pharmacopoeias officially used in the Member States. Homeopathic stocks constitute the basis. The Veterinary Medicinal Products Regulation contains specific quality and safety requirements for this group of veterinary medicinal products.
Characteristics of homeopathic veterinary medicinal products
A homeopathic veterinary medicinal product may be of plant, animal, chemical or mineral origin. Examples of these various homeopathic stocks include:
- Plant: Calendula officinalis (pot marigold)
- Animal: Apis mellifera (honey bee)
- Chemical: Natrium chloricum (NaCl, common salt)
- Mineral: Quartz
A homeopathic veterinary medicinal product may be highly diluted, but not necessarily so. An undiluted homeopathic veterinary medicinal product is known as a mother tincture, which is indicated by the symbol Ø or the acronym MT or TM. The number of dilution steps is reflected in the potency number. For example, D3 means three times a dilution of 1 to 10. The solution is shaken after every dilution step. The dilution methods are described in a homeopathic pharmacopoeia.
Authorised homeopathic veterinary medicinal products
A homeopathic veterinary medicinal product with a marketing authorisation may be sold in the Netherlands. An authorised homeopathic veterinary medicinal product can be identified by its REG NL H number. A list of the homeopathic veterinary medicinal products authorised in the Netherlands can be found in the Veterinary Medicines Information Bank.
Simplified registration
Article 86 of the Veterinary Medicinal Products Regulation provides for a simplified registration procedure in respect of highly diluted homeopathic veterinary medicinal products. Article 16 specifies the information which the package leaflet of these products should contain.
These products must be diluted to such an extent that their safety is guaranteed. This will be the case if the homeopathic veterinary medicinal product does not contain more than one part per 10,000 of the mother tincture. Furthermore, no therapeutic indication may appear on the labelling or in any information relating to the veterinary medicinal product.
Article 87 of the Veterinary Medical Products Regulation describes the procedure for these highly diluted homeopathic veterinary medicinal products.
If a homeopathic veterinary medicinal product is not subject to the requirements of Article 86(1), the normal requirements for the authorisation of veterinary medicinal products (as described in Article 5) will apply.
Dossier requirements
In the Netherlands, the assessment of the quality part is the same for both human homeopathic medicinal products and homeopathic veterinary medicinal products. The Homeopathic Medicinal Products Working Group (HMPWG) has drawn up various assessment guidelines. These also apply to homeopathic veterinary medicinal products.
The preparation methods of the homeopathic stocks are described in monographs. These monographs can be found in the European Pharmacopoeia. The European Pharmacopoeia also describes the routes of administration. Products are administered orally in the form of:
- tablets
- globuli (small pellets)
- granules (larger pellets)
- drops.
Homeopathic veterinary medicinal products may also be administered externally (for example, as a cream). The quality of the excipients and the forms of administration must comply with the applicable pharmacopoeia standards.
Some of the dossier requirements for homeopathic veterinary medicinal products relate specifically to the homeopathic nature of the veterinary medicinal product (such as the degree of dilution). Authorisation may also be obtained for homeopathic veterinary medicinal products without a specific indication (Article 86). In other respects, the assessment of homeopathic and non-homeopathic veterinary medicinal products is largely the same.
Fees for registration of homeopathic veterinary medicinal products
The fees for registration of homeopathic veterinary medicinal products can be found under fees and product types Veterinary Medicinal Products Unit.
Applying for a marketing authorisation for homeopathic veterinary medicinal products
If you intend to submit a registration application for a homeopathic veterinary medicinal product, then please contact the Veterinary Medicinal Products Unit in advance.