Marketing authorisation application homeopathic veterinary medicinal product

A homeopathic veterinary medicinal product is any medicinal product for veterinary use that is obtained according to a homeopathic manufacturing process and from substances referred to as homeopathic raw materials as outlined in the European Pharmacopeia or, in the absence thereof, in pharmacopeias officially used in Member States. A homeopathic medicinal product for veterinary use may contain various active substances.

Manufacturing method

Homeopathic manufacturing methods are described in the European Pharmacopeia, the French Pharmacopeia and the Homöopathisches ArzneiBuch (HAB), a section of the official German national pharmacopeia. A homeopathic product is generally referred to by the scientific name for the raw material, with the homeopathic dilution or potency listed using the following symbols:

  • Dilution method in steps of 1 to 10 (decimal); labelled as D, DH, or X
  • Dilution method in steps of 1 to 100 (centesimal); labelled as C or CH
  • Specific dilution method in steps of 1:50,000; labelled as LM
  • Mother tinctures according to the German HAB method; labelled as Ø
  • Mother tinctures according to the French method; labelled as MT (or TM: teinture-mère)
  • Dilution method with continuous dilution; labelled as K

Raw material

Raw materials for the manufacture of homeopathic products may be of both natural and synthetic origin. Raw materials of plant or animal origin may be processed in either fresh or dried form. Fresh plant material is softened in ethanol into a mother tincture. For starting materials manufactured from plant or animal substances, the mother tincture is considered the homeopathic stock. If the raw material is a chemical substance or a mineral, the chemical substance or mineral itself is considered the stock, or the basis for the homeopathic product.

Examples of these various homeopathic raw materials are:

  • Plant: Calendula officinalis (Goudsbloem)
  • Animal: Apis mellifera (honey bee)
  • Chemical: Natrium chloricum (NaCl, kitchen salt)
  • Mineral: Quartz

Potentiation (homeopathic dilution)

Homeopathic dilutions or triturations are manufactured from homeopathic raw materials via potentiation methods described in a homeopathic pharmacopeia. The solutions are sequentially diluted further and further. The number of dilution steps is expressed by the potency number: 'D3 / 3DH / 3X' means three decimal dilution steps (1 to 10); "“C8 / 8CH” means eight sequential dilution steps in centesimal steps of 1 to 100. This is referred to as 'potentiation' by homeopaths, as the solution is shaken between each dilution step in accordance with homeopathic tradition.

Legislation

The following legislation applies to homeopathic veterinary medicinal products:

In Directive 2001/82/EC includes specific stipulations concerning homeopathic veterinary medicinal products.
These have been incorporated in national legislation, namely:

Allowed homeopathic veterinary medicinal products

The Animals act determines that all homeopathic veterinary medicinal products on the market in the Netherlands must apply for a marketing authorisation.

All homeopathic veterinary medicinal products for which a marketing authorisation was submitted prior to 1 January 2014 may remain on the market until a final decision has been made regarding the application. This pertains to those homeopathic veterinary medicinal products which are included on the List of homeopathic veterinary medicinal products, subject to Article 10.4 of the Regulation on Veterinary Medicinal Products.

All other homeopathic veterinary medicinal products which do not appear on this list are no longer allowed on the Dutch market.

Applying for a market authorisation for a homeopathic veterinary medicinal product

The authorisation requirements for an application for a homeopathic veterinary medicinal product are listed in the Evaluation reference for homeopathic veterinary medicinal products. The aim is to follow the requirements that apply to human homeopathic medicinal products as closely as possible.

The evaluation reference for homeopathic veterinary medicinal products also applies to applications for marketing authorisations for homeopathic veterinary medicines submitted after 1 January 2014.

However, the transitional period does not apply to these applications. This means that from now on any homeopathic veterinary medicinal products for which an application is submitted may only be put on the market once final approval is given.

Fees for authorisation homeopathic veterinary medicinal product

Type of application Fee

Complete application homeopathic VMP – food-producing animals

€ 5,707

Complete application homeopathic VMP – non-food-producing animals
(in accordance with article 3.5 of the Decree VMP)

€ 2,456

Simplified application for homeopathic VMP*
(in accordance with article 3.4 Decree VMP)

€ 1,200

* If an application is submitted for a dilution series of a single homeopathic veterinary medicinal product, for example: ‘Calendula officinalis D6, D12, D30’, this is seen as 1 authorisation and a one-off fee of € 1,200 must be paid for the entire series.