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July 18, 2012 - Request for pilot files on homeopathic veterinary medicines
As of yet, no homeopathic veterinary medicines have been authorised
in the Netherlands. However, homeopathic veterinary medicines are
available on the market in the Netherlands. These medicines appear
on the “List of homeopathic veterinary medicines 1993” and are
therefore exempted from authorisation.
However, under the Animals Act this list will not be continued.
This means that all homeopathic veterinary medicines on the market
in the Netherlands will have to be authorised. This decision is
based on Directive 2001/82/EC of the European Parliament and the
Council of 31 March 2004. The quality and safety of homeopathic
veterinary medicines must satisfy this Directive and the
requirements of the European Pharmacopoeia.
The evaluation of homeopathic veterinary medicines is a special
branch in and of itself and, for this reason, we would like to gain
some experience in this before the actual authorisation requirement
As part of this, we are looking for manufacturers with a
homeopathic veterinary medicine on the market which is already
supported by a good authorisation file. This would include products
that are already authorised as a homeopathic medicine in another
Our interest focuses primarily on products with a specific
We would like to test these files against the available European
assessment framework. This trial assessment will be free of
If you are interested in this, please contact the Veterinary
Medicinal Products Unit (VMPU) at firstname.lastname@example.org.
Note: There is capacity for only a limited number of files and,
therefore, selection for participation will be based on the date of
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