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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 becomes effective.

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 Member State.

Our interest focuses primarily on products with a specific veterinary use.

We would like to test these files against the available European assessment framework. This trial assessment will be free of charge.

If you are interested in this, please contact the Veterinary Medicinal Products Unit (VMPU) at infobd@cbg-meb.nl.

Note: There is capacity for only a limited number of files and, therefore, selection for participation will be based on the date of application.

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