Veterinary Medicines
There are some general features for the registration of veterinary products in the EU. The first registration application is always for a formulated product, even if the active component has never previously been approved as a veterinary medicine in the EU. Once the first product has received an approval, further approvals will be "extension applications". Modifications that require such extension applications include, for example:
Changes in the formulation, such as modifications in the content of the active substance, changes of solvents/diluents, etc.
Extension of the recommendation for an existing product to new target species, but for the same pest, e.g. to include dogs as a target species for a product initially covering only cats
New indication for an existing product, e.g. tick control for a product initially approved only for flea control
As a big advantage it is possible in Europe to use the so called "Centralised Procedure" to make the MAA for a veterinary medicine containing a new active moiety (or new techno-logy) that was previously not approved directly to the Euro-pean Agency for the Evaluation of Medicinal Products (EMEA). Using this centralized procedure, it is possible to get a marketing authorization which is valid in all Member States of the EU. This will usually be the registration procedure of choice for a product which has commercial opportunity throughout the EU. An important aspect of the centralized procedure is that the product label and enclosure leaflet must be in all EU languages (the bulk of the documentation will be in English).
An alternative to the centralized procedure is to use the "Mutual Recognition Procedure". In this case the MAA is made directly to the appropriate regulatory body in one Member State. That authority, together with another as a "peer" reviewer, will review the documentation and, if sufficient, grant a marketing authorisation which is for that country only. The authorisation holder can then apply for a marketing authorisation in another EU country seeking a "mutual recognition". The first submission for the Mutual Recognition procedure must be only in the language of the host country, but when a second country is sought it is necessary to submit the label and enclosure leaflet in the relevant language(s).
Finally, there still exists the possibility of getting authorisations using Independent (of EU law) National Procedures on a country by country basis. However, this possibility has been restricted to special cases since 1998.
Related Information
Contact LKC
LKC Switzerland Ltd
Hauptstrasse 10
P.O. Box 167
4414 Füllinsdorf
Switzerland
Phone: +41 (61) 906 8500
Fax: +41 (61) 906 8509