The European Group for Generic Veterinary Products (EGGVP) was established on 15th April 2002 and is based in Brussels. At the time the reasons for the establishment were the increasing concern  by a growing number of European companies involved in the manufacturing and distribution of generic veterinary medicines and the need to promote a harmonised regulatory framework for the licensing of veterinary medicinal products in the European Union. When the new legislation Directive 2004/28/EC  came into force the new text improved some points for generics but created on the other hand new challenges as well. And as generics are becoming more numerous,  companies are increasingly active in more than one European market and as the legislation for generics is now even more European based (viewing the EU as one source market) the work of the group in reviewing the developing guidance, safeguarding/improving  the harmonisation between member states and supporting/advising individual companies is becoming more important. For the future the preparatory work on the next revision of the legislation is a crucial focus point to improve the position of generics and make sure the obstacles in the current legislation are removed.
 
 
Generics in this context are all applications and marketing authorisations based on Article 13, 13a and 13c of Directive 2004/28/EC:
 
-  “True” generic applications based on essential similarity to a reference product.
-      Bibliographical applications based on the well established use of the active(s);
-      Informed consent applications;
-      Immunologicals.
 
 
The generic veterinary medicines industry plays an important role in the promotion of animal health and welfare by providing high quality, efficacious and economically affordable veterinary medicines. This can only continue and develop if the generic veterinary manufacturers are able to benefit properly from the legislation by its uniform and practical application across the European Union. On behalf of her members, EGGVP ensures that all involved parties (among which the Commission and member states) will be properly informed of the effect any proposed legislative changes will have on the generic industry and the veterinary medicinal products market. Furthermore EGGVP will provide proposals for legislative changes that would support the development and authorisation of (generic) medicines for use in companion animals and livestock.
 
 
EGGVP is working with industry, regulatory agencies and government bodies to highlight current difficulties experienced by her members and aims, through effective lobbying, to achieve a harmonised, practical and pragmatic approach towards the licensing of generic products in Europe.
EGGVP stays in close contact with their “human” counterpart: the European Generic Medicines Association (EGA) as all veterinary medicinal legislation is strongly linked to the human legislation.
 
 
One of the first accomplished tasks of the EGGVP was an in-depth comment on the draft modification of Directive 2001/82 EC. EGGVP is now recognised by the Commission as a legitimate lobbying group that should be consulted on proposed legislative changes. EGGVP has also been invited by the EMEA and is now an  ‘Interested Party’ at CVMP,- and CMD(v) level and is attending this meetings to be informed about the work of this parties but more importantly to put forward problems with and obscurities in the legislation, its interpretation and the guidance based upon it.
 
 
Since 2006 an important focus is to monitor the implementation of Directive 2004/28/EC in the individual member states. Other important points are the interpretation of the European reference product, global marketing authorisations and environmental risk studies as well as identifying ´point to improve´ in the current legislation. Ongoing is the monitoring of the draft guidance and providing information on EU developments to member companies.
 

Most Member companies are located in the European Union or EFTA countries and some are located outside the EU but in that case they have interests in the EU market for veterinary medicinal products.
Since January 1st 2008, the EGGVP has contracted a independent Technical Director, Ms Inge Sandberg, in order to intensify its presence in EU platforms and facilitate its internal information stream.
 
 
Anyone interested in knowing more about the European Group for Generic Veterinary Products can contact:
 
EGGVP

Espace Meeûs

de Meeûs Square 38/40

B-1000 BRUSSELS
BELGIUM
 
Telephone: + 32(0) 40187 95 (ask for Inge Sandberg [Technical Director], or Rob Joosten, [Chairman of the EGGVP])
e-mail: info@eggvp.org