Directive 2004/28 came into force in October 2005, amending Directive 2001/82, and has brought with it significant changes to the regulation of generic veterinary medicines in the European Union. This also applies to so-called ‘branded generics’ that are usually authorised by way of Article 13.1 (a) ii (‘bibliographic dossiers’) as well as to true generic products authorised according to Article 13. The changes have implications for both manufacturers of generic veterinary medicines and for research-based companies that seek to protect their products from competition.

This seminar will examine the experience gained in implementing the new legislation to provide valuable advice to all in the animal health industry. The difficulties of authorisation of generic products will also be addressed. The day will provide an opportunity to hear the views and latest experience of regulatory and industry experts in the implementation of the legislation and procedures.

In addition, it will provide a valuable forum for those planning the authorisation of generic veterinary medicines to discuss the detailed requirements.