Directive 2004/28 came into force in October 2005, amending Directive 2001/82, and brought with it significant changes to the regulation of generic veterinary medicines in the European Union. This applies also 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 in the Mutual Recognition and Decentralised Procedures will also be addressed.
Weblink: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=499
Weblink: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?id=499
- Name des EventsVeterinary Generics In The Eu
- Adresse der VeranstaltungHarrington Hall Hotel
- Stadt/RegionLondon
Management Forum Ltd
- Adresse98-100 Maybury Road, Woking
- Stadt/RegionSurrey
- LandVereinigtes Königreich
- Telefon-Nummer+44-1483-730071
- Fax-Nummer+44-1483-730008
- Emailadresse
- Homepage
Management Forum organise Conferences and Seminars on specialised topics relating to aspects of Biotechnology, Complementary Medicine, General Healthcare, Human Resources, Intellectual Property, Medical Devices, Nutritional Sciences, Pharmaceutical and Veterinary Medicine.
Our events cover a variety of areas including: production manufacturing, regulatory affairs, pharmacovigilance, clinical trials, research and development, therapeutics, respiratory medicine, marketing, health economics, quality assurance, patents and trade marks and licensing.
Attendance at Seminars is usually limited in order to offer ample opportunity for informal discussion. We also organise international Conferences on important issues affecting the pharmaceutical and related industries.
Our events cover a variety of areas including: production manufacturing, regulatory affairs, pharmacovigilance, clinical trials, research and development, therapeutics, respiratory medicine, marketing, health economics, quality assurance, patents and trade marks and licensing.
Attendance at Seminars is usually limited in order to offer ample opportunity for informal discussion. We also organise international Conferences on important issues affecting the pharmaceutical and related industries.