Die Themen

• Scope of the EU pharmaceutical legislation in practice
• Marketing authorisation application in the Balkan States
• Dossier content and CTD format
• Communication with the national authorities
• Maintenance - renewal & variations

Ziele

Some of the Balkan States belong to the European Union, while others are candidates for membership.
This seminar mainly focuses on the regulatory environment of the non-EU states, e.g. Albania, Croatia, Montenegro, Macedonia, Bosnia & Herzegovina, Serbia and Kosovo.

• What are the key factors for the successful marketing authorisation and the market access in these countries?
• What do the applicants need to keep in mind with regard to the marketing authorisation application (dossier requirements and communication with the authorities)?
• Once granted, what maintenance duties have to be fulfilled?

Here you'll get first-hand information from a local expert!

Ihre Referenten