Die Themen

• New national drug laws
• Structure and working procedures of the national authorities
• The application dossier - CTD format?
• The application procedure - timeframes, clock stops, fees
• Maintenance of the marketing authorisation - variations, renewals?

Ziele

Russia, Ukraine, Belarus and Kazakhstan are often underestimated as attractive markets for pharmaceuticals. Being located outside of the European Union, there are different requirements for pharmaceuticals to receive a marketing authorisation.
This seminar addresses these requirements:

• What kind of documents do I really need for the marketing authorisation?
• What do I need to know when communicating with the national authorities?
• What do I need to keep in mind as regards maintaining an existing marketing authorisation?

Two experts will share their experiences with you in detail and also address the changed requirements arising out of new national drug laws.

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