Is your company preparing to market a new pharmaceutical product in Europe? Pharma companies intending to bring new products to market in the EU must follow one of three distinct processes – Centralized Procedure, Decentralized Procedure or Mutual Recognition. Previous presentations by Dr. Granzer have dealt with Centralized Procedure. This presentation focuses on the other two methods, Decentralized Procedure and Mutual Recogniton.
These procedures can be used for certain new drugs, generics and herbal medicinal products. In the case of the MRP there must be a national marketing authorization in place, whereas DCP can be used to seek approvals where none currently exist. This presentation provides an overview of DCP and MRP, including which procedure is appropriate for which products, the expected timeframe for each, and the kinds of submissions expected.
Using Mutual Recognition and Decentralized Procedure for EU Drug Registrations is presented by Dr. Ulrich Granzer, of Granzer Regulatory Consulting on 2008-10-02. You can register at our site www.fxconferences.com
