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What Are The Changes In Rates of European Medicines Agency’s Fees For Orphan Drugs For 2013 ?

December 18, 2012

The European Union (EC) offers incentives for orphan drugs. For example, one incentive is a reduction in regulatory fees when a company applies for an orphan designation.  This includes reduced fees for marketing-authorization applications, inspections before authorization, applications for changes to marketing authorizations made after approval, and annual fees.

According to a December 17, 2012 letter from the European Medicines Agency (EMA), there is a change to rates of fee reductions granted by the EMA for designated orphan medicinal products. The revised rates are effective January 1, 2013, and only apply to companies who don’t have micro and SME (Small & Medium-Sized Enterprises) status assigned by the EMA.

The revised rates ONLY for companies that don’t have SME status are as follows :

  1. 40% fee reduction for non-pediatric-related initial & follow-up protocol assistance (currently there is a 75% fee reduction)
  2. 100% fee waiver for pediatric-related requests continues
  3. No fee reduction for initial marketing authorization applications (currently there is a 10% fee reduction
  4. No fee reduction for pre-authorization inspections (currently there is a 100% fee waiver).

The rates for companies assigned SME status will not change.


EMA Orphan Designation Incentives

EMA SME Register

European Confederation Of Pharmaceutical Entrepreneurs (EUCOPE) December 17, 2012 article titled, “New rates of EMA fees for orphan drugs from 1.1.2013”

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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