European Medicines Agency maintains fee reduction for SMEs developing orphan medicines in 2013

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18/12/2012

European Medicines Agency maintains fee reduction for SMEs developing orphan medicines in 2013

The European Medicines Agency’s policy on fee reductions for orphan medicinal products is set to continue into 2013.  The policy, as advised by the Agency’s Committee for Orphan Medicinal Products (COMP), focuses primarily on assistance to micro, small and medium-sized enterprises (SMEs) with the objective of providing incentives to support research and innovation for medicines intended for the diagnosis, prevention or treatment of rare diseases.

Fee reductions for SMEs

The following services will remain free-of-charge for SMEs in 2013:

  • all initial and follow-up protocol assistance (scientific advice);
  • initial marketing-authorisation applications;
  • pre-authorisation inspections;
  • post-authorisation applications and annual fees in the first year from marketing authorisation.

Fee reduction for non-SMEs

The following changes to fee reductions will apply for non-SMEs in 2013:

  • 40% fee reduction for non-paediatric-related initial and follow-up protocol assistance (currently 75% fee reduction);
  • no fee reduction for initial marketing-authorisation applications (currently 10% fee reduction);
  • no fee reduction for pre-authorisation inspections (currently 100% fee waiver);
  • 100% fee waiver for paediatric-related initial and follow-up protocol assistance (no change from 2012).

The current fee reduction rates will apply to all applications received at the Agency by 31 December 2012. Applications received after that date will be subject to the revised reduction rates, where applicable.

In the case of protocol assistance, the cut-off point is the date of validation of the request for advice.

Related information

Contact point:

info@ema.europa.eu