European Medicines Agency applies greater fee-reduction rates for orphan medicines in 2014

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03/12/2013

European Medicines Agency applies greater fee-reduction rates for orphan medicines in 2014

The European Medicines Agency’s policy on fee reductions for orphan medicinal products has been revised. The changes, which take effect as of 1 January 2014, will provide enhanced fee reductions for companies that are not micro, small or medium-sized enterprises (SMEs).

In addition, as recommended by the Agency’s Committee for Orphan Medicinal Products (COMP), the policy will continue to focus primarily on assistance to SMEs with the objective of providing incentives to support research and innovation on medicines intended for the diagnosis, prevention or treatment of rare diseases.

Fee reductions for non-SMEs

The following fee reductions will apply for non-SMEs in 2014:

  • 75% fee reduction for non-paediatric-related initial and follow-up protocol assistance (currently a 40% fee reduction);
  • 100% fee waiver for paediatric-related initial and follow-up protocol assistance (no change from 2013);
  • 10% fee reduction for initial marketing-authorisation applications (currently no fee reduction);
  • 100% fee reduction for pre-authorisation inspections (currently no fee reduction).

Fee reductions for SMEs

The following services will remain free-of-charge for SMEs in 2014:

  • all initial and follow-up protocol assistance;
  • initial marketing-authorisation applications;
  • pre-authorisation inspections;
  • post-authorisation applications and annual fees in the first year of marketing authorisation.

The current fee-reduction rates will apply to all applications received by the Agency by 31 December 2013. Applications received after that date will be subject to the revised fee-reduction rates, where applicable.

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

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