The European Medicines Agency has cancelled the procedure by which sponsors of medicines with an orphan designation need to inform the Agency of their intention to submit an application in order to be eligible for a fee reduction. This forms part of the Agency's effort to reduce administrative burden for applicants and streamline the procedures for fee reductions. Medicines that have been granted orphan designation by the European Commission on the recommendation of the Agency's Committee for Orphan Medicinal Products (COMP) are eligible for fee reductions for a range of regulatory activities. These include pre-authorisation activities such as protocol assistance, the application for marketing authorisation and inspections.
The Agency now needs no additional information from the sponsor before submitting an application eligible for fee reduction for orphan medicines.
As a consequence, the document 'procedural advice on fee reductions for designated orphan medicinal products' has been removed from the Agency's website and the standard operating procedure on processing of fee reductions for designated orphan medicinal products (SOP/H/3048) is now obsolete.
These changes apply with immediate effect.