Regulatory information – Changes in SME registration procedures to reduce administrative burden

SME declaration form has been revised and procedure for renewal of SME qualification has been simplified

The European Medicines Agency has simplified the procedure for the renewal of the status of micro, small or medium enterprise (SME). The changes will reduce the administrative burden for companies that are already registered as SMEs with the Agency and wish to maintain their SME status.

A revised SME declaration form has been made available for the submission of data as part of the SME registration process as well as information on enterprises for the SME public register.

Companies registered as SMEs with the Agency have access to a number of incentives, including regulatory assistance from the SME office, reduced fees for certain Agency procedures such as scientific advice and inspections, and fee incentives for pharmacovigilance activities.