From 1 July, annual fees will be collected at €67 per chargeable unit
Pharmaceutical companies have been advised on how they will be charged by the European Medicines Agency (EMA) for its pharmacovigilance work monitoring the safety of authorised medicines sold in the European Union (EU).
The Agency began charging fees for such procedures in August 2014, including the assessment of periodic safety update reports (PSUR); post-authorisation safety study (PASS) protocols and study results; and for pharmacovigilance-related referrals. These fees are charged to companies owning nationally or EU-authorised medicines. Fees can be high. For referrals, they are €179,000 where referrals concern one or two active substances and/or combinations, and rise by €38,800 for every additional active substance or combination, up to €295,400.
PSURs cost €19,500 per procedure; and PASS assessments €43,000 per procedure. From 1 July, annual fees will be collected at €67 per chargeable unit.
'The income from the pharmacovigilance procedural fees will…remunerate national competent authorities for the scientific assessment carried out by the rapporteurs of EMA’s pharmacovigilance risk assessment committee,' said the EMA.