The EMA revised Q&A guidance on pharmacovigilance fees, clarifying which sponsors and assessments are subject to charges.
The fees, which were implemented in 2015, apply only to sponsors of nationally authorized drugs. They do not apply to sponsors of centrally authorized drugs, which can be commercialized across the EU. Dosage strengths do not affect fees.
Sponsors of drugs withdrawn from the market can avoid paying the fee if the withdrawal is documented in the appropriate database to notify the agency before it starts any pharmacovigilance activities, EMA said.