Pharmacovigilance fees: questions and answers

The European Medicines Agency (EMA) has published detailed questions-and-answers (Q&As) on the fees it charges pharmaceutical companies for carrying out pharmacovigilance activities. These explain how the different types of procedure-based and annual fees are calculated and levied, the availability of fee reductions and exemptions and the invoicing and payment procedures.

Please also refer to the ' PDF icon Explanatory note on pharmacovigilance fees payable to the EMA ' for further guidance on pharmacovigilance fees payable to the Agency.

If your question still remains unanswered, please submit your query by completing our dedicated form:

You can also download the PDF icon pharmacovigilance fees Q&A in PDF format.

1. Pharmacovigilance fees payable to the EMA under Regulation (EU) No 658/2014

2. Single assessment of periodic safety update reports (PSURs)

3. Assessment of imposed, non-interventional post-authorisation safety studies (PASS)

4. Assessment of pharmacovigilance-related referrals

5. Annual fee for information technology systems and literature monitoring

6. Fee reductions and exemptions

7. Information in Article 57 database and pharmacovigilance fees

8. Payment modalities


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