Council of the European Union and European Parliament 15 May 2014, Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use Text with EEA relevance

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European Union · · · Cited by 92 · 15-05-2014

Article 1. Subject matter and scope
Article 2. Definitions
Article 3. Types of fees
Article 4. Fee for assessment of periodic safety update reports
Article 5. Fee for assessment of post-authorisation safety studies
Article 6. Fee for assessments in the context of referrals initiated as a result of the evaluation of pharmacovigilance data
Article 7. Annual fee for information technology systems and literature monitoring
Article 8. Fee reductions and fee exemption
Article 9. Payment of remuneration by the Agency to national competent authorities
Article 10. Method of payment of the fee
Article 11. Identification of the payment of the fee
Article 12. Date of payment of the fee
Article 13. Refund of fee amounts paid in excess
Article 14. Provisional estimate of Agency budget
Article 15. Transparency and monitoring
Article 16. Exercise of the delegation
Article 17. Transitional provisions
Article 18. Entry into force and application

27.6.2014

Official Journal of the European Union

L 189/112

REGULATION (EU) No 658/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 15 May 2014

on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN

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