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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)- Recitals
- 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
- Final
- ANNEX — PART I