Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 M... (32014R0658)
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
- 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)
- 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
- ANNEX
- PART I
- FEE FOR ASSESSMENT OF PERIODIC SAFETY UPDATE REPORTS REFERRED TO IN ARTICLE 4
- PART II
- FEE FOR ASSESSMENT OF A POST-AUTHORISATION SAFETY STUDIES REFERRED TO IN ARTICLE 5
- PART III
- FEE FOR ASSESSMENT IN THE CONTEXT OF REFERRALS INITIATED AS A RESULT OF THE EVALUATION OF PHARMACOVIGILANCE DATA REFERRED TO IN ARTICLE 6
- PART IV
- ANNUAL FEE FOR INFORMATION TECHNOLOGY SYSTEMS AND LITERATURE MONITORING REFERRED TO IN ARTICLE 7
- PART V
- PERFORMANCE INFORMATION
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