Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 Febru... (32024R0568)
INHALT
Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95
- REGULATION (EU) 2024/568 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
- of 7 February 2024
- on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95
- Article 1
- Subject matter and scope
- Article 2
- Definitions
- Article 3
- Types of fees and charges
- Article 4
- Additional fees and charges
- Article 5
- Payment of remuneration to competent authorities of the Member States for the provision of services to the Agency
- Article 6
- Reductions and deferrals of fees and charges
- Article 7
- Payment of fees and charges
- Article 8
- Working arrangements
- Article 9
- Due date and measures in case of non-payment
- Article 10
- Transparency and monitoring
- Article 11
- Revision
- Article 12
- Estimate of the Agency’s budget
- Article 13
- Exercise of the delegation
- Article 14
- Amendment to Regulation (EU) 2017/745
- Article 15
- Amendment to Regulation (EU) 2022/123
- Article 16
- Repeal
- Article 17
- Transitional provisions
- Article 18
- Entry into force and date of application
- ANNEX I
- Fees, charges and remuneration for assessment procedures and services relating to medicinal products for human use
- ANNEX II
- Fees, charges and remuneration for assessment procedures and services relating to veterinary medicinal products
- ANNEX III
- Annual fees and remuneration
- ANNEX IV
- Other fees and charges for medicinal products for human use, veterinary medicinal products and consultations on medical devices
- ANNEX V
- Fee reductions and deferrals
- ANNEX VI
- Performance information
- ANNEX VII
- Correlation table
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