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Document 32022R1520
Adjustment of EMA Pharmacovigilance fees for inflation (Regulation (EU) No 658/2014)
Commission Delegated Regulation (EU) 2022/1520 of 17 June 2022 amending Regulation (EU) No 658/2014 of the European Parliament and of the Council as regards the adjustment to the inflation rate of the amounts of the fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
- Legal basis:
- 32014R0658 - A15P6
- Initiative summary:
- Technical update of the EMA fees for pharmacovigilance and the corresponding remuneration of rapporteurs from the National Competent Authorities to take into account the inflation rate for 2020 and 2021 in the EU, as published by the Statistical Office of the European Union.
- EuroVoc thesaurus:
- health policy; payment; medicinal product; inflation; market approval; European Medicines Agency; drug surveillance
- See the lifecycle of this act on the Interinstitutional register of delegated acts
-
- Leading service:
- Directorate-General for Health and Food Safety
- Expert group:
- X02858
- Planned adoption period:
- 01/07/2022 - 30/09/2022
- Check the status of this initiative on the Better Regulation Portal
-
- Documents:
- Ares(2022)2609271 (Draft delegated regulation)
- Legal basis:
- 32014R0658 - A15P6
- Leading service:
- Directorate-General for Health and Food Safety
- Expert group:
- X02858
- Check the status of this initiative on the Better Regulation Portal
-
- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 4
-
- Documents:
- C/2022/3948 final (Delegated regulation)
- Leading service:
- Directorate-General for Health and Food Safety
-
- Foreseen end of objection period:
- 17/08/2022
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- Documents:
- 32022R1520 (Delegated regulation)
- Date of publication:
- 13/09/2022