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Document 32022R1520
Adjustment of EMA Pharmacovigilance fees for inflation (Regulation (EU) No 658/2014)
Kommissionens delegerede forordning (EU) 2022/1520 af 17. juni 2022 om ændring af Europa-Parlamentets og Rådets forordning (EU) nr. 658/2014 for så vidt angår tilpasningen til inflationen af de gebyrbeløb, som skal betales til Det Europæiske Lægemiddelagentur for udførelse af lægemiddelovervågningsaktiviteter i forbindelse med humanmedicinske lægemidler
- 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:
- sundhedspolitik; betaling; lægemiddel; inflation; salgstilladelse; Det Europæiske Lægemiddelagentur; lægemiddelkontrol
- 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
-
- Documents:
- 32022R1520 (Delegated regulation)
- Date of publication:
- 13/09/2022