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Document 32022R1520
Adjustment of EMA Pharmacovigilance fees for inflation (Regulation (EU) No 658/2014)
Delegirana uredba Komisije (EU) 2022/1520 z dne 17. junija 2022 o spremembi Uredbe (EU) št. 658/2014 Evropskega parlamenta in Sveta glede prilagoditve zneskov pristojbin, ki se plačujejo Evropski agenciji za zdravila za izvajanje dejavnosti farmakovigilance v zvezi z zdravili za uporabo v humani medicini, stopnji inflacije
- 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:
- zdravstvena politika; plačilo; zdravilo; inflacija; dovoljenje za prodajo; Evropska agencija za zdravila; nadzor zdravil
- 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