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Document 32022R1520
Adjustment of EMA Pharmacovigilance fees for inflation (Regulation (EU) No 658/2014)
Κατ’ εξουσιοδότηση κανονισμός (ΕΕ) 2022/1520 της Επιτροπής της 17ης Ιουνίου 2022 για την τροποποίηση του κανονισμού (ΕΕ) αριθ. 658/2014 του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου, όσον αφορά την προσαρμογή στο ποσοστό του πληθωρισμού των τελών που καταβάλλονται στον Ευρωπαϊκό Οργανισμό Φαρμάκων για τη διενέργεια των δραστηριοτήτων φαρμακοεπαγρύπνησης όσον αφορά τα φάρμακα που προορίζονται για ανθρώπινη χρήση
- 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:
- πολιτική για την υγεία; πληρωμή; φάρμακο; πληθωρισμός; άδεια πώλησης; Ευρωπαϊκός Οργανισμός Φαρμάκων; επιτήρηση των φαρμάκων
- 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