English
Select your language
Official EU languages:
Access to European Union law
EUR-Lex
Access to European Union law
This document is an excerpt from the EUR-Lex website
Use quotation marks to search for an "exact phrase". Append an asterisk (*) to a search term to find variations of it (transp*, 32019R*). Use a question mark (?) instead of a single character in your search term to find variations of it (ca?e finds case, cane, care).
Need more search options? Use the
Advanced search
Document C(2025)4827
Performance of pharmacovigilance activities for human medicines ( update of Implementing Regulation (EU) 520/2012)
ROZPORZĄDZENIE WYKONAWCZE KOMISJI (UE) …/… zmieniające rozporządzenie wykonawcze (UE) nr 520/2012 z dnia 19 czerwca 2012 r. w sprawie działań związanych z nadzorem nad bezpieczeństwem farmakoterapii, o których mowa w rozporządzeniu (WE) nr 726/2004 Parlamentu Europejskiego i Rady i w dyrektywie 2001/83/WE Parlamentu Europejskiego i Rady
- Legal basis:
- 32004R0726 - A87a ; 32001L0083 - A108
- Initiative summary:
- Targeted amendment to the Commission Implementing Regulation (EU) No 520/2012 harmonising the performance of pharmacovigilance activities by marketing authorisation holders, national competent authorities and the European Medicines Agency. Those activities cover the whole life-cycle managements of medicines with regard to safety.
- EuroVoc thesaurus:
- polityka zdrowotna; kontrola leków; produkt leczniczy; system informacyjny; archiwum; zdrowie publiczne
-
- Documents:
- Ares(2024)9099429 (Draft implementing regulation)Ares(2024)9099429 (Draft implementing regulation)
- Legal basis:
- 32004R0726 - A87a ; 32001L0083 - A108
- Leading service:
- Directorate-General for Health and Food Safety
- Committee:
- Standing Committee on medicinal products for human use
- Check the status of this initiative on the Better Regulation Portal
-
- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 4
-
- Leading service:
- Directorate-General for Health and Food Safety
- Committee:
- Standing Committee on medicinal products for human use
- Planned adoption period:
- 01/04/2025 - 30/06/2025
- Check the status of this initiative on the Better Regulation Portal
-
- Documents:
- C/2025/4827 final (Implementing regulation)
- Leading service:
- Directorate-General for Health and Food Safety
-
- Documents:
- 32025R1466 (Implementing regulation)