Amendment: Pharmacovigilance Directive 2001/83/EC
This procedure aims to update the existing rules for monitoring the safety of medicines available in the EU. It focuses on improving the collection and assessment of information about potential side effects of drugs after they have been authorised.
The changes will affect pharmaceutical companies, national health authorities, and ultimately, patients. The goal is to ensure that any safety issues with medicines are identified and addressed quickly to protect public health.
Documents
[DE] Drittes Gesetz zur Änderung arzneimittelrechtlicher und anderer Vorschriften — https://www.gesetze-im-internet.de/de-mail-g/BJNR066610011.html
national transposition · DE · 2026-08-10
[PL] Ustawa z dnia 27 września 2013 r. o zmianie ustawy – Prawo farmaceutyczne oraz niektórych innych ustaw — https://isap.sejm.gov.pl/isap.nsf/DocDetails.xsp?id=WDU20130001245
national transposition · PL · 2026-08-07
[SE] Lag om ändring i lagen (2009:366) om handel med läkemedel — https://lagen.nu/2009:366
national transposition · SV · 2026-06-09
Amendment: Directive 2001/83/EC on pharmacovigilance
proposal · EN · 2026-05-15
Amendment: Directive 2001/83/EC on pharmacovigilance
report · EN · 2026-05-15