Amendment: Community code for human medicinal products (Directive 2001/83/EC)
This procedure updates the existing EU rules for medicines. It aims to ensure that medicines available in the EU are safe, effective, and of high quality, protecting public health.
The changes affect pharmaceutical companies and healthcare providers. It may lead to updated procedures for drug approval, manufacturing standards, and market surveillance.
Documents
[DE] Verordnung zur Anwendung der Arzneimittelprüfrichtlinien (Arzneimittelprüfrichtlinien-Verordnung - AMPV) — https://www.gesetze-im-internet.de/vrv/BJNR014710999.html
national transposition · DE · 2026-08-16
[IT] decreto legislativo 6 febbraio 2025, n. 10 recante “Adeguamento della normativa nazionale alle disposizioni del regolamento delegato (UE) 2016/161 della Commissione del 2 ottobre 2015, che integra la — https://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:2025-02-06;10
national transposition · IT · 2026-07-24
[SE] Läkemedelsverkets föreskrifter (LVFS 2009:6) om marknadsföring av humanläkemedel — https://rkrattsbaser.gov.se/sfst?bet=2009:6
national transposition · SV · 2026-06-08
[ES] CORRECCIÓN de error de la Ley 29/2006, de 26 de julio, de garantías y uso racional de los medicamentos y productos sanitarios — https://www.boe.es/buscar/act.php?q=CORRECCI%C3%93N%20de%20error%20de%20la%20Ley%2029%2F2006%20de%2026%20de%20julio%20de%20garant%C3%ADas%20y%20uso%20racional%20de%20los%20medicamentos%20y%20productos%20sanitarios
national transposition · ES · 2026-06-08
[FI] Lääkelaki / Läkemedelslag (395/1987) 10.4.1987, muutettuna laeilla / ändrad i lagen (553/2020) 9.7.2020 ja / och (1258/2021) 22.12.2021 — https://opendata.finlex.fi/finlex/avoindata/v1/akn/fi/act/statute/1987/395/fin@
national transposition · FI · 2026-06-08
[NL] Regeling van de Minister van Volksgezondheid, Welzijn en Sport van 25 juni 2007, nr. GMT/MVG 2780607, houdende uitvoering van bepalingen van de Geneesmiddelenwet (Regeling Geneesmiddelenwet) — https://wetten.overheid.nl/BWBR0022606
national transposition · NL · 2026-06-08
[DE] Vierzehntes Gesetz zur Änderung des Arzneimittelgesetzes — https://www.gesetze-im-internet.de/vstg_1974/BJNR109490974.html
national transposition · DE · 2026-06-08
[IT] Attuazione della direttiva 2001/83/CE (e successive direttive di modifica) relativa ad un codice comunitario concernente i medicinali per uso umano, nonchè della direttiva 2003/94/CE. — https://www.normattiva.it/ricerca/semplice?q=Attuazione%20della%20direttiva%202001%2F83%2FCE%20e%20successive%20direttive%20di%20modifica%20relativa%20ad%20un%20codice%20comunitario%20concernente%20i%20medicinali%20per%20uso%20umano%20nonch%C3%A8%20della%20direttiva%202003%2F94%2FCE.
national transposition · IT · 2026-06-08
Amendment: Community code for human medicinal products (Directive 2001/83/EC)
report · EN · 2026-05-18
Amendment: Community code for human medicinal products (Directive 2001/83/EC)
report · EN · 2026-05-18