Amendment: Traditional herbal medicinal products (Directive 2001/83/EC)
This procedure aims to update the rules for the registration and sale of traditional herbal medicines. It seeks to simplify the authorization process for products that have a long history of safe use, ensuring patients have access to traditional remedies while maintaining safety standards.
This affects pharmaceutical companies and herbal product manufacturers. It changes how these products are approved for the market, balancing traditional knowledge with modern safety requirements.
Documents
[PL] Rozporządzenie Ministra Zdrowia z dnia 21 listopada 2008 r. w sprawie reklamy produktów leczniczych — https://isap.sejm.gov.pl/isap.nsf/DocDetails.xsp?id=WDU20080000210
national transposition · PL · 2026-07-18
[FI] Valtioneuvoston asetus lääkeasetuksen muuttamisesta / Statsrådets förordning om ändring av läkemedelsförordningen (868/2005) — https://opendata.finlex.fi/finlex/avoindata/v1/akn/fi/act/statute/2005/868/fin@
national transposition · FI · 2026-06-12
[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 · 2026-06-12
[SE] Läkemedelsverkets föreskrifter (LVFS 2006:3) om traditionella växtbaserade läkemedel för humant bruk — https://rkrattsbaser.gov.se/sfst?bet=2006:3
national transposition · SV · 2026-06-12
[ES] Real Decreto 1345/2007, de 11 de octubre, por el que se regula el procedimiento de autorización, registro y condiciones de dispensación de los medicamentos de uso humano fabricados industrialmente — https://www.boe.es/buscar/act.php?q=Real%20Decreto%201345%2F2007%20de%2011%20de%20octubre%20por%20el%20que%20se%20regula%20el%20procedimiento%20de%20autorizaci%C3%B3n%20registro%20y%20condiciones%20de%20dispensaci%C3%B3n%20de%20los%20medicamentos%20de%20uso%20humano%20fabricados%20industrialmente
national transposition · ES · 2026-06-12
[DE] Vierzehntes Gesetz zur Änderung des Arzneimittelgesetzes — https://www.gesetze-im-internet.de/vstg_1974/BJNR109490974.html
national transposition · DE · 2026-06-12
[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 · 2026-06-12
Public health: traditional herbal medicinal products (amendment of Directive 2001/83/EC)
proposal · EN · 2026-05-03
Public health: traditional herbal medicinal products (amendment of Directive 2001/83/EC)
report · EN · 2026-05-03
Public health: traditional herbal medicinal products (amendment of Directive 2001/83/EC)
proposal · EN · 2026-05-03
Public health: traditional herbal medicinal products (amendment of Directive 2001/83/EC)
report · EN · 2026-05-03