English
български
Español
Čeština
Dansk
Deutsch
Eesti keel
Ελληνικά
English
Français
Gaeilge
Hrvatski
Italiano
Latviešu valoda
Lietuvių kalba
Magyar
Malti
Nederlands
Polski
Português
Română
Slovenčina
Slovenščina
Suomi
Svenska
Sign in
Register
Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (Text with EEA relevance)
Text
Chronology
Context
en
bg
es
cs
da
de
et
el
en
fr
ga
hr
it
lv
lt
hu
mt
nl
pl
pt
ro
sk
sl
fi
sv
Basic information
No longer in force
CELEX number:
32003L0094
Official Journal:
JOL_2003_262_R_0022_01
Form:
Directive
Procedure number:
--
Languages:
bg
cs
da
de
el
en
et
fi
fr
hr
hu
it
lv
lt
mt
nl
pl
pt
ro
sk
sl
es
sv
Dates
Date of document:
October 8, 2003
Date of publication:
October 14, 2003
Date of effect:
November 3, 2003
Entry into force - Date pub. + 20 See Art 18
Date of transposition:
April 30, 2004
At the latest See Art 17.1
Date of end of validity:
January 31, 2022
Repealed by
32017L1572
Art. 15 See 32021D1240
Modified by
Repealed by:
Directive (UE) 2017/1572 de la Commission du 15 septembre 2017 complétant la directive 2001/83/CE du Parlement européen et du Conseil en ce qui concerne les principes et lignes directrices relatifs aux bonnes pratiques de fabrication pour les médicaments à usage humain (Texte présentant de l'intérêt pour l'EEE. )
Modifies
Repeal:
Directive 91/356/CEE de la Commission, du 13 juin 1991, établissant les principes et lignes directrices de bonnes pratiques de fabrication pour les médicaments à usage humain
Affected by case
Legal basis
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
EuroVoc Vocabulary
Pharmaceutical product
Marketing standard
Approximation of laws
Technical barriers
Internal market - Principles
Proprietary medicinal products
Pharmaceutical legislation
Product quality