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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
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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No longer in force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Repealed by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Repealed by:
Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (Text with EEA relevance. )
Modifies
Repeal:
Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use
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