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Medicines and investigational medicines for human use — safe production
Medicines and investigational medicines for human use — safe production
Medicines and investigational medicines for human use — safe production
This summary has been archived and will not be updated, because the summarised document is no longer in force or does not reflect the current situation.
Medicines and investigational medicines for human use — safe production
SUMMARY OF:
SUMMARY
WHAT DOES THE DIRECTIVE DO?
It sets out the principles and guidelines of good manufacturing practice for medicines and investigational medicines* for human use.
KEY POINTS
FROM WHEN DOES THE DIRECTIVE APPLY?
It has applied since 3 November 2003. EU countries had to incorporate it into national law by 30 April 2004.
BACKGROUND
For more information, see:
KEY TERM
* Investigational medicine: a pharmaceutical form of an active substance or placebo that is being tested or used as a reference in a clinical trial.
ACT
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 (OJ L 262, 14.10.2003, pp. 22–26)
RELATED ACTS
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, pp. 1–33).
Subsequent amendments to Regulation (EC) No 726/2004 have been incorporated into the basic text. This consolidated version is of documentary value only.
Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 136, 30.4.2004, pp. 34–57)
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 (OJ L 311, 28.11.2001, pp. 67–128). See consolidated version.
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, pp. 1–76)
last update 19.04.2016