COM(1997)369 EU - Directive
Approximation of provisions laid down by law, regulation or administrative action relating to the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use

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Contents

  1. Key information
  2. Key dates
  3. Related information
  4. Resulting legislation
  5. Full version
  6. EU Monitor

1.

Key information

official title

Proposal for a European Parliament and Council Directive on the approximation of provisions laid down by law, regulation or administrative action relating to the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use
 
Legal instrument Directive
Decision making procedure ordinary legislative procedure (COD)
reference by COM-number i COM(1997)369 EN
Additional COM-numbers COM(1999)193; SEC(1999)581; SEC(2000)1293
procedure number i 1997/0197(COD)
CELEX number i 51997PC0369

2.

Key dates

Document 03-09-1997
Online publication 03-09-1997
Decision 04-04-2001; 31901L0020
Publication in Official Journal i 01-05-2001; Special edition in Romanian: Chapter 13 Volume 031,Special edition in Czech: Chapter 13 Volume 026,Special edition in Slovak: Chapter 13 Volume 026,Special edition in Latvian: Chapter 13 Volume 026,Special edition in Lithuanian: Chapter 13 Volume 026,Special edition in Slovenian: Chapter 13 Volume 026,Special edition in Estonian: Chapter 13 Volume 026,OJ L 121, 1.5.2001,Special edition in Polish: Chapter 13 Volume 026,Special edition in Croatian: Chapter 13 Volume 061,Special edition in Bulgarian: Chapter 13 Volume 031,Special edition in Hungarian: Chapter 13 Volume 026,Special edition in Maltese: Chapter 13 Volume 026

3.

Related information

4.

Resulting legislation

 

5.

Full version

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6.

EU Monitor

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