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Directive 2005/28/EC

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The Directive 2005/28/EC or Good Clinical Practice Directive, of 8 April 2005 of the European Parliament and of the Council, lays down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.

The Directive deals with the following items:

  • Good Clinical Practice for the design, conduct, recording and reporting of clinical trials:
  • Investigator's Brochure
  • Manufacturing or import authorisation
    • Exemption for Hospital & Health Centres and Reconstitution
    • Conditions of Holding a Manufacturing Licence
  • The trial master file and archiving
    • Format of Trial Master File
    • Retention of Essential and Medical Records
  • Inspectors
  • Inspection procedures
  • Final provisions

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