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Eudralex Volume 10 Guidance for exchange of GCP Inspection Reports according to Article 15(2) of Directive 2001/20/EC

Short Title:
Guidance for exchange of GCP Inspection Reports
Origin/Publisher:

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals

Document Type:
Guidance document
Content:
process of request, release and transmission of Good Clinical Practice (“GCP”) inspection reports between the Competent Authorities of the Member States of the European Union according to Article 15(2) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

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