Directive 2005/28 / EC on principles and guidelines of good clinical practice

Directive 2005/28 / EC
Title:	Commission Directive 2005/28 / EC of April 8, 2005 laying down principles and detailed guidelines of good clinical practice for investigational medicinal products intended for use in humans, as well as requirements for the granting of a license to manufacture or import such products
Date of issue:	April 8, 2005
Release date:	April 9, 2005
Come into effect:	April 29, 2005
To be used from:	January 29, 2006
Replaced by:	Implementing Regulation (EU) 2017/556
Full text	Basic version
Regulation has expired.
Please note the information on the current version of legal acts of the European Union !

The Directive 2005/28 / EC laying down principles and detailed guidelines for good clinical practice for human use and investigational requests for authorization of the manufacturing or importation of such products was the European by the Commission on 8 April 2005 Community enact. It established the principles and guidelines of good clinical practice (GCP) for investigational medicinal products intended for use in humans, as well as requirements for the granting of a license to manufacture or import such products. It is based on Directive 2001/20 / EC on the application of good clinical practice of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws and regulations of the member states on the application of good clinical practice in the implementation of clinical trials Tests with human medicinal products , in particular Article 1 paragraph 3, Article 13 paragraph 1 and Article 15 paragraph 5.

It is divided into the following seven chapters:

• object
• Good clinical practice for planning, conducting, recording and reporting clinical trials
• Authorization of manufacture or import
• As a continuous file for documentation ( Trial Master File ) and archiving
• Inspectors
• Inspection procedure
• Final provisions

The directive was repealed by the Implementing Regulation (EU) 2017/556 of March 24, 2017.

Individual evidence

1. ↑ EUR-Lex - 32017R0556 - EN - EUR-Lex. In: eur-lex.europa.eu. Retrieved July 20, 2020 . 

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