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null Regulation 1/2007 on clinical trials published in English

Regulation 1/2007 on clinical trials published in English

18.11.2008

Regulation 1/2007 on clinical trials published in English

Administrative regulation 1/2007 (Clinical trials on medicinal products in human subjects) has been translated into English. The unofficial translation has been published on the National Agency for Medicines website.

The regulation nationally implements Directive 2001/20/EC of the European Parliament and of the Council on the conduct of clinical trials on medicinal products for human use and, concerning its application, Commission Directives 2003/94/EC on good manufacturing practice and 2005/28/EC laying 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 Regulation does not concern Article 6 of Commission Directive 2005/28/EC.

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Clinical trials on medicinal products in human subjects (Regulation 1/2007)