Legal and Regulatory

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  • EMA/CAT/486831/2008/corr 15 October 2010

    Committee for advanced therapies (CAT)Guideline on the minimum quality and non-clinical data for certification of advanced therapy medicinal products

    COMMISSION DIRECTIVE 2006/86/EC of 24 October 2006

    Implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells

    COMMISSION DIRECTIVE 2006/17/EC of 8 February 2006

    Implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells

    COMMISSION DIRECTIVE 2005/28/EC of 8 April 2005

    Laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorization of the manufacturing or importation of such products