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Role and interventions of the Council
in the regulatory procedures for dossiers (EC) 726/2004 on medicinal products
(last update: 24/10/2006)
The authorisation procedure for placing on the market of a medicinal product containing a GMO is summarized in the diagram below.
For the scientific evaluation of those dossiers the experts can refer to several available guidelines.
European documents
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Eudralex Volume 3 - Medicinal Products for Human use - Biotechnology Guidelines - 3AB6A: Gene Therapy Product Quality Aspects in the Production of Vectors and Genetically Modified Somatic Cells (December 1994) (Link - PDF)
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Eudralex Volume 3 - Medicinal Products for Human use - Biotechnology Guidelines - 3BR1A : Environmental Risk Assessment for Human MedicinalProducts Containing or Consisting of GMOs (December 1994) ( Link - PDF)
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Eudralex Volume 7 - Veterinary Medicinal Products - Guidelines: Presentation and contents of the dossier for marketing authorisation for veterinary medicinal products: Data related to the environmental risk assessment for products containing or consisting of genetically modified organisms(GMOs) (September 2001) ( link-PDF)
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EMEA/CPMP/BWP/3088/99 Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products (October 2001) ( Link-PDF)
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EMEA/CHMP/BWP/2558/03 Guideline on development and manufacture of lentiviral vectors (May 2005) ( Link-PDF)
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