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Guideline

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Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1)
Short Title:Detailed guidance on the request to the competent authorities
Internet:http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2010:082:0001:0019:EN:PDF
Origin/Publisher:European Commission - Enterprise and Industry Directorate General - Consumer goods - Pharmaceuticals
Content:Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1)
Status:Revision 3