CTD答疑ctd-qa-updatev3_2008-02_en.pdfVIP

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, F2/SM D (2008) QUESTIONS and ANSWERS The rules governing medicinal products in the European Union VOLUME 2 NOTICE TO APPLICANTS Volume 2B Presentation and content of the dossier Common Technical Document (CTD) 2003 Edition UPDATE Feb 2008 Common Technical Document (CTD) Questions and answers Feb 2008 General Notes In case of Regulatory or Administrative questions on the NTA-CTD format, specifically concerning EU related procedures, please send an E-mail to entr-pharmaceuticals@ec.europa.eu. Other questions on the location of studies within the Quality, Non-clinical and Clinical modules or on general CTD related issues should be sent via the IFPMA website: . Questions related to specific scientific requirements are not covered by these mechanisms. The question and answers No 1, 5, 10, 11 and 15 have been deleted because these questions dealt with transitional periods which already ended. The questions and answers No 17a and 17b have been deleted due to the existing guideline on the processing of renewals in the Centralised Procedure and the Mutual Recognition Procedure (http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm#2c). Question 1: deleted Question 2: Reformatting of dossiers for already authorised products After 1 July 2003, is it necessary to reformat the old EU-format (NTA, Volume 2B, 1998) documentation of already authorised medicinal products into the new EU-CTD-format (NTA, Volume 2B, 2001)?