Electronic Submissions EXPERTS
useful links about xevmpd and Article 57
- The European Medicines Agency (EMA) is encouraging questions to be asked via the Eudravigilance help desk: eudravigilance@ema.europa.eu
- News item: "European Medicines Agency publishes format for submission of information on medicines:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011
/06/news_detail_001293.jsp&murl=menus/news_and_events/news_and_events.jsp&
mid=WC0b01ac058004d5c1&jsenabled=true" - News item: "European Medicines Agency provides update on electronic submission of information on medicines:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011
/08/news_detail_001330.jsp&mid=WC0b01ac058004d5c1&murl=menus/news_and_events
/news_and_events.jsp" - Legal notice on the implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency:
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/07/WC500108212.pdf - Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004:
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/07/WC500108213.pdf - Regulation (EC) No. 1394/2007, OJ, 10 December 2007, L234, 121-137:
http://ec.europa.eu/health/files/eudralex/vol-1/reg_2007_1394/reg_2007_1394_en.pdf - Directive 2010/84/EU, OJ, 31 December 2010, L348, 74-99:
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF - Regulation (EU) No. 1235/2010, OJ, 31 December 2010, L348, 1-16:
http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2010:348:SOM:EN:HTML