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Manufacturing and Importation Authorisation:
A new Community format for a Manufacturing and Importation Authorisation document has been established in accordance with Art. 47 of Directive 2004/27/EC and Art. 51 of Directive 2004/28/EC, amending Directives 2001/83/EC and 2001/82/EC respectively. The new format superseded the 1999 format, upon which it was based.

The Community format for the Manufacturing and Importation Authorisation document is published in the Compilation of Community Procedures, which can be found at the following location: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000156.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac05800296cb&jsenabled=true.

Manufacturing and Importation Authorisations are to be entered into EudraGMDP, as referred to in Art. 40(4) of Directive 2001/83/EC and Art. 44(4) of Directive 2001/82/EC.
 
 
 
     
 
 
 
 
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