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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 The new format superseded the 1999 format, upon which it was based.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.
 
 
 
     
 
 
 
 
The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.
Due to the restrictions caused by COVID-19, the period of validity of MIA’s, WDA’s, GMP and GDP certificates is automatically extended until the end of 2021. On-site inspections will resume as soon as there is a consensus that the period of the public health crisis has passed. The clarifying remark section of individual MIA’s, WDA’s, GMP and GDP certificates will indicate any exceptions. Competent authorities reserve the right to inspect a manufacturing site should the need arise.
As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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