Parallel distribution: Regulatory and procedural guidance

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The procedure described here is intended to provide guidance and assist parallel distributors to fulfil their obligations, without prejudice to the interpretation of Community Directives and Regulations by the European Commission and/or European Court of Justice.

Table of contents


Guidance Documents

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Document(s) Language Status First published Last updated Effective Date
List of centrally authorised products requiring a notification of a change for update of annexes (English only)   17/08/2010 20/05/2016  

Notification Templates

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Document(s) Language Status First published Last updated Effective Date
Notification of annual update to the parallel distribution of a centrally authorised medicinal product (English only)   26/04/2013 04/02/2015  
Notification of parallel distribution of a centrally authorised medicinal product (English only)   01/04/2009 09/07/2013  
Notification of a change for parallel distribution of a centrally authorised medicinal product (English only)   06/04/2008 09/07/2013  

Overview of Notification issued by the European Medicines Agency

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Document(s) Language Status First published Last updated Effective Date
Initial notices for parallel distribution - June 2015 (English only)   20/07/2015    
Initial notices for parallel distribution - May 2015 (English only)   18/06/2015    
Initial notices for parallel distribution - May 2015 (English only)   18/06/2015    
Initial notices for parallel distribution - April 2015 (English only)   19/05/2015    
Initial notices for parallel distribution - March 2015 (English only)   17/04/2015    
Initial notices for parallel distribution – February 2015 (English only)   16/03/2015    
Initial notices for parallel distribution – January 2015 (English only)   04/03/2015    
Initial notices for parallel distribution – December 2014 (English only)   12/01/2015    
Initial notices for parallel distribution – November 2014 (English only)   11/12/2014    
Initial notices for parallel distribution – October 2014 (English only)   10/11/2014    
Initial notices for parallel distribution – September 2014 (English only)   14/10/2014    
Initial notices for parallel distribution – August 2014 (English only)   09/09/2014    
Initial notices for parallel distribution – July 2014 (English only)   11/08/2014 09/09/2014  
Initial notices for parallel distribution – June 2014 (English only)   09/07/2014    
Initial notices for parallel distribution – May 2014 (English only)   16/06/2014    
Initial notices for parallel distribution – April 2014 (English only)   19/05/2014    
Initial notices for parallel distribution – March 2014 (English only)   22/04/2014    
Initial notices for parallel distribution – February 2014 (English only)   18/03/2014    
Initial notices for parallel distribution – January 2014 (English only)   10/07/2014 10/02/2014  
Initial notices for parallel distribution – 2013 (English only)   16/06/2014    
Initial notices for parallel distribution – 2012 (English only)   22/07/2013    
Initial notices for parallel distribution – 2011 (English only)   10/10/2012    
Initial notices for parallel distribution - 2010 (English only)   26/09/2011    
Initial notices for parallel distribution - 2009 (English only)   26/09/2011    
Initial notices for parallel distribution - 2008 (English only)   18/06/2009    
Initial notices for parallel distribution - 2007 (English only)   26/06/2008