Parallel distribution: Regulatory and procedural guidance

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This content applies to human and veterinary medicines. 

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 Regulatons 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)   2010-08-17 2017-09-25  

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)   2013-04-26 2015-02-04  
Notification of parallel distribution of a centrally authorised medicinal product (English only)   2009-04-01 2013-07-09  
Notification of a change for parallel distribution of a centrally authorised medicinal product (English only)   2008-04-06 2013-07-09  

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