New variations regulation: Regulatory and procedural guidance

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Document(s) Language Status First published Last updated Effective Date
Practical questions and answers to support the implementation of the variations guidelines in the centralised procedure - superseded (English only)   2015-05-18 2016-06-02  
Practical questions and answers to support the implementation of the variations guidelines in the centralised procedure: document with track changes - superseded (English only)   2013-07-25 2016-06-02  
Transitional provisions for implementation of Commission Regulation (EU) No 712/2012 amending Variations Regulation (EC) No 1234/2008 (English only)   2012-10-25    
Questions and answers on variations to an existing pharmacovigilance system as described in the detailed description of the pharmacovigilance system (English only) adopted 2011-03-02 2013-08-02  
Annex B Word template (English only)   2009-12-20 2017-04-06  
Annex B PDF template (English only)   2009-12-20 2013-08-02  
Template letter of intent work sharing procedure (English only)   2009-12-17 2017-06-01  
Template cover letter for worksharing procedures including centrally authorised products and nationally authorised products (English only)   2010-06-18 2013-08-02  
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (English only)   2009-07-01 2017-06-30  

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