Referral procedures: Regulatory and procedural guidance

  • Email
  • Help

Table of contents


Referrals

Back to top

Document(s) Language Status First published Last updated Effective Date
Procedural advice to CHMP members (English only) adopted 06/08/2008    
Guidance to applicants/marketing authorisation holders on oral explanations at European Medicines Agency (English only)   16/04/2015    
Standard operating procedure for Article 29(4) referrals (mutual-recognition-procedure / decentralised-procedure referrals) (English only) adopted 02/10/2008 06/09/2012 04/09/2012
Standard operating procedure for Article 6(12), 6(13), 31 and 36 referral procedures (English only) adopted 23/05/2008 30/11/2010 29/11/2010
Work instructions for sending out documents in the context of referrals (Article 6(12), 6(13), 31, 36 and Article 20 procedures) (English only) adopted 23/05/2008 27/01/2011 27/01/2011

Referral Submissions

Back to top

Referral Product Information

Back to top

Document(s) Language Status First published Last updated Effective Date
Mutual-recognition, decentralised and referral product-information template version 4 BG = bălgarski   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 ES = español   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 CS = čeština   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 DA = dansk   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 DE = Deutsch   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 ET = eesti keel   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 EL = elliniká   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 EN = English   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 FR = français   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 IT = italiano   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 LV = latviešu valoda   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 LT = lietuvių kalba   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 HU = magyar   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 MT = Malti   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 NL = Nederlands   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 PL = polski   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 PT = português   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 RO = română   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 SK = slovenčina   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 SL = slovenščina   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 FI = suomi   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 SV = svenska   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 HR = Hrvatski   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 IS = Islenska   30/08/2011 09/02/2016  
Mutual-recognition, decentralised and referral product-information template version 4 NO = Norsk   30/08/2011 09/02/2016  
Practical information on translations for referral procedures (human) (English only)   19/12/2012 28/11/2013  
Standard operating procedure for Product Information Quality/Quality Review of Documents pre-opinion review of product information for referral procedures and Article 29 paediatric procedures (English only) adopted 08/04/2009 24/08/2011 08/04/2009