Referral procedures: Regulatory and procedural guidance

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Referrals

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Document(s) Language Status First published Last updated Effective Date
Procedural advice to CHMP members (English only) adopted 06/08/2008    
Practical information on oral explanation for all referral procedures (English only)   19/12/2012    
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

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Referral Product Information

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Document(s) Language Status First published Last updated Effective Date
Mutual-recognition, decentralised and referral product-information template version 3 BG = bălgarski   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 ES = español   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 CS = čeština   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 DA = dansk   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 DE = Deutsch   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 ET = eesti keel   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 EL = elliniká   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 EN = English   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 FR = français   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 IT = italiano   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 LV = latviešu valoda   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 LT = lietuvių kalba   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 HU = magyar   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 MT = Malti   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 NL = Nederlands   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 PL = polski   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 PT = português   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 RO = română   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 SK = slovenčina   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 SL = slovenščina   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 FI = suomi   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 SV = svenska   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 HR = Hrvatski   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 IS = Islenska   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 NO = Norsk   30/08/2011 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) BG = bălgarski   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) ES = español   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) CS = čeština   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) DA = dansk   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) DE = Deutsch   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) ET = eesti keel   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) EL = elliniká   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) EN = English   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) FR = français   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) IT = italiano   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) LV = latviešu valoda   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) LT = lietuvių kalba   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) HU = magyar   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) MT = Malti   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) NL = Nederlands   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) PL = polski   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) PT = português   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) RO = română   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) SK = slovenčina   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) SL = slovenščina   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) FI = suomi   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) SV = svenska   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) HR = Hrvatski   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) IS = Islenska   01/10/2006 11/04/2013  
Mutual-recognition, decentralised and referral product-information template version 3 (highlighted) NO = Norsk   01/10/2006 11/04/2013  
Practical information on translations for referral procedures (human) (English only)   19/12/2012 28/11/2013  
Guidance on templates for referral procedures (English only)   08/12/2005 30/08/2011  
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