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 2008-08-06    
Guidance to applicants/marketing authorisation holders on oral explanations at European Medicines Agency (English only)   2015-04-16    
Standard operating procedure for Article 29(4) referrals (mutual-recognition-procedure / decentralised-procedure referrals) (English only) adopted 2008-10-02 2012-09-06 2012-09-04
Standard operating procedure for Article 6(12), 6(13), 31 and 36 referral procedures (English only) adopted 2008-05-23 2010-11-30 2010-11-29
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 2008-05-23 2011-01-27 2011-01-27

Referral Submissions

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Document(s) Language Status First published Last updated Effective Date
Formatted table template to be inserted in each referral procedural submission cover letter (English only)   2014-05-16 2017-03-31  
Dossier requirements for referral, active substance master files (ASMF) and nationally authorised products (NAPs) submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device (English only)   2014-05-16 2017-07-04  

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 4 BG = bălgarski   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 ES = español   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 CS = čeština   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 DA = dansk   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 DE = Deutsch   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 ET = eesti keel   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 EL = elliniká   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 EN = English   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 FR = français   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 IT = italiano   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 LV = latviešu valoda   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 LT = lietuvių kalba   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 HU = magyar   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 MT = Malti   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 NL = Nederlands   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 PL = polski   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 PT = português   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 RO = română   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 SK = slovenčina   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 SL = slovenščina   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 FI = suomi   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 SV = svenska   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 HR = Hrvatski   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 IS = Islenska   2011-08-30 2016-02-09  
Mutual-recognition, decentralised and referral product-information template version 4 NO = Norsk   2011-08-30 2016-02-09  
Practical information on translations for referral procedures (human) (English only)   2012-12-19 2013-11-28  
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 2009-04-08 2011-08-24 2009-04-08