Referrals

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Document(s) Language Status First published Last updated Effective Date
Standard operating procedure on Article 30 referrals triggered by the European Commission or a Member State (English only) adopted 2012-09-06   2012-09-04
Standard operating procedure on Article 29 procedures according to the Paediatric Regulation No 1901/2006 (English only) adopted 2012-06-28    
Standard operating procedure on Article 107 procedures - Pharmacovigilance urgent measures (English only) adopted 2012-06-28    
Standard operating procedure for procedures in accordance with Article 78 of Directive 2001/82/EC, related to pharmacovigilance measures for veterinary medicinal products authorised in the European Union (English only) adopted 2012-04-19 2016-02-11 2016-02-11
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
Standard operating procedure for CHMP rapporteur / co-rapporteur appointment for Community procedures (English only) adopted 2009-02-11 2012-09-26 2012-09-25
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 20 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
Work Instructions for preparation of referral opinions for publication on the EMA website (Referrals according to Article 5(3), 5(11),6(12), 6(13), 13, 20, 29(4), 29 (paediatric), 30, 31, 36 and 107 for medicinal products for human use) (English only) adopted 2008-05-23 2010-10-29 2010-10-28
Standard operating procedure for referral procedures in accordance with the provisions of Articles 33(4), 34 and 35 of Directive 2001/82/EC, and Article 13 of Commission Regulation (EC) No 1234/2008, related to veterinary medicinal products authorised in the European Union (English only) adopted 2008-04-15 2016-01-14 2015-12-18