Referrals procedures
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Standard operating procedure on Article 30 referrals triggered by the European Commission or a Member State (PDF/218.57 KB)
Adopted
First published: 06/09/2012
Last updated: 06/09/2012
Legal effective date: 04/09/2012
SOP/H/3215 -
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Standard operating procedure on Article 29 procedures according to the Paediatric Regulation No 1901/2006 (PDF/234.58 KB)
Adopted
First published: 28/06/2012
Last updated: 28/06/2012
SOP/H/3249 -
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Standard operating procedure on Article 107 procedures - Pharmacovigilance urgent measures (PDF/218.61 KB)
Adopted
First published: 28/06/2012
Last updated: 28/06/2012
SOP/H/3250 -
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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 (PDF/181.2 KB)
Adopted
First published: 19/04/2012
Last updated: 11/02/2016
Legal effective date: 11/02/2016
SOP/V/4025 -
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Standard operating procedure for CHMP rapporteur / co-rapporteur appointment for Community procedures (PDF/105.51 KB)
Adopted
First published: 11/02/2009
Last updated: 26/09/2012
Legal effective date: 25/09/2012
SOP/H/3176 -
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Standard operating procedure for Article 20 procedures (PDF/287.33 KB)
Adopted
First published: 23/05/2008
Last updated: 30/11/2010
Legal effective date: 29/11/2010
SOP/H/3192 -
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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 product... (PDF/203.66 KB)
Adopted
First published: 23/05/2008
Last updated: 29/10/2010
Legal effective date: 28/10/2010
WIN/H/3205 -
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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 veterinar... (PDF/380.42 KB)
Adopted
First published: 15/04/2008
Last updated: 14/01/2016
Legal effective date: 18/12/2015
SOP/V/4024