Initial evaluation

  • Email
  • Help

Table of contents

Human

Back to top

Document(s) Language Status First published Last updated Effective Date
Standard Operating Procedure for handling of a request for accelerated assessment of initial marketing authorisation applications (human use) (English only) adopted 2009-01-05   2009-01-05
Standard operating procedure for consultation of environmental competent authorities on genetically modified organisms with respect to environmental risk assessment in product evaluation (human use) (English only) adopted 2009-10-07 2012-09-17 2012-09-18

Veterinary

Back to top

Document(s) Language Status First published Last updated Effective Date
Work instructions for checking of MRL status of constituents of veterinary medicinal products subject to a marketing authorisation application to the EMA (English only) adopted 2015-05-28    
Work instructions for handling of withdrawals of applications for marketing authorisation of veterinary medicines (English only) adopted 2014-05-08   2014-05-15
Work instructions for additional administrative actions for veterinary medicines arising during the preparation of Innovation Task Force briefing meetings in line with SOP/H/3044 (English only)   2014-03-26    
Standard operating procedure for evaluation of veterinary medicinal products containing or consisting of genetically modified organisms (English only) adopted 2007-05-16 2015-05-07 2015-02-05
Standard Operating Procedure for SIAMED-related data validation of new veterinary centralised procedures (English only) adopted 2007-02-16 2010-04-27 2010-04-26
Standard operating procedure for involvement of the CVMP Antimicrobials Working Party in the evaluation of applications for centralised marketing authorisations for veterinary medicinal products containing antimicrobial substances (English only) adopted 2008-12-19 2015-07-03 2014-10-01
External Standard Operating Procedure on submission of an application for the granting of a community marketing authorisation (English only) adopted 2006-01-27   2006-01-27
Standard Operating Procedure on submission of an application for the granting of a community marketing authorisation Annex: Centralised procedure distribution of dossiers between the members of the committee for medicinal products for veterinary use (English only) adopted 2007-12-12   2007-12-12