Initial evaluation
Table of contents
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List item
Standard Operating Procedure for handling of a request for accelerated assessment of initial marketing authorisation applications (human use) (PDF/77.7 KB)
Adopted
First published: 05/01/2009
Last updated: 05/01/2009
Legal effective date: 05/01/2009
SOP/H/3182 -
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Standard operating procedure for consultation of environmental competent authorities on genetically modified organisms with respect to environmental risk assessment in product evaluation (human use) (PDF/387.42 KB)
Adopted
First published: 07/10/2009
Last updated: 17/09/2012
Legal effective date: 18/09/2012
SOP/H/3191
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List item
Standard operating procedure for evaluation procedure for veterinary medicines initial marketing authorisation procedures and extensions (PDF/218.75 KB)
Adopted
First published: 19/01/2018
Last updated: 01/10/2018
Legal effective date: 16/01/2018
SOP/V/4110 -
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Work instructions for checking of MRL status of constituents of veterinary medicinal products subject to a marketing authorisation application to the EMA (PDF/103.54 KB)
Adopted
First published: 28/05/2015
Last updated: 28/05/2015
WIN/V/4046 -
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Work instructions for handling of withdrawals of applications for marketing authorisation of veterinary medicines (PDF/114.91 KB)
Adopted
First published: 08/05/2014
Last updated: 08/05/2014
Legal effective date: 15/05/2014
WIN/V/4031 -
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Standard operating procedure for evaluation of veterinary medicinal products containing or consisting of genetically modified organisms (PDF/199.44 KB)
Adopted
First published: 16/05/2007
Last updated: 07/05/2015
Legal effective date: 05/02/2015
SOP/V/4012 -
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Standard Operating Procedure for SIAMED-related data validation of new veterinary centralised procedures (PDF/127.11 KB)
Adopted
First published: 16/02/2007
Last updated: 27/04/2010
Legal effective date: 26/04/2010
SOP/V/4033 -
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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 ... (PDF/138.93 KB)
Adopted
First published: 19/12/2008
Last updated: 03/07/2015
Legal effective date: 01/10/2014
SOP/V/4042