Veterinary
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Work instructions for management of the procedure for assessment of the final report of Post-Authorisation Safety Studies (PASS) for veterinary medicines (PDF/122 KB)
Adopted
First published: 04/04/2016
Last updated: 04/04/2016
Legal effective date: 26/02/2016
WIN/V/4028 -
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Standard operating procedure for procedure to be followed when the incident management plan for medicines for veterinary use is triggered (PDF/168.21 KB)
Adopted
First published: 20/09/2012
Last updated: 04/04/2016
Legal effective date: 26/02/2016
SOP/V/4003 -
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Standard operating procedure for annual review of VeDDRA list to be used in EudraVigilance Veterinary (PDF/108.05 KB)
Adopted
First published: 26/05/2015
Last updated: 26/05/2015
Legal effective date: 15/05/2015
SOP/V/4019 -
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Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products (PDF/135.94 KB)
Adopted
First published: 03/06/2009
Last updated: 07/05/2015
Legal effective date: 07/05/2015
SOP/V/4023 -
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Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products: Annex I – contact details of national competent authorities (NCAs) for PSUR submission (PDF/164.56 KB)
Adopted
First published: 01/04/2007
Last updated: 19/07/2019
SOP/V/4023 – Annex I -
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Standard operating procedure for management of pharmacovigilance rapid alerts and non-urgent information for medicinal products for veterinary use (PDF/163.92 KB)
Adopted
First published: 27/03/2009
Last updated: 09/08/2013
Legal effective date: 09/08/2013
SOP/V/4041 -
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Standard operating procedure for surveillance of centrally authorised veterinary medicinal products (PDF/156.52 KB)
Adopted
First published: 03/10/2011
Last updated: 21/08/2015
Legal effective date: 18/08/2015
SOP/V/4032 -
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Work instructions for processing pharmacovigilance data in renewal procedures for centrally authorised medicinal products for veterinary use (PDF/100.3 KB)
Adopted
First published: 05/02/2009
Last updated: 10/09/2013
Legal effective date: 30/08/2013
WIN/V/4048