Veterinary

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Document(s) Language Status First published Last updated Effective Date
Work instructions for management of the procedure for assessment of the final report of Post-Authorisation Safety Studies (PASS) for veterinary medicines (English only) adopted 2016-04-04   2016-02-26
Standard operating procedure for procedure to be followed when the incident management plan for medicines for veterinary use is triggered (English only) adopted 2012-09-20 2016-04-04 2016-02-26
Standard operating procedure for annual review of VeDDRA list to be used in EudraVigilance Veterinary (English only) adopted 2015-05-26   2015-05-15
Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products (English only) adopted 2009-06-03 2015-05-07 2015-05-07
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 (English only) adopted 2007-04-01 2017-02-14  
Standard operating procedure for management of pharmacovigilance rapid alerts and non-urgent information for medicinal products for veterinary use (English only) adopted 2009-03-27 2013-08-09 2013-08-09
Standard operating procedure for surveillance of centrally authorised veterinary medicinal products (English only) adopted 2011-10-03 2015-08-21 2015-08-18
Work instructions for processing pharmacovigilance data in renewal procedures for centrally authorised medicinal products for veterinary use (English only) adopted 2009-02-05 2013-09-10 2013-08-30