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Search results (61)
Work instructions for key activities when screening the electronic reaction monitoring reports (eRMRs) for new signals
Key activities when screening the electronic reaction monitoring reports (eRMRs) for new signals
English (EN) (386.38 KB - PDF)
Work Instructions for design of an analysis of EudraVigilance data
English (EN) (109.48 KB - PDF)
Work instructions for maintenance of signal management tracking table
Work instructions for maintenance of signal management tracking table
English (EN) (431.75 KB - PDF)
Work instructions for validation of signals from the review of individual cases
English (EN) (152.28 KB - PDF)
Work instructions for marketing status and sunset clause monitoring for centrally authorised veterinary medicinal products
New WIN following revision of IQM structure and simplification of procedure.
English (EN) (90.8 KB - PDF)
Work instructions for Processing requests for inclusion in the list of substances not falling within the scope of Regulation EC 470/2009 (out of scope)
Processing requests for inclusion in the list of substances not falling within the scope of Regulation EC 470/2009 (out of scope)
English (EN) (93.32 KB - PDF)
Work instructions for inspection of quality control facilities located in third countries
English (EN) (99.73 KB - PDF)
Work instructions for paediatric core master files and numbering
English (EN) (103.74 KB - PDF)
Work instructions for review of granted paediatric product-specific and class waivers
English (EN) (96.02 KB - PDF)
Work instructions for organisation of CVMP Working Party meetings
The WIN applies to the Veterinary Medicines Division and in particular to the assistants who are responsible for the organisation and distribution of mailings for the relevant CVMP Working Party.
English (EN) (155.2 KB - PDF)