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Holder of marketing authorisation PDF Print E-mail
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This part is dedicted to marketing authorisation holders and their obligations in the field of pharmacovigilance of veterinary medicinal products. There are published information how to report adverse reactions to competent authorities and EMEA. Specific attention is focused on electronic reporting and other ways for handing over of these information, e.g. using standard templates. Also information on HMA work sharing project and European Bulletin are published in this section.

Last Updated on Friday, 11 May 2018 13:13