Final october 2011 volume 9b of the rules governing medicinal products in the european union guidelines on pharmacovigilance for medicinal products for veterinary use. Veterinary pharmacovigilance in an industry setting a. Pharmacovigilance in the netherlands 277 kees van grootheest and eugene van puijenbroek 23. Legal basis and structure of volume 9b veterinary pharmacovigilance. In cases in which you can order through the internet we have established a hyperlink. Veterinary pharmacovigilance is the ongoing monitoring and. The following guideline can be ordered through the address listed in the sourcepublishercategory. In the past the european commission also published pharmacovigilance guidance for human medicinal products volume 9a. Eudralex consists of 10 volumes, of which only volume 1.
Volume 9 of the rules governing medicinal products in the european union. Safety for the use of antimicrobial veterinary medicinal. Current approaches to the responsible and prudent use of antimicrobial veterinary medicinal products involve monitoring of their efficacy and safety, which is ensured by. Prasentation ibrahim ecopharmacovigilance umweltbundesamt. United kingdoms spontaneous reporting scheme, commonly known as the yellow card scheme, is the cornerstone of the monitoring process. Volume 9b of the rules governing medicinal products in the. What is lifethreatening in the context of a serious adverse event. Volume 9b pharmacovigilance for medicinal products for veterinary use. Cioms working groups and their contribution to pharmacovigilance 287. Guidelines on pharmacovigilance for medicinal products for veterinary use volume 9b version october 2011. Volume 9b of the rules governing medicinal products in the european union pdf 0. However detailed guidance on handling such reports is 27 not given and interpretation of requirements has been variable between national competent authorities 28 ncas to date. Top 36 drug safety interview questions with answers pdf. Questions and answers on serious nonfatal adverse events.
Overview of pharmacovigilance and good distribution practices. Volume 9 a guidelines on pharmacovigilance1 slideshare. Guideline for pharmacovigilance of veterinary medicinal. Eudralex volume 9 pharmacovigilance guidelines public health. At present, one section of volume 9b, guideline on. Pharmacovigilance pv or phv, otherwise called tranquilize wellbeing, is the pharmacological science identifying with the accumulation, discovery, appraisal, observing, and counteractive action of. In the past the european commission also published pharmacovigilance guidance for human medicinal products. Volume 9b of the rules governing medicinal products in the european union guidelines on pharmacovigilance for medicinal products for veterinary use. Structure of volume 9a part i deals with guidelines for marketing authorisation. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Pharmacovigilance title ix pharmacovigilance chapter 2 transparency and communications art 106 mah announcements on pv concerns each nca shall set up and maintain a web portal and link it to the ema member states shall make publicly available at least the following public assessment reports, together with a summary thereof spcs and pils.
Eu qualified person for pharmacovigilance qppv responsible for. Veterinary pharmacovigilance broadly describes the science and activities relating. This chapter discusses the past, present and future of the. Program and activities in indonesia presented in joint symposium pmda japan badan pom ri, in collaboration with gp farmasi indonesia jakarta, februari 20 raja ampat, papua indonesia.
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