SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product|veterinary drug
- tuairisc maidir leis an teagmhas díobhálach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Comhthéacs 'Déanfaidh sealbhóirí údaruithe margaíochta taifead sa bhunachar sonraí faireachais cógas ar gach teagmhas díobhálach amhrasta a tuairiscíodh dóibh agus a tharla san Aontas nó i dtríú tír nó a foilsíodh sa litríocht eolaíoch maidir lena dtáirgí íocshláinte tréidliachta údaraithe, gan mhoill agus tráth nach déanaí ná 30 lá ón lá a fuarthas an tuairisc maidir leis an teagmhas díobhálach amhrasta.' Tagairt "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
- tuairisc ar theagmhas díobhálach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- adverse event report | AER
- en
- Sainmhíniú direct communication from an identifiable first-hand reporter that includes at least the following information: - an identifiable reporter- an identifiable animal(s) or human(s)- an identifiable veterinary medicinal product (VMP)- one or more adverse events Tagairt "European Medicines Agency (EMA). 'VICH GL24 on pharmacovigilance of veterinary medicinal products: management of adverse event reports (AERs)' (2.6.2022). EMA/CVMP/VICH/547/2000"
- Nóta Although reporting via the attending veterinarian is encouraged, an AER (adverse event report) may be initiated by anyone directly involved with the purported adverse event. Preferably, an AER is communicated by the reporter directly to the MAH (marketing authorisation holder), but the AER may also have been routed through an agent or the RA (regulatory authority). A communication through an intermediate agent is considered an AER only if the agent has been authorized by the reporter and provides sufficient information to allow direct contact between the reporter and the MAH.