Suspected Adverse Reaction Surveillance Scheme
This article is about Veterinary Medicines. For Human Medicines, see the Yellow Card Scheme.
The Suspect Adverse Reaction Surveillance Scheme used by the Veterinary Medicines Directorate (VMD) is similar to the Human Yellow Card Scheme. It is used in the UK to gather information on Suspected Adverse Reactions (SARs) to veterinary medicines (in animals and humans) and other aspects of veterinary pharmacovigilance, namely suspected lack of expected efficacy, environmental problems, and residues in foodstuffs which cast doubt on the validity of the withdrawal period of the medicine concerned. SARs can be reported by anyone: most are reported by marketing authorisation holders, followed by veterinary surgeons.
The following must be reported by marketing authorisation holders within 15 days:
- Serious SARs (suspected adverse reaction that results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or that results in permanent or prolonged signs in the animals treated)
- Human adverse reactions (a reaction that is noxious and unintended and that occurs in a human being following exposure to a veterinary medicine)
- unintended transmission of an infectious agent through a veterinary medicinal product
All other adverse reactions must be reported in a Periodic Safety Update Report. All SARs (to animals and humans) should be reported by veterinary surgeons (this is a professional duty).
In addition to the Yellow Card (form MLA252A) for SARs in animals and humans, there is a green card (form MLA1) to report environmental incidents, and a blue card (form MLA2) to report suspected residues of antibiotics in milk.
The reports are monitored and analysed by the Suspected Adverse Reactions Surveillance Scheme of the VMD, who make reports to the Veterinary Products Committee. Where the Secretary of State for Environment, Food and Rural Affairs considers, as a result of the evaluation of veterinary pharmacovigilance data that there is a significant safety concern, the marketing authorisation may be suspended, revoked or varied to restrict the indications, change the distribution category, amend the dose, add a contraindication, or add a new precautionary measure.
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