The electronic notification has additional data fields that are marked as mandatory. Where an adverse event has occurred in an untreated animal exposed to a treated animal, even if it belongs to another species, a single report should be submitted for only the animal in which the adverse event occurred. In this case, a brief explanation should be included in the dosage indications to clearly indicate which animal or species has been treated. In addition, details of the route of administration should reflect the route by which the affected animal was exposed, e.g., oral route of administration if contact was through licking or grooming, dermal route of administration if there was skin contact between the treated and untreated animal. Adverse event reports from the global literature are considered to be reports that can reasonably be expected to be known to the marketing authorisation holder. The marketing authorisation holder is therefore expected to regularly monitor the scientific literature in order to identify adverse events related to its medicinal products that can be notified. For all veterinary medicinal products, irrespective of the authorisation procedure, the marketing authorisation holder must report to the VMD on an accelerated basis all serious adverse events, adverse reactions in humans and unintentional transmission of an infectious agent by a veterinary medicinal product occurring in the United Kingdom. Reports of adverse events resulting from an application not indicated on the label can be obtained: for a describable case, accreditation bodies are expected to record all data relevant for the assessment and provided by the consignor or received in the context of the case and at least the minimum criteria. If relevant for the assessment, the marketing authorisation holder is expected to follow up on the adverse event with reasonable efforts to obtain other relevant information. It is important that regulatory authorities provide as complete information as possible, including all relevant clinical information and the results of appropriate diagnostic tests, in order to facilitate assessment. Original words and/or phrases used by the registrant should be provided even if they are also coded using the VeDDRA list of clinical terms for adverse event reporting in animals and humans. Regular review and analysis of adverse events over a predefined period may lead to the identification of potential signals if, for example: Electronic reporting of adverse events is mandatory, except in exceptional cases. Where premixtures incorporated in medicated feed have an adverse effect in animals or humans, both the premix and the medicated feed shall be investigated immediately.

Where residues of veterinary medicinal products in tissues or foodstuffs of treated food-producing animals exceed the MRLs set even though the recommended withdrawal period for the medicinal product concerned has been respected, this information may raise doubts as to the validity of the withdrawal period and should therefore be investigated and notified to the VMD. If the case meets the minimum information required for adverse event reporting, this should be recorded and reported, even if the information on whether the recommended latency was met is unknown. The marketing authorisation holder must report published adverse events related to the use of its veterinary medicinal products to VMD in accordance with the adverse event reporting requirements described above. These details enable the electronic management and distribution of adverse event reports and help detect duplicate reports. You can report drug-related adverse events to the FDA in one of the following ways: These reports can provide useful information on the safety of the veterinary medicinal product and should be recorded by the person responsible for pharmacovigilance and reported to the VMD in the same way as other adverse events. For some products, a specific target species is indicated in the “Target species” section of the Summary of Product Characteristics (SmPC), and in other sections of the same SmPC, such as indications, contraindications, special precautions for use, there is a restriction of use within that target species, e.g. an age category restriction, weight, physiological status, type of production, etc. In all cases, any potential adverse events identified via company websites or social media accounts should be tracked by Mahas, as is the case with reports identified by other means.

All adverse events related to veterinary medicinal products must be reported either to the marketing authorisation holder of the medicinal product concerned or to the VMD. This can be done online at www.gov.uk/report-veterinary-medicine-problem. The marketing authorisation holder is expected to validate all adverse events reported by veterinarians, other healthcare professionals and the public to ensure that the minimum required information is included in the report prior to notification to the VMD. Reports should be monitored in order to obtain additional information relevant to the case, if any, and relevant follow-up information should be communicated to the VMD. All available information relevant to the assessment of the adverse event shall be provided. When more than one species is affected by the same adverse event, separate reports must be submitted for each species, indicating that the reports are linked. This applies if more than one animal species is affected or if an animal and a human are involved. It should be emphasised that these are minimum requirements and that the marketing authorisation holder should endeavour to include as much information as possible, which is described below to facilitate a full assessment. Non-spontaneous adverse event reports and pharmacovigilance information can come from an ever-increasing number of online resources. The main sources of information currently known to VMD are discussed below. The online reporting form is preferred; However, if you prefer to use a hard copy, you can download and print an animal form to report an animal`s side effects to a veterinary drug or human product. You can also download and print a human form to report an adverse reaction to a veterinary medicinal product in humans.

Send the forms to the address at the top of the reports. All medicinal products prior to the adverse event should be made available as soon as they are available. This should include, where appropriate, non-prescription medicinal products, extemporaneous preparations and medicated feed. In the case of extemporaneous preparations, information on the various components of the formula must be provided. The authorisation holder must record and report all serious adverse events in animals and human reactions occurring in the United Kingdom which are brought to his attention or of which they can reasonably be expected to become aware. These reports must be reported immediately to the VMD, but no later than 15 calendar days after receipt. In this context, approval means that the marketing authorisation holder becomes aware of an adverse event. A serious adverse event is any adverse event that results in death, is life-threatening, results in persistent or significant disability or disability, or a birth defect or birth defect as defined in VICH GL24. In animals treated as a group, only an increased incidence of serious adverse events as defined above, exceeding the levels normally expected in this group, is considered a serious adverse event. Where an authorisation holder becomes aware of an adverse event report from sources other than those mentioned above, such as the specialised press or other media, reasonable efforts should be made to obtain the minimum amount of information constituting a single adverse event and to follow up on the report. The approach taken by the marketing authorisation holder to notifications from other sources should be similar to that taken for website and social media reporting.

MAHs are not expected to scan the Internet for reports of potential adverse events. However, where the marketing authorisation holder becomes aware of potential adverse events in the course of active investigations established by the authorisation authority, reasonable efforts should be made to follow up on notifications in order to obtain at least the minimum reporting criteria in order to feed into the formal pharmacovigilance reporting system.