The Veterinary Medicines Regulations 2005

Adverse reactions to a veterinary medicinal product administered in the United Kingdom

56.—(1) A marketing authorisation holder must act in accordance with this paragraph if he learns of any suspected—

(a) serious adverse reaction;

(b) human adverse reaction; or

(c) unintended transmission of an infectious agent through a veterinary medicinal product,

following the administration of the product in the United Kingdom.

(2) He must make a record of what happened.

(3) He must without delay and in any event within 15 days report it (electronically if this is practicable) to the Secretary of State.

(4) In addition, he must supply to the Secretary of State all relevant veterinary pharmacovigilance information in his possession relating to the reaction, giving a full description of the incident and a list of all the symptoms using internationally recognised veterinary and medical terminology(1), either with the report or, if the information becomes available after the report has been sent, as soon after it becomes available as is reasonably practicable.

(5) In this and the following paragraph—

“human adverse reaction” means a reaction that is noxious and unintended and that occurs in a human being following exposure to a veterinary medicine;

“serious adverse reaction” means an 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.

(6) It is an offence to fail to comply with this paragraph.

(1)

A list of clinical terms for reporting suspected adverse reactions to veterinary medicinal products (the Veterinary Dictionary for Drug Regulatory Activities) is published by the Committee for Medicinal Products for Veterinary Use. It is available at www.veddra.org