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The Veterinary Medicines Regulations 2013

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[F3Adverse events following administration of a veterinary medicinal product]E+W+S

This section has no associated Explanatory Memorandum

57.—(1) A marketing authorisation holder must act in accordance with this paragraph on learning of any suspected—

(a)[F4adverse event in respect of an animal];

(b)human [F5adverse event]; F6...

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

[F7(d)occurrence of an adverse environmental event, or

(e)lack of efficacy,]

following the administration of the product F8....

[F9(1A) A marketing authorisation holder must also act in accordance with this paragraph where—

(a)after the end of the withdrawal period a product of animal origin is found to include a pharmacologically active substance or marker residue exceeding the maximum residue limit established in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council; or

(b)there is evidence in published scientific literature of an adverse event in connection with the product.]

(2) The holder must make a record of what happened.

(3) The holder must without delay and in any event within [F1030] days report it (electronically if this is practicable) to the Secretary of State.

(4) In addition, the holder must supply to the Secretary of State all relevant veterinary pharmacovigilance information that the holder possesses relating to the [F11event], giving a full description of the incident and a list of all the symptoms using internationally recognised veterinary and medical terminology, 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.

[F12(4A) The Secretary of State may require the marketing authorisation holder—

(a)to collect specific pharmacovigilance data (in addition to the data mentioned in sub-paragraph (4)) and submit those data to the Secretary of State; and

(b)to carry out specific post-marketing surveillance studies.

(4B) Where the Secretary of State exercises the power mentioned in sub-paragraph (4A), the Secretary of State must—

(a)state the reason for the requirement; and

(b)state the time by which, or the period during which, the requirement must be complied with.]

F13(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Adverse reactions to a veterinary medicinal product administered in [F14Northern Ireland] N.I.

57.—(1) A marketing authorisation holder must act in accordance with this paragraph on learning 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 [F15Northern Ireland].

(2) The holder must make a record of what happened.

(3) The holder 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, the holder must supply to the Secretary of State all relevant veterinary pharmacovigilance information that the holder possesses 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, 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 or birth defect, or that results in permanent or prolonged signs in the animals treated.

Extent Information

E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

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