Adverse reactions to a veterinary medicinal product administered in [F3another ] countryE+W+S

58.—(1) A marketing authorisation holder for a veterinary medicinal product authorised in [F4Great Britain] must act in accordance with this paragraph on learning of any suspected—

(a)serious, unexpected adverse reaction (for these purposes a reaction is unexpected if its nature, severity or outcome is not consistent with the summary of the product characteristics);

(b)human adverse reaction; or

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

following the administration of the product in [F5another] country.

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

(3) The holder must without delay and in any event within 15 days report the suspected reaction or transmission (electronically if this is practicable) to the Secretary of StateF6....

(4) In addition to the report, the holder must supply to the Secretary of StateF7... all relevant veterinary pharmacovigilance information in the holder’s possession relating to the reaction as in the preceding paragraph.

Adverse reactions to a veterinary medicinal product administered in a third countryN.I.

58.—(1) A marketing authorisation holder for a veterinary medicinal product authorised in [F8Northern Ireland] must act in accordance with this paragraph on learning of any suspected—

(a)serious, unexpected adverse reaction (for these purposes a reaction is unexpected if its nature, severity or outcome is not consistent with the summary of the product characteristics);

(b)human adverse reaction; or

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

following the administration of the product in a third country.

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

(3) The holder must without delay and in any event within 15 days report the suspected reaction or transmission (electronically if this is practicable) to the Secretary of State, the competent authorities of all member States in which the product is authorised, and the Agency.

(4) In addition to the report, the holder must supply to the Secretary of State, the competent authorities of all F9... member States where the product is authorised and the Agency, all relevant veterinary pharmacovigilance information in the holder’s possession relating to the reaction as in the preceding paragraph.