SCHEDULE 4U.K.Administration of a veterinary medicinal product outside the terms of a marketing authorisation

Administration by veterinary surgeons from other [F1countries] E+W+S

6.—(1) Veterinary surgeons practising in another [F2country with equivalent medicines regulation standards to those of the United Kingdom] may bring into the United Kingdom and administer to animals small quantities of veterinary medicinal products that are not authorised for use in the United Kingdom if—

(a)the quantity does not exceed the requirements for the treatment of specific animals;

(b)the product is authorised in the [F3country] in which the veterinary surgeon is established;

(c)the product is transported by the veterinary surgeon in the original manufacturer’s packaging;

(d)in the case of administration to food-producing animals, there is a veterinary medicinal product authorised in the United Kingdom that has the same qualitative and quantitative composition in terms of active substances;

(e)the veterinary surgeon is acquainted with the Code of Professional Conduct for veterinary surgeons issued by the Royal College of Veterinary Surgeons(1).

(2) The veterinary surgeon must only supply to the owner or keeper enough veterinary medicinal product to complete the treatment of animals concerned.

(3) The veterinary surgeon must—

(a)ensure that the withdrawal period specified on the label of the product is complied with, or the United Kingdom withdrawal period for the equivalent product authorised in the United Kingdom if this is longer than the one on the label; and

(b)keep detailed records of the animals treated, the diagnosis or clinical assessment, the products administered, the dosage administered, the duration of treatment and the withdrawal period applied, and must keep them in the United Kingdom for at least three years.

(4) The overall range and quantity of veterinary medicinal products carried by the veterinary surgeon must not exceed that generally required for the daily needs of good veterinary practice.

(5) This paragraph does not apply in relation to immunological veterinary medicinal products.

Administration by veterinary surgeons from F4... member StatesN.I.

6.—(1) Veterinary surgeons practising in [F5a] member State may bring into [F6Northern Ireland] and administer to animals small quantities of veterinary medicinal products that are not authorised for use in [F6Northern Ireland] if—

(a)the quantity does not exceed the requirements for the treatment of specific animals;

(b)the product is authorised in the member State in which the veterinary surgeon is established;

(c)the product is transported by the veterinary surgeon in the original manufacturer’s packaging;

(d)in the case of administration to food-producing animals, there is a veterinary medicinal product authorised in [F7Northern Ireland] that has the same qualitative and quantitative composition in terms of active substances;

(e)the veterinary surgeon is acquainted with the Code of Professional Conduct for veterinary surgeons issued by the Royal College of Veterinary Surgeons(1).

(2) The veterinary surgeon must only supply to the owner or keeper enough veterinary medicinal product to complete the treatment of animals concerned.

(3) The veterinary surgeon must—

[F8(a)ensure that the withdrawal period specified on the label of the product is complied with, or the Northern Ireland withdrawal period for the equivalent product authorised in Northern Ireland if this is longer than the one on the label; and]

(b)keep detailed records of the animals treated, the diagnosis or clinical assessment, the products administered, the dosage administered, the duration of treatment and the withdrawal period applied, and must keep them in [F9Northern Ireland] for at least three years.

(4) The overall range and quantity of veterinary medicinal products carried by the veterinary surgeon must not exceed that generally required for the daily needs of good veterinary practice.

(5) This paragraph does not apply in relation to immunological veterinary medicinal products.