SCHEDULE 2U.K.The manufacture of veterinary medicinal products

PART 3U.K.Authorisation of blood banks

Authorisation of blood banksU.K.

20.—(1) The Secretary of State may authorise blood banks for—

(a)the collection, storage and supply of blood, or

(b)the storage and supply of blood constituents obtained by the physical separation of donor blood into different fractions within a closed-bag system,

for the treatment of non-food-producing animals.

(2) The authorisation may be for either or both of these activities.

(3) In order to be authorised a blood bank must be under the supervision of—

(a)a veterinary surgeon named in the authorisation; or

(b)a person named in the authorisation who the Secretary of State is satisfied is suitably qualified to operate the blood bank.

(4) Before authorising a blood bank, the Secretary of State must be satisfied—

(a)that the welfare of animals used in the collection of blood will be respected; and

(b)that the production process will produce a consistent, safe product.

(5) The Secretary of State may suspend, vary or revoke an authorisation of a blood bank if—

(a)the holder no longer uses fit and proper processes;

(b)the premises in which the blood bank is being or is to be operated are not suitable;

(c)the equipment is not suitable; or

(d)the holder has not complied with these Regulations.

(6) Blood may only be collected under the responsibility of a veterinary surgeon.

(7) No person may operate a blood bank for treatment of animals other than in accordance with such an authorisation.