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SCHEDULE 2The manufacture of veterinary medicinal products

PART 3Authorisation of blood banks

Authorisation of blood banks

21.—(1) The Secretary of State may authorise blood banks for the collection, storage and supply of blood for the treatment of non-food producing animals.

(2) 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.

(3) Before she authorises a blood bank, the Secretary of State must be satisfied —

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

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

(4) Procedure for the suspension or revocation of the authorisation shall be the same as for the holder of a manufacturing authorisation.

(5) Blood may only be collected under the supervision of a veterinary surgeon.

(6) It is an offence to operate a blood bank for treatment of animals other than in accordance with such an authorisation.

Supply and administration of blood from a blood bank

22.—(1) The blood may only be supplied to a veterinary surgeon.

(2) It may only be administered by a veterinary surgeon or under his supervision.

(3) It may only be administered to non-food producing animals.

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

Labelling

23.—(1) The operator must ensure that every container used for the blood is labelled with—

(a)the identity of the donor animal;

(b)the date of collection;

(c)the name of the veterinary surgeon who collected it;

(d)any necessary warnings;

(e)the expiry date.

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

Records

24.—(1) The operator of a blood bank must, as soon as is reasonably practicable, record—

(a)the date of collection;

(b)the identity of the donor animal;

(c)the veterinary surgeon who collected it;

(d)the expiry date;

(e)the date the blood was used or, if it was supplied to another veterinary surgeon, the name of that veterinary surgeon and the date it was supplied.

(2) He must keep the records for at least five years.

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

Inspection of blood banks

25.  The Secretary of State shall inspect a blood bank every two years.