SCHEDULE 2The manufacture of veterinary medicinal products

PART 3Authorisation of blood banks

Authorisation of blood banks20

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.