SCHEDULE 2THE MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS
PART 3Authorisation of blood banks
Authorisation of blood banksI321
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 he authorises 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.
4
The procedure for the suspension or revocation of the authorisation is 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 bankI122
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.
LabellingI523
1
The operator of a blood bank 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; and
e
the expiry date.
2
It is an offence to fail to comply with this paragraph.
RecordsI224
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; and
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 banksI425
The Secretary of State shall inspect a blood bank every two years.