Office of Public Sector Information
SCHEDULE 2 continued PART 2
15.—(1) The Secretary of State may authorise a person and premises to manufacture autogenous vaccines.
(2) In order to be authorised the premises must be under the supervision of—
(a) a veterinary surgeon, or
(b) a person who the Secretary of State is satisfied has sufficient qualifications and experience to manufacture the product safely.
(3) Before he authorises the premises, the Secretary of State must be satisfied that the production process will produce a consistent, safe product.
(4) Procedure for the suspension or revocation of the authorisation is the same as for the holder of a manufacturing authorisation.
(5) It is an offence to manufacture an autogenous vaccine other than in accordance with such an authorisation.
16.—(1) The authorisation must specify the products that may be manufactured.
(2) It may either be for the production of a single batch of product or for on-going production of the products specified in the authorisation.
(3) If it is for a single batch it must be time-limited.
(4) Only the products specified in the authorisation may be manufactured, and in the case of an authorisation for a single batch the product may only be manufactured before the expiry of the authorisation.
17.—(1) The operator of the premises must ensure that every container containing autogenous vaccine is labelled with—
(a) the name of the veterinary surgeon who ordered the vaccine;
(b) a precise description of the vaccine;
(c) the date the vaccine was produced;
(d) the name of the authorisation holder and address of the authorised premises;
(e) the expiry date;
(f) any necessary warnings; and
(g) instructions for use.
(2) It is an offence to fail to comply with this paragraph.
18.—(1) The operator of the premises must, as soon as is reasonably practicable, record—
(a) the name and address of the veterinary surgeon who ordered the vaccine;
(b) the identification of the source animal;
(c) the expiry date;
(d) the date of supply to the veterinary surgeon.
(2) He must keep the records for at least five years.
(3) It is an offence to fail to comply with this paragraph.
19.—(1) The authorised person must notify the Secretary of State of any adverse reactions to an autogenous vaccine within 15 days of learning of the reaction.
(2) It is an offence to fail to comply with this paragraph.
20. The Secretary of State must inspect the authorised premises every two years.
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 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 responsibility 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.
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 responsibility.
(3) It may only be administered to non-food-producing animals.
(4) It is an offence to fail to comply with this paragraph.
23.—(1) The operator of a blood bank must ensure that every container used for the blood is labelled with—
(a) the identification of the donor animal;
(b) the date of collection;
(c) the authorisation number of the blood bank;
(d) any necessary warnings;
(e) the expiry date.
(2) It is an offence to fail to comply with this paragraph.
24.—(1) The operator of a blood bank must, as soon as is reasonably practicable, record—
(a) the date of collection;
(b) the identification 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.
25. The Secretary of State must inspect a blood bank every two years.
The Veterinary Medicines Regulations 2007