The Veterinary Medicines Regulations 2009

PART 3 Records

Food-producing animals: proof of purchase of veterinary medicinal products

17.—(1) The keeper of a food-producing animal must keep proof of purchase of all veterinary medicinal products acquired for the animal (or, if they were not bought, documentary evidence of how they were acquired).

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

Food-producing animals: records of administration by a veterinary surgeon

18.—(1) A veterinary surgeon who administers a veterinary medicinal product to a food-producing animal must either enter the following information personally in the keeper’s records or give it to the keeper in writing (in which case the keeper must enter the following into those records)—

(a) the name of the veterinary surgeon;

(b) the name of the product and the batch number;

(c) the date of administration of the product;

(d) the amount of product administered;

(e) the identification of the animals treated; and

(f) the withdrawal period.

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

Food-producing animals: records of acquisition and administration

19.—(1) When a veterinary medicinal product is bought or otherwise acquired for a food-producing animal the keeper must, at the time, record—

(a) the name of the product and the batch number;

(b) the date of acquisition;

(c) the quantity acquired; and

(d) the name and address of the supplier.

(2) At the time of administration (unless the administration is by a veterinary surgeon in which case the record must be in accordance with regulation 18) the keeper must record—

(a) the name of the product;

(b) the date of administration;

(c) the quantity administered;

(d) the withdrawal period; and

(e) the identification of the animals treated.

(3) A keeper who disposes of any or all of the veterinary medicinal product other than by treating an animal must record—

(a) the date of disposal;

(b) the quantity of product involved; and

(c) how and where it was disposed of.

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

Food-producing animals: retention of records

20.—(1) The keeper of a food-producing animal must keep the documentation on the acquisition of a veterinary medicinal product and the records relating to the product for at least five years following the administration or other disposal of the product, irrespective of whether or not the animal concerned is no longer in that keeper’s possession or has been slaughtered or has died during that period.

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

Records by a holder of a manufacturing authorisation

21.—(1) A holder of a manufacturing authorisation must, as soon as is reasonably practicable, make a record of each batch of veterinary medicinal product manufactured, assembled or supplied, which must include—

(a) the name of the product;

(b) the quantity manufactured, assembled or supplied;

(c) the date of manufacture, assembly or supply;

(d) the batch number and expiry date; and

(e) in the case of supply, the name and address of the recipient.

(2) The holder must keep with the record all certification provided by the qualified person (manufacture) in relation to that batch.

(3) The holder must keep all records and certificates for at least five years from the date the veterinary medicinal product is placed on the market.

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

Records by a holder of a wholesale dealer’s authorisation

22.—(1) A holder of a wholesale dealer’s authorisation must record the following as soon as is reasonably practicable after each incoming or outgoing transaction (including disposal) relating to a veterinary medicinal product—

(a) the date and nature of the transaction;

(b) the name of the veterinary medicinal product;

(c) the manufacturer’s batch number;

(d) the expiry date;

(e) the quantity; and

(f) the name and address of the supplier or recipient,

and must keep the records for at least three years.

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

Records of the receipt or supply of prescription products

23.—(1) Any person permitted under these Regulations to supply a veterinary medicinal product classified as POM-V or POM-VPS who receives or supplies any such veterinary medicinal product must keep all documents relating to the transaction that show—

(a) the date;

(b) the name of the veterinary medicinal product;

(c) the batch number (except that, in the case of a product for a non-food-producing animal, this need only be recorded either on the date of receipt of the batch or the date a veterinary medicinal product from the batch is first supplied);

(d) the quantity;

(e) the name and address of the supplier or recipient; and

(f) if there is a written prescription, the name and address of the person who wrote the prescription and a copy of the prescription.

(2) If the documents do not include this information that person must make a record of the missing information as soon as is reasonably practicable following the transaction.

(3) As an alternative to paragraphs (1) and (2) that person may make a record of all the information required there provided that this is done as soon as is reasonably practicable following the transaction.

(4) The documentation and records must be kept for at least five years.

(5) It is an offence to fail to comply with this regulation.

Records of products administered to a food-producing animal under the cascade

24.—(1) A veterinary surgeon administering a veterinary medicinal product to food-producing animals under the cascade, or permitting another person to administer it under that veterinary surgeon’s responsibility, must, as soon as is reasonably practicable, record—

(a) the date of examination of the animals;

(b) the name and address of the owner;

(c) the identification and number of animals treated;

(d) the result of the veterinary surgeon’s clinical assessment;

(e) the trade name of the product if there is one;

(f) the manufacturer’s batch number shown on the product if there is one;

(g) the name and quantity of the active substances;

(h) the doses administered or supplied;

(i) the duration of treatment; and

(j) the withdrawal period,

and must keep the record for at least five years.

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