The Veterinary Medicines Regulations 2005

PART 3Records

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

17.—(1) The owner or keeper of food-producing animals must keep proof of purchase of all veterinary medicinal products acquired for those animals.

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

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

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

(a)the name of the veterinary surgeon;

(b)the name of the product;

(c)the date of administration of the product;

(d)the amount of product administered;

(e)the identification of the animals treated;

(f)the withdrawal period.

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

Food-producing animals: records of purchase and administration

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

(a)the name of the product;

(b)the date of purchase;

(c)the quantity purchased;

(d)the withdrawal period;

(e)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) he must record—

(a)the name of the product;

(b)the date of administration;

(c)the quantity administered;

(d)the identity of the animals treated.

(3) If he disposes of it other than by treating an animal, he must record the date and route of disposal.

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

Food-producing animals: retention of records

20.—(1) The keeper must retain the proof of purchase and the record for at least five years following the administration or other disposal of the product, irrespective of whether or not the animals concerned are no longer in his possession or have been slaughtered or have died during that period.

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

Records by holders 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 by him, 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;

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

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

(3) He 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 wholesale dealers

22.—(1) A wholesale dealer must record, as soon as is reasonably practicable after each incoming or outgoing transaction (including disposals), the following—

(a)the date and nature of the transaction;

(b)the identity 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.

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

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

Records of products supplied on prescription

23.—(1) When any person permitted under these Regulations to supply veterinary medicinal products classified as POM-V or POM-VPS receives or supplies any such veterinary medicinal product he must keep all documents relating to the transaction, which must include—

(a)the date;

(b)the identity of the veterinary medicinal product;

(c)the quantity;

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

(e)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 he must make a record of the missing information as soon as is reasonably practicable.

(3) As an alternative to paragraphs (1) and (2) he may make a record of all the information required there provided that he does so as soon as is reasonably practicable.

(4) When he starts to use the veterinary medicinal product he must also record the batch number and the date.

(5) He must keep the documentation and records for at least five years.

(6) 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 a food-producing animal under the cascade, or permitting another person to administer it under his responsibility, must, as soon as is reasonably practicable, record—

(a)the date he examined the animals;

(b)the name and address of the owner;

(c)the identification and number of animals treated;

(d)the diagnosis;

(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;

(i)the duration of treatment; and

(j)the withdrawal period.

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

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