ENFORCEMENT

LEGISLATION AND OFFENCES
 

Offences under the Veterinary Medicines Regulations 2009

There are a number of offences under the Regulations, some of which are new.  The full text of the Regulations can be seen here.  A summary of the offences, grouped by activity, appears below.  The number is the regulation number.

Quick links to sections –
 

Sale / Supply / Placing on the market

Possession

Administration

Importation

Exportation

Duties on authorisation holders

Sale / Supply / Placing on the market

4(1) It is an offence to place a veterinary medicinal product on the market unless that product has been granted a marketing authorisation by the Secretary of State or the Agency.

7(2) Any person who supplies a veterinary medicinal product that has passed its expiry date is guilty of an offence.

7(3) Any person who opens the package (including the outer package) of a veterinary medicinal product before it has been supplied to the final user, other than as permitted under Schedule 3, is guilty of an offence.

7(4) Any person who supplies an authorised human medicinal product for administration to an animal (other than a product supplied by a veterinary surgeon or in accordance with a written prescription from a veterinary surgeon that includes all the information specified in paragraph 6 of Schedule 3) is guilty of an offence)

10(1) It is an offence to advertise a veterinary medicinal product if the advertisement is misleading or contains any medicinal claims that is not in the summary of product characteristics.

10(2) It is an offence to advertise an authorised human medicinal product for administration to animals (including sending a price list of or including authorised human medicinal products to a veterinary surgeon or veterinary practice).

11(1) It is an offence to advertise a veterinary medicinal product that –

(a)   is available on veterinary prescription only; or

(b)   contains psychotropic drugs or narcotics.

13.  It is an offence to buy a veterinary medicinal product, other than by retail or for the purposes of retail supply in accordance with Schedule 3, unless the buyer has a wholesale dealer’s authorisation granted by the Secretary of State under this regulation and Schedule 3.

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.

22(2) It is an offence to fail to comply with this regulation.

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 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 first batch is 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.

23(2) If the documents do not include this information that person must make a record of the missing information as soon as it reasonably practicable following the transaction.

23(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.

23(4) The documentation and records must be kept for at least five years.

23(5) It is an offence to fail to comply with this regulation.

27(1) It is an offence to supply an unauthorised veterinary medicinal product.

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Possession

7(5) Any person in possession of a veterinary medicinal product that was supplied to that person other than in accordance with Schedule 3 is guilty of an offence.

19(1) When a veterinary medicinal product is brought 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.
 

19(3) A keeper who disposes of any or all of the veterinary medicinal products other than by treating an animal must record –

(a)   the date of disposal;

(b)   the quantity of product involved; and

(c)   how and when it was disposed of.
 

19(4) It is an offence to fail to comply with this regulation.

26(1) It is an offence to be in possession of an unauthorised veterinary medicinal product.

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Administration

8(1) It is an offence to administer a veterinary medicinal product unless –

(a)   the product has a marketing authorisation authorising its administration in the United Kingdom, and the administration is in accordance with that marketing authorisation; or

(b)   it is administered in accordance with Schedule 4 (administration of a veterinary medicinal product outside the terms of a marketing authorisation) or Schedule 6 (exemption for small pet animals).

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).

17(2) It is an offence to fail to comply with this regulation.

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 the product administered;

(e)   the identification of the animals treated; and

(f)     the withdrawal period.

18(2) It is an offence to fail to comply with this regulation.

19(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.

19(4) It is an offence to fail to comply with this regulation.

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 had died during that period.

20(2) It is an offence to fail to comply with this regulation.

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.

24(2) It is an offence to fail to comply with this regulation.

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Importation

9(1) It is an offence to import a veterinary medicinal product authorised for use in the United Kingdom except in accordance with this regulation.

25(1) It is an offence to import an unauthorised veterinary medicinal product except in accordance with this regulation.

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Duties on authorisation holders

4(2) Any person who certifies data in relation to an application for a marketing authorisation or in relation to an existing marketing authorisation and who knows that those data are false, or does not believe that they are accurate, is guilty of an offence.

5(1) The holder of a marketing authorisation must ensure that every stage in the manufacture of the veterinary medicinal product is carried out by the manufacturer specified in the marketing authorisation (who must, if the manufacture if carried out in the United Kingdom, hold a manufacturing authorisation for that type of product granted by the Secretary of State) and failure to do so is an offence.

6. The holder of a marketing authorisation for a veterinary medicinal product is guilty of an offence if either the holder or the manufacturer supplies a product that is not completely in accordance with the marketing 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.
 

21(2) The holder must keep with the record all certification provided by the qualified person (manufacture) in relation to that batch.

21(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.

21(4) It is an offence to fail to comply with this regulation.

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