ENFORCEMENT
LEGISLATION
AND OFFENCES
Offences under the Veterinary Medicines Regulations 2006
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
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.
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 supplies a medicinal product authorised for human use for administration to an animal (other than in accordance with a prescription from a veterinary surgeon for administration under the cascade) 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 are not in the summary of product characteristics.
10(2) It is an offence to advertise a human medicine for administration to animals (including sending a price list of, or including human medicines to a veterinary surgeon or veterinary practice).
11 (1) It is an offence to advertise veterinary medicinal products that –
(a) are available on veterinary prescription only; or
(b) contain 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 these regulations and Schedule 3.
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.
22(2) He/she must keep the records for at least three years.
22(3) It is an offence to fail to comply with this regulation.
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/she must keep all documents relating to the transaction, which must include –
(a) the date;
(b) the identity of the veterinary medicinal product;
(c) the batch number (except that, in the case of a product for a non-food-producing animal, this only need be recorded either on the date he/she receives the batch or the date he/she starts to use it);
(d) the quantity;
(e) the name and address of the supplier or recipient;
(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 he must make a record of the missing information as soon as it reasonably practicable.
23(3) As an alternative to paragraphs (1) and (2) he/she may make a record of all the information required there provided that he does so as soon as is reasonably practicable.
23(4) He/she must keep the documentation and records 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.
7(4) Any person in possession of a veterinary medicinal product that was supplied to him 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;
(b) the date of acquisition;
(c) the quantity acquired;
(d)
the name and address
of the supplier.
19(3) if he/she disposes of it other than by treating an animal, he/she must record -
(a) the date of disposal;
(b) the quantity of product involved;
(c) how and where he disposed of it.
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.
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).
17 (1) The owner or keeper
of food-producing animals must keep proof of purchase of all veterinary
medicines (or if he did not buy them, documentary evidence of how he/she
aquired them) acquired for those animals.
17(2) It is an offence to fail to comply with this regulation.
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 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;
(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) he [the keeper of the food-producing animal] must record –
(a) the name of the product;
(b) the date of administration;
(c) the quantity administered;
(d) the withdrawal period;
(e)
the identity of the
animals treated.
19(4) It is an offence to fail to comply with this regulation.
20 (1) The keeper [of food-producing animals] must keep the documentation on the acquisition of a veterinary medicinal product and 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 animals concerned are no longer in his possession or have been slaughtered or have 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 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/she 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.
24(2) He/she must keep the record for at least five years.
24(3) It is an offence to fail to comply with this regulation.
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.
31(1) It is an offence to export a veterinary medicinal product for use in another member State unless the veterinary medicinal product may be lawfully supplied or administered in that member State.
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 the finished product supplied by him or the manufacturer 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 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.
21(2) He/she must keep with the record all certification provided by the qualified person (manufacturing) in relation to that batch.
21(3) He/she 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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