The Veterinary Medicines Regulations 2006

UK Statutory Instrument 2006 No. 2407 — creates 50 criminal offences.

50offences created

0recorded in force

50revoked

Made: 5 September 2006
In force from: 1 October 2006
Extent: Not stated
Subject: Drugs and medicines
Made under: (EC) No. 178/2002, European Communities Act 1972, Finance Act 1973, In accordance with section 56(1) of the Finance Act 1973, Regulations under section 2(2) of the European Communities Act 1972

Explanatory note

(This note is not part of the Regulations) — published with the instrument by the department that made it. © Crown copyright, reused under the Open Government Licence v3.0.

These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2005. They also amend the Medicines Act 1968, the Medicines Act 1971 and associated legislation so that they no longer apply to veterinary medicinal products. The principal changes to the 2005 Regulations are as follows. The Regulations re-introduce requirements for recording specific batches of veterinary medicinal products administered to food-producing animals (regulations 18 and 19). They introduce provisions for the approval of a manufacturer of a veterinary medicine for administration under the cascade (Part 4 of Schedule 2). They clarify the existing regulations in respect of retail supply by veterinary surgeons, pharmacists and suitably qualified persons (Part 1 of Schedule 3). They re-introduce requirements in respect of labelling veterinary medicinal products at the time of retail supply to avoid essential safety warnings and other information being obscured (Schedule 3 paragraph 11). They extend the requirement to hold a Certificate of Competence from those purchasing a product to those who are engaged in dipping sheep (Part 3 of Schedule 3). They introduce a provision that the incorporation of veterinary medicinal products into feed for animals for domestic consumption or non-food animals no longer requires approval (Schedule 5 paragraph 6). They change the way that fees are charged for a marketing authorisation to reflect more accurately the work involved in any individual application (Schedule 7). The Regulations make provision for the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products. They implement Directive 2001/82/EC of the European Parliament and of the Council on the Community Code relating to veterinary medicinal products (OJ No. L311, 28.11.2001, p. 1), as amended by Directive 2004/28/EC (OJ No. L136, 30.4.2004, p. 58). They also identify the competent authority for, and provide for enforcement of, Regulations (EC) No. 178/2002 (OJ No. L31, 1.2.2002, p. 1), (EC) No. 1831/2003 (OJ No. L268, 18.10.2003, p. 29), (EC) No. 882/2004 (corrected version at OJ No. L191, 28.5.2004, p. 1) and (EC) No. 183/2005 (OJ No. L35, 8.2.2005, p. 1), in so far as they apply to veterinary medicinal products used in feedingstuffs, and to the following additives used in feedingstuffs: a coccidiostats; b histomonostats; c all other zootechnical additives except— i digestibility enhancers; ii gut flora stabilisers; and iii substances incorporated with the intention of favourably affecting the environment. In addition they implement Council Directive 90/167 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community (OJ No. L92, 7.4.90, p. 42) so far as they are not rendered spent by Regulation (EC) No. 183/2005. They provide that a veterinary medicinal product must have a marketing authorisation granted by the Secretary of State before being placed on the market, and make provision for the grant of a marketing authorisation (regulation 4 and Schedule 1). They specify that a veterinary medicinal product must be manufactured by a person holding a manufacturing authorisation, and make provision for granting an authorisation (regulation 5 and Schedule 2). They regulate supply and possession of veterinary medicinal products, and introduce new classifications of those products (regulation 7 and Schedule 3). They provide that a veterinary medicinal product may only be administered as specified in its marketing authorisation or, in the case of administration by a veterinary surgeon, administration under the “cascade” (regulation 8 and Schedule 4). They control bringing a veterinary medicinal product into the United Kingdom (regulation 9) and advertising (regulation 10 to 12). They control wholesale dealing (regulation 13). They control medicated feedingstuffs and feedingstuffs containing additives specified in the Regulations (regulation 14 and Schedule 5). They provide for exemptions (regulation 15 and Schedule 6). They provide for fees (regulation 16 and Schedule 7). They require records to be kept (regulations 17 to 24). They create offences of importation, possession and supply of unauthorised veterinary medicinal products (regulations 25 to 27). They make provision for the existence of the Veterinary Products Committee (regulation 28). They make provision for a representations procedure in the case of a refusal, etc., of a marketing authorisation (regulation 29). They create administrative arrangements for the enforcement of the Regulations (regulations 32 to 41). Under regulation 42 breach of the Regulations is an offence punishable— a on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or both, or b on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both. A Regulatory Impact Assessment has been prepared and placed in the libraries of both Houses of Parliament. It is available, together with a transposition note and a table showing fee changes, on www.vmd.gov.uk at “Publications, Veterinary Medicines Regulations and Guidance, new legislative developments”.

Offences created by this instrument

Labelling a premixture containing a veterinary medicinal product paragraph 10(3) of SCHEDULE 5 · Revoked · Strict liability
Labelling at the time of retail supply paragraph 11(1) of SCHEDULE 3 · Revoked · Strict liability
Labelling of feedingstuffs containing a specified feed additive paragraph 11(2) of SCHEDULE 5 · Revoked · Strict liability
Labelling at the time of retail supply paragraph 11(3) of SCHEDULE 3 · Revoked · Strict liability
Labelling of feedingstuffs containing a veterinary medicinal product paragraph 12(2) of SCHEDULE 5 · Revoked · Strict liability
Supply by a suitably qualified person paragraph 13(6) of SCHEDULE 3 · Revoked · Strict liability
Authorisation to manufacture autogenous vaccines paragraph 15(5) of SCHEDULE 2 · Revoked · Strict liability
Possession paragraph 16(1) of SCHEDULE 5 · Revoked · Strict liability
Possession paragraph 16(2) of SCHEDULE 5 · Revoked · Strict liability
Enforcement of Regulation (EC) No. 178/2002 paragraph 2(2) of SCHEDULE 5 · Revoked · Strict liability
Possession, placing on the market and use of feedingstuffs paragraph 21(1) of SCHEDULE 5 · Revoked · Strict liability
Possession, placing on the market and use of feedingstuffs paragraph 21(2) of SCHEDULE 5 · Revoked · Strict liability
Authorisation of blood banks paragraph 21(6) of SCHEDULE 2 · Revoked · Strict liability
Supply of sheep dip paragraph 22(1) of SCHEDULE 3 · Revoked · Strict liability
Imports from third countries paragraph 23 of SCHEDULE 5 · Revoked · Strict liability
Use of sheep dip paragraph 23(1) of SCHEDULE 3 · Revoked · Strict liability
Authorisation to manufacture products for administration under the cascade paragraph 26(6) of SCHEDULE 2 · Revoked · Strict liability
Provisions of samples and expertise paragraph 27(3) of SCHEDULE 1 · Revoked · Strict liability
Duties on the holder of a marketing authorisation relating to an immunological product paragraph 29(2) of SCHEDULE 1 · Revoked · Strict liability
Enforcement of Regulation (EC) No. 1831/2003 paragraph 3(3) of SCHEDULE 5 · Revoked · Strict liability
Enforcement of Regulation (EC) No. 1831/2003 paragraph 3(4) of SCHEDULE 5 · Revoked · Strict liability
Suspension, etc. of a marketing authorisation paragraph 38(4) of SCHEDULE 1 · Revoked · Strict liability
Prescriptions by a veterinary surgeon paragraph 4 of SCHEDULE 3 · Revoked · Strict liability
Prohibiting the supply of veterinary medicinal products paragraph 40(1) of SCHEDULE 1 · Revoked · Strict liability
Enforcement of Regulation (EC) No. 183/2005 paragraph 5(2) of SCHEDULE 5 · Revoked · Strict liability
Administration by veterinary surgeons from other member States paragraph 5(3) of SCHEDULE 4 · Revoked · Strict liability
Enforcement of Regulation (EC) No. 183/2005 paragraph 5(3) of SCHEDULE 5 · Revoked · Objective fault
Administration by veterinary surgeons from other member States paragraph 5(3)(b) of SCHEDULE 4 · Revoked · Strict liability
It is an offence to incorporate a veterinary medicinal product into a premixture or feedingstuffs, or to act as a… paragraph 6(1) of SCHEDULE 5 · Revoked · Strict liability
A manufacturer must ensure that, so far as is reasonably practicable, the veterinary medicinal product is evenly… paragraph 6(4) of SCHEDULE 5 · Revoked · Objective fault
Advertising the product regulation 10(1) · Revoked · Strict liability
Advertising the product regulation 10(2) · Revoked · Strict liability
It is an offence to advertise a veterinary medicinal product that— a is available on veterinary prescription only; or… regulation 11(1) · Revoked · Strict liability
Wholesale dealing regulation 13 · Revoked · Strict liability
Food-producing animals: proof of purchase of veterinary medicinal products regulation 17(2) · Revoked · Strict liability
Importation of an unauthorised veterinary medicinal product regulation 25(1) · Revoked · Strict liability
Possession of an unauthorised veterinary medicinal product regulation 26(1) · Revoked · Strict liability
Supply of an unauthorised veterinary medicinal product regulation 27(1) · Revoked · Strict liability
Obstruction regulation 36 · Revoked · Requires proof of a state of mind
Improvement notices regulation 37(2) · Revoked · Strict liability
Placing a veterinary medicinal product on the market regulation 4(1) · Revoked · Strict liability
Placing a veterinary medicinal product on the market regulation 4(2) · Revoked · Requires proof of a state of mind
Seizure notices regulation 40(3) · Revoked · Strict liability
Manufacture of veterinary medicinal products regulation 5(1) · Revoked · Strict liability
The finished product regulation 6 · Revoked · Strict liability
Classification, supply and possession of the product regulation 7(2) · Revoked · Strict liability
Classification, supply and possession of the product regulation 7(3) · Revoked · Strict liability
Classification, supply and possession of the product regulation 7(4) · Revoked · Strict liability
Administration of the product regulation 8(1) · Revoked · Strict liability
Importation of authorised veterinary medicinal products regulation 9(1) · Revoked · Strict liability

What Parliament said about it

Contributions, debates and written statements mentioning this instrument by name. Parliamentary material is reused under the Open Parliament Licence v3.0.

Organophosphate Sheep Dip Commons · Westminster Hall · 10 June 2015 · George Eustice
The 1991 report—it is important to recognise that that report was published at the time—was a survey of farmers who self-reported symptoms. We should bear two things in mind. First, it was not a scientific report; all the reports that the Committee on Toxicity has looked at are scientifically robust research projects. The other thing to note is that the focus of the 1991 report was whether farmers had the correct protective equipment to prevent acute poisoning. We must make a distinction between actual poisoning—organophosphates are poisonous substances that cause tetanus-like symptoms if…

How Parliament handled it

Parliament's Statutory Instruments service records procedure from May 2017 onwards, and this instrument predates it. That is a limit of the source, not a statement that nothing happened.

Check the source

This instrument on legislation.gov.uk The authoritative text, including amendments made since
Other instruments from 2006