The Veterinary Medicines Regulations 2005

UK Statutory Instrument 2005 No. 2745 — creates 44 criminal offences.

44offences created

0recorded in force

44revoked

Made: 6 October 2005
In force from: 30 October 2005
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 make provision for the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products. They revoke and amend the provisions set out in Parts 1 to 3 of Schedule 8, provide transitional provisions in Part 4 of that Schedule, and provide that the Medicines Act 1968 no longer regulates 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 on www.vmd.gov.uk at “Publications, Veterinary Medicines Regulations 2005”. A transposition note has been prepared and is available at www.vmd.gov.uk at “Publications, Veterinary Medicines Regulations 2005”.

Offences created by this instrument

Labelling of feedingstuffs containing specified feed additives paragraph 10(2) of SCHEDULE 5 · Revoked · Strict liability
Supply of sheep dip paragraph 11(1) of SCHEDULE 3 · Revoked · Strict liability
Possession paragraph 15(1) of SCHEDULE 5 · Revoked · Strict liability
Possession paragraph 15(2) of SCHEDULE 5 · Revoked · Strict liability
Authorisation to manufacture autogenous vaccines paragraph 15(5) of SCHEDULE 2 · 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 20(1) of SCHEDULE 5 · Revoked · Strict liability
Possession, placing on the market and use of feedingstuffs paragraph 20(2) of SCHEDULE 5 · Revoked · Strict liability
Prescriptions for feedingstuffs containing a veterinary medicinal product paragraph 21(1) of SCHEDULE 5 · Revoked · Strict liability
Authorisation of blood banks paragraph 21(6) of SCHEDULE 2 · Revoked · Strict liability
Imports from third countries paragraph 22 of SCHEDULE 5 · 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
Suspension, etc., of a marketing authorisation paragraph 38(4) of SCHEDULE 1 · Revoked · Strict liability
Prohibiting the supply of veterinary medicinal products paragraph 40(1) of SCHEDULE 1 · Revoked · Strict liability
Records paragraph 5 of SCHEDULE 8 · Revoked · Strict liability
Prescriptions paragraph 5(1) of SCHEDULE 3 · Revoked · Strict liability
Prescriptions paragraph 5(2) of SCHEDULE 3 · Revoked · Strict liability
Enforcement of Regulation (EC) No. 183/2005 paragraph 5(2) of SCHEDULE 5 · Revoked · Strict liability
Enforcement of Regulation (EC) No. 183/2005 paragraph 5(4) of SCHEDULE 5 · Revoked · Objective fault
Administration by veterinary surgeons from other member States paragraph 6(3) of SCHEDULE 4 · Revoked · Strict liability
A label on a premixture containing a veterinary medicinal product must contain the information required under Article… paragraph 9 of SCHEDULE 5 · Revoked · Strict liability
Advertising the product regulation 10(1) · Revoked · Strict liability
Advertising the product regulation 10(2) · Revoked · Strict liability
Advertising of prescription products and products with psychotropic drugs or narcotics 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(1) · 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
Administration of the product regulation 8(2) · 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.

Scotland Act 1998 (Transfer of Functions to the Scottish Ministers etc.) Order 2006 Lords · Lords Chamber · 25 January 2006 · Lord Evans of Temple Guiting
My Lords, the first order before us this evening is the draft Scotland Act 1998 (Transfer of Functions to the Scottish Ministers etc.) Order 2006. The order is being made under section 63 of the Scotland Act 1998, which gives the power to Her Majesty, by Order in Council, to, "provide for any functions, so far as they are exercisable", by, "a Minister of the Crown in or as regards Scotland, to be exercisable... by the Scottish Ministers instead of", or, "concurrently with the Minister of the Crown, or... by the Minister of the Crown... after consultation with... the Scottish Ministers". That…
Scotland Act 1998 (Transfer of Functions to the Scottish Ministers etc.) Order 2006 Lords · Lords Chamber · 25 January 2006 · The Duke of Montrose
My Lords, I thank the Minister most warmly for the way in which he has introduced the measure and for the trouble that he has taken to include us in the thinking that has gone on behind it. The order to transfer functions to the Scottish Ministers piqued my curiosity because it contains a power to devolve Section 26 of the Fire Services Act 1947. The note attached to the Schedule says, as the Minister explained, that it concerns firefighters' pensions. It was only on 22 March 2005 that we passed a Statutory Instrument devolving functions in regard to firefighters' pensions, in so far as…
Department for Environment, Food and Rural Affairs: Regulations Lords · Lords Chamber · 18 June 2007 · Lord Rooker
My Lords, I shall look again at the Question for Written Answer. I did not realise that there had been a problem. There is no difficulty finding the answer. Some of the 846 statutory instruments are general operating instruments governing things such as fees. Some actually abolish dozens of statutory instruments. For example, the Veterinary Medicines Regulations 2005 abolished and repealed 49 separate statutory instruments. There is no difficulty getting the information.
Scotland Act 1998 (Modification of Schedule 5) Order 2014 Lords · Grand Committee · 7 May 2014 · The Advocate-General for Scotland (Lord Wallace of Tankerness) (LD)
My Lords, I shall provide a brief summary of what this draft order, which was laid before the House on 17 March 2014, seeks to achieve. The order is made under Section 30(2) of the Scotland Act 1998, which provides a mechanism whereby Schedule 4 or Schedule 5 to that Act can be modified by an Order in Council, subject to the agreement of both the UK Parliament and the Scottish Parliament. This order will amend Schedule 5 to the Scotland Act 1998, which I shall refer to as the 1998 Act, to update the definition of “food” in that Act. It will also amend Section J4 of Schedule 5 to the 1998 Act…

How Parliament handled it

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