The Veterinary Medicines Regulations 2009

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2008.

Principal changes to the 2008 Regulations: implementation of European obligations

These Regulations implement—

(a) Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products;

(b) Commission Directive 2009/9/EC amending Directive 2001/82 of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use.

(c) Regulation (EC) No 470/2009 of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin in so far as it amends Directive 2001/82.

They replace references to Council Regulation (EC) No 2377/90 on establishing maximum residue limits for pharmacologically active substances with Regulation (EC) 470/2009 of the European Parliament and of the Council (Regulation (EC) No 470/2009 repeals and replaces Council Regulation (EC) No 2377/90 but the Annexes to Regulation 2377/90 are preserved pending the adoption of a Commission Regulation replacing them).

For horse passports, they now refer to Commission Regulation (EC) No 504/2008 implementing Council Directives 90/426/EEC and 90/427/EEC as regards methods for identification of equidae.

Other changes

Otherwise the principal changes are as follows.

They remove the requirement to publicise a seizure notice in the case of a common carrier who does not own the seized goods (regulation 42).

They create a new type of authorisation (a limited marketing authorisation) (paragraph 26 of Schedule 1).

They create an offence of altering a written prescription without authorisation (paragraph 5 of Schedule 3).

They introduce inflation-only fee increases to all application fees. They introduce a new fee structure for variations to European Marketing Authorisations from 1 January 2010, necessary as a result of the adoption of Commission Regulation 1234/2008, and remove the fees for on line applications for special import certificates, repeat special treatment certificates and Research Import Certificates (Schedule 7).

The Regulations

The Regulations make provision for the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products.

They implement Directive 2001/82/EC.

They enforce Regulations (EC) No 178/2002, No 1831/2003, No 882/2004, No 183/2005, in so far as they apply to veterinary medicinal products used in feedingstuffs, and to some specified feed additives used in feedingstuffs.

They implement Council Directive 90/167 so far it is not superseded 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 rules of 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 and Schedule 3).

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 an appeals procedure in the case of a refusal, etc., of a marketing authorisation (regulation 30).

They create administrative arrangements for the enforcement of the Regulations (regulations 32 to 42).

Under regulation 43 breach of the Regulations is an offence punishable—

(d) on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or both, or

(e) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both.

A full 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”.