(This note is not part of the Regulations)
These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2009.
Implementation of European obligations
These Regulations introduce a new fee-structure for variations to national procedures necessary as a result of the adoption of Commission Regulation (EC) 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products.
They implement Commission Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin.
They also provide for the enforcement of Article 8 of Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed in relation to feedingstuffs containing specified feed additives, and also for the enforcement of Articles 15 and 17 of that Regulation as they refer to the labelling requirements for feedingstuffs containing specified feed additives (regulation 14 and Schedule 5).
Other changes
Otherwise the principal changes made are as follows.
They introduce procedures and a fee for giving formal advice as to whether a product requires a marketing authorisation (regulation 16 and paragraph 53 of Schedule 7).
They introduce a procedure and fee to change the distribution category for products authorised through the centralised procedure (regulation 16 and paragraph 16 of Schedule 7).
They introduce a waiver for fees for variations to remove or reduce animal testing (regulation 16 and paragraph 21 of Schedule 7).
They introduce a below-inflation fee increase for some inspection fees (regulation 16 and Schedule 7).
The Regulations
The Regulations make provision for the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products.
They implement the following EU instruments that are Directives:
Council Directive 90/167 laying down conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community, so far it is not superseded by Regulation (EC) No 183/2005;
Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products; and
Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products.
They provide for the enforcement of the following EU instruments that are Regulations besides those mentioned above:
Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, in so far as it applies to veterinary medicinal products used in feedingstuffs;
Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition, in so far as it applies to veterinary medicinal products used in feedingstuffs;
Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, in so far as it applies to veterinary medicinal products used in feedingstuffs;
Regulation (EC) No 183/2005 of the European Parliament and of the Council laying down requirements for feed hygiene, in so far as it applies to veterinary medicinal products used in feedingstuffs; and
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.
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 they 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 the 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 36 and 38 to 42) and create offences of obstructing a person acting in the execution of these Regulations (regulation 37) and of failing to comply with an improvement notice (regulation 38).
Under regulation 43 breach of the Regulations is an offence punishable—
on summary conviction, by a fine not exceeding the statutory maximum or by imprisonment for a term not exceeding three months or both, or
on conviction on indictment, by a fine or to imprisonment for a term not exceeding two years or both.
Regulation 45 requires the Secretary of State to review the operation and effect of these Regulations, other than regulation 16 and Schedule 7 (which relate to fees), and lay a report before Parliament within five years after they come into force and within every five years after that. Following a review it will fall to the Secretary of State to consider whether the Regulations should remain as they are, or be revoked or be amended. A further instrument would be needed to revoke the Regulations or to amend them.
Regulation 46 contains revocations.
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.defra.gov.uk at “Publications, Veterinary Medicines Regulations and Guidance”.