- active substance
means any substance or mixture of substances intended to be used in the manufacture of a veterinary medicinal product, that, when used in its production, is responsible for the activity of that veterinary medicinal product;
- adverse environmental event
means an event where a non-target organism, population or ecosystem is adversely affected as a result of exposure to a veterinary medicinal product, its active substances or its metabolites present in soil, water or animal remains;
- adverse event
means any observation in animals that occurs after any use of a veterinary medicinal product, whether or not considered to be product-related, that is unfavourable and unintended;
- advertising
means, in relation to veterinary medicinal products, the making of a representation in any form in connection with those products in order to promote their supply, distribution, sale, prescription or use and includes any action taken for this purpose by way of the supply of samples or by means of sponsorship, and “advertise” and “advertisement” are to be construed accordingly;
- animal
means all animals other than man and includes birds, reptiles, fish, molluscs, crustacea and bees;
- animal keeper
means any natural or legal person responsible for animals, whether on a permanent or a temporary basis;
- antibiotic
means any substance with a direct action on bacteria that is used for treatment or prevention of infections or infectious diseases;
- antimicrobial
means any substance with a direct action on micro-organisms that is used for treatment or prevention of infections or infectious diseases and includes antibiotics, antivirals, antifungals and antiprotozoals;
- antimicrobial resistance
means the ability of micro-organisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to inhibit or kill micro-organisms of the same species;
- batch
means an identifiable quantity of feed determined to have common characteristics whether in relation to origin, variety, type of packaging, packer, consignor or labelling and, in the case of a production process, a unit of production from a single plant using uniform production parameters or a number of such units when produced in continuous order and stored together;
- benefit-risk balance
means, in relation to a veterinary medicinal product, an evaluation of the positive effects of the veterinary medicinal product in relation to the following risks relating to the use of that product— (a) any risk to human or animal health relating to the quality, safety or efficacy of the veterinary medicinal product;
- biological substance
means a substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physical, chemical and biological testing, together with knowledge of the production process and its control;
- biological veterinary medicinal product
means a veterinary medicinal product where an active substance is a biological substance;
- closed bag system
means a system in which the blood pack assembly is manufactured under clean conditions, sealed to the external environment and sterilised.
- complementary feedingstuffs
means compound feed which has a high content of certain substances and which, by reason of its composition, is sufficient for a daily ration only if used in combination with other feed;
- complete feed
means compound feed which, by reason of its composition, is sufficient for a daily ration;
- compound feed
means a mixture of at least two feed additives for oral animal-feeding in the form of complete or complementary feed;
- converted EU marketing authorisation
means an EU marketing authorisation to which paragraph 2 applies;
- cross-contamination
means contamination of a non-target feed with an active substance originating from the previous use of the relevant facilities or equipment;
- daily ration
means the average total quantity of feedingstuffs, calculated on a moisture content of 12%, required daily by an animal of a given species, age category and yield, to satisfy all its nutritional needs;
- distributor
means a feed business operator distributing specified feed additives, intermediate feedingstuff or complete feed containing specified feed additives, or intermediate feedingstuff or complete feed containing medicinal premixes;
- excipient
means any constituent of a veterinary medicinal product other than an active substance;
- feed additives
means substances, micro-organisms or preparations, other than feed material and intermediate feedingstuff, which are intentionally added to feed or water in order to perform, in particular, one or more of the functions mentioned in Schedule 5;
- feed business
means any undertaking whether for profit or not and whether public or private, carrying out any operation of production, manufacture, processing, storage, transport or distribution of feed including any producer producing, processing or storing feed for feeding to animals on their own holding;
- feed business operator
means any person responsible for ensuring that the requirements of this Schedule are met within the feed business under that person’s control;
- feed materials
means products of vegetable or animal origin whose principal purpose is to meet animals’ nutritional needs, and which are intended for use in oral animal feed either directly, or after processing, or in the preparation of compound feed, or as a carrier of intermediate feedingstuffs;
- feedingstuff
means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals;
- generic veterinary medicinal product
means a veterinary medicinal product which has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as a reference veterinary medicinal product;
- GMO
means a genetically modified organism for the purposes of the GMO Deliberate Release Regulations;
- good distribution practice
means that part of quality assurance which ensures that products are consistently stored, supplied and controlled in accordance with the quality standards appropriate for their intended use and as required by the applicable marketing authorisation or product specifications;
- good manufacturing practice
means that part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use and as required by the applicable marketing authorisation or product specifications;
- horse passport
means (EC) No 504/200890/426/EEC90/427/EECan identification document which complies with Commission Implementing Regulation (EU) 2015/262 laying down rules pursuant to Council Directives 90/427/EEC and 2009/156/EC as regards the methods for the identification of equidae;
- human adverse event
means a reaction that is noxious and unintended and that occurs in a human being following exposure to a veterinary medicinal product;
- hybrid
means an application to which paragraph 10A of Schedule 1 applies.
- immunological veterinary medicinal product
means a veterinary medicinal product intended to be administered to an animal in order to produce active or passive immunity or to diagnose its state of immunity;
- improvement notice
has the meaning given in regulation 38(1);
- information
includes any information contained in advertising material.
- inspector
means an inspector appointed under this regulation or a veterinary inspector appointed under the Animal Health Act 1981.
- intermediate feedingstuffs
means a feed which is not ready to be directly fed to animals without further processing, consisting of a homogenous mixture of one or more of the following— (a) a medicinal premix;
- lack of efficacy
means the apparent inability of an authorised veterinary medicinal product to have the expected efficacy in an animal, whether or not the product was used in accordance with the summary of product characteristics;
- large marketing authorisation holder
means a marketing authorisation holder who holds 30 or more marketing authorisations;
- limited market
means a market for one of the following types of veterinary medicinal product— (a) a veterinary medicinal product for the treatment or prevention of diseases that occur infrequently or in limited geographical areas;
- major species
means cattle, sheep (for meat production), pigs, chickens, dogs and cats.
- manufacturing authorisation
means the following activities—
- medicated feedingstuffs
means a feed which is ready to be directly fed to animals without any further processing, consisting of a homogenous mixture of one or more medicinal premixes or intermediate feedingstuff with feed materials or compound feed;
- medicinal premix
means a veterinary medicinal product authorised for incorporation into feedingstuffs;
- mixed practice
means premises supplying veterinary medicinal products to livestock in addition to any other category mentioned in that provision.
- non-target feed
means feed, whether medicated or not which is not intended to contain a specific active substance;
- Northern Ireland VMRs
means the Veterinary Medicines Regulations 2013 as they have effect in Northern Ireland.
- novel therapy
means a veterinary medicinal product which is considered to be in a nascent field in veterinary medicine, including a product of a type not previously authorised, and “novel therapies” is to be construed accordingly;
- pharmaceutical product
means any veterinary medicinal product other than an immunological product or a biological veterinary medicinal product that is not immunological;
- pharmacologically equivalent
means containing an active substance in the same proportions, in the same dosage form and concentration (in the case of a liquid dose) and meeting the same or comparable standards in relation to the clinical needs of a patient at the time of use;
- pharmacovigilance
means the science and activities relating to the detection, assessment, understanding and prevention of suspected adverse events or any other problem related to a medicinal product;
- pharmacovigilance system master file
means a detailed description of the pharmacovigilance system used by the holder of the marketing authorisation in relation to one or more authorised veterinary medicinal products;
- premises
includes any place, vehicle, trailer, container, stall, moveable structure, ship or aircraft.
- principles of good laboratory practice
has the meaning given in regulation 2(1) of the Good Laboratory Practice Regulations 1999;
- qualified person (pharmacovigilance)
has the meaning given in paragraph 56(9) of Schedule 1;
- qualifying Northern Ireland goods
has the meaning given to it from time to time in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;
- reference veterinary medicinal product
has the meaning given in paragraph 10(1) of Schedule 1;
- Regulation (EC) No 178/2002
means 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;
- Regulation (EC) No 183/2005
means Regulation (EC) No 183/2005 of the European Parliament and of the Council laying down requirements for feed hygiene;
- Regulation (EC) No 1831/2003
means Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition;
- Regulation (EC) No 470/2009 of the European Parliament and of the Council
means 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;
- Regulation (EC) No 767/2009 of the European Parliament and of the Council
means 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, as last amended by Regulation (EU) No 2017/2279;
- Regulation (EU) 2017/625
means Regulation (EU) 2017/625 of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products;
- relevant person
means a person employed on the premises and systems inspected.
- relevant substance
means—
- retail supply
means a supply whether or not for payment to the owner or keeper of an animal for administration to that animal;
- review period
means the period of five years ending on 31st December 2028, and, subject to paragraph (6), each successive period of five years thereafter;
- serious adverse event
means an adverse reaction that results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly or birth defect, or that results in permanent or prolonged signs in the animals treated;
- signal management process
has the meaning given in paragraph 56C of Schedule 1;
- small marketing authorisation holder
means a marketing authorisation holder who holds fewer than 30 marketing authorisations.
- strength
means the content of active substances in a veterinary medicinal product, expressed quantitatively per dosage unit, per unit of volume or per unit of weight according to the pharmaceutical form;
- the cascade
has the meaning given in paragraph 1 of Schedule 4;
- the fees provisions
means regulation 16 and Schedule 7.
- turnover
means the sales value at manufacturers’ prices of all authorised veterinary medicinal products sold or supplied in the United Kingdom;
- veterinary medicinal product
means—
- wholesale dealing
means all activities consisting of procuring, holding, supplying, distributing or exporting veterinary medicinal products whether for profit or not, but does not include retail supply of veterinary medicinal products to the public;
- wholesale qualified person
has the meaning given in paragraph 17(2)(d) of Schedule 3;
- withdrawal period
means the minimum period under normal conditions of use between the last administration of a veterinary medicinal product to an animal and the production of foodstuffs from that animal which is necessary to ensure that such foodstuffs do not contain residues in quantities harmful to public health
- zootechnical additive
means any additive used to maintain animals in good health or favourably affect their performance.