- 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, becomes an active ingredient of that product;
- advertising of veterinary medicinal products
means the making of a representation in any form in connection with veterinary medicinal products in order to promote the supply, distribution, sale, prescription or use of veterinary medicinal products and comprising also the supply of samples and sponsorships;
- 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 used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals, antifungals and anti-protozoals;
- 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;
- antiparasitic
means a substance that kills or interrupts the development of parasites, used for the purpose of treating or preventing an infection, infestation or disease caused or transmitted by parasites, including substances with a repelling activity;
- benefit-risk balance
means an evaluation of the positive effects of the veterinary medicinal product in relation to the following risks relating to the use of that 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 physico-chemical-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;
- clinical trial
means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a marketing authorisation or a change thereof;
- common name
means the international non-proprietary name recommended by the World Health Organization (WHO) for a substance or, if one does not exist, the name generally used;
- competent authority
means an authority designated by a Member State in accordance with Article 137;
- control
means any task performed by a competent authority for the verification of compliance with this Regulation;
- epidemiological unit
means an epidemiological unit as defined in point (39) of Article 4 of Regulation (EU) 2016/429.
- excipient
means any constituent of a veterinary medicinal product other than an active substance or packaging material;
- 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 the reference veterinary medicinal product, and with regard to which bioequivalence with the reference veterinary medicinal product has been demonstrated;
- homeopathic veterinary medicinal product
means a veterinary medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States;
- immediate packaging
means the container or any other form of packaging that is in direct contact with the veterinary medicinal product;
- 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;
- isolated intermediate
shall mean partly processed material that may be stored for a defined amount of time and that shall undergo further processing step(s) before it becomes finished product.
- labelling
means information on the immediate packaging or the outer packaging;
- letter of access
means an original document, signed by the data owner or its representative, which states that the data may be used for the benefit of the applicant in relation to the competent authorities, the European Medicines Agency established by Regulation (EC) No 726/2004 (‘the Agency’) or the Commission for the purposes of this Regulation;
- limited market
means a market for one of the following medicinal product types:
- metaphylaxis
means the administration of a medicinal product to a group of animals after a diagnosis of clinical disease in part of the group has been established, with the aim of treating the clinically sick animals and controlling the spread of the disease to animals in close contact and at risk and which may already be subclinically infected;
- name of the veterinary medicinal product
means either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder;
- novel therapy veterinary medicinal product
means:
- outer packaging
means packaging in which the immediate packaging is placed;
- package leaflet
means a documentation leaflet on a veterinary medicinal product which contains information to ensure its safe and efficacious 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 marketing authorisation holder with respect to one or more authorised veterinary medicinal products;
- placing on the market
means the first making available of a veterinary medicinal product on the whole of the Union market or in one or more Member States, as applicable;
- potential serious risk to human or animal health or to the environment
means a situation where there is a significantly high probability that a serious hazard resulting from the use of a veterinary medicinal product will affect human or animal health or the environment;
- pre-clinical study
means a study not covered by the definition of clinical trial which aims to investigate the safety or efficacy of a veterinary medicinal product for the purpose of obtaining a marketing authorisation or a change thereof;
- prophylaxis
means the administration of a medicinal product to an animal or group of animals before clinical signs of a disease, in order to prevent the occurrence of disease or infection;
- reference veterinary medicinal product
means a veterinary medicinal product authorised in accordance with Article 44, 47, 49, 52, 53 or 54 as referred to in Article 5(1) on the basis of an application submitted in accordance with Article 8;
- signal management process
means a process for performing active surveillance of pharmacovigilance data for veterinary medicinal products in order to assess the pharmacovigilance data and determine whether there is any change to the benefit-risk balance of those veterinary medicinal products, with a view to detecting risks to animal or public health or protection of the environment;
- starting materials
means all components, including the active substances used in the production of the biological veterinary medicinal product.
- 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;
- substance
means any matter of the following origin:
- variation
means a change to the terms of the marketing authorisation for a veterinary medicinal product as referred to in Article 36;
- veterinary medicinal product
means any substance or combination of substances which fulfils at least one of the following conditions:
- veterinary prescription
means a document issued by a veterinarian for a veterinary medicinal product or a medicinal product for human use for its use in animals;
- wholesale distribution
means all activities consisting of procuring, holding, supplying or exporting veterinary medicinal products whether for profit or not, apart from retail supply of veterinary medicinal products to the public;
- withdrawal period
means the minimum period between the last administration of a veterinary medicinal product to an animal and the production of foodstuffs from that animal which under normal conditions of use is necessary to ensure that such foodstuffs do not contain residues in quantities harmful to public health;