Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products
Modified by
Directive 2004/28/EC of the European Parliament and of the Councilof 31 March 2004amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products, 32004L0028, April 30, 2004
Commission Directive 2009/9/ECof 10 February 2009amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use(Text with EEA relevance), 32009L0009, February 14, 2009
Regulation (EC) No 470/2009 of the European Parliament and of the Councilof 6 May 2009laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council(Text with EEA relevance), 32009R0470, June 16, 2009
Directive 2009/53/EC of the European Parliament and of the Councilof 18 June 2009amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products(Text with EEA relevance), 32009L0053, June 30, 2009
Regulation (EC) No 596/2009 of the European Parliament and of the Councilof 18 June 2009adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutinyAdaptation to the regulatory procedure with scrutiny — Part FourCorrigendum to Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four(Official Journal of the European Union L 188 of 18 July 2009), 32009R059632009R0596R(01), July 18, 2009
Regulation (EU) 2019/6 of the European Parliament and of the Councilof 11 December 2018on veterinary medicinal products and repealing Directive 2001/82/EC(Text with EEA relevance), 32019R0006, January 7, 2019
Corrected by
Corrigendum to Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four, 32009R0596R(01), March 24, 2012
Directive 2001/82/EC of the European Parliament and of the Councilof 6 November 2001on the Community code relating to veterinary medicinal productsTITLE IDEFINITIONSArticle 1For the purposes of this Directive, the following terms shall bear the following meanings:1.Proprietary medicinal productAny ready-prepared medicinal product placed on the market under a special name and in a special pack.2.Veterinary medicinal product(a)any substance or combination of substances presented as having properties for treating or preventing disease in animals; or(b)any substance or combination of substances which may be used in or administered to animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.3.Ready-made veterinary medicinal productAny veterinary medicinal product prepared in advance which does not comply with the definition of proprietary medicinal products and which is marketed in a pharmaceutical form which may be used without further processing.4.SubstanceAny matter irrespective of origin which may be:human, e.g.human blood and human blood products;animal, e.g.micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products;vegetable, e.g.micro-organisms, plants, parts of plants, vegetable secretions, extracts;chemical, e.g.elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.5.Pre-mix for medicated feedingstuffsAny veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feedingstuffs.6.Medicated feedingstuffsAny mixture of a veterinary medicinal product or products and feed or feeds which is ready prepared for marketing and intended to be fed to animals without further processing, because of its curative or preventive properties or other properties as a medicinal product covered by point 2.7.Immunological veterinary medicinal productA veterinary medicinal product administered to animals in order to produce active or passive immunity or to diagnose the state of immunity.8.Homeopathic veterinary medicinal productAny veterinary medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in Member States. A homeopathic veterinary medicinal product may contain a number of principles.9.Withdrawal periodThe period necessary between the last administration of the veterinary medicinal product to animals, under normal conditions of use and in accordance with the provisions of this Directive, and the production of foodstuffs from such animals, in order to protect public health by ensuring that such foodstuffs do not contain residues in quantities in excess of the maximum residue limits for active substances laid down pursuant to Regulation (EEC) No 2377/90.10.Adverse reactionA reaction to a veterinary medicinal product which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function.11.Human adverse reactionA reaction which is noxious and unintended and which occurs in a human being following exposure to a veterinary medicine.12.Serious adverse reactionAn adverse reaction which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or which results in permanent or prolonged signs in the animals treated.13.Unexpected adverse reactionAn adverse reaction, the nature, severity or outcome of which is not consistent with the summary of the product characteristics.14.Periodic safety update reportsThe periodical reports containing the records referred to in Article 75.15.Post-marketing surveillance studiesPharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorization, conducted with the aim of identifying and investigating a safety hazard relating to an authorized veterinary medicinal product.16.Off-label useThe use of a veterinary medicinal product that is not in accordance with the summary of the product characteristics, including the misuse and serious abuse of the product.17.Wholesale dealing in veterinary medicinal productsAny activity which includes the purchase, sale, import, export, or any other commercial transaction in veterinary medicinal products, whether or not for profit, except for:the supply by a manufacturer of veterinary medicinal products manufactured by himself,retail supplies of veterinary medicinal products by persons entitled to carry out such supplies in accordance with Article 66.17a.Representative of the marketing authorisation holderThe person, commonly known as local representative, designated by the marketing authorisation holder to represent him in the Member State concerned.18.AgencyThe European Medicines Agency established by Regulation (EC) No 726/2004OJ L 136, 30.4.2004, p. 1..19.Risks relating to use of the productany risk relating to the quality, safety and efficacy of the veterinary medicinal products as regards animal or human health;any risk of undesirable effects on the environment.20.Risk/benefit balanceAn evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to the risks as defined above.21.Veterinary prescriptionAny prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law.22.Name of veterinary medicinal productThe name, which may be 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.23.Common nameThe international non-proprietary name recommended by the World Health Organisation, or, if one does not exist, the usual common name.24.StrengthThe content of active substances, expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form.25.Immediate packagingThe container or any other form of packaging that is in direct contact with the medicinal product.26.Outer packagingThe packaging into which is placed the immediate packaging.27.LabellingInformation on the immediate or outer packaging.28.Package leafletThe leaflet containing information for the user that accompanies the medicinal product.