LegalizeRegulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter
This Regulation lays down rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of veterinary medicinal products.
Article 2
Scope
In addition to the products referred to in paragraph 1 of this Article, Chapter VII shall also apply to:
(a) substances that have anabolic, anti-infectious, antiparasitic, anti-inflammatory, hormonal, narcotic or psychotropic properties and that may be used in animals;
(b) veterinary medicinal products prepared in a pharmacy or by a person permitted to do so under national law, in accordance with a veterinary prescription for an individual animal or a small group of animals (‘magistral formula’);
(c) veterinary medicinal products prepared in a pharmacy in accordance with the directions of a pharmacopoeia and intended to be supplied directly to the end-user (‘officinal formula’). Such officinal formula shall be subject to a veterinary prescription when intended for food-producing animals.
This Regulation shall not apply to:
(a) veterinary medicinal products containing autologous or allogeneic cells or tissues that have not been subjected to an industrial process;
(b) veterinary medicinal products based on radio-active isotopes;
(c) feed additives as defined in point (a) of Article 2(2) of Regulation (EC) No 1831/2003 of the European Parliament and of the Council (1);
(d) veterinary medicinal products intended for research and development;
(e) medicated feed and intermediate products as defined in points (a) and (b) of Article 3(2) of Regulation (EU) 2019/4.
Article 3
Conflict of laws
Article 4
Definitions
For the purposes of this Regulation, the following definitions apply:
(1) ‘veterinary medicinal product’ means any substance or combination of substances which fulfils at least one of the following conditions: (a) it is presented as having properties for treating or preventing disease in animals; (b) its purpose is to be used in, or administered to, animals with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action; (c) its purpose is to be used in animals with a view to making a medical diagnosis; (d) its purpose is to be used for euthanasia of animals;
(2) ‘substance’ means any matter of the following origin: (a) human; (b) animal; (c) vegetable; (d) chemical;
(3) ‘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;
(4) ‘excipient’ means any constituent of a veterinary medicinal product other than an active substance or packaging material;
(5) ‘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;
(6) ‘biological veterinary medicinal product’ means a veterinary medicinal product where an active substance is a biological substance;
(7) ‘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;
(8) ‘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;
(9) ‘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;
(10) ‘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;
(11) ‘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;
(12) ‘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;
(13) ‘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;
(14) ‘antibiotic’ means any substance with a direct action on bacteria that is used for treatment or prevention of infections or infectious diseases;
(15) ‘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;
(16) ‘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;
(17) ‘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;
(18) ‘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;
(19) ‘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: (a) any risk relating to the quality, safety and efficacy of the veterinary medicinal products as regards animal or human health; (b) any risk of undesirable effects on the environment; (c) any risk relating to the development of resistance;
(20) ‘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;
(21) ‘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;
(22) ‘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;
(23) ‘competent authority’ means an authority designated by a Member State in accordance with Article 137;
(24) ‘labelling’ means information on the immediate packaging or the outer packaging;
(25) ‘immediate packaging’ means the container or any other form of packaging that is in direct contact with the veterinary medicinal product;
(26) ‘outer packaging’ means packaging in which the immediate packaging is placed;
(27) ‘package leaflet’ means a documentation leaflet on a veterinary medicinal product which contains information to ensure its safe and efficacious use;
(28) ‘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;
(29) ‘limited market’ means a market for one of the following medicinal product types: (a) veterinary medicinal products for the treatment or prevention of diseases that occur infrequently or in limited geographical areas; (b) veterinary medicinal products for animal species other than cattle, sheep for meat production, pigs, chickens, dogs and cats;
(30) ‘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;
(31) ‘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;
(32) ‘control’ means any task performed by a competent authority for the verification of compliance with this Regulation;
(33) ‘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;
(34) ‘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;
(35) ‘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;
(36) ‘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;
(37) ‘aquatic species’ mean species referred to in point (3) of Article 4 of Regulation (EU) 2016/429 of the European Parliament and of the Council (3);
(38) ‘food-producing animals’ mean food-producing animals as defined in point (b) of Article 2 of Regulation (EC) No 470/2009;
(39) ‘variation’ means a change to the terms of the marketing authorisation for a veterinary medicinal product as referred to in Article 36;
(40) ‘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;
(41) ‘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;
(42) ‘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;
(43) ‘novel therapy veterinary medicinal product’ means: (a) a veterinary medicinal product specifically designed for gene therapy, regenerative medicine, tissue engineering, blood product therapy, phage therapy; (b) a veterinary medicinal product issued from nanotechnologies; or (c) any other therapy which is considered as a nascent field in veterinary medicine;
(44) ‘epidemiological unit’ means an epidemiological unit as defined in point (39) of Article 4 of Regulation (EU) 2016/429.
CHAPTER II
MARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS
Section 1
General provisions
Article 5
Marketing authorisations
Article 6
Submission of applications for marketing authorisations
Applications for marketing authorisations shall be submitted to the competent authority where they concern the granting of marketing authorisations in accordance with any of the following procedures:
(a) the national procedure laid down in Articles 46 and 47;
(b) the decentralised procedure laid down in Articles 48 and 49;
(c) the mutual recognition procedure laid down in Articles 51 and 52;
(d) the subsequent recognition procedure laid down in Article 53.
Article 7
Languages
Section 2
Dossier requirements
Article 8
Data to be submitted with the application
An application for a marketing authorisation shall contain the following:
(a) the information set out in Annex I;
(b) technical documentation necessary for demonstrating the quality, safety and efficacy of the veterinary medicinal product in accordance with the requirements set out in Annex II;
(c) a summary of the pharmacovigilance system master file.
Where the application concerns an antimicrobial veterinary medicinal product, the following shall be submitted in addition to the information, technical documentation and summary listed in paragraph 1:
(a) documentation on the direct or indirect risks to public or animal health or to the environment of use of the antimicrobial veterinary medicinal product in animals;
(b) information about risk mitigation measures to limit antimicrobial resistance development related to the use of the veterinary medicinal product.
Where the application concerns a veterinary medicinal product containing or consisting of genetically modified organisms within the meaning of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council (4), the application shall, in addition to the information, technical documentation and summary listed in paragraph 1 of this Article, be accompanied by:
(a) a copy of the written consent of the competent authorities to the deliberate release into the environment of the genetically modified organisms for research and development purposes, as provided for in Part B of Directive 2001/18/EC;
(b) the complete technical file supplying the information required under Annexes III and IV to Directive 2001/18/EC;
(c) the environmental risk assessment in accordance with the principles set out in Annex II to Directive 2001/18/EC; and
(d) the results of any investigations performed for the purposes of research or development.
Section 3
Clinical trials
Article 9
Clinical trials
Section 4
Labelling and package leaflet
Article 10
Labelling of the immediate packaging of veterinary medicinal products
The immediate packaging of a veterinary medicinal product shall contain the following information and shall, subject to Article 11(4), contain no information other than:
(a) the name of the veterinary medicinal product, followed by its strength and pharmaceutical form;
(b) a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names;
(c) the batch number, preceded by the word ‘Lot’;
(d) the name or company name or logo name of the marketing authorisation holder;
(e) the target species;
(f) the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’;
(g) special storage precautions, if any;
(h) route of administration; and
(i) if applicable, the withdrawal period, even if such period is zero.
Article 11
Labelling of the outer packaging of veterinary medicinal products
The outer packaging of a veterinary medicinal product shall contain the following information and shall contain no information other than:
(a) the information referred to in Article 10(1);
(b) the contents by weight, volume or number of immediate packaging units of the veterinary medicinal product;
(c) a warning that the veterinary medicinal product must be kept out of the sight and reach of children;
(d) a warning that the veterinary medicinal product is ‘for animal treatment only’;
(e) without prejudice to Article 14(4), a recommendation to read the package leaflet;
(f) in the case of homeopathic veterinary medicinal products, the statement ‘homeopathic veterinary medicinal product’;
(g) in the case of veterinary medicinal products not subject to a veterinary prescription, the indication or indications;
(h) the marketing authorisation number.
Article 12
Labelling of small immediate packaging units of veterinary medicinal products
By way of derogation from Article 10, immediate packaging units which are too small to contain in a readable form the information referred to in that Article shall contain the following information and shall contain no information other than:
(a) the name of veterinary medicinal product;
(b) the quantitative particulars of the active substances;
(c) the batch number, preceded by the word ‘Lot’;
(d) the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’.
Article 13
Additional information on the immediate packaging or outer packaging of veterinary medicinal products
By way of derogation from Articles 10(1), 11(1) and 12(1), Member States may, within their territory, and on request of the applicant, allow an applicant to include on the immediate packaging or outer packaging of a veterinary medicinal product additional useful information which is compatible with the summary of the product characteristics and which is not an advertisement for a veterinary medicinal product.
Article 14
Package leaflet of veterinary medicinal products
The marketing authorisation holder shall make readily available a package leaflet for each veterinary medicinal product. That package leaflet shall contain at least the following information:
(a) the name or company name and permanent address or registered place of business of the marketing authorisation holder and of the manufacturer and, where applicable, of the representative of the marketing authorisation holder;
(b) the name of the veterinary medicinal product, followed by its strength and pharmaceutical form;
(c) qualitative and quantitative composition of the active substance or substances;
(d) the target species, the dosage for each species, the method and route of administration and, if necessary, advice on correct administration;
(e) the indications for use;
(f) the contra-indications and adverse events;
(g) if applicable, the withdrawal period, even if such period is zero;
(h) special storage precautions, if any;
(i) information essential for safety or health protection, including any special precautions relating to use and any other warnings;
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