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Regulation (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)

Type Regulation

Publication 2018-12-11

Last updated 2022-01-28

State In force

Department Council of the European Union, European Parliament

Source EUR-Lex

articles 160

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REGULATION (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;

(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;

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;

(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;

(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;

(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;

(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;

(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;

(j) information on the collection systems referred to in Article 117 applicable to the veterinary medicinal product concerned;

(k) the marketing authorisation number;

(l) contact details of the marketing authorisation holder or its representative, as appropriate, for the reporting of suspected adverse events;

(m) classification of the veterinary medicinal product as referred to in Article 34.

Article 15

General requirement regarding product information

The information listed in Articles 10 to 14 shall comply with the summary of the product characteristics as set out in Article 35.

Article 16

Package leaflet of registered homeopathic veterinary medicinal products

By way of derogation from Article 14(1), the package leaflet of homeopathic veterinary medicinal products registered in accordance with Article 86 shall contain at least the following information:

(a) the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the European Pharmacopoeia or, in the absence thereof, of the pharmacopoeias used officially in Member States;

(b) name or company name and permanent address or registered place of business of the registration holder and, where appropriate, of the manufacturer;

(d) pharmaceutical form;

(e) special storage precautions, if any;

(f) the target species and, where appropriate, dosage for each such species;

(g) a special warning, if necessary, for the homeopathic veterinary medicinal product;

(h) registration number;

(i) withdrawal period, if applicable;

(j) the statement ‘homeopathic veterinary medicinal product’.

Article 17

Implementing powers with respect to this Section

Section 5

Article 18

Generic veterinary medicinal products

By way of derogation from point (b) of Article 8(1), it shall not be required that an application for a marketing authorisation for a generic veterinary medicinal product contain the documentation on safety and efficacy if all the following conditions are fulfilled:

(a) bioavailability studies have demonstrated bioequivalence of a generic veterinary medicinal product with the reference veterinary medicinal product or a justification is provided as to why such studies were not performed;

(b) the application satisfies the requirements set out in Annex II;

(c) the applicant demonstrates that the application concerns a generic veterinary medicinal product of a reference veterinary medicinal product for which the period of protection of the technical documentation laid down in Articles 39 and 40 has elapsed or is due to elapse in less than two years.

Article 19

Hybrid veterinary medicinal products

By way of derogation from Article 18(1), the results of appropriate pre-clinical studies or clinical trials shall be required when the veterinary medicinal product does not meet all the characteristics of a generic veterinary medicinal product because of one or more of the following reasons:

(a) there are changes in the active substance or substances, indications for use, strength, pharmaceutical form or route of administration of the generic veterinary medicinal product compared to the reference veterinary medicinal product;

(b) bioavailability studies cannot be used to demonstrate bioequivalence with the reference veterinary medicinal product; or

(c) there are differences relating to raw materials or in manufacturing processes of the biological veterinary medicinal product and the reference biological veterinary medicinal product.

The applicant shall demonstrate that the reference veterinary medicinal product authorised in a third country has been authorised in accordance with requirements equivalent to those established in the Union for the reference veterinary medicinal product and are so highly similar that they can substitute each other in the clinical trials.

Article 20

Combination veterinary medicinal products

By way of derogation from point (b) of Article 8(1), in the case of veterinary medicinal products containing active substances used in the composition of authorised veterinary medicinal products it shall not be required to provide safety and efficacy data relating to each individual active substance.

Article 21

By way of derogation from point (b) of Article 8(1), an applicant for a marketing authorisation for a veterinary medicinal product shall not be required to provide the technical documentation on quality, safety and efficacy if that applicant demonstrates permission, in the form of a letter of access, to use such documentation submitted in respect of the already authorised veterinary medicinal product.

Article 22

Application based on bibliographic data

Section 6

Marketing authorisations for limited market and in exceptional circumstances

Article 23

Applications for limited markets

By way of derogation from point (b) of Article 8(1), the applicant shall not be required to provide the comprehensive safety or efficacy documentation required in accordance with Annex II, if all of the following conditions are met:

(a) the benefit of the availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided;

(b) the applicant provides the evidence that the veterinary medicinal product is intended for a limited market.

Article 24

Validity of a marketing authorisation for a limited market and procedure for its re-examination

On the basis of that assessment, if the benefit-risk balance remains positive, the competent authority or the Commission, as applicable, shall extend the validity of the marketing authorisation by additional periods of five years.

Article 25

Applications in exceptional circumstances

By way of derogation from point (b) of Article 8(1), in exceptional circumstances related to animal or public health, an applicant may submit an application which does not meet all requirements of that point, for which the benefit of the immediate availability on the market of the veterinary medicinal product concerned to the animal or public health outweighs the risk inherent in the fact that certain quality, safety or efficacy documentation has not been provided. In such a case, the applicant shall be required to demonstrate that for objective and verifiable reasons certain quality, safety or efficacy documentation required in accordance with Annex II cannot be provided.

Article 26

Terms of the marketing authorisation in exceptional circumstances

In the exceptional circumstances referred to in Article 25, a marketing authorisation may be granted subject to one or more of the following requirements for the marketing authorisation holder:

(a) a requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product;

(b) a requirement to notify to the competent authorities or the Agency, as applicable, of any adverse event relating to the use of the veterinary medicinal product;

Article 27

Validity of a marketing authorisation in exceptional circumstances and procedure for its re-examination

Section 7

Examination of applications and basis for granting marketing authorisations

Article 28

Examination of applications

The competent authority or the Agency, as applicable, to which the application has been submitted in accordance with Article 6 shall:

(a) verify that the data submitted complies with the requirements laid down in Article 8;

(b) assess the veterinary medicinal product regarding the quality, safety and efficacy documentation provided;

Article 29

Requests to laboratories in the course of the examination of applications

The competent authority or the Agency, as applicable, examining the application may require an applicant to provide to the European Union reference laboratory, an official medicines control laboratory or a laboratory that a Member State has designated for that purpose samples which are necessary to:

(a) test the veterinary medicinal product, its starting materials and, if necessary, intermediate products or other constituent materials in order to ensure that the control methods employed by the manufacturer and described in the application documents are satisfactory;

(b) verify that, in the case of veterinary medicinal products intended for food-producing animals, the analytical detection method proposed by the applicant for the purposes of residue depletion tests is satisfactory and suitable for use to reveal the presence of residue levels, particularly those exceeding the maximum residue level of the pharmacologically active substance established by the Commission in accordance with Regulation (EC) No 470/2009, and for the purpose of official controls of animals and products of animal origin in accordance with Regulation (EU) 2017/625.

Article 30

Information on manufacturers in third countries

The competent authority or the Agency, as applicable, to which the application has been submitted in accordance with Article 6 shall ascertain, through the procedure laid down in Articles 88, 89 and 90, that the manufacturers of veterinary medicinal products from third countries are able to manufacture the veterinary medicinal product concerned or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with Article 8(1). A competent authority or the Agency, as applicable, may request the relevant competent authority to present information ascertaining that the manufacturers of veterinary medicinal products are able to carry out the activities referred to in this Article.

Article 31

Additional information from the applicant

The competent authority or the Agency, as applicable, to which the application has been submitted in accordance with Article 6, shall inform the applicant if the documentation submitted in support of the application is insufficient. The competent authority or the Agency, as applicable, shall request the applicant to provide additional information within a given time limit. In such a case the time limits laid down in Articles 44, 47, 49, 52 and 53 shall be suspended until the additional information has been provided.

Article 32

Withdrawal of applications

Article 33

Outcome of the assessment

The competent authority or the Agency, as applicable, examining the application in accordance with Article 28, shall prepare, respectively, an assessment report or an opinion. In case of a favourable assessment, that assessment report or opinion shall include the following:

(a) a summary of the product characteristics containing the information laid down in Article 35;

(b) details of any conditions or restrictions to be imposed as regards the supply or safe and effective use of the veterinary medicinal product concerned, including the classification of a veterinary medicinal product in accordance with Article 34;

Article 34

Classification of veterinary medicinal products

The competent authority or the Commission, as applicable, granting a marketing authorisation as referred to in Article 5(1) shall classify the following veterinary medicinal products as subject to veterinary prescription:

(a) veterinary medicinal products which contain narcotic drugs or psychotropic substances, or substances frequently used in the illicit manufacture of those drugs or substances, including those covered by the United Nations Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol, the United Nations Convention on Psychotropic Substances of 1971, the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 or by Union legislation on drug precursors;

(b) veterinary medicinal products for food-producing animals;

(d) veterinary medicinal products intended for treatments of pathological processes which require a precise prior diagnosis or the use of which may have effects which impede or interfere with subsequent diagnostic or therapeutic measures;

(e) veterinary medicinal products used for euthanasia of animals;

(f) veterinary medicinal products containing an active substance that has been authorised for less than five years in the Union;

(g) immunological veterinary medicinal products;

(h) without prejudice to Council Directive 96/22/EC (⁵), veterinary medicinal products containing active substances having a hormonal or thyrostatic action or beta-agonists.

By way of derogation from paragraph 1, the competent authority or the Commission, as applicable, may, except as regards veterinary medicinal products referred to in points (a), (c), (e) and (h) of paragraph 1, classify a veterinary medicinal product as not subject to veterinary prescription if all of the following conditions are fulfilled:

(a) the administration of the veterinary medicinal product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products;

(b) the veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal or animals treated or to other animals, to the person administering it or to the environment;

(c) the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious adverse events deriving from its correct use;

(d) neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent adverse event reporting;

(e) the summary of the product characteristics does not refer to contra-indications related to the use of the product concerned in combination with other veterinary medicinal products commonly used without prescription;

(f) there is no risk for public health as regards residues in food obtained from treated animals even where the veterinary medicinal product is used incorrectly;

(g) there is no risk to public or animal health as regards the development of resistance to substances even where the veterinary medicinal product containing those substances is used incorrectly.

Article 35

Summary of the product characteristics

The summary of the product characteristics referred to in point (a) of Article 33(1) shall contain, in the order indicated below, the following information:

(a) name of the veterinary medicinal product followed by its strength and pharmaceutical form and, where applicable, a list of the names of the veterinary medicinal product, as authorised in different Member States;

(b) qualitative and quantitative composition of the active substance or substances and qualitative composition of excipients and other constituents stating their common name or their chemical description and their quantitative composition, if that information is essential for proper administration of the veterinary medicinal product;

(c) clinical information: (i) target species; (ii) indications for use for each target species; (iii) contra-indications; (iv) special warnings; (v) special precautions for use, including in particular special precautions for safe use in the target species, special precautions to be taken by the person administering the veterinary medicinal product to the animals and special precautions for the protection of the environment; (vi) frequency and seriousness of adverse events; (vii) use during pregnancy, lactation or lay; (viii) interaction with other medicinal products and other forms of interaction; (ix) administration route and dosage; (x) symptoms of overdose and, where applicable, emergency procedures and antidotes in the event of overdose; (xi) special restrictions for use; (xii) special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance; (xiii) if applicable, withdrawal periods, even if such periods are zero;

(d) pharmacological information: (i) Anatomical Therapeutic Chemical Veterinary Code (‘ATCvet Code’); (ii) pharmacodynamics; (iii) pharmacokinetics. In case of an immunological veterinary medicinal product, instead of points (i), (ii) and (iii), immunological information;

(e) pharmaceutical particulars: (i) major incompatibilities; (ii) shelf life, where applicable after reconstitution of the medicinal product or after the immediate packaging has been opened for the first time; (iii) special precautions for storage; (iv) nature and composition of immediate packaging; (v) requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;

(f) name of the marketing authorisation holder;

(g) marketing authorisation number or numbers;

(h) date of the first marketing authorisation;

(i) date of the last revision of the summary of the product characteristics;

(j) if applicable, for veterinary medicinal products referred to in Article 23 or 25, the statement: (i) ‘marketing authorisation granted for a limited market and therefore assessment based on customised requirements for documentation’; or (ii) ‘marketing authorisation in exceptional circumstances and therefore assessment based on customised requirements for documentation’;

(k) information on the collection systems referred to in Article 117 applicable to the veterinary medicinal product concerned;

(l) classification of the veterinary medicinal product as referred to in Article 34 for each Member State in which it is authorised.

Article 36

Decisions granting marketing authorisations

Article 37

Decisions refusing marketing authorisations

A marketing authorisation shall be refused if any of the following conditions are met:

(a) the application does not comply with this Chapter;

(b) the benefit-risk balance of the veterinary medicinal product is negative;

(c) the applicant has not provided sufficient information on the quality, safety or efficacy of the veterinary medicinal product;

(d) the veterinary medicinal product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals or to increase yields from treated animals;

(e) the proposed withdrawal period is not long enough to ensure food safety or is insufficiently substantiated;

(f) the risk for public health in case of development of antimicrobial resistance or antiparasitic resistance outweighs the benefits of the veterinary medicinal product to animal health;

(g) the applicant has not provided sufficient proof of efficacy as regards the target species;

(h) the qualitative or quantitative composition of the veterinary medicinal product is not as stated in the application;

(i) risks to public or animal health or to the environment are not sufficiently addressed; or

(j) the active substance within the veterinary medicinal product meets the criteria for being considered persistent, bioaccumulative and toxic or very persistent and very bioaccumulative, and the veterinary medicinal product is intended to be used in food-producing animals, unless it is demonstrated that the active substance is essential to prevent or control a serious risk to animal health.

Section 8

Protection of technical documentation

Article 38

Protection of technical documentation

Without prejudice to the requirements and obligations laid down in Directive 2010/63/EU, technical documentation on quality, safety and efficacy originally submitted with a view to obtaining a marketing authorisation or a variation thereof shall not be referred to by other applicants for a marketing authorisation or a variation of the terms of a marketing authorisation for a veterinary medicinal product unless:

(a) the period of the protection of technical documentation as set out in Articles 39 and 40 of this Regulation has elapsed, or is due to elapse in less than two years;

(b) the applicants have obtained written agreement in the form of a letter of access with regard to that documentation.

Article 39

Periods of the protection of technical documentation

The period of the protection of technical documentation shall be:

(a) 10 years for veterinary medicinal products for cattle, sheep for meat production, pigs, chickens, dogs and cats;

(b) 14 years for antimicrobial veterinary medicinal products for cattle, sheep for meat production, pigs, chickens, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;

(d) 14 years for veterinary medicinal products for animal species other than those referred to in points (a) and (c).

Article 40

Prolongation and additional periods of the protection of technical documentation

If a variation to the terms of the marketing authorisation approved in accordance with Article 67 involves a change to the pharmaceutical form, administration route or dosage, which is assessed by the Agency or the competent authorities referred to in Article 66 to have demonstrated:

(a) a reduction in the antimicrobial or antiparasitic resistance; or

(b) an improvement of the benefit-risk balance of the veterinary medicinal product,

the results of the concerned pre-clinical studies or clinical trials shall benefit from four years protection.

The prohibition on using those results shall not apply, insofar as the other applicants have obtained a letter of access with regard to those studies and trials.

Article 41

Conducting the necessary tests, studies and trials with a view to applying for a marketing authorisation in accordance with Article 18 shall not be regarded as contrary to patent-related rights or to supplementary-protection certificates for veterinary medicinal products and medicinal products for human use.

CHAPTER III

PROCEDURES FOR MARKETING AUTHORISATIONS

Section 1

Marketing authorisations valid throughout the Union (‘centralised marketing authorisations’)

Article 42

Scope of the centralised marketing authorisation procedure

Centralised marketing authorisation procedure shall apply in respect of the following veterinary medicinal products:

(a) veterinary medicinal products developed by means of one of the following biotechnological processes: (i) recombinant DNA technology; (ii) controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells; (iii) hybridoma and monoclonal antibody methods;

(b) veterinary medicinal products intended primarily for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals;

(c) veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application;

(d) biological veterinary medicinal products which contain or consist of engineered allogeneic tissues or cells;

(e) novel therapy veterinary medicinal products.

Article 43

Application for centralised marketing authorisation

Article 44

Procedure for centralised marketing authorisation

Article 45

Re-examination of the opinion of the Agency

Section 2

Marketing authorisations valid in a single Member State (‘national marketing authorisations’)

Article 46

Scope of national marketing authorisation

Article 47

Procedure for national marketing authorisation

Section 3

Marketing authorisations valid in several Member States (‘decentralised marketing authorisations’)

Article 48

Scope of decentralised marketing authorisation

Article 49

Procedure for decentralised marketing authorisation

Article 50

Request by the applicant for re-examination of the assessment report

Section 4

Mutual recognition of national marketing authorisations

Article 51

Scope of mutual recognition of national marketing authorisations

A national marketing authorisation for a veterinary medicinal product, granted in accordance with Article 47, shall be recognised in other Member States in accordance with the procedure laid down in Article 52.

Article 52

Procedure for mutual recognition of national marketing authorisations

Section 5

Subsequent recognition in the mutual recognition and decentralised marketing authorisation procedures

Article 53

Subsequent recognition of marketing authorisations by additional Member States concerned

After completion of a decentralised procedure laid down in Article 49 or a mutual recognition procedure laid down in Article 52 granting a marketing authorisation, the marketing authorisation holder may submit an application for a marketing authorisation for the veterinary medicinal product to the competent authorities in additional Member States concerned and to the competent authority in the reference Member State referred to in Article 49 or 52, as applicable, in accordance with the procedure laid down in this Article. In addition to the data referred to in Article 8, the application shall include the following:

(a) a list of all decisions granting, suspending or revoking marketing authorisations which concern the veterinary medicinal product;

(b) information on the variations introduced since the grant of the marketing authorisation by decentralised procedure laid down in Article 49(7) or by mutual recognition procedure laid down in Article 52(8);

Section 6

Review procedure

Article 54

Review procedure

CHAPTER IV

POST-MARKETING AUTHORISATION MEASURES

Section 1

Union product database

Article 55

Union database on veterinary medicinal products

The product database shall contain at least the following information:

(a) for veterinary medicinal products authorised within the Union by the Commission and by the competent authorities: (i) name of the veterinary medicinal product; (ii) active substance or substances, and the strength of the veterinary medicinal product; (iii) summary of product characteristics; (iv) package leaflet; (v) the assessment report; (vi) list of sites where the veterinary medicinal product is manufactured; and (vii) the dates of the placing of the veterinary medicinal product on the market in a Member State;

(b) for homeopathic veterinary medicinal products registered in accordance with Chapter V within the Union by the competent authorities: (i) name of the registered homeopathic veterinary medicinal product; (ii) package leaflet; and (iii) lists of sites where the registered homeopathic veterinary medicinal product is manufactured;

(d) the annual volume of sales and information on the availability for each veterinary medicinal product.

The Commission shall, by means of implementing acts, adopt the necessary measures and practical arrangements laying down:

(a) the technical specifications of the product database including the electronic data exchange mechanism for exchanging with the existing national systems and the format for electronic submission;

(b) the practical arrangements for the functioning of the product database, in particular to ensure protection of commercially confidential information and security of exchange of information;

(d) contingency arrangements to be applied in case of unavailability of any of the functionalities of the product database;

(e) where appropriate, data to be included in the product database in addition to the information referred to in paragraph 2 of this Article.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 56

Access to the product database

Section 2

Collection of data by Member States and responsibilities of marketing authorisation holders

Article 57

Collection of data on antimicrobial medicinal products used in animals

The Commission shall adopt delegated acts in accordance with Article 147, in order to supplement this Article, establishing the requirements as regards:

(a) the types of antimicrobial medicinal products used in animals for which data shall be collected;

(b) the quality assurance that Member States and the Agency shall put in place to ensure quality and comparability of data; and

(c) the rules on the methods of gathering data on the use of the antimicrobial medicinal products used in animals and on the method of transfer of those data to the Agency.

Member States shall be allowed to apply a progressive stepwise approach regarding the obligations set out in this Article so that:

(a) within two years from 28 January 2022, data shall be collected at least for the species and categories included in Commission Implementing Decision 2013/652/EU (⁶) in its version of 11 December 2018;

(b) within five years from 28 January 2022, data shall be collected for all food-producing animal species;

Article 58

Responsibilities of the marketing authorisation holders

Article 59

Small and medium-sized enterprises

Member States shall, in accordance with their national law, take appropriate measures to advise small and medium-sized enterprises on compliance with the requirements of this Regulation.

Section 3

Changes to the terms of the marketing authorisations

Article 60

Variations

The Commission shall take account of the following criteria when adopting the implementing acts referred to in paragraph 1:

(a) the need for a scientific assessment of changes in order to determine the risk to public or animal health or to the environment;

(b) whether changes have an impact on the quality, safety or efficacy of the veterinary medicinal product;

(d) whether changes are of an administrative nature.

Article 61

Variations that do not require assessment

Article 62

Application for variations requiring assessment

The application referred to in paragraph 1 shall contain:

(a) a description of the variation;

(b) data referred to in Article 8 relevant to the variation;

(d) where the variation leads to consequential variations to the terms of the same marketing authorisation, a description of those consequential variations;

(e) where the variation concerns marketing authorisations granted under the mutual recognition or decentralised procedures, a list of Member States which granted those marketing authorisations.

Article 63

Consequential changes to product information

Where a variation entails consequential changes to the summary of the product characteristics, the labelling or the package leaflet, those changes shall be considered as part of that variation for the purposes of the examination of the application for a variation.

Article 64

Groups of variations

When the marketing authorisation holder applies for several variations not included in the list established in accordance with Article 60(1) regarding the same marketing authorisation or for one variation not appearing in that list in respect of several different marketing authorisations, that marketing authorisation holder may submit one application for all variations.

Article 65

Article 66

Procedure for variations requiring assessment

Article 67

Measures to close the procedure for variations requiring assessment

Article 68

Implementation of variations requiring assessment

Section 4

Harmonisation of the summaries of product characteristics for nationally authorised products

Article 69

Scope of the harmonisation of summaries of product characteristics of a veterinary medicinal product

A harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in Articles 70 and 71 for:

(a) reference veterinary medicinal products which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and for which marketing authorisations have been granted in accordance with Article 47 in different Member States for the same marketing authorisation holder;

(b) generic and hybrid veterinary medicinal products.

Article 70

Procedure for harmonisation of summaries of product characteristics for the reference veterinary medicinal products

Article 71

Procedure for harmonisation of summaries of product characteristics for generic and hybrid veterinary medicinal products

When the procedure referred to in Article 70 has been closed and a harmonised summary of product characteristics for a reference veterinary medicinal product has been agreed, the marketing authorisation holders of generic veterinary medicinal products shall apply, within 60 days of the decision by the competent authorities in each Member State and in accordance with Article 62, for the harmonisation of the following sections of the summary of product characteristics for the generic veterinary medicinal products concerned, as applicable:

(a) target species;

(b) clinical information referred to in point (c) of Article 35(1);

Article 72

Environmental safety documentation and environmental risk assessment of certain veterinary medicinal products

The list referred to in Article 70(1) shall not contain any reference veterinary medicinal product authorised before 1 October 2005 and which is identified as potentially harmful to the environment and has not been subject to an environmental risk assessment.

Where the reference veterinary medicinal product is authorised before 1 October 2005 and is identified as potentially harmful to the environment and has not been subject to an environmental risk assessment, the competent authority shall request the marketing authorisation holder to update the relevant environmental safety documentation referred to in point (b) of Article 8(1), taking into account the review referred to in Article 156, and, if applicable, the environmental risk assessment of generic veterinary medicinal products of such reference medicinal products.

Section 5

Pharmacovigilance

Article 73

Union pharmacovigilance system

Competent authorities, the Agency and marketing authorisation holders shall take the necessary measures to make available means to report and encourage reporting of the following suspected adverse events:

(a) any unfavourable and unintended reaction in any animal to a veterinary medicinal product;

(b) any observation of a lack of efficacy of a veterinary medicinal product following its administration to an animal, whether or not in accordance with the summary of product characteristics;

(d) any noxious reaction in humans exposed to a veterinary medicinal product;

(e) any finding of a pharmacologically active substance or marker residue in a product of animal origin exceeding the maximum levels of residues established in accordance with Regulation (EC) No 470/2009 after the set withdrawal period has been respected;

(f) any suspected transmission of an infectious agent via a veterinary medicinal product;

(g) any unfavourable and unintended reaction in an animal to a medicinal product for human use.

Article 74

Union pharmacovigilance database

Article 75

Access to the pharmacovigilance database

The general public shall have access to the pharmacovigilance database, without the possibility to change the information therein, as regards the following information:

(a) the number and at the latest within two years from 28 January 2022 the incidence of suspected adverse events reported each year, broken down by veterinary medicinal product, animal species and type of suspected adverse event;

(b) the results and outcomes referred to in Article 81(1) that arise from the signal management process performed by the marketing authorisation holder for veterinary medicinal products or groups of veterinary medicinal products.

Article 76

Reporting and recording of suspected adverse events

Article 77

Pharmacovigilance responsibilities of the marketing authorisation holder

The marketing authorisation holder shall ensure that such public announcement is presented objectively and is not misleading.

Article 78

Qualified person responsible for pharmacovigilance

The qualified person responsible for pharmacovigilance as referred to in Article 77(8) shall ensure that the following tasks are carried out:

(a) elaborating and maintaining the pharmacovigilance system master file;

(b) allocating reference numbers to the pharmacovigilance system master file and communicating that reference number to the pharmacovigilance database for each product;

(d) establishing and maintaining a system which ensures that all suspected adverse events which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the Union;

(e) compiling the suspected adverse event reports referred to in Article 76(2), evaluating them, where necessary, and recording them in the pharmacovigilance database;

(f) ensuring that any request from the competent authorities or the Agency for the provision of additional information necessary for the evaluation of the benefit-risk balance of a veterinary medicinal product is answered fully and promptly;

(g) providing competent authorities or the Agency, as applicable, with any other information relevant to detecting a change to the benefit-risk balance of a veterinary medicinal product, including appropriate information on post-marketing surveillance studies;

(h) applying the signal management process referred to in Article 81 and ensuring that any arrangements for the fulfilment of responsibilities referred to in Article 77(4) are in place;

(i) monitoring the pharmacovigilance system and ensuring that if needed, an appropriate preventive or corrective action plan is prepared, implemented and, where necessary, ensuring changes to the pharmacovigilance system master file;

(j) ensuring that all personnel of the marketing authorisation holder involved in the performance of pharmacovigilance activities receives continued training;

(k) communicating any regulatory measure that is taken in a third country and is related to pharmacovigilance data to the competent authorities and to the Agency within 21 days of receipt of such information.

Article 79

Pharmacovigilance responsibilities of the competent authorities and the Agency

Article 80

Delegation of tasks by competent authority

Article 81

Signal management process

The marketing authorisation holder shall record, at least annually, all results and outcomes of the signal management process, including a conclusion on the benefit-risk balance, and, if applicable, references to relevant scientific literature in the pharmacovigilance database.

In the case of veterinary medicinal products referred to in point (c) of Article 42(2), the marketing authorisation holder shall record in the pharmacovigilance database all results and outcomes of the signal management process, including a conclusion on the benefit-risk balance, and, if applicable, references to relevant scientific literature according to the frequency specified in the marketing authorisation.

Section 6

Union interest referral

Article 82

Scope of the Union interest referral

Article 83

Union interest referral procedure

Article 84

Decision following the Union interest referral

CHAPTER V

HOMEOPATHIC VETERINARY MEDICINAL PRODUCTS

Article 85

Homeopathic veterinary medicinal products

Article 86

Registration of homeopathic veterinary medicinal products

A homeopathic veterinary medicinal product that meets all of the following conditions shall be subject to a registration procedure:

(a) it is administered by a route described in the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States;

(b) it has a sufficient degree of dilution to guarantee its safety, and shall not contain more than one part per 10 000 of the mother tincture;

Article 87

Application and procedure for registration of homeopathic veterinary medicinal products

The following documents shall be included in the application for a registration of a homeopathic veterinary medicinal product:

(a) scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the route of administration, pharmaceutical form and degree of dilution to be registered;

(b) a dossier describing how the homeopathic stock or stocks are obtained and controlled, and justifying their homeopathic use, on the basis of an adequate bibliography; in the case of homeopathic veterinary medicinal products containing biological substances, a description of the measures taken to ensure the absence of pathogens;

(c) the manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation;

(d) the manufacturing authorisation for the homeopathic veterinary medicinal products concerned;

(e) copies of any registrations obtained for the same homeopathic veterinary medicinal products in other Member States;

(f) the text to appear on the package leaflet, outer packaging and immediate packaging of the homeopathic veterinary medicinal products to be registered;

(g) data concerning the stability of the homeopathic veterinary medicinal product;

(h) in the case of homeopathic veterinary medicinal products intended for food-producing animal species, the active substances shall be those pharmacologically active substances allowed in accordance with Regulation (EC) No 470/2009 and any acts adopted on the basis thereof.

CHAPTER VI

MANUFACTURING, IMPORT AND EXPORT

Article 88

Manufacturing authorisations

A manufacturing authorisation shall be required in order to carry out any of the following activities:

(a) to manufacture veterinary medicinal products even if intended only for export;

(b) to engage in any part of the process of manufacturing a veterinary medicinal product or of bringing a veterinary medicinal product to its final state, including engagement in the processing, assembling, packaging and repackaging, labelling and relabelling, storing, sterilising, testing or releasing it for supply as part of that process; or

Article 89

Application for manufacturing authorisation

An application for a manufacturing authorisation shall contain at least the following information:

(a) veterinary medicinal products which are to be manufactured or imported;

(b) name or company name and permanent address or registered place of business of the applicant;

(d) details about the manufacturing site where the veterinary medicinal products are to be manufactured or imported;

(e) a statement to the effect that the applicant fulfils the requirements laid down in Articles 93 and 97.

Article 90

Procedure for granting of manufacturing authorisations

Article 91

Database on manufacturing and wholesale distribution

Article 92

Changes to manufacturing authorisations on request

Article 93

Obligations of the holder of a manufacturing authorisation

The holder of a manufacturing authorisation shall:

(a) have at its disposal suitable and sufficient premises, technical equipment and testing facilities, for the activities stated in its manufacturing authorisation;

(b) have at its disposal the services of at least one qualified person referred to in Article 97 and ensure that the qualified person operates in compliance with that Article;

(c) enable the qualified person referred to in Article 97 to carry out his or her duties, particularly by providing access to all the necessary documents and premises, and by placing at his or her disposal all the necessary technical equipment and testing facilities;

(d) give at least a 30 days prior notice to the competent authority before the replacement of the qualified person referred to in Article 97 or, if prior notice is not possible because the replacement is unexpected, inform the competent authority immediately;

(e) have at its disposal the services of staff complying with the legal requirements existing in the relevant Member State as regards both manufacture and controls;

(f) allow the representatives of the competent authority access to the premises at any time;

(g) keep detailed records of all veterinary medicinal products which the holder of a manufacturing authorisation supplies in accordance with Article 96, and keep samples of each batch;

(h) only supply veterinary medicinal products to wholesale distributors of veterinary medicinal products;

(i) inform the competent authority and the marketing authorisation holder immediately if the holder of a manufacturing authorisation obtains information that veterinary medicinal products which fall within the scope of its manufacturing authorisation are, or are suspected of being, falsified irrespective of whether those veterinary medicinal products were distributed within the legal supply chain or by illegal means, including illegal sale by means of information society services;

(j) comply with good manufacturing practice for veterinary medicinal products and use as starting materials only active substances which have been manufactured in accordance with good manufacturing practice for active substances and distributed in accordance with good distribution practice for active substances;

(k) verify that each manufacturer, distributor and importer within the Union from whom the holder of a manufacturing authorisation obtains active substances is registered with the competent authority of the Member State in which the manufacturer, distributor and importer are established, in accordance with Article 95;

(l) perform audits based on a risk assessment on the manufacturers, distributors and importers from whom the holder of a manufacturing authorisation obtains active substances.

Article 94

Certificates of good manufacturing practice

Article 95

Importers, manufacturers and distributors of active substances established in the Union

The registration form for registering the activity with the competent authority shall include at least the following information:

(a) name or company name and permanent address or registered place of business;

(b) the active substances which are to be imported, manufactured or distributed;

Article 96

Record keeping

The holder of a manufacturing authorisation shall record the following information in respect of all veterinary medicinal products that it supplies:

(a) date of the transaction;

(b) name of the veterinary medicinal product, and marketing authorisation number if applicable, as well as pharmaceutical form and strength, as appropriate;

(d) name or company name and permanent address or registered place of business of the recipient;

(e) batch number;

(f) date of expiry.

Article 97

Qualified person responsible for manufacturing and batch release

The duration of practical experience required in the first subparagraph may be reduced by one year where a university course lasts for at least five years and by a year and a half where the university course lasts for at least six years.

Article 98

Certificates of veterinary medicinal products

On the request of a manufacturer or an exporter of veterinary medicinal products, or of the authorities of an importing third country, the competent authority or the Agency shall certify that:

(a) the manufacturer holds a manufacturing authorisation;

(b) the manufacturer possesses a certificate of good manufacturing practice as referred to in Article 94; or

(c) the veterinary medicinal product concerned has been granted a marketing authorisation in that Member State or, in the case of a request to the Agency, that it has been granted a centralised marketing authorisation.

CHAPTER VII

SUPPLY AND USE

Section 1

Wholesale distribution

Article 99

Wholesale distribution authorisations

Article 100

Application and procedures for wholesale distribution authorisations

An applicant shall demonstrate in the application that the following requirements are met:

(a) the applicant has at its disposal technically competent staff and in particular at least one person designated as responsible person, meeting the conditions provided for in national law;

(b) the applicant has suitable and sufficient premises complying with the requirements laid down by the relevant Member State as regards the storage and handling of veterinary medicinal products;

(c) the applicant has a plan guaranteeing effective implementation of any withdrawal or recall from the market ordered by the competent authorities or the Commission or undertaken in cooperation with the manufacturer or marketing authorisation holder of the veterinary medicinal product concerned;

(d) the applicant has an appropriate record-keeping system ensuring compliance with the requirements referred to in Article 101;

(e) the applicant has a statement to the effect that it fulfils the requirements referred to in Article 101.

The competent authority shall:

(a) inform the applicant of the outcome of the evaluation;

(b) grant, refuse or change the wholesale distribution authorisation; and

(c) upload the relevant information of the authorisation in the manufacturing and wholesale distribution database referred to in Article 91.

Article 101

Obligations of wholesale distributors

A wholesale distributor shall keep detailed records of at least the following information in respect of each transaction:

(a) date of the transaction;

(b) name of the veterinary medicinal product including, as appropriate, pharmaceutical form and strength;

(d) expiry date of the veterinary medicinal product;

(e) quantity received or supplied, stating pack size and number of packs;

(f) name or company name and permanent address or registered place of business of the supplier in the event of purchase or of the recipient in the event of sale.

Article 102

Parallel trade in veterinary medicinal products

For the purpose of parallel trade in veterinary medicinal products, the wholesale distributor shall ensure that the veterinary medicinal product it intends to obtain from a Member State (‘source Member State’) and distribute in another Member State (‘destination Member State’) share a common origin with the veterinary medicinal product already authorised in the destination Member State. The veterinary medicinal products are considered as sharing a common origin if they fulfil all the following conditions:

(a) they have the same qualitative and quantitative composition in terms of active substances and excipients;

(b) they have the same pharmaceutical form;

(d) they have been manufactured by the same manufacturer or by a manufacturer working under licence according to the same formulation.

Each wholesale distributor intending to parallel trade a veterinary medicinal product to a destination Member State shall comply with at least the following obligations:

(a) submit a declaration to the competent authority in the destination Member State and take appropriate measures to ensure that the wholesale distributor in the source Member State will keep it informed of any pharmacovigilance issues;

(b) notify the marketing authorisation holder in the destination Member State about the veterinary medicinal product to be obtained from the source Member State and intended to be placed on the market in the destination Member State at least one month prior to submitting to the competent authority the application for parallel trade in that veterinary medicinal product;

(c) submit a written declaration to the competent authority of the destination Member State that the marketing authorisation holder in the destination Member State was notified in accordance with point (b) together with a copy of that notification;

(d) not trade a veterinary medicinal product which has been recalled from the market of the source Member State or destination Member State for quality, safety or efficacy reasons;

(e) collect suspected adverse events and report them to the marketing authorisation holder of the parallel-traded veterinary medicinal product.

The following information shall be attached to the list referred to in paragraph 4 in respect of all veterinary medicinal products:

(a) name of the veterinary medicinal products;

(b) active substances;

(d) classification of the veterinary medicinal products in the destination Member State;

(e) marketing authorisation number of the veterinary medicinal products in the source Member State;

(f) marketing authorisation number of the veterinary medicinal products in the destination Member State;

(g) name or company name and permanent address or registered place of business of the wholesale distributor in the source Member State and of the wholesale distributor in the destination Member State.

Section 2

Retail

Article 103

Retail of veterinary medicinal products and record keeping

Retailers of veterinary medicinal products shall keep detailed records of the following information in respect of each transaction of veterinary medicinal products requiring a veterinary prescription under Article 34:

(a) date of the transaction;

(b) name of the veterinary medicinal product including, as appropriate, pharmaceutical form and strength;

(d) quantity received or supplied;

(e) name or company name and permanent address or registered place of business of the supplier in the event of purchase, or of the recipient in the event of sale;

(f) name and contact details of the prescribing veterinarian and, where appropriate, a copy of the veterinary prescription;

(g) marketing authorisation number.

Article 104

Retail of veterinary medicinal products at a distance

In addition to the information requirements set out in Article 6 of Directive 2000/31/EC of the European Parliament and of the Council (⁸), retailers offering veterinary medicinal products by means of information society services shall provide at least the following information:

(a) the contact details of the competent authority of the Member State in which the retailer offering the veterinary medicinal products is established;

(b) a hyperlink to the website of the Member State of establishment set up in accordance with paragraph 8 of this Article;

(c) the common logo established in accordance with paragraph 6 of this Article is clearly displayed on every page of the website that relates to the offer for sale at a distance of veterinary medicinal products and contains a hyperlink to the entry of the retailer in the list of permitted retailers referred to in point (c) of paragraph 8 of this Article.

Each Member State shall set up a website regarding sale of veterinary medicinal products at a distance, providing at least the following information:

(a) information on its national law applicable to the offering of veterinary medicinal products for sale at a distance by means of information society services, in accordance with paragraphs 1 and 2, including information on the fact that there may be differences between Member States regarding the classification of the supply of the veterinary medicinal products;

(b) information on the common logo;

(c) a list of retailers established in the Member State permitted to offer veterinary medicinal products for sale at a distance by means of information society services in accordance with paragraphs 1 and 2 as well as the website addresses of those retailers.

Article 105

Veterinary prescriptions

Veterinary prescriptions issued by a professional, other than a veterinarian shall be, mutatis mutandis, subject to paragraphs 5, 6, 8, 9 and 11 of this Article.

A veterinary prescription shall contain at least the following elements:

(a) identification of the animal or groups of animals to be treated;

(b) full name and contact details of the animal owner or keeper;

(d) full name and contact details of the veterinarian including, if available, the professional number;

(e) signature or an equivalent electronic form of identification of the veterinarian;

(f) name of the prescribed medicinal product, including its active substances;

(g) pharmaceutical form and strength;

(h) quantity prescribed, or the number of packs, including pack size;

(i) dosage regimen;

(j) for food-producing animal species, withdrawal period even if such period is zero;

(k) any warnings necessary to ensure the proper use including, where relevant, to ensure prudent use of antimicrobials;

(l) if a medicinal product is prescribed in accordance with Articles 112, 113 and 114, a statement to that effect;

(m) if a medicinal product is prescribed in accordance with Article 107(3) and (4), a statement to that effect.

Section 3

Use

Article 106

Use of medicinal products

Article 107

Use of antimicrobial medicinal products

In such cases, the use of antibiotic medicinal products for prophylaxis shall be limited to the administration to an individual animal only, under the conditions laid down in the first subparagraph.

The Commission may, by means of implementing acts, and taking into consideration scientific advice of the Agency, establish a list of antimicrobials which:

(a) shall not be used in accordance with Articles 112, 113 and 114; or

(b) shall only be used in accordance with Articles 112, 113 and 114 subject to certain conditions.

When adopting those implementing acts, the Commission shall take account of the following criteria:

(a) risks to animal or public health if the antimicrobial is used in accordance with Articles 112, 113 and 114;

(b) risk for animal or public health in case of development of antimicrobial resistance;

(d) availability of other antimicrobial treatments for humans;

(e) impact on aquaculture and farming if the animal affected by the condition receives no treatment.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 108

Record-keeping by owners and keepers of food-producing animals

Records referred to in paragraph 1 shall include:

(a) date of the first administration of the medicinal product to the animals;

(b) name of the medicinal product;

(d) name or company name and permanent address or registered place of business of the supplier;

(e) evidence of acquisition of the medicinal products they use;

(f) identification of the animal or group of animals treated;

(g) name and contact details of the prescribing veterinarian, if applicable;

(h) withdrawal period even if such period is zero;

(i) duration of treatment.

Article 109

Record-keeping obligations for equine animals

Article 110

Use of immunological veterinary medicinal products

The competent authorities may, in accordance with the applicable national law, prohibit the manufacture, import, distribution, possession, sale, supply or use of immunological veterinary medicinal products on their territory or in a part of it if at least one of the following conditions is fulfilled:

(a) the administration of the product to animals may interfere with the implementation of a national programme for the diagnosis, control or eradication of animal disease;

(b) the administration of the product to animals may cause difficulties in certifying the absence of disease in live animals or contamination of foodstuffs or other products obtained from treated animals;

(c) the strains of disease agents to which the product is intended to confer immunity is largely absent in terms of geographic spread from the territory concerned.

Article 111

Use of veterinary medicinal products by veterinarians providing services in other Member States

A veterinarian providing services in a Member State other than the one in which the veterinarian is established (‘host Member State’) shall be allowed to possess and administer veterinary medicinal products which are not authorised in the host Member State to animals or groups of animals which are under the veterinarian’s care in the necessary quantity not exceeding the amount required for the treatment prescribed by the veterinarian, provided that the following conditions are met:

(a) a marketing authorisation for the veterinary medicinal product to be administered to the animals has been granted by the competent authorities of the Member State in which the veterinarian is established or by the Commission;

(b) the veterinary medicinal products concerned are transported by the veterinarian in their original packaging;

(d) the veterinarian sets the withdrawal period specified on the labelling or package leaflet of the veterinary medicinal product used;

(e) the veterinarian does not retail any veterinary medicinal product to an owner or keeper of animals treated in the host Member State unless this is permissible under the rules of the host Member State.

Article 112

Use of medicinal products outside the terms of the marketing authorisation in non-food-producing animal species

By way of derogation from Article 106(1), where there is no authorised veterinary medicinal product in a Member State for an indication concerning a non-food-producing animal species, the veterinarian responsible may, under his or her direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animals concerned with the following medicinal product:

(a) a veterinary medicinal product authorised under this Regulation in the relevant Member State or in another Member State for use in the same species or another animal species for the same indication or for another indication;

(b) if there is no veterinary medicinal product as referred to in point (a) of this paragraph, a medicinal product for human use authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004;

(c) if there is no medicinal product as referred to in point (a) or (b) of this paragraph, a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription.

Article 113

Use of medicinal products outside the terms of the marketing authorisation in food-producing terrestrial animal species

By way of derogation from Article 106(1), where there is no authorised veterinary medicinal product in a Member State for an indication concerning a food-producing terrestrial animal species, the veterinarian responsible may, under his or her direct personal responsibility, and in particular to avoid causing unacceptable suffering, exceptionally treat the animals concerned with the following medicinal product:

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Regulation (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)

REGULATION (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

Article 2

Scope

Article 3

Conflict of laws

Article 4

Definitions

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

Article 7

Languages

Section 2

Dossier requirements

Article 8

Data to be submitted with the application

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

Article 11

Labelling of the outer packaging of veterinary medicinal products

Article 12

Labelling of small immediate packaging units of veterinary medicinal products

Article 13

Additional information on the immediate packaging or outer packaging of veterinary medicinal products

Article 14

Package leaflet of veterinary medicinal products

Article 15

General requirement regarding product information

Article 16

Package leaflet of registered homeopathic veterinary medicinal products

Article 17

Implementing powers with respect to this Section

Section 5

Specific requirements for generic, hybrid and combination veterinary medicinal products and for applications based on informed consent and bibliographic data

Article 18

Generic veterinary medicinal products

Article 19

Hybrid veterinary medicinal products

Article 20

Combination veterinary medicinal products

Article 21

Application based on informed consent

Article 22

Application based on bibliographic data

Section 6

Marketing authorisations for limited market and in exceptional circumstances

Article 23

Applications for limited markets

Article 24

Validity of a marketing authorisation for a limited market and procedure for its re-examination

Article 25

Applications in exceptional circumstances

Article 26

Terms of the marketing authorisation in exceptional circumstances

Article 27

Validity of a marketing authorisation in exceptional circumstances and procedure for its re-examination

Section 7

Examination of applications and basis for granting marketing authorisations

Article 28

Examination of applications

Article 29

Requests to laboratories in the course of the examination of applications

Article 30

Information on manufacturers in third countries