02019R0006 — EN — 28.01.2022 — 001.001

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►B 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) (OJ L 004 7.1.2019, p. 43)

Amended by:









▼B

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

1. This Regulation shall apply to veterinary medicinal products prepared industrially or by a method involving an industrial process and intended to be placed on the market.

2. In addition to the products referred to in paragraph 1 of this Article, Articles 94 and 95 shall also apply to active substances used as starting materials in veterinary medicinal products.

3. In addition to the products referred to in paragraph 1 of this Article, Articles 94, 105, 108, 117, 120, 123 and 134 shall also apply to inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals in an epidemiological unit and used for the treatment of that animal or those animals in the same epidemiological unit or for the treatment of an animal or animals in a unit having a confirmed epidemiological link.

4. By way of derogation from paragraphs 1 and 2 of this Article, only Articles 55, 56, 94, 117, 119, 123, 134 and Section 5 of Chapter IV shall apply to veterinary medicinal products authorised in accordance with Article 5(6).

5. By way of derogation from paragraph 1 of this Article, Articles 5 to 15, 17 to 33, 35 to 54, 57 to 72, 82 to 84, 95, 98, 106, 107, 110, 112 to 116, 128, 130 and 136 shall not apply to homeopathic veterinary medicinal products which are registered in accordance with Article 86.

6. 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.

7. 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.

8. This Regulation shall, except as regards the centralised marketing authorisation procedure, be without prejudice to national provisions on fees.

9. Nothing in this Regulation shall prevent a Member State from maintaining or introducing on its territory any national control measure it deems appropriate regarding narcotic and psychotropic substances.

Article 3

Conflict of laws

1. Where a veterinary medicinal product referred to in Article 2(1) of this Regulation also falls within the scope of Regulation (EU) No 528/2012 of the European Parliament and of the Council ( 2 ) or Regulation (EC) No 1831/2003, and there is a conflict between this Regulation and Regulation (EU) No 528/2012 or Regulation (EC) No 1831/2003, this Regulation shall prevail.

2. For the purpose of paragraph 1 of this Article, the Commission may, by means of implementing acts, adopt decisions on whether a specific product or group of products is to be considered as a veterinary medicinal product. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

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

1. A veterinary medicinal product shall be placed on the market only when a competent authority or the Commission, as applicable, has granted a marketing authorisation for that product in accordance with Article 44, 47, 49, 52, 53 or 54.

2. A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time.

3. Decisions to grant, refuse, suspend, revoke or amend by way of a variation a marketing authorisation shall be made public.

4. A marketing authorisation for a veterinary medicinal product shall only be granted to an applicant established in the Union. The requirement to be established in the Union shall also apply to marketing authorisation holders.

5. A marketing authorisation for a veterinary medicinal product intended for one or more food-producing animal species may only be granted if the pharmacologically active substance is allowed in accordance with Regulation (EC) No 470/2009 and any acts adopted on the basis thereof for the animal species concerned.

6. In the case of veterinary medicinal products intended for animals which are exclusively kept as pets: aquarium or pond animals, ornamental fish, cage birds, homing pigeons, terrarium animals, small rodents, ferrets and rabbits, Member States may allow exemptions from this Article, provided that such veterinary medicinal products are not subject to a veterinary prescription and that all necessary measures are in place in the Member State to prevent unauthorised use of those veterinary medicinal products for other animals.

Article 6

Submission of applications for marketing authorisations

1. 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.

2. Applications for marketing authorisations shall be submitted to the Agency where they concern the granting of marketing authorisations in accordance with the centralised marketing authorisation procedure laid down in Articles 42 to 45.

3. Applications referred to in paragraphs 1 and 2 shall be submitted electronically and the formats made available by the Agency shall be used.

4. The applicant shall be responsible for the accuracy of the information and documentation submitted with respect to its application.

5. Within 15 days of receipt of the application, the competent authority or the Agency, as applicable, shall notify the applicant as to whether all the information and documentation required in accordance with Article 8 have been submitted and whether the application is valid.

6. Where the competent authority or the Agency, as applicable, considers that the application is incomplete, it shall inform the applicant accordingly and shall set a time limit for submitting the missing information and documentation. If the applicant fails to provide the missing information and documentation within the time limit set, the application shall be considered to have been withdrawn.

7. If the applicant fails to provide a complete translation of the required documentation within a period of six months after having received the information referred to in Article 49(7), 52(8) or 53(2), the application shall be considered to have been withdrawn.

Article 7

Languages

1. The language or languages of the summary of the product characteristics and the information on the labelling and on the package leaflet shall, unless the Member State determines otherwise, be an official language or languages of the Member State where the veterinary medicinal product is made available on the market.

2. Veterinary medicinal products may be labelled in several languages.







Section 2

Dossier requirements

Article 8

Data to be submitted with the application

1. 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.

2. 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.

3. Where the application concerns a veterinary medicinal product intended for food-producing animals and containing pharmacologically active substances that are not allowed in accordance with Regulation (EC) No 470/2009 and with any acts adopted on the basis thereof for the animal species concerned, a document certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with that Regulation shall be submitted in addition to the information, technical documentation and summary listed in paragraph 1 of this Article.

4. Paragraph 3 of this Article shall not apply to veterinary medicinal products intended for animals of the equine species that have been declared as not being intended for slaughter for human consumption in the single lifetime identification document referred to in point (c) of Article 114(1) of Regulation (EU) 2016/429 and in any acts adopted on the basis thereof and the active substances contained in those veterinary medicinal products are not allowed in accordance with Regulation (EC) No 470/2009 or with any acts adopted on the basis thereof.

5. 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.

6. Where the application is submitted in accordance with the national procedure set out in Articles 46 and 47, the applicant shall, in addition to the information, technical documentation and summary listed in paragraph 1 of this Article, submit a declaration stating that he or she has not submitted an application for a marketing authorisation for the same veterinary medicinal product in another Member State or in the Union and, if applicable, that no such marketing authorisation has been granted in another Member State or in the Union.







Section 3

Clinical trials

Article 9

Clinical trials

1. An application for the approval of a clinical trial shall be submitted in accordance with the applicable national law to a competent authority of the Member State in which the clinical trial is to take place.

2. Approvals of clinical trials shall be granted on condition that food-producing animals used in the clinical trials or their produce do not enter the food chain unless an appropriate withdrawal period has been set by the competent authority.

3. The competent authority shall issue a decision to approve or refuse a clinical trial within 60 days of the receipt of a valid application.

4. The clinical trials shall be carried out taking due account of the international guidelines on good clinical practice of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (‘VICH’).

5. Data stemming from clinical trials shall be submitted with the application for a marketing authorisation for the purposes of providing the documentation referred to in point (b) of Article 8(1).

6. Data stemming from clinical trials conducted outside the Union may be taken into consideration for the assessment of an application for a marketing authorisation only if those trials were designed, implemented and reported in accordance with the international guidelines on good clinical practice of the VICH.







Section 4

Labelling and package leaflet

Article 10

Labelling of the immediate packaging of veterinary medicinal products

1. 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.

2. The information referred to in paragraph 1 of this Article shall appear in easily legible and clearly comprehensible characters, or in abbreviations or pictograms common throughout the Union as listed in accordance with Article 17(2).

3. Notwithstanding paragraph 1, a Member State may decide that, on the immediate packaging of a veterinary medicinal product made available in its territory, an identification code shall be added to the information required under paragraph 1.

Article 11

Labelling of the outer packaging of veterinary medicinal products

1. 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.

2. A Member State may decide that, on the outer packaging of a veterinary medicinal product made available in its territory, an identification code shall be added to the information required under paragraph 1. Such a code may be used to replace the marketing authorisation number referred to in point (h) of paragraph 1.

3. The information referred to in paragraph 1 of this Article shall appear in easily legible and clearly comprehensible characters, or in abbreviations or pictograms common throughout the Union, as listed in accordance with Article 17(2).

4. Where there is no outer packaging, all the information referred to in paragraphs 1 and 2 shall appear on the immediate packaging.

Article 12

Labelling of small immediate packaging units of veterinary medicinal products

1. 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.’.

2. The immediate packaging units referred to in paragraph 1 of this Article shall have an outer packaging containing information required in Article 11(1), (2) and (3).

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

1. 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; (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.

2. The package leaflet may bear additional information concerning distribution, possession or any necessary precaution in conformity with the marketing authorisation, provided that the information is not promotional. That additional information shall appear in the package leaflet clearly separated from the information referred to in paragraph 1.

3. The package leaflet shall be written and designed to be readable, clear and understandable, in terms that are comprehensible to the general public. Member States may decide that it shall be made available on paper or electronically, or both.

4. By derogation from paragraph 1, the information required in accordance with this Article may, alternatively, be provided on the packaging of the veterinary medicinal product.

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;

(c) method of administration and, if necessary, route of administration;

(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

1. The Commission shall, when appropriate, by means of implementing acts, establish uniform rules on the identification code referred to in Articles 10(3) and 11(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

2. The Commission shall, by means of implementing acts, adopt a list of the abbreviations and pictograms common throughout the Union to be used for the purposes of Articles 10(2) and 11(3). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

3. The Commission shall, by means of implementing acts, provide uniform rules on the size of small immediate packaging units referred to in Article 12. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).







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

1. 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.

2. Where the active substance of a generic veterinary medicinal product consists of salts, esters, ethers, isomers and mixtures of isomers, complexes or derivatives differing from the active substance used in the reference veterinary medicinal product, it shall be considered to be the same active substance as that used in the reference veterinary medicinal product, unless it differs significantly in respect of properties with regard to safety or efficacy. Where it differs significantly in respect of those properties, the applicant shall submit additional information in order to prove the safety or efficacy of the various salts, esters or derivatives of the authorised active substance of the reference veterinary medicinal product.

3. Where several immediate-release oral pharmaceutical forms of a generic veterinary medicinal product are presented, they shall be considered to be the same pharmaceutical form.

4. Where the reference veterinary medicinal product is not authorised in the Member State in which the application for the generic veterinary medicinal product is submitted, or the application is submitted in accordance with Article 42(4) and the reference veterinary medicinal product is authorised in a Member State, the applicant shall indicate in its application the Member State in which the reference veterinary medicinal product has been authorised.

5. The competent authority or the Agency, as applicable, may request information on the reference veterinary medicinal product from the competent authority of the Member State where it is authorised. Such information shall be transmitted to the requestor within 30 days of receipt of the request.

6. The summary of the product characteristics of the generic veterinary medicinal product shall be essentially similar to that of the reference veterinary medicinal product. However, that requirement shall not apply to those parts of the summary of the product characteristics of the reference veterinary medicinal product that refer to indications or pharmaceutical forms which are still covered by patent law at the time when the generic veterinary medicinal product is authorised.

7. A competent authority or the Agency, as applicable, may require the applicant to provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment where the marketing authorisation for the reference veterinary medicinal product was granted before 1 October 2005.

Article 19

Hybrid veterinary medicinal products

1. 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.

2. The pre-clinical studies or clinical trials for a hybrid veterinary medicinal product may be conducted with batches of the reference veterinary medicinal product authorised in the Union or in a third country.

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

Application based on informed consent

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

1. By way of derogation from point (b) of Article 8(1), the applicant shall not be required to provide the documentation on safety and efficacy if that applicant demonstrates that the active substances of the veterinary medicinal product have been in well-established veterinary use within the Union for at least 10 years, that their efficacy is documented and that they provide an acceptable level of safety.

2. The application shall satisfy the requirements set out in Annex II.







Section 6

Marketing authorisations for limited market and in exceptional circumstances

Article 23

Applications for limited markets

1. 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.

2. Where a veterinary medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of safety or efficacy has been conducted due to the lack of comprehensive safety or efficacy data.

Article 24

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

1. By way of derogation from Article 5(2), a marketing authorisation for a limited market shall be valid for a period of five years.

2. Before the expiry of the five-year period of validity referred to in paragraph 1 of this Article, marketing authorisations for a limited market granted in accordance with Article 23 shall be re-examined on the basis of an application from the holder of that marketing authorisation. That application shall include an updated benefit-risk assessment.

3. A holder of a marketing authorisation for a limited market shall submit an application for a re-examination to the competent authority that granted the authorisation or to the Agency, as applicable, at least six months before the expiry of the five-year period of validity referred to in paragraph 1 of this Article. The application for re-examination shall be limited to demonstrating that the conditions referred to in Article 23(1) continue to be fulfilled.

4. When an application for re-examination has been submitted, the marketing authorisation for a limited market shall remain valid until a decision has been adopted by the competent authority or the Commission, as applicable.

5. The competent authority or the Agency, as applicable, shall assess applications for a re-examination and for an extension of the validity of the marketing authorisation.

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.

6. The competent authority or the Commission, as applicable, may at any time grant a marketing authorisation valid for an unlimited period of time in respect of a veterinary medicinal product authorised for a limited market, provided that the holder of the marketing authorisation for a limited market submits the missing data on safety or efficacy referred to in Article 23(1).

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

1. 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; (c) a requirement to conduct post-authorisation studies.

2. Where a veterinary medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality, safety or efficacy has been conducted due to the lack of comprehensive quality, safety or efficacy data.

Article 27

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

1. By way of derogation from Article 5(2), a marketing authorisation in exceptional circumstances shall be valid for a period of one year.

2. Before the expiry of the one-year period of validity referred to in paragraph 1 of this Article, marketing authorisations granted in accordance with Articles 25 and 26 shall be re-examined on the basis of an application from the holder of that marketing authorisation. That application shall include an updated benefit-risk assessment.

3. A holder of a marketing authorisation in exceptional circumstances shall submit an application for re-examination to the competent authority that granted the authorisation or to the Agency, as applicable, at least three months before the expiry of the one-year period of validity referred to in paragraph 1. The application for re-examination shall demonstrate that the exceptional circumstances related to animal health or public health remain.

4. When an application for re-examination has been submitted, the marketing authorisation shall remain valid until a decision has been adopted by the competent authority or the Commission, as applicable.

5. The competent authority or the Agency, as applicable, shall assess the application.

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 for one year.

6. The competent authority or the Commission, as applicable, may at any time grant a marketing authorisation valid for an unlimited period of time in respect of a veterinary medicinal product authorised in accordance with Articles 25 and 26, provided that the marketing authorisation holder submits the missing data on quality, safety or efficacy referred to in Article 25.







Section 7

Examination of applications and basis for granting marketing authorisations

Article 28

Examination of applications

1. 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; (c) draw up a conclusion on the benefit-risk balance for the veterinary medicinal product.

2. During the process of examination of applications for marketing authorisations for veterinary medicinal products containing or consisting of genetically modified organisms as referred to in Article 8(5) of this Regulation, the Agency shall hold the necessary consultations with the bodies set up by the Union or Member States in accordance with Directive 2001/18/EC.

Article 29

Requests to laboratories in the course of the examination of applications

1. 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.

2. The time limits laid down in Articles 44, 47, 49, 52 and 53 shall be suspended until the samples requested in accordance with paragraph 1 of this Article have been provided.

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

1. An applicant may withdraw the application for marketing authorisation submitted to a competent authority or the Agency, as applicable, at any time before the decision referred to in Article 44, 47, 49, 52 or 53 has been taken.

2. If an applicant withdraws the application for a marketing authorisation submitted to a competent authority or the Agency, as applicable, before the examination of the application as referred to in Article 28 has been completed, the applicant shall communicate the reasons for doing so to the competent authority or the Agency, as applicable, to which the application was submitted in accordance with Article 6.

3. The competent authority or the Agency, as applicable, shall make publicly available the information that the application has been withdrawn, together with the report or the opinion, as applicable, if already drawn up, after deletion of any commercially confidential information.

Article 33

Outcome of the assessment

1. 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; (c) the text of the labelling and package leaflet referred to in Articles 10 to 14.

2. In the case of an unfavourable assessment, the assessment report or the opinion referred to in paragraph 1 shall contain the justification for its conclusions.

Article 34

Classification of veterinary medicinal products

1. 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; (c) antimicrobial veterinary medicinal products; (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.

2. The competent authority or the Commission, as applicable, may, notwithstanding paragraph 1 of this Article, classify a veterinary medicinal product as subject to veterinary prescription if it is classified as a narcotic drug in accordance with national law or where special precautions are contained in the summary of product characteristics referred to in Article 35.

3. 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

1. 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.

2. In the case of generic veterinary medicinal products, the parts of the summary of the product characteristics of the reference veterinary medicinal product that refer to indications or pharmaceutical forms which are protected by patent law in a Member State at the time of placing of the generic veterinary medicinal product on the market may be omitted.

Article 36

Decisions granting marketing authorisations

1. Decisions granting marketing authorisations referred to in Article 5(1) shall be taken on the basis of the documents prepared in accordance with Article 33(1) and shall set out any conditions attached to the placing on the market of the veterinary medicinal product and the summary of the product characteristics (‘terms of the marketing authorisation’).

2. Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission, as applicable, may require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive given the potential development of antimicrobial resistance.

Article 37

Decisions refusing marketing authorisations

1. Decisions refusing marketing authorisations referred to in Article 5(1) shall be taken on the basis of the documents prepared in accordance with Article 33(1) and shall be duly justified and include the reasons for refusal.

2. 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.

3. A marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans as provided for in paragraph 5.

4. The Commission shall adopt delegated acts in accordance with Article 147 in order to supplement this Regulation by establishing the criteria for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of those antimicrobials.

5. The Commission shall, by means of implementing acts, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

6. The Commission shall, when adopting the acts referred to in paragraphs 4 and 5, take into account the scientific advice of the Agency, the EFSA and other relevant Union agencies.







Section 8

Protection of technical documentation

Article 38

Protection of technical documentation

1. 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.

2. The protection of the technical documentation as set out to in paragraph 1 (‘the protection of technical documentation’) shall also apply in Member States where the veterinary medicinal product is not authorised or is no longer authorised.

3. A marketing authorisation or a variation to the terms of a marketing authorisation differing from the marketing authorisation previously granted to the same marketing authorisation holder only with regard to target species, strengths, pharmaceutical forms, administration routes or presentations shall be regarded as the same marketing authorisation as the one previously granted to the same marketing authorisation holder for the purpose of applying the rules of the protection of technical documentation.

Article 39

Periods of the protection of technical documentation

1. 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; (c) 18 years for veterinary medicinal products for bees; (d) 14 years for veterinary medicinal products for animal species other than those referred to in points (a) and (c).

2. The protection of technical documentation shall apply from the day when the marketing authorisation for the veterinary medicinal product was granted in accordance with Article 5(1).

Article 40

Prolongation and additional periods of the protection of technical documentation

1. Where the first marketing authorisation is granted for more than one animal species referred to in point (a) or (b) of Article 39(1) or a variation is approved in accordance with Article 67 extending the marketing authorisation to another species referred to in point (a) or (b) of Article 39(1), the period of the protection provided for in Article 39 shall be prolonged by one year for each additional target species, provided that, in the case of a variation, the application has been submitted at least three years before the expiration of the protection period laid down in point (a) or (b) of Article 39(1).

2. Where the first marketing authorisation is granted for more than one animal species referred to in point (d) of Article 39(1), or a variation is approved in accordance with Article 67 extending the marketing authorisation to another animal species not referred to in point (a) of Article 39(1), the period of the protection provided for in Article 39 shall be prolonged by four years, provided that, in the case of a variation, the application has been submitted at least three years before the expiration of the protection period laid down in point (d) of Article 39(1).

3. The period of the protection of technical documentation provided for in Article 39 of the first marketing authorisation, prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation, shall not exceed 18 years.

4. Where an applicant for a marketing authorisation for a veterinary medicinal product or for a variation to the terms of a marketing authorisation submits an application in accordance with Regulation (EC) No 470/2009 for the establishment of a maximum residue limit, together with safety and residues tests and pre-clinical studies and clinical trials during the application procedure, other applicants shall not refer to results of those tests, studies and trials for a period of five years from the granting of the marketing authorisation for which they were carried out. The prohibition on using those results shall not apply, insofar as the other applicants have obtained a letter of access with regard to those tests, studies and trials.

5. 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

Patent-related rights

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

1. Centralised marketing authorisations shall be valid throughout the Union.

2. 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.

3. Points (d) and (e) of paragraph 2 shall not apply to veterinary medicinal products consisting exclusively of blood components.

4. For veterinary medicinal products other than those referred to in paragraph 2, a centralised marketing authorisation may be granted if no other marketing authorisation has been granted for the veterinary medicinal product within the Union.

Article 43

Application for centralised marketing authorisation

1. An application for a centralised marketing authorisation shall be submitted to the Agency. The application shall be accompanied by the fee payable to the Agency for the examination of the application.

2. The application for a centralised marketing authorisation of a veterinary medicinal product shall state a single name for the veterinary medicinal product to be used throughout the Union.

Article 44

Procedure for centralised marketing authorisation

1. The Agency shall assess the application referred to in Article 43. The Agency shall prepare, as an outcome of the assessment, an opinion containing the information referred to in Article 33.

2. The Agency shall issue the opinion referred to in paragraph 1 within 210 days of receipt of a valid application. Exceptionally, where a particular expertise is required, the time limit may be extended by a maximum of 90 days.

3. When an application is submitted for a marketing authorisation in respect of veterinary medicinal products of major interest, particularly from the point of view of animal health and therapeutic innovation, the applicant may request an accelerated assessment procedure. The request shall be duly substantiated. If the Agency accepts the request, the time limit of 210 days shall be reduced to 150 days.

4. The Agency shall forward the opinion to the applicant. Within 15 days of receipt of the opinion, the applicant may provide written notice to the Agency that he or she wishes to request a re-examination of the opinion. In such a case, Article 45 shall apply.

5. Where the applicant has not provided written notice in accordance with paragraph 4, the Agency shall, without undue delay, forward its opinion to the Commission.

6. The Commission may request clarifications from the Agency as regards the content of the opinion, in which case the Agency shall provide a response to this request within 90 days.

7. The applicant shall submit to the Agency the necessary translations of the summary of product characteristics, package leaflet and labelling in accordance with Article 7, within the time limit set by the Agency, but at the latest on the date that the draft decision is forwarded to the competent authorities in accordance with paragraph 8 of this Article.

8. Within 15 days of receipt of the opinion of the Agency, the Commission shall prepare a draft decision to be taken in respect of the application. Where a draft decision envisages granting of a marketing authorisation, it shall include the opinion of the Agency prepared in accordance with paragraph 1. Where the draft decision is not in accordance with the opinion of the Agency, the Commission shall annex a detailed explanation of the reasons for the differences. The Commission shall forward the draft decision to the competent authorities of Member States and to the applicant.

9. The Commission shall, by means of implementing acts, take a decision to grant or refuse a centralised marketing authorisation in accordance with this Section and on the basis of the opinion of the Agency. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

10. The Agency shall make its opinion publicly available, after deleting any commercially confidential information.

Article 45

Re-examination of the opinion of the Agency

1. Where the applicant requests a re-examination of the opinion of the Agency in accordance with Article 44(4), that applicant shall forward to the Agency detailed grounds for such request within 60 days of receipt of the opinion.

2. Within 90 days of receipt of the detailed grounds for the request, the Agency shall re-examine its opinion. The conclusions reached and the reasons for those conclusions shall be annexed to its opinion and shall form an integral part thereof.

3. Within 15 days of the re-examination of its opinion, the Agency shall forward its opinion to the Commission and the applicant.

4. Subsequent to the procedure set out in paragraph 3 of this Article, Article 44(6) to (10) shall apply.







Section 2

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

Article 46

Scope of national marketing authorisation

1. An application for a national marketing authorisation shall be submitted to the competent authority in the Member State for which the authorisation is applied. The competent authority shall grant a national marketing authorisation in accordance with this Section and applicable national provisions. A national marketing authorisation shall be valid only in the Member State of the competent authority which granted it.

2. National marketing authorisations shall not be granted in respect of veterinary medicinal products which fall within the scope of Article 42(2), or for which a national marketing authorisation has been granted, or for which an application for a national marketing authorisation is pending in another Member State at the time of the application.

Article 47

Procedure for national marketing authorisation

1. The procedure for granting or refusing a national marketing authorisation for a veterinary medicinal product shall be completed within a maximum of 210 days of the submission of the valid application.

2. The competent authority shall prepare an assessment report containing the information referred to in Article 33.

3. The competent authority shall make the assessment report publicly available, after deleting any commercially confidential information.







Section 3

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

Article 48

Scope of decentralised marketing authorisation

1. Decentralised marketing authorisations shall be granted by the competent authorities in the Member States in which the applicant seeks to obtain a marketing authorisation (‘Member States concerned’) in accordance with this Section. Such decentralised marketing authorisations shall be valid in those Member States.

2. Decentralised marketing authorisations shall not be granted in respect of veterinary medicinal products for which a national marketing authorisation has been granted, or for which an application for a marketing authorisation is pending at the time of the application for a decentralised marketing authorisation, or which fall within the scope of Article 42(2).

Article 49

Procedure for decentralised marketing authorisation

1. An application for a decentralised marketing authorisation shall be submitted to the competent authority in the Member State chosen by the applicant to prepare an assessment report and to act in accordance with this Section (‘reference Member State’) and to the competent authorities in the other Member States concerned.

2. The application shall list the Member States concerned.

3. If the applicant indicates that one or more of the Member States concerned shall no longer be considered as such, the competent authorities in those Member States shall provide to the competent authority in the reference Member State and to the competent authorities in the other Member States concerned any information they consider relevant with respect to the withdrawal of the application.

4. Within 120 days of receipt of a valid application, the competent authority in the reference Member State shall prepare an assessment report containing the information referred to in Article 33 and shall forward it to the competent authorities in the Member States concerned and to the applicant.

5. Within 90 days of receipt of the assessment report referred to in paragraph 4, the competent authorities in the Member States concerned shall examine the report and inform the competent authority in the reference Member State whether they have any objections to it on the ground that the veterinary medicinal product would pose a potential serious risk to human or animal health or to the environment. The competent authority in the reference Member State shall forward the assessment report resulting from that examination to the competent authorities in the Member States concerned and to the applicant.

6. On the request of the competent authority in the reference Member State or the competent authority in any of the Member States concerned, the coordination group shall be convened to examine the assessment report within the period referred to in paragraph 5.

7. Where the assessment report is favourable and where no competent authority has informed the competent authority in the reference Member State of an objection thereto, as referred to in paragraph 5, the competent authority in the reference Member State shall record that there is an agreement, close the procedure and, without undue delay, inform the applicant and the competent authorities in all Member States accordingly. The competent authorities in the Member States concerned shall grant a marketing authorisation in conformity with the assessment report within 30 days of receipt of both the information on the agreement from the competent authority in the reference Member State and the complete translations of the summary of product characteristics, labelling and package leaflet from the applicant.

8. Where the assessment report is unfavourable and where none of the competent authorities in the Member States concerned has informed the competent authority in the reference Member State of an objection thereto, as set out in paragraph 5, the competent authority in the reference Member State shall record that there is a refusal to grant the marketing authorisation, close the procedure and, without undue delay, inform the applicant and the competent authorities in all Member States accordingly.

9. Where a competent authority in a Member State concerned informs the competent authority in the reference Member State of an objection to the assessment report in accordance with paragraph 5 of this Article, the procedure referred to in Article 54 shall apply.

10. If at any stage of the procedure for a decentralised marketing authorisation the competent authority in a Member State concerned invokes the reasons referred to in Article 110(1) for prohibiting the veterinary medicinal product, that Member State shall no longer be considered as a Member State concerned.

11. The competent authority in the reference Member State shall make the assessment report publicly available, after deleting any commercially confidential information.

Article 50

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

1. Within 15 days of receipt of the assessment report referred to in Article 49(5), the applicant may provide written notice to the competent authority in the reference Member State requesting a re-examination of the assessment report. In that case, the applicant shall forward to the competent authority in the reference Member State detailed grounds for such a request within 60 days of receipt of that assessment report. The competent authority in the reference Member State shall without delay forward that request and the detailed grounds to the coordination group.

2. Within 60 days of receipt of the detailed grounds for the request for re-examination of the assessment report, the coordination group shall re-examine the assessment report. The conclusions reached by the coordination group and the reasons for those conclusions shall be annexed to the assessment report and shall form an integral part thereof.

3. Within 15 days of the re-examination of the assessment report, the competent authority in the reference Member State shall forward the assessment report to the applicant.

4. Subsequent to the procedure set out in paragraph 3 of this Article, Article 49(7), (8), (10) and (11) shall apply.







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

1. An application for mutual recognition of a national marketing authorisation shall be submitted to the competent authority in the Member State that granted the national marketing authorisation in accordance with Article 47 (‘reference Member State’) and to the competent authorities in the Member States where the applicant seeks to obtain a marketing authorisation (‘Member States concerned’).

2. The application for mutual recognition shall list the Member States concerned.

3. A minimum of six months shall elapse between the decision granting the national marketing authorisation and the submission of the application for mutual recognition of that national marketing authorisation.

4. If the applicant indicates that one or more of the Member States concerned shall no longer be considered as such, the competent authorities in those Member States shall provide to the competent authority in the reference Member State and to the competent authorities in the other Member States concerned any information they consider relevant with respect to the withdrawal of the application.

5. Within 90 days of receipt of a valid application for mutual recognition, the competent authority in the reference Member State shall prepare an updated assessment report containing the information referred to in Article 33 for the veterinary medicinal product and shall forward it to the competent authorities in the Member States concerned and to the applicant.

6. Within 90 days of receipt of the updated assessment report referred to in paragraph 5, the competent authorities in the Member States concerned shall examine it and inform the competent authority in the reference Member State of whether they have any objections to it on the ground that the veterinary medicinal product would pose a potential serious risk to human or animal health or to the environment. The competent authority in the reference Member State shall forward the assessment report resulting from that examination to the competent authorities in the Member States concerned and to the applicant.

7. On the request of the competent authority in the reference Member State or the competent authority in any of the Member States concerned, the coordination group shall be convened to examine the updated assessment report within the period referred to in paragraph 6.

8. Where no competent authority of any Member State concerned has informed the competent authority in the reference Member State of an objection to the updated assessment report, as referred to in paragraph 6, the competent authority in the reference Member State shall record that there is an agreement, close the procedure and, without undue delay, inform the applicant and the competent authorities in all Member States accordingly. The competent authorities in the Member States concerned shall grant a marketing authorisation in conformity with the updated assessment report within 30 days of receipt of both the information on the agreement from the competent authority in the reference Member State and the complete translations of the summary of product characteristics, labelling and package leaflet from the applicant.

9. Where a competent authority in a Member State concerned informs the competent authority in the reference Member State of an objection to the updated assessment report in accordance with paragraph 6 of this Article, the procedure referred to in Article 54 shall apply.

10. If at any stage of the procedure for mutual recognition the competent authority in a Member State concerned invokes the reasons referred to in Article 110(1) for prohibiting the veterinary medicinal product, that Member State shall no longer be considered as a Member State concerned.

11. The competent authority in the reference Member State shall make the assessment report publicly available, after deleting any commercially confidential information.







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

1. 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); (c) a summary report on pharmacovigilance data.

2. The competent authority in the reference Member State referred to in Article 49 or 52, as applicable, shall forward within 60 days to the competent authorities in the additional Member States concerned the decision to grant the marketing authorisation and any variations thereto and shall, within that period, prepare and forward an updated assessment report concerning that marketing authorisation and those variations, as applicable, and inform the applicant accordingly.

3. The competent authority in each additional Member State concerned shall grant a marketing authorisation in conformity with the updated assessment report referred to in paragraph 2 within 60 days of receipt of both the data and information referred to in paragraph 1 and the complete translations of the summary of product characteristics, labelling and package leaflet.

4. By derogation from paragraph 3 of this Article, if the competent authority in an additional Member State concerned has reasons for refusing the marketing authorisation on the ground that the veterinary medicinal product would pose a potential serious risk to human or animal health or to the environment, it shall, at the latest within a period of 60 days of receipt of both the data and information referred to in paragraph 1 and updated assessment report referred to in paragraph 2 of this Article raise its objections and provide a detailed statement of the reasons to the competent authority in the reference Member State referred to in Article 49 or 52, as applicable, and to the competent authorities in the Member States concerned, referred to in those Articles, and to the applicant.

5. In the case of objections raised by the competent authority in an additional Member State concerned in accordance with paragraph 4, the competent authority in the reference Member State shall take any appropriate steps in order to seek an agreement as regards the objections made. The competent authorities in the reference Member State and in the additional Member State concerned shall make their best efforts to reach an agreement on the action to be taken.

6. The competent authority in the reference Member State shall provide the applicant with the opportunity to provide, orally or in writing, the applicant’s point of view as regards the objections raised by the competent authority in an additional Member State concerned.

7. Where, following the steps taken by the competent authority in the reference Member State, an agreement is reached by the competent authorities in the reference Member State and in the Member States which have already granted a marketing authorisation and the competent authorities in the additional Member States concerned, the competent authorities in the additional Member States concerned shall grant a marketing authorisation in accordance with paragraph 3.

8. If the competent authority in the reference Member State has not been able to find an agreement with the competent authorities in the Member States concerned and additional Member States concerned at the latest within 60 days from the date on which the objections referred to in paragraph 4 of this Article were raised, it shall refer the application together with the updated assessment report referred to in paragraph 2 of this Article and the objections of the competent authorities in the additional Member States concerned to the coordination group in accordance with the review procedure laid down in Article 54.







Section 6

Review procedure

Article 54

Review procedure

1. If the competent authority in a Member State concerned raises, in accordance with Article 49(5), 52(6), 53(8) or 66(8) an objection as referred to in those Articles to, respectively, the assessment report or the updated assessment report, it shall provide without delay a detailed statement of the reasons for any such objection to the competent authority in the reference Member State, to the competent authorities in the Member States concerned and to the applicant or the marketing authorisation holder. The competent authority in the reference Member State shall refer the points of disagreement without delay to the coordination group.

2. The competent authority in the reference Member State shall take, within 90 days of receipt of the objection, any appropriate steps in order to seek an agreement as regards the objection raised.

3. The competent authority in the reference Member State shall provide the applicant or the marketing authorisation holder with the opportunity to provide, orally or in writing, their point of view as regards the objection raised.

4. Where an agreement among the competent authorities referred to in Articles 49(1), 52(1), 53(1) and 66(1) is reached, the competent authority in the reference Member State shall close the procedure and inform the applicant or the marketing authorisation holder. The competent authorities in the Member States concerned shall grant or vary a marketing authorisation.

5. When the competent authorities referred to in Articles 49(1), 52(1), 53(1) and 66(1) reach an agreement by consensus to refuse the marketing authorisation or to reject the variation, the competent authority in the reference Member State shall close the procedure and inform the applicant or the marketing authorisation holder thereof, duly justifying the refusal or the rejection. The competent authorities in the Member States concerned shall thereafter refuse the marketing authorisation or reject the variation.

6. If an agreement among the competent authorities referred to in Articles 49(1), 52(1), 53(1) and 66(1) cannot be reached by consensus, the coordination group shall provide the Commission with the assessment report referred to in Articles 49(5), 52(6), 53(2) and 66(3), respectively, together with information on the points of disagreement at the latest within a period of 90 days from the date on which the objection referred to in paragraph 1 of this Article was raised.

7. Within 30 days of receipt of the report and information referred to in paragraph 6, the Commission shall prepare a draft decision to be taken in respect of the application. The Commission shall forward the draft decision to the competent authorities and to the applicant or the marketing authorisation holder.

8. The Commission may request clarifications from the competent authorities or the Agency. The time limit laid down in paragraph 7 shall be suspended until the clarifications have been provided.

9. For the purpose of the work-sharing procedure in respect of variations requiring assessment in accordance with Article 66, references in this Article to a competent authority in the reference Member State shall be understood as references to a competent authority agreed upon in accordance with Article 65(3), and references to Member States concerned as references to relevant Member States.

10. The Commission shall, by means of implementing acts, take a decision to grant, change, refuse or revoke a marketing authorisation or to reject a variation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).







CHAPTER IV

POST-MARKETING AUTHORISATION MEASURES







Section 1

Union product database

Article 55

Union database on veterinary medicinal products

1. The Agency shall establish and, in collaboration with the Member States, maintain, a Union database on veterinary medicinal products (‘product database’).

2. 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; (c) veterinary medicinal products allowed to be used in a Member State in accordance with Article 5(6); (d) the annual volume of sales and information on the availability for each veterinary medicinal product.

3. 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; (c) detailed specifications of the information to be included, updated and shared in the product database and by whom; (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

1. The competent authorities, the Agency and the Commission shall have full access to the information in the product database.

2. Marketing authorisation holders shall have full access to the information in the product database as regards their marketing authorisations.

3. The general public shall have access to information in the product database, without the possibility to change the information therein, as regards the list of the veterinary medicinal products, the summary of product characteristics, package leaflets and, after the deletion of any commercially confidential information by the competent authority, assessment reports.







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

1. Member States shall collect relevant and comparable data on the volume of sales and on the use of antimicrobial medicinal products used in animals, to enable in particular the direct or indirect evaluation of the use of such products in food-producing animals at farm level, in accordance with this Article and within the time limits set out in paragraph 5.

2. Member States shall send collated data on the volume of sales and the use per animal species and per types of antimicrobial medicinal products used in animals to the Agency in accordance with paragraph 5 and within the time limits referred to therein. The Agency shall cooperate with Member States and with other Union agencies to analyse those data and shall publish an annual report. The Agency shall take into account those data when adopting any relevant guidelines and recommendations.

3. 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