2001L0082 — EN — 06.03.2009 — 002.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B DIRECTIVE 2001/82/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p.1)

Amended by:









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DIRECTIVE 2001/82/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 6 November 2001

on the Community code relating to veterinary medicinal products







THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the Economic and Social Committee ( 1 ), Acting in accordance with the procedure laid down in Article 251 of the Treaty ( 2 ), Whereas: (1) Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products ( 3 ), Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products ( 4 ), Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products ( 5 ), and Council Directive 92/74/EEC of 22 September 1992 widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products ( 6 ) have been frequently and substantially amended; in the interests of clarity and rationality, the said Directives should therefore be codified by assembling them in a single text. (2) The primary purpose of any rules for the production and distribution of veterinary medicinal products must be the safeguarding of public health. (3) However, this objective must be achieved by means which will not hinder the development of industry and trade in medicinal products within the Community. (4) In so far as the Member States already have certain provisions laid down by law, regulation or administrative action governing veterinary medicinal products, such provisions differ in essential principles. This results in the hindering of trade in medicinal products within the Community, thereby directly affecting the functioning of the internal market. (5) Such hindrances must, accordingly, be removed; whereas this entails approximation of the relevant provisions. (6) It is necessary from the point of view of public health and the free movement of veterinary medicinal products for the competent authorities to have at their disposal all useful information on authorized veterinary medicinal products in the form of approved summaries of the characteristics of products. (7) With the exception of those medicinal products which are subject to the centralised Community authorization procedure established by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products ( 7 ), a marketing authorization in one Member State ought to be recognized by the competent authority of the other Member States unless there are serious grounds for supposing that the authorization of the veterinary medicinal product concerned may present a risk to human or animal health, or to the environment; in the event of a disagreement between Member States about the quality, the safety or the efficacy of a medicinal product, a scientific evaluation of the matter should be undertaken at a Community level, lead to a single decision on the area of disagreement, binding on the Member States concerned. This Decision should be adopted by a rapid procedure ensuring close cooperation between the Commission and the Member States. (8) For this purpose, a Committee for Veterinary Medicinal Products should be set up in accordance with the European Agency for the Evaluation of Medicinal Products laid down in the aforementioned Regulation (EEC) No 2309/93. (9) This Directive is only one stage in the achievement of the aim of freedom of movement of veterinary medicinal products. However, for this purpose, new measures will prove necessary, in the light of experience gained — especially within the Committee for Veterinary Medicinal Products — for the removal of the remaining barriers to freedom of movement. (10) Medicated feedingstuffs do not come within the scope of this Directive. However, it is necessary, for both public health and economic reasons, to prohibit the use of unauthorized medicinal products in the manufacture of medicated feedingstuffs. (11) The concepts of harmfulness and therapeutic efficacy can be examined only in relation to one another and have only a relative significance, depending on the progress of scientific knowledge and the use for which the medicinal product is intended. The particulars and documents which must accompany an application for marketing authorization must demonstrate that potential hazards are outweighed by the benefits due to efficacy. Failing such demonstration, the application must be rejected. (12) Marketing authorization should be refused where a medicinal product lacks therapeutic effect or where there is insufficient proof of such effect. The concept of therapeutic effect must be understood as being the effect promised by the manufacturers. (13) Such marketing authorization should also be refused where the withdrawal period indicated is not long enough to eliminate health hazards arising from residues. (14) Before an authorization to market an immunological veterinary medicinal product can be granted, the manufacturer must demonstrate his ability to attain batch-to-batch consistency. (15) The competent authorities should also be empowered to prohibit the use of an immunological veterinary medicinal product when the immunological responses of the treated animal will interfere with a national or Community programme for the diagnosis, eradication or control of animal disease. (16) It is desirable in the first instance to provide users of homeopathic medicinal products with a very clear indication of their homeopathic character and with sufficient guarantees of their quality and safety. (17) The rules relating to the manufacture, control and inspection of homeopathic veterinary medicinal products must be harmonised to permit the circulation throughout the Community of medicinal products which are safe and of good quality. (18) Having regard to the particular characteristics of these homeopathic veterinary medicinal products, such as the very low level of active principles they contain and the difficulty of applying to them the conventional statistical methods relating to clinical trials, it is desirable to provide a special, simplified registration procedure for those traditional homeopathic medicinal products which are placed on the market without therapeutic indications in a pharmaceutical form and dosage which do not present a risk for the animal. (19) The usual rules governing the authorization to market veterinary medicinal products must be applied to homeopathic veterinary medicinal products marketed with therapeutic indications or in a form which may present risks which must be balanced against the desired therapeutic effect. Member States should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products for pet animals and exotic species, provided that they notify them to the Commission. (20) In order to better protect human and animal health and avoid any unnecessary duplication of effort during the examination of application for a marketing authorization, Member States should systematically prepare assessment reports in respect of each veterinary medicinal product which is authorized by them, and exchange the reports upon request. Furthermore, a Member State should be able to suspend the examination of an application for authorization to place a veterinary medicinal product on the market which is currently under active consideration in another Member State with a view to recognizing the decision reached by the latter Member State. (21) In order to facilitate the movement of veterinary medicinal products and to prevent the checks carried out in one Member State from being repeated in another, minimum requirements for manufacture and imports from third countries, and the grant of corresponding authorizations, should be applied to veterinary medicinal products. (22) The quality of veterinary medicinal products manufactured within the Community should be guaranteed by requiring compliance with the principles of good manufacturing practice for medicinal products irrespective of the final destination of the medicinal products. (23) Measures should also be taken to ensure that distributors of veterinary medicinal products are authorized by Member States and maintain adequate records. (24) Standards and protocols for the performance of tests and trials on veterinary medicinal products are an effective means of control of these products and, hence, of protecting public health and can facilitate the movement of these products by laying down uniform rules applicable to tests and the compilation of dossiers, allowing the competent authorities to arrive at their decisions on the basis of uniform tests and by reference to uniform criteria, and therefore helping to obviate differences in evaluation. (25) It is advisable to stipulate more precisely the cases in which the results of pharmacological and toxicological tests or clinical trials do not have to be provided with a view to obtaining authorization for a veterinary medicinal product which is essentially similar to an innovative product, while ensuring that innovative forms are not placed at a disadvantage. However, there are reasons of public policy for not repeating tests carried out on animals without overriding cause. (26) Following the establishment of the internal market, specific controls to guarantee the quality of veterinary medicinal products imported from third countries can be waived only if appropriate arrangements have been made by the Community to ensure that the necessary controls are carried out in the exporting country. (27) In order to ensure the continued safety of veterinary medicinal products in use, it is necessary to ensure that pharmacovigilance systems in the Community are continually adapted to take account of scientific and technical progress. (28) For public health protection, relevant data on adverse effects in humans related to the use of veterinary medicines should be collected and evaluated. (29) The pharmacovigilance systems should consider the available data on lack of efficacy. (30) In addition, collection of information on adverse reactions due to off-label use, investigations of the validity of the withdrawal period and on potential environmental problems may contribute to improve regular monitoring of good usage of veterinary medicines. (31) It is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance. (32) The increasing use of electronic means of communication of information on adverse reactions to veterinary medicinal products marketed in the Community is intended to allow a single reporting point for adverse reactions, at the same time ensuring that this information is shared with the competent authorities in all Member States. (33) It is the interest of the Community to ensure that the veterinary pharmacovigilance systems for centrally authorised medicinal products and those authorised by other procedures are consistent. (34) Holders of marketing authorisations should be proactively responsible for ongoing pharmacovigilance of the veterinary medicinal products they place on the market. (35) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission ( 8 ). (36) In order to improve the protection of public health, it is necessary to specify that foodstuffs for human consumption may not be taken from animals which have been used in clinical trials of veterinary medicinal products unless a maximum residue limit has been laid down for residues of the veterinary medicinal product concerned in accordance with the provisions of Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin ( 9 ). (37) The Commission should be empowered to adopt the changes necessary in order to adapt Annex I to scientific and technical progress. (38) This Directive should be without prejudice to the obligations of the Member States concerning the time-limits for transposition of the Directives set out in Annex II, Part B, Whereas: HAVE ADOPTED THIS DIRECTIVE:







TITLE I

DEFINITIONS

Article 1

For the purposes of this Directive, the following terms shall bear the following meanings:

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2. Veterinary medicinal product : (a) any substance or combination of substances presented as having properties for treating or preventing disease in animals; or (b) any substance or combination of substances which may be used in or administered to animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

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4. Substance : Any matter irrespective of origin which may be: — human, e.g. — human blood and human blood products; — animal, e.g. — micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products; — vegetable, e.g. — micro-organisms, plants, parts of plants, vegetable secretions, extracts; — chemical, e.g. — elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.

5. Pre-mix for medicated feedingstuffs : Any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feedingstuffs.

6. Medicated feedingstuffs : Any mixture of a veterinary medicinal product or products and feed or feeds which is ready prepared for marketing and intended to be fed to animals without further processing, because of its curative or preventive properties or other properties as a medicinal product covered by point 2.

7. Immunological veterinary medicinal product : A veterinary medicinal product administered to animals in order to produce active or passive immunity or to diagnose the state of immunity.

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8. Homeopathic veterinary medicinal product : Any veterinary medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in Member States. A homeopathic veterinary medicinal product may contain a number of principles.

9. Withdrawal period : The period necessary between the last administration of the veterinary medicinal product to animals, under normal conditions of use and in accordance with the provisions of this Directive, and the production of foodstuffs from such animals, in order to protect public health by ensuring that such foodstuffs do not contain residues in quantities in excess of the maximum residue limits for active substances laid down pursuant to Regulation (EEC) No 2377/90.

10. Adverse reaction : A reaction to a veterinary medicinal product which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function.

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11. Human adverse reaction : A reaction which is noxious and unintended and which occurs in a human being following exposure to a veterinary medicine.

12. Serious adverse reaction : An adverse reaction which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or which results in permanent or prolonged signs in the animals treated.

13. Unexpected adverse reaction : An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of the product characteristics.

14. Periodic safety update reports : The periodical reports containing the records referred to in Article 75.

15. Post-marketing surveillance studies : Pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorization, conducted with the aim of identifying and investigating a safety hazard relating to an authorized veterinary medicinal product.

16. Off-label use : The use of a veterinary medicinal product that is not in accordance with the summary of the product characteristics, including the misuse and serious abuse of the product.

17. Wholesale dealing in veterinary medicinal products : Any activity which includes the purchase, sale, import, export, or any other commercial transaction in veterinary medicinal products, whether or not for profit, except for: — the supply by a manufacturer of veterinary medicinal products manufactured by himself, — retail supplies of veterinary medicinal products by persons entitled to carry out such supplies in accordance with Article 66.

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17a. Representative of the marketing authorisation holder : The person, commonly known as local representative, designated by the marketing authorisation holder to represent him in the Member State concerned.

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18. Agency : The European Medicines Agency established by Regulation (EC) No 726/2004 ( 10 ).

19. Risks relating to use of the product : — any risk relating to the quality, safety and efficacy of the veterinary medicinal products as regards animal or human health; — any risk of undesirable effects on the environment.

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20. Risk/benefit balance : An evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to the risks as defined above.

21. Veterinary prescription : Any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law.

22. Name of veterinary medicinal product : The name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder.

23. Common name : The international non-proprietary name recommended by the World Health Organisation, or, if one does not exist, the usual common name.

24. Strength : The content of active substances, expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form.

25. Immediate packaging : The container or any other form of packaging that is in direct contact with the medicinal product.

26. Outer packaging : The packaging into which is placed the immediate packaging.

27. Labelling : Information on the immediate or outer packaging.

28. Package leaflet : The leaflet containing information for the user that accompanies the medicinal product.

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TITLE II

SCOPE

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Article 2

1. This Directive shall apply to veterinary medicinal products, including pre-mixes for medicated feedingstuffs, intended to be placed on the market in Member States and prepared industrially or by a method involving an industrial process.

2. In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a ‘veterinary medicinal product’ and within the definition of a product covered by other Community legislation, the provisions of this Directive shall apply.

3. Notwithstanding paragraph 1, this Directive shall also apply to active substances used as starting materials to the extent set out in Articles 50, 50a, 51 and 80 and additionally to certain substances that may be used as veterinary medicinal products that have anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties to the extent set out in Article 68.

Article 3

1. This Directive shall not apply to:

(a) medicated feedingstuffs as defined in Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community ( 11 );

(b) inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals from a holding and used for the treatment of that animal or the animals of that holding in the same locality;

(c) veterinary medicinal products based on radio-active isotopes;

(d) any additives covered by Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs ( 12 ) where they are incorporated in animal feedingstuffs and supplementary animal feedingstuffs in accordance with that Directive; and

(e) without prejudice to Article 95, medicinal products for veterinary use intended for research and development trials.

However, medicated feedingstuffs referred to in subparagraph (a) may be prepared only from pre-mixes that have been authorised under this Directive.

2. Except for the provisions on the possession, prescription, dispensing and administration of veterinary medicinal products, this Directive shall not apply to:

(a) any medicinal product prepared in a pharmacy in accordance with a veterinary prescription for an individual animal or a small group of animals, commonly known as the magistral formula; and

(b) any medicinal product prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the end-user, commonly known as the officinal formula.

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Article 4

1. Member States may provide that this Directive shall not apply to non-inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals from a holding and used for the treatment of that animal or the animals of that holding in the same locality.

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2. In the case of veterinary medicinal products intended solely for aquarium fish, cage birds, homing pigeons, terrarium animals, small rodents, and ferrets and rabbits kept exclusively as pets, Member States may permit exemptions, in their territory, from the provisions in Articles 5 to 8, provided that such products do not contain substances the use of which requires veterinary control and that all possible measures are taken to prevent unauthorised use of the products for other animals.

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TITLE III

MARKETING







CHAPTER 1

Marketing authorization

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Article 5

1. No veterinary medicinal product may be placed on the market of a Member State unless a marketing authorisation has been granted by the competent authorities of that Member State in accordance with this Directive or a marketing authorisation has been granted in accordance with Regulation (EC) No 726/2004.

When a veterinary medicinal product has been granted an initial authorisation in accordance with the first subparagraph, any additional species, strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions, shall also be granted an authorisation in accordance with the first subparagraph or be included in the initial marketing authorisation. All these marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 13(1).

2. The marketing authorisation holder shall be responsible for the marketing of the medicinal product. The designation of a representative shall not relieve the marketing authorisation holder of his legal responsibility.

Article 6

1. A veterinary medicinal product may not be the subject of a marketing authorisation for the purpose of administering it to one or more food-producing species unless the pharmacologically active substances which it contains appear in Annexes I, II or III to Regulation (EEC) No 2377/90.

2. If an amendment to the Annexes to Regulation (EEC) No 2377/90 so warrants, the marketing authorisation holder or, where appropriate, the competent authorities shall take all necessary measures to amend or revoke the marketing authorisation within 60 days of the date on which the amendment to the Annexes to that Regulation was published in the Official Journal of the European Union.

3. By way of derogation from paragraph 1, a veterinary medicinal product containing pharmacologically active substances not included in Annexes I, II or III to Regulation (EEC) No 2377/90 may be authorised for particular animals of the equidae family that have been declared, in accordance with Commission Decision 93/623/EEC of 20 October 1993 establishing the identification document (passport) accompanying registered equidae ( 13 ) and Commission Decision 2000/68/EC of 22 December 1999 amending Decision 93/623/EEC and establishing the identification of equidae for breeding and production ( 14 ), as not being intended for slaughter for human consumption. Such veterinary medicinal products shall neither include active substances that appear in Annex IV to Regulation (EEC) No 2377/90 nor be intended for use in the treatment of conditions, as detailed in the authorised Summary of Product Characteristics, for which a veterinary medicinal product is authorised for animals of the equidae family.

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Article 7

Where the health situation so requires, a Member State may authorise the marketing or administration to animals of veterinary medicinal products which have been authorized by another Member State in accordance with this Directive.

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Article 8

In the event of serious epizootic diseases, Member States may provisionally allow the use of immunological veterinary medicinal products without a marketing authorisation, in the absence of a suitable medicinal product and after informing the Commission of the detailed conditions of use.

The Commission may avail itself of the option set out in the first paragraph when explicit provision is made for that option under Community rules concerning certain serious epizootic diseases.

If an animal is being imported from, or exported to, a third country and is thereby subject to specific binding health rules, a Member State may permit the use, for the animal in question, of an immunological veterinary medicinal product that is not covered by a marketing authorisation in the Member State in question but is authorised under the legislation of the third country. Member States shall take all appropriate measures concerning the supervision of the importation and the use of such immunological products.

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Article 9

No veterinary medicinal product may be administered to animals unless the marketing authorization has been issued, except for the tests of veterinary medicinal products referred to in Article 12(3)(j) which have been accepted by the competent national authorities, following notification or authorization, in accordance with the national rules in force.

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Article 10

1. Member States shall take the necessary measures to ensure that, if there is no authorised veterinary medicinal product in a Member State for a condition affecting a non food-producing species, by way of exception, the veterinarian responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable suffering, treat the animal concerned with:

(a) a veterinary medicinal product authorised in the Member State concerned under this Directive or under Regulation (EC) No 726/2004 for use with another animal species, or for another condition in the same species; or

(b) if there is no product as referred to in point (a), either: (i) a medicinal product authorised for human use in the Member State concerned in accordance with Directive 2001/83/EC of the European Parliament and of the Council or under Regulation (EC) No 726/2004, or (ii) in accordance with specific national measures, a veterinary medicinal product authorised in another Member State in accordance with this Directive for use in the same species or in another species for the condition in question or for another condition; or

(c) if there is no product as referred to in subparagraph (b), and within the limits of the law of the Member State concerned, a veterinary medicinal product prepared extemporaneously by a person authorised to do so under national legislation in accordance with the terms of a veterinary prescription.

The veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian's responsibility.

2. By way of derogation from Article 11, the provisions of paragraph 1 of this Article shall also apply to the treatment by a veterinarian of an animal belonging to the equidae family provided that it has been declared, in accordance with Commission Decisions 93/623/EEC and 2000/68/EC, as not being intended for slaughter for human consumption.

3. By way of derogation from Article 11, and in accordance with the procedure referred to in Article 89(2), the Commission shall establish a list of substances essential for the treatment of equidae and for which the withdrawal period shall be not less than six months according to the control mechanisms laid down in Commission Decisions 93/623/EEC and 2000/68/EC.

Article 11

1. Member States shall take the necessary measures to ensure that, if there is no authorised veterinary medicinal product in a Member State for a condition affecting a food-producing species, by way of exception, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, treat the animals concerned on a particular holding with:

(a) a veterinary medicinal product authorised in the Member State concerned under this Directive or under Regulation (EC) No 726/2004 for use with another animal species, or for another condition in the same species; or

(b) if there is no product as referred to in point (a), either: (i) a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004, or (ii) a veterinary medicinal product authorised in another Member State in accordance with this Directive for use in the same species or in another food-producing species for the condition in question or for another condition; or

(c) if there is no product as referred to in subparagraph (b), and within the limits of the law of the Member State concerned, a veterinary medicinal product prepared extemporaneously by a person authorised to do so under national legislation in accordance with the terms of a veterinary prescription.

The veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian's responsibility.

2. Paragraph 1 shall apply provided that pharmacologically active substances included in the medicinal product are listed in Annex I, II or III to Regulation (EEC) No 2377/90, and that the veterinarian specifies an appropriate withdrawal period.

Unless the medicinal product used indicates a withdrawal period for the species concerned, the specified withdrawal period shall not be less than:

— 7 days for eggs,

— 7 days for milk,

— 28 days for meat from poultry and mammals including fat and offal,

— 500 degree-days for fish meat.

However, these specific withdrawal periods may be modified in accordance with the procedure referred to in Article 89(2).

3. With regard to homeopathic veterinary medicinal products in which active principles figure in Annex II to Regulation (EEC) No 2377/90, the withdrawal period referred to in the second subparagraph of paragraph 2 shall be reduced to zero.

4. When a veterinarian has recourse to the provisions of paragraphs 1 and 2 of this Article, he shall keep adequate records of the date of examination of the animals, details of the owner, the number of animals treated, the diagnosis, the medicinal products prescribed, the doses administered, the duration of treatment and the withdrawal periods recommended, and shall make these records available for inspection by the competent authorities for a period of at least five years.

5. Without prejudice to the other provisions of this Directive, Member States shall take all necessary measures concerning the import, distribution, dispensing of and information on the medicinal products which they permit for administration to food-producing animals in accordance with paragraph 1(b)(ii).

Article 12

1. For the purposes of obtaining a marketing authorisation in respect of a veterinary medicinal product, otherwise than under the procedure established by Regulation (EC) No 726/2004, an application shall be lodged with the competent authority of the Member State concerned.

In the case of veterinary medicinal products which are intended for one or more food-producing species but whose pharmacologically active substances have not yet been included, for the species in question, in Annexes I, II or III to Regulation (EEC) No 2377/90, a marketing authorisation may not be applied for until after a valid application has been made for the establishment of maximum residue limits in accordance with that Regulation. At least six months shall elapse between a valid application for the establishment of maximum residue limits and an application for a marketing authorisation.

However, in the case of veterinary medicinal products referred to in Article 6(3), a marketing authorisation may be applied for without a valid application in accordance with Regulation (EEC) No 2377/90. All the scientific documentation necessary for the demonstration of the quality, safety and efficacy of the veterinary medicinal product, as provided for in paragraph 3, shall be submitted.

2. A marketing authorisation may only be granted to an applicant established in the Community.

3. The application for marketing authorisation shall include all the administrative information and scientific documentation necessary for demonstrating the quality, safety and efficacy of the veterinary medicinal product in question. The file shall be submitted in accordance with Annex I and shall contain, in particular, the following information:

(a) name or business name and permanent address or registered place of business of the person responsible for placing the product on the market and, if different, of the manufacturer or manufacturers involved and of the sites of manufacture;

(b) name of veterinary medicinal product;

(c) qualitative and quantitative particulars of all the constituents of the veterinary medicinal product, including its international non-proprietary name (INN) recommended by the WHO, where an INN exists, or its chemical name;

(d) description of the method of manufacture;

(e) therapeutic indications, contra-indications and adverse reactions;

(f) dosage for the various species of animal for which the veterinary medicinal product is intended, its pharmaceutical form, method and route of administration and proposed shelf life;

(g) reasons for any precautionary and safety measures to be taken when storing the veterinary medicinal product, administering it to animals and disposing of waste, together with an indication of potential risks that the veterinary medicinal product might pose to the environment, to human and animal health and to plants;

(h) indication of the withdrawal period in the case of medicinal products intended for food-producing species;

(i) description of the testing methods employed by the manufacturer;

(j) results of: — pharmaceutical (physico-chemical, biological or microbiological) tests, — safety tests and residue tests, — pre-clinical and clinical trials; — tests assessing the potential risks posed by the medicinal product for the environment. This impact shall be studied and consideration shall be given on a case-by-case basis to specific provisions seeking to limit it.

(k) a detailed description of the pharmacovigilance system and, where appropriate, the risk management system that the applicant will put in place;

(l) a summary in accordance with Article 14 of the product characteristics, a mock-up of the immediate packaging and the outer packaging of the veterinary medicinal product, together with the package leaflet, in accordance with Articles 58 to 61;

(m) a document showing that the manufacturer is authorised in his own country to produce veterinary medicinal products;

(n) copies of any marketing authorisation obtained in another Member State or in a third country for the relevant veterinary medicinal product, together with a list of those Member States in which an application for authorisation submitted in accordance with this Directive is under examination. Copies of the summary of the product characteristics proposed by the applicant in accordance with Article 14 or approved by the competent authority of the Member State in accordance with Article 25 and copies of the package insert proposed, details of any decision to refuse authorisation, whether in the Community or a third country and the reasons for that decision. All this information shall be updated on a regular basis;

(o) proof that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country;

(p) in the case of veterinary medicinal products intended for one or more food-producing species and containing one or more pharmacologically active substances not yet included, for the species in question, in Annexes I, II or III to Regulation (EEC) No 2377/90, a document certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with the aforementioned Regulation.

The documents and particulars relating to the results of the tests referred to in point (j) of the first subparagraph shall be accompanied by detailed and critical summaries, drawn up as specified in Article 15.

Article 13

1. By way of derogation from point (j) of the first subparagraph of Article 12(3), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of the safety and residue tests or of the pre-clinical and clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 5 for not less than eight years in a Member State or the Community.

A generic veterinary medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product.

The first subparagraph shall also apply when the reference medicinal product was not authorised in the Member State in which the application for the generic medicinal product is submitted. In this case, the applicant shall indicate in the application the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit, within a period of one month, confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference product and if necessary other relevant documentation.

However, the ten-year period provided for in the second subparagraph shall be extended to 13 years in the case of veterinary medicinal products for fish or bees or other species designated in accordance with the procedure referred to in Article 89(2).

2. For the purposes of this Article:

(a) ‘reference medicinal product’ shall mean a product authorised within the meaning of Article 5 in accordance with the provisions of Article 12;

(b) ‘generic medicinal product’ shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information intended to provide proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines.

3. In cases where the veterinary medicinal product does not fall under the definition of a generic medicinal product set out in paragraph 2(b) or where bio-equivalence cannot be demonstrated through bioavailability studies or in the case of changes to the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration vis-à-vis the reference medicinal product, the results of the appropriate safety and residue tests and pre-clinical tests or clinical trials shall be provided.

4. Where a biological veterinary medicinal product which is similar to a reference biological veterinary medicinal product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or in manufacturing processes of the biological veterinary medicinal product and the reference biological veterinary medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex I and the related detailed guidelines. The results of other tests and trials from the reference medicinal product's dossier shall not be provided.

5. In the case of veterinary medicinal products intended for one or more food-producing species and containing a new active substance that has not been authorised in the Community by 30 April 2004 the ten-year period provided for in the second subparagraph of paragraph 1 shall be extended by one year for each extension of the marketing authorisation to another food-producing species, if it is authorised within the five years following the granting of the initial marketing authorisation.

This period shall not, however, exceed a total of 13 years, for a marketing authorisation for four or more food-producing species.

The extension of the ten-year period to 11, 12, or 13 years for a veterinary medicinal product intended for food-producing species shall be granted only if the marketing authorisation holder also originally applied for determination of the maximum residue limits established for the species covered by the authorisation.

6. Conducting the necessary studies, tests and trials with a view to the application of paragraphs 1 to 5 and the consequential practical requirements shall not be regarded as contrary to patent-related rights or to supplementary-protection certificates for medicinal products.

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Article 13a

1. By way of derogation from point (j) of the first subparagraph of Article 12(3), and without prejudice to the law on the protection of industrial and commercial property, the applicant shall not be required to provide the results of safety and residue tests or of pre-clinical tests or clinical trials if he can demonstrate that the active substances of the veterinary medicinal product have been in well-established veterinary use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I. In that event, the applicant shall provide appropriate scientific literature.

2. The assessment report published by the Agency following the evaluation of an application for the establishment of maximum residue limits in accordance with Regulation (EEC) No 2377/90 may be used in an appropriate manner as literature, particularly for the safety tests.

3. If an applicant makes use of scientific literature to obtain authorisation for a food-producing species, and submits, in respect of the same medicinal product and with a view to obtaining authorisation for another food-producing species, new residue studies in accordance with Regulation (EEC) No 2377/90, together with further clinical trials, it shall not be permissible for a third party to use such studies or such trials pursuant to Article 13, for a period of three years from the grant of the authorisation for which they were carried out.

Article 13b

In the case of veterinary medicinal products containing active substances used in the composition of authorised veterinary medicinal products but not hitherto used in combination for therapeutic purposes, the results of safety and residue tests, if necessary, and new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with point (j) of the first subparagraph of Article 12(3), but it shall not be necessary to provide scientific references relating to each individual active substance.

Article 13c

After the marketing authorisation has been granted, the marketing authorisation holder may allow use to be made of the pharmaceutical, safety and residues, pre-clinical and clinical documentation contained in the file for the veterinary medicinal product with a view to examining a subsequent application for a veterinary medicinal product having the same qualitative and quantitative composition in active substances and the same pharmaceutical form.

Article 13d

By way of derogation from point (j) of the first subparagraph of Article 12(3), and in exceptional circumstances with respect to immunological veterinary medicinal products, the applicant shall not be required to provide the results of certain field trials on the target species if these trials cannot be carried out for duly substantiated reasons, in particular on account of other Community provisions.

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Article 14

The summary of the product characteristics shall contain, in the order indicated below, the following information:

1) name of the veterinary medicinal product followed by the strength and the pharmaceutical form;

2) qualitative and quantitative composition in terms of the active substances and constituents of the excipient, knowledge of which is essential for proper administration of the medicinal product. The usual common name or chemical description shall be used;

3) pharmaceutical form;

4) clinical particulars: 4.1. target species, 4.2. indications for use, specifying the target species, 4.3. contra-indications, 4.4. special warnings for each target species, 4.5. special precautions for use, including special precautions to be taken by the person administering the medicinal product to the animals, 4.6. adverse reactions (frequency and seriousness), 4.7. use during pregnancy, lactation or lay, 4.8. interaction with other medicinal products and other forms of interaction, 4.9. amounts to be administered and administration route, 4.10. overdose (symptoms, emergency procedures, antidotes), if necessary, 4.11. withdrawal periods for the various foodstuffs, including those for which the withdrawal period is zero;

5) pharmacological properties: 5.1. pharmacodynamic properties, 5.2. pharmacokinetic particulars;

6) pharmaceutical particulars: 6.1. list of excipients, 6.2. major incompatibilities, 6.3. shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time, 6.4. special precautions for storage, 6.5. nature and composition of immediate packaging, 6.6. special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate;

7) marketing authorisation holder;

8) marketing authorisation number(s);

9) date of the first authorisation or date of renewal of the authorisation;

10) date of revision of the text.

For authorisation under Article 13, those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosage forms which were still covered by patent law at the time when a generic medicine was marketed need not be included.

Article 15

1. Applicants shall ensure that the detailed and critical summaries referred to in the second subparagraph of Article 12(3) are drafted and signed by persons with the requisite technical or professional qualifications, set out in a brief curriculum vitae, before being submitted to the competent authorities.

2. Persons with the technical or professional qualifications referred to in paragraph 1 shall justify any use made of the scientific literature referred to in Article 13a(1) in accordance with the conditions set out in Annex I.

3. A brief curriculum vitae of the persons referred to in paragraph 1 shall be appended to the detailed critical summaries.

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CHAPTER 2

Particular provisions applicable to homeopathic veterinary medicinal products

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Article 16

1. Member States shall ensure that homeopathic veterinary medicinal products manufactured and placed on the market within the Community are registered or authorised in accordance with Articles 17, 18 and 19, except where such veterinary medicinal products are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In the case of homeopathic medicinal products registered in accordance with Article 17, Article 32 and Article 33(1) to (3) shall apply.

2. Member States shall establish a simplified registration procedure for the homeopathic veterinary medicinal products referred to in Article 17.

3. By way of derogation from Article 10, homeopathic veterinary medicinal products may be administered to non-food producing animals under the responsibility of a veterinarian.

4. By way of derogation from Article 11(1) and (2), Member States shall permit the administration of homeopathic veterinary medicinal products intended for food-producing species the active constituents of which appear in Annex II to Regulation (EEC) No 2377/90 under the responsibility of a veterinarian. Member States shall take appropriate measures to control the use of veterinary homeopathic medicinal products registered or authorised in another Member State in accordance with this Directive for use in the same species.

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Article 17

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1. Without prejudice to the provisions of Regulation (EEC) No 2377/90 on the establishment of maximum residue limits of pharmacologically active substances intended for food-producing animals, only homeopathic veterinary medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure:

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

(b) no specific therapeutic indication appears on the labelling of the veterinary medicinal product or in any information relating thereto;

(c) there is a sufficient degree of dilution to guarantee the safety of the medicinal product. In particular, the medicinal product shall not contain more than one part per 10 000 of the mother tincture.

If it appears justified in the light of new scientific evidence, points (b) and (c) of the first subparagraph may be adapted in accordance with the procedure referred to in Article 89(2).

At the time of registration, Member States shall determine the classification for the dispensing of the medicinal product.

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2. The criteria and rules of procedure provided for in Chapter 3, with the exception of Article 25, shall apply by analogy to the special, simplified registration procedure for homeopathic veterinary medicinal products referred to in paragraph 1, with the exception of the proof of therapeutic effect.

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Article 18

A special, simplified application for registration may cover a series of medicinal products derived from the same homeopathic stock or stocks. The following documents shall be included with the application in order to demonstrate, in particular, the pharmaceutical quality and the batch-to-batch homogeneity of the products concerned:

— scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered,

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

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— manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation,

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— manufacturing authorization for the medicinal products concerned,

— copies of any registrations or authorizations obtained for the same medicinal products in other Member States,

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— one or more mock-ups of the outer packaging and immediate packaging of the medicinal products to be registered,

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— data concerning the stability of the medicinal product,

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— proposed withdrawal period together with all requisite justification.

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Article 19

1. Homeopathic veterinary medicinal products other than those referred to in Article 17(1) shall be authorised in accordance with Articles 12, 13a, 13b, 13c, 13d and 14.

2. A Member State may introduce or retain on its territory specific rules for the safety tests and pre-clinical and clinical trials of homeopathic veterinary medicinal products intended for pet species and non-food-producing exotic species other than those referred to in Article 17(1), in accordance with the principles and characteristics of homeopathy as practised in that Member State. In this case, the Member State concerned shall notify the Commission of the specific rules in force.

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Article 20

This Chapter shall not apply to immunological homeopathic veterinary medicinal products.

The provisions of titles VI and VII shall apply to homeopathic veterinary medicinal products.







CHAPTER 3

Procedure for marketing authorization

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Article 21

1. Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for a veterinary medicinal product is completed within a maximum of 210 days after the submission of a valid application.

Applications for marketing authorisations for the same veterinary medicinal product in two or more Member States, shall be submitted in accordance with Articles 31 to 43.

2. Where a Member State notes that another marketing authorisation application for the same medicinal product is being examined in another Member State, the Member State concerned shall decline to assess the application and shall advise the applicant that Articles 31 to 43 apply.

Article 22

Where a Member State is informed, in accordance with point (n) of Article 12(3), that another Member State has authorised a veterinary medicinal product which is the subject of an application for authorisation in the Member State concerned, that Member State shall reject the application unless it was submitted in compliance with Articles 31 to 43.

Article 23

In order to examine the application submitted pursuant to Articles 12 to 13d, Member States' competent authorities:

1) shall check that the documentation submitted in support of the application complies with Articles 12 to 13d and ascertain whether the conditions for the issue of the marketing authorisation have been fulfilled;

2) may submit the medicinal product, its starting materials and if necessary intermediate products or other constituent materials for testing by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose, in order to ensure that the testing methods employed by the manufacturer and described in the application documents, in accordance with point (i) of the first subparagraph of Article 12(3), are satisfactory;

3) may similarly check, in particular through consultation of a national or Community reference laboratory, that the analytical method used for detecting residues presented by the applicant for the purposes of Article 12(3)(j), second indent is satisfactory;

4) may, where appropriate, require the applicant to provide further information as regards the items listed in Articles 12, 13a, 13b, 13c and 13d. Where the competent authorities take this course of action, the time-limits specified in Article 21 shall be suspended until the further data required have been provided. Similarly, these time-limits shall be suspended for any period which the applicant may be given to provide oral or written explanations.

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Article 24

Member States shall take all appropriate measures to ensure that:

(a) the competent authorities ascertain that the manufacturers and importers of veterinary medicinal products from third countries are able to manufacture them in compliance with the details supplied pursuant to Article 12(3)(d), and/or to carry out control tests in accordance with the methods described in the application documents under Article 12(3)(i);

(b) the competent authorities may authorize manufacturers and importers of veterinary medicinal products from third countries, where circumstances so justify, to have certain stages of manufacture and/or certain of the control tests referred to in (a) carried out by third parties; in such cases, checks by the competent authorities shall also be carried out in the establishments concerned.

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Article 25

1. When granting a marketing authorisation, the competent authority shall inform the holder of the summary of product characteristics that it has approved.

2. The competent authority shall take all necessary measures to ensure that information concerning the veterinary medicinal product, and in particular the labelling and package leaflet, is in conformity with the summary of product characteristics approved when the marketing authorisation was granted or subsequently.

3. The competent authority shall make the marketing authorisation publicly available without delay, together with the summary of product characteristics for each veterinary medicinal product that it has authorised.

4. The competent authority shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical, safety and residue tests and the pre-clinical and clinical trials of the veterinary medicinal product concerned. The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the veterinary medicinal product concerned.

The competent authority shall make the assessment report and its reasons for the opinion publicly available without delay, after deleting any information of a commercially confidential nature.

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Article 26

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1. The marketing authorisation may require the holder to indicate on the immediate packaging and/or the outer wrapping and the package leaflet, where the latter is required, other particulars essential for safety or health protection, including any special precautions relating to use and any other warnings resulting from the clinical and pharmacological trials prescribed in Article 12(3)(j) and in Articles 13 to 13d or from experience gained during the use of the veterinary medicinal product once it has been marketed.

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3. In exceptional circumstances, and following consultation with the applicant, the authorisation may be granted subject to a requirement for the applicant to introduce specific procedures, in particular concerning the safety of the veterinary medicinal product, notification to the competent authorities of any incident relating to its use, and action to be taken. Such authorisations may be granted only for objective, verifiable reasons. Continuation of the authorisation shall be linked to the annual reassessment of these conditions.

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Article 27

1. After a marketing authorization has been issued, the holder must, in respect of the manufacturing methods and control methods provided for in Article 12(3)(d) and (i), take account of scientific and technical progress and introduce any changes that may be required to enable that veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.

These changes shall be subject to the approval of the competent authorities of the Member State concerned.

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2. The competent authority may require the applicant or the marketing authorisation holder to provide sufficient quantities of the substances to enable controls to be made on the identification of the presence of residues of the veterinary medicinal products in question.

At the competent authority's request, the marketing authorisation holder shall provide his technical expertise to facilitate the implementation of the analytical method for detecting residues of the veterinary medicinal products in the national reference laboratory designated under Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products ( 15 ).

3. The authorisation holder shall immediately supply the competent authority with any new information that might entail the amendment of the particulars or documents referred to in Articles 12(3), 13, 13a, 13b and 14 or Annex I.

In particular, he shall immediately inform the competent authority of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is placed on the market and of any other new information which might influence the assessment of the benefits and risks of the veterinary medicinal product concerned.

In order to permit continuous assessment of the risk-benefit balance, the competent authority may at any time ask the marketing authorisation holder to forward data demonstrating that the risk-benefit balance remains favourable.

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5. The marketing authorisation holder shall immediately inform the competent authorities, with a view to authorisation, of any alteration which he proposes to make to the particulars or documents referred to in Articles 12 to 13d.

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Article 27a

After a marketing authorisation has been granted, the holder of the authorisation shall inform the competent authority of the authorising Member State of the date of the actual placing on the market of the veterinary medicinal product in that Member State, taking into account the various presentations authorised.

The holder shall also notify the competent authority if the product ceases to be placed on the market of the Member State, either temporarily or permanently. Such notification shall, otherwise than in exceptional circumstances, be made no less than two months before the interruption in the placing on the market of the product.

Upon request by the competent authority, particularly in the context of pharmacovigilance, the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the veterinary medicinal product, and any data in his possession relating to the volume of prescriptions.

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Article 28

1. Without prejudice to paragraphs 4 and 5, a marketing authorisation shall be valid for five years.

2. The authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance.

To this end, the marketing authorisation holder shall submit a consolidated list of all documents submitted in respect of quality, safety and efficacy, including all variations introduced since the marketing authorisation was granted, at least six months before the marketing authorisation ceases to be valid in accordance with paragraph 1. The competent authority may require the applicant to submit the listed documents at any time.

3. Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal in accordance with paragraph 2.

4. Any authorisation that is not followed within three years of its granting by the actual placing on the market of the authorised veterinary medicinal product in the authorising Member State shall cease to be valid.

5. When an authorised veterinary medicinal product previously placed on the market in the authorising Member State is no longer actually present on the market in that Member State for a period of three consecutive years, the authorisation granted for that veterinary medicinal product shall cease to be valid.

6. The competent authority may, in exceptional circumstances, and on human or animal health grounds, grant exemptions from paragraphs 4 and 5. Such exemptions shall be duly justified.

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Article 29

The granting of authorization shall not diminish the general legal liability of the manufacturer and, where appropriate, of the authorization holder.

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Article 30

The marketing authorisation shall be refused if the file submitted to the competent authorities does not comply with Articles 12 to 13d and Article 15.

The authorisation shall also be refused if, after examination of the documents and particulars listed in Articles 12 and 13(1), it is clear that:

(a) the risk-benefit balance of the veterinary medicinal product is, under the authorised conditions of use, unfavourable; when the application concerns a veterinary medicinal product for zootechnical use, particular regard shall be had to the benefits for animal health and welfare and to consumer safety; or

(b) the product has no therapeutic effect or the applicant has not provided sufficient proof of such effect as regards the species of animal which is to be treated; or

(c) its qualitative or quantitative composition is not as stated; or

(d) the withdrawal period recommended by the applicant is not long enough to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer, or is insufficiently substantiated; or

(e) the labelling or the package leaflet proposed by the applicant does not comply with this Directive; or

(f) the veterinary medicinal product is offered for sale for a use prohibited under other Community provisions.

However, when a Community legislative framework is in the course of being adopted, the competent authority may refuse authorisation for a veterinary medicinal product where such action is necessary for the protection of public health, consumer or animal health.

The applicant or marketing authorisation holder shall be responsible for the accuracy of documents and data submitted.







CHAPTER 4

Mutual recognition procedure and decentralised procedure

Article 31

1. A coordination group shall be set up for the examination of any question relating to marketing authorisation of a veterinary medicinal product in two or more Member States in accordance with the procedures laid down in this Chapter. The Agency shall provide the secretariat of this coordination group.

2. The coordination group shall be composed of one representative per Member State appointed for a renewable period of three years. Members of the group may arrange to be accompanied by experts.

3. The coordination group shall draw up its own rules of procedure, which shall enter into force after a favourable opinion has been given by the Commission. These rules of procedure shall be made public.

Article 32

1. With a view to the granting of a marketing authorisation for a veterinary medicinal product in more than one Member State, the applicant shall submit an application based on an identical dossier in those Member States. The dossier shall contain all the administrative information and scientific and technical documentation described in Articles 12 to 14. The documents submitted shall include a list of Member States concerned by the application.

The applicant shall request one Member State to act as reference Member State and to prepare an assessment report in respect of the veterinary medicinal product in accordance with paragraphs 2 or 3.

Where appropriate, the assessment report shall contain an evaluation for the purposes of Article 13(5) or Article 13a(3).

2. If the veterinary medicinal product has already received a marketing authorisation at the time of application, the concerned Member States shall recognise the marketing authorisation granted by the reference Member State. To this end, the marketing authorisation holder shall request the reference Member State either to prepare an assessment report in respect of the veterinary medicinal product or, if necessary, to update any existing assessment report. The reference Member State shall prepare or update the assessment report within 90 days of receipt of a valid application. The assessment report together with the approved summary of product characteristics, labelling and package leaflet shall be forwarded to the concerned Member States and the applicant.

3. If the veterinary medicinal product has not received authorisation by the time of application, the applicant shall request the reference Member State to prepare a draft assessment report and drafts of the summary of product characteristics, labelling and package leaflet. The reference Member State shall prepare these drafts within 120 days of the receipt of a valid application and shall send them to the concerned Member States and the applicant.

4. Within 90 days after receipt of the documents referred to in paragraphs 2 and 3, the Member States concerned shall approve the assessment report, the summary of product characteristics, the labelling and the package leaflet and inform the reference Member State accordingly. The reference Member State shall record the agreement of all parties, close the procedure and inform the applicant accordingly.

5. Each Member State in which an application following paragraph 1 has been submitted shall adopt a decision in conformity with the approved assessment report, summary of product characteristics, labelling and package leaflet within 30 days after acknowledgement of the agreement.

Article 33

1. If a Member State cannot, within the period allowed in Article 32(4), agree with the assessment report, summary of product characteristics, labelling and package leaflet on grounds of a potential serious risk to human or animal health or to the environment, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States concerned and the applicant. The points of disagreement shall be referred without delay to the coordination group.

If a Member State to which an application has been submitted invokes the reasons referred to in Article 71(1), it shall no longer be regarded as a Member State concerned by this Chapter.

2. The Commission shall adopt guidelines defining a potential serious risk for human or animal health or for the environment.

3. Within the coordination group, all Member States referred to in paragraph 1 shall use their best endeavours to reach agreement on the action to be taken. They shall provide the applicant with the opportunity to make his point of view known orally or in writing. If, within 60 days of the communication of the reasons for disagreement to the coordination group the Member States reach an agreement, the reference Member State shall record the agreement, close the procedure and inform the applicant accordingly. Article 32(5) shall apply.

4. If within the period of 60 days the Member States fail to reach an agreement, the Agency shall be immediately informed with a view to application of the procedure laid down in Articles 36, 37 and 38. The Agency shall be provided with a detailed description of the matters on which agreement could not be reached and the reasons for the disagreement. The applicant shall be provided with a copy of this information.

5. As soon as the applicant has been informed that the matter has been referred to the Agency, he shall forthwith forward to the Agency a copy of the information and documents referred to in the first subparagraph of Article 32(1).

6. In the case referred to in paragraph 4, the Member States that have approved the assessment report, summary of product characteristics, labelling and package leaflet of the reference Member State may, on request by the applicant, grant a marketing authorisation for the veterinary medicinal product without waiting for the outcome of the procedure laid down in Article 36. In that case, the authorisation granted shall be without prejudice to the outcome of that procedure.

Article 34

1. If two or more applications submitted in accordance with Articles 12 to 14 have been made for marketing authorisation for a particular veterinary medicinal product and Member States have adopted divergent decisions concerning the authorisation of that veterinary medicinal product, or suspension or revocation of authorisation, a Member State, or the Commission, or the marketing-authorisation holder may refer the matter to the Committee for Medicinal Products for Veterinary Use, hereinafter referred to as ‘the Committee’, for the application of the procedure laid down in Articles 36, 37 and 38.

2. With a view to promoting the harmonisation of veterinary medicinal products authorised in the Community, and to strengthening the efficiency of the provisions of Articles 10 and 11, Member States shall send to the coordination group, no later than 30 April 2005, a list of veterinary medicinal products for which a harmonised summary of product characteristics should be prepared.

The coordination group shall agree on a list of medicinal products, on the basis of proposals sent by Member States, and shall forward the list to the Commission.

The medicinal products on the list shall be subject to the provisions in paragraph 1 in accordance with a timetable established in cooperation with the Agency.

The Commission, acting in collaboration with the Agency, and taking into consideration the views of the interested parties, shall agree the final list and timetable.

Article 35

1. Member States or the Commission or the applicant or marketing authorisation holder shall, in specific cases where the interests of the Community are involved, refer the matter to the Committee for the application of the procedure laid down in Articles 36, 37 and 38 before a decision is reached on a request for a marketing authorisation or on the suspension or withdrawal of an authorisation, or on any other variations to the terms of a marketing authorisation which appear necessary, so as to take account in particular of the information collected in accordance with Title VII.

The Member State concerned or the Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the applicant or the marketing authorisation holder.

The Member State and the applicant or the marketing authorisation holder shall forward to the Committee all available information relating to the matter in question.

2. Where the referral to the Committee concerns a range of medicinal products or a therapeutic class, the Agency may limit the procedure to specific parts of the authorisation.

In that case, Article 39 shall apply to those medicinal products only if they are covered by the marketing authorisation procedure referred to in this Chapter.

Article 36

1. When reference is made to the procedure laid down in this Article, the Committee shall consider the matter concerned and shall issue a reasoned opinion within 60 days of the date on which the matter was referred to it.

However, in cases submitted to the Committee in accordance with Articles 34 and 35, this period may be extended by the Committee for a further period of up to 90 days, taking into account the views of the marketing authorisation holders concerned.

In an emergency, and on a proposal from its Chairman, the Committee may agree to a shorter deadline.

2. In order to consider the matter, the Committee shall appoint one of its members to act as rapporteur. The Committee may also appoint independent experts to advise it on specific questions. When appointing such experts, the Committee shall define their tasks and specify the time limit for the completion of these tasks.

3. Before issuing its opinion, the Committee shall provide the applicant or the marketing authorisation holder with an opportunity to present written or oral explanations within a time limit that it will specify.

The opinion of the Committee shall include the draft summary of product characteristics and the drafts of the labelling and package leaflet.

If it considers appropriate, the Committee may invite any other person to provide information relating to the matter before it.

The Committee may suspend the time limit referred to in paragraph 1 to allow the applicant or the marketing authorisation holder to prepare the explanations.

4. The Agency shall forthwith inform the applicant or the marketing authorisation holder when the opinion of the Committee is that:

— the application does not satisfy the criteria for authorisation, or

— the summary of product characteristics proposed by the applicant or the marketing authorisation holder in accordance with Article 14 should be amended, or

— the authorisation should be granted subject to conditions, with regard to conditions considered essential for the safe and effective use of the veterinary medicinal product including pharmacovigilance, or

— a marketing authorisation should be suspended, varied or revoked.

Within 15 days after receipt of the opinion, the applicant or the marketing authorisation holder may notify the Agency in writing of his intention to request a re-examination of the opinion. In that case, he shall forward to the Agency the detailed grounds for the request within 60 days after receipt of the opinion.

Within 60 days following receipt of the grounds for the request, the Committee shall re-examine its opinion in accordance with the fourth subparagraph of Article 62(1) of Regulation (EC) No 726/2004. The reasons for the conclusion reached shall be annexed to the assessment report referred to in paragraph 5 of this Article.

5. Within 15 days after its adoption, the Agency shall forward the final opinion of the Committee to Member States, the Commission and the applicant or the marketing authorisation holder, together with a report describing the assessment of the veterinary medicinal product and the reasons for its conclusions.

In the event of an opinion in favour of granting or maintaining a marketing authorisation, the following documents shall be annexed to the opinion:

(a) a draft summary of the product characteristics, as referred to in Article 14; where necessary this will reflect the differences in the veterinary conditions in Member States;

(b) any conditions affecting the authorisation within the meaning of paragraph 4;

(c) details of any recommended conditions or restrictions with regard to the safe and effective use of the veterinary medicinal product; and

(d) drafts of the labelling and package leaflet.

Article 37

Within 15 days after receipt of the opinion, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account Community law.

In the event of a draft decision that envisages the granting of a marketing authorisation, the documents referred to in the second subparagraph of Article 36(5) shall be annexed.

If, exceptionally, the draft decision is not in accordance with the opinion of the Agency, the Commission shall also annex a detailed explanation of the reasons for the differences.

The draft decision shall be forwarded to Member States and the applicant or marketing authorisation holder.

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Article 38

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1. The Commission shall take a final decision in accordance with, and within 15 days after the end of, the procedure referred to in Article 89(3).

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2. The rules of procedure of the Standing Committee set up by Article 89(1) shall be adjusted to take account of the tasks incumbent upon it in accordance with this Chapter.

These adjustments shall involve the following:

— except in cases referred to in the third paragraph of Article 37, the opinion of the Standing Committee shall be obtained in writing,

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— Member States shall have 22 days to forward their written observations on the draft decision to the Commission. However, if a decision has to be taken urgently, a shorter time-limit may be set by the Chairman according to the degree of urgency involved. This time-limit shall not, otherwise than in exceptional circumstances, be shorter than 5 days,

— Member States shall have the option of submitting a written request that the draft decision be discussed in a plenary meeting of the Standing Committee.

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Where, in the opinion of the Commission, the written observations of a Member State raise important new questions of a scientific or technical nature which have not been addressed in the opinion of the Agency, the Chairman shall suspend the procedure and refer the application back to the Agency for further consideration.

The provisions necessary for the implementation of this paragraph shall be adopted by the Commission in accordance with the procedure referred to in Article 89(2).

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3. A decision as referred to in paragraph 1 shall be addressed to all Member States and communicated to the marketing authorisation holder or the applicant for information. The concerned Member States and the reference Member State shall either grant or withdraw marketing authorisation, or vary the terms of a marketing authorisation as necessary to comply with the decision within 30 days of its notification and shall refer to it. They shall inform the Commission and the Agency accordingly.

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Article 39

1. Any application by the marketing authorization holder to vary a marketing authorization which has been granted in accordance with the provisions of this Chapter shall be submitted to all the Member States which have previously authorized the veterinary medicinal product concerned.

The Commission shall, in consultation with the Agency, adopt appropriate arrangements for the examination of variations to the terms of a marketing authorization.

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These arrangements shall be adopted by the Commission in the form of an implementing regulation in accordance with the procedure referred to in Article 89(2).

2. In case of arbitration submitted to the Commission, the procedure laid down in Articles 36, 37 and 38 shall apply by analogy to variations made to marketing authorizations.

Article 40

1. Where a Member State considers that the variation of the terms of a marketing authorization which has been granted in accordance with the provisions of this Chapter or its suspension or withdrawal is necessary for the protection of human or animal health or the environment, the Member State concerned shall forthwith refer the matter to the Agency for the application of the procedures laid down in Articles 36, 37 and 38.

2. Without prejudice to the provisions of Article 35, in exceptional cases, where urgent action is essential to protect human or animal health or the environment, until a definitive decision is adopted, a Member State may suspend the marketing and the use of the veterinary medicinal product concerned on its territory. It shall inform the Commission and the other Member States no later than the following working day of the reasons for its action.

Article 41

Articles 39 and 40 shall apply by analogy to veterinary medicinal products authorized by Member States following an opinion of the Committee given in accordance with Article 4 of Directive 87/22/EEC before 1 January 1995.

Article 42

1. The Agency shall publish an annual report on the operation of the procedures laid down in this Chapter and shall forward it to the European Parliament and the Council for information.

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2. At least every ten years the Commission shall publish a report on experience gained on the basis of the procedures provided for in this chapter and shall propose any amendments necessary to improve the procedures. The Commission shall submit this report to the European Parliament and the Council.

Article 43

Articles 33(4), (5) and (6) and 34 to 38 shall not apply to the homeopathic veterinary medicinal products referred to in Article 17.

Articles 32 to 38 shall not apply to the homeopathic veterinary medicinal products referred to in Article 19(2).

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TITLE IV

MANUFACTURE AND IMPORTS

Article 44

1. Member States shall take all appropriate measures to ensure that the manufacture of veterinary medicinal products in their territory is subject to the holding of an authorization. This manufacturing authorization shall likewise be required for veterinary medicinal products intended for export.

2. The authorization referred to in paragraph 1 shall be required both for total and partial manufacture and for the various processes of dividing up, packaging or presentation.

However, such authorization shall not be required for preparation, dividing up, changes in packaging or presentation where these processes are carried out solely for retail supply by pharmacists in dispensing pharmacies or by persons legally authorized in the Member States to carry out such processes.

3. The authorization referred to in paragraph 1 shall also be required for imports from third countries into a Member State; this Title and Article 83 shall apply to such imports in the same way as to manufacture.

Member States shall take all appropriate measures to ensure that veterinary medicinal products brought into their territory from a third country and destined for another Member State are accompanied by a copy of the authorization referred to in paragraph 1.

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4. The Member State shall forward to the Agency a copy of the manufacturing authorisations referred to in paragraph 1. The Agency shall enter that information in the Community database referred to in Article 80(6).

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Article 45

In order to obtain the manufacturing authorization, the applicant shall meet at least the following requirements:

(a) he shall specify the veterinary medicinal products and pharmaceutical forms which are to be manufactured or imported and also the place where they are to be manufactured and/or controlled;

(b) he shall have at his disposal, for the manufacture or import of the above, suitable and sufficient premises, technical equipment and control facilities complying with the legal requirements which the Member State concerned lays down as regards both manufacture and control and the storage of products, in accordance with Article 24;

(c) he shall have at his disposal the services of at least one qualified person within the meaning of Article 52.

The applicant shall provide particulars in his application to establish his compliance with the above requirements.

Article 46

1. The competent authority of the Member State shall not issue the manufacturing authorization until it has established the accuracy of the particulars supplied pursuant to Article 45 by means of an inquiry carried out by its representatives.

2. In order to ensure that the requirements referred to in Article 45 are complied with, authorization may be made conditional on the fulfilment of certain obligations imposed either when authorization is granted or at a later date.

3. The authorization shall apply only to the premises specified in the application and to the veterinary medicinal products and pharmaceutical forms specified in that application.

Article 47

The Member States shall take all appropriate measures to ensure that the time taken for the procedure for granting the manufacturing authorization does not exceed 90 days from the day on which the competent authority receives the application.

Article 48

If the holder of the manufacturing authorization requests a change in any of the particulars referred to in Article 45, first paragraph, (a) and (b), the time taken for the procedure relating to this request shall not exceed 30 days. In exceptional cases, this period of time may be extended to 90 days.

Article 49

The competent authority of the Member States may require from the applicant further information concerning both the particulars supplied pursuant to Article 45 and the qualified person referred to in Article 52; where the competent authority concerned exercises this right, application of the time-limits referred to in Articles 47 and 48 shall be suspended until the additional data required have been supplied.

Article 50

The holder of a manufacturing authorization shall at least be obliged to:

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

(b) dispose of the authorized veterinary medicinal products only in accordance with the legislation of the Member States concerned;

(c) give prior notice to the competent authority of any changes which he may wish to make to any of the particulars supplied pursuant to Article 45; the competent authority shall, in any event, be immediately informed if the qualified person referred to in Article 52 is replaced unexpectedly;

(d) allow the representatives of the competent authority of the Member State concerned access to his premises at any time;

(e) enable the qualified person referred to in Article 52 to carry out his duties, particularly by placing at his disposal all the necessary facilities;

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(f) comply with the principles and the guidelines on good manufacturing practice for medicinal products and use as starting materials only active substances which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials;

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(g) keep detailed records of all veterinary medicinal products supplied by him, including samples, in accordance with the laws of the countries of destination. The following information at least shall be recorded in respect of each transaction, whether or not it is made for payment: — date, — name of the veterinary medicinal product, — quantity supplied, — name and address of the recipient, — batch number.

These records shall be available for inspection by the competent authorities for a period of at least three years.

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Article 50a

1. For the purposes of this Directive, manufacturing active substances for use as starting materials shall include the complete or partial manufacture or the import of an active substance used as a starting material, as defined in Part 2, Section C of Annex I, and the various processes of dividing up, packaging or presentation prior to its incorporation in a veterinary medicinal product, including repackaging or re-labelling, such as carried out by a starting material distributor.

2. Any amendments which may be necessary to adapt the provisions of this Article to scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 89(2).

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Article 51

The principles and guidelines of good manufacturing practice for veterinary medicinal products referred to in Article 50(f) shall be adopted in the form of a Directive addressed to the Member States in accordance with the procedure referred to in Article 89(2).

Detailed guidelines shall be published by the Commission and revised as appropriate to take account of scientific and technical progress.

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The principles of good manufacturing practice as regards the manufacturing of active substances for use as starting materials as referred to in Article 50(f) shall be adopted in the form of detailed guidelines.

The Commission shall also publish guidelines on the form and content of the authorisation referred to in Article 44(1), the reports referred to in Article 80(3) and the form and content of the certificate of good manufacturing practice referred to in Article 80(5).

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Article 52

1. Member States shall take all appropriate measures to ensure that the holder of the manufacturing authorization has permanently and continuously at his disposal the services of at least one qualified person who fulfils the conditions laid down in Article 53 and is responsible, in particular, for carrying out the duties specified in Article 55.

2. If he personally fulfils the conditions laid down in Article 53, the holder of the authorization may himself assume the responsibility referred to in paragraph 1.

Article 53

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1. Member States shall ensure that the qualified person referred to in Article 52(1) fulfils the conditions of qualification referred to in paragraphs 2 and 3.

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2. The qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary science, chemistry, pharmaceutical chemistry and technology, biology.

However, the minimum duration of the university course may be three and a half years where the course is followed by a period of theoretical and practical training of at least one year and includes a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level.

Where two university or recognized equivalent courses coexist in a Member State and where one of these extends over four years and the other over three years, the diploma, certificate or other evidence of formal qualifications awarded on completion of the three-year university course or its recognized equivalent shall be considered to fulfil the condition of duration referred to in the first subparagraph in so far as the diplomas, certificates or other evidence of formal qualifications awarded on completion of both courses are recognized as equivalent by the State in question.

The course shall include theoretical and practical tuition bearing upon at least the following basic subjects:

— experimental physics,

— general and inorganic chemistry,

— organic chemistry,

— analytical chemistry,

— pharmaceutical chemistry, including analysis of medicinal products,

— general and applied biochemistry (medical),

— physiology,

— microbiology,

— pharmacology,

— pharmaceutical technology,

— toxicology,

— pharmacognosy (study of the composition and effects of the active principles of natural substances of plant and animal origin).

Tuition in these subjects should be so balanced as to enable the person concerned to fulfil the obligations specified in Article 55.

In so far as certain diplomas, certificates or other evidence of formal qualifications mentioned in this paragraph do not fulfil the criteria laid down above, the competent authority of the Member State shall ensure that the person concerned provides evidence that he has, in the subjects involved, the knowledge required for the manufacture and control of veterinary medicinal products.

3. The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized manufacturers, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of veterinary medicinal products.

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

Article 54

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1. A person engaging, in a Member State, in the activities of the person referred to in Article 52(1) on the date on which Directive 81/851/EEC became applicable, without complying with the provisions of Article 53, shall be eligible to continue to engage in those activities within the Community.

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2. The holder of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course — or a course recognized as equivalent by the Member State concerned — in a scientific discipline allowing him to engage in the activities of the person referred to in Article 52 in accordance with the laws of that State may — if he began his course prior to 9 October 1981 — be considered as qualified to carry out in that State the duties of the person referred to in Article 52, provided that he has previously engaged in the following activities for at least two years before 9 October 1991 in one or more undertakings with a manufacturing authorization; production supervision and/or qualitative and quantitative analysis of active substances, and the necessary testing and checking under the direct authority of a person as referred to in Article 52 to ensure the quality of veterinary medicinal products.

If the person concerned has acquired the practical experience referred to in the first subparagraph before 9 October 1971, a further one year's practical experience in accordance with the conditions referred to in the first subparagraph shall be completed by him immediately before he engages in such activities.

Article 55

1. Member States shall take all appropriate measures to ensure that the qualified person referred to in Article 52 is, without prejudice to his relationship with the holder of the manufacturing authorization, responsible, in the context of the procedures referred to in Article 56, for ensuring that:

(a) in the case of veterinary medicinal products manufactured within the Member State concerned, each batch of veterinary medicinal products has been manufactured and checked in compliance with the la