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http://publications.europa.eu/resource/cellar/4ff0e658-e48a-4e85-8b68-2bfab41fa86e.0006 4ff0e658-e48a-4e85-8b68-2bfab41fa86e.0006 cellar http://publications.europa.eu/resource/celex/02001L0082-20090807.ENG 02001L0082-20090807.ENG celex http://publications.europa.eu/resource/consolidation/2001L0082%2F20090807.ENG 2001L0082/20090807.ENG consolidation en http://publications.europa.eu/resource/authority/language/ENG ENG language ENG ENG English English 2014-10-10T13:48:23.271+02:00 2014 10 10 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 eng <VALUE>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 </VALUE> <VALUE>CELEX1</VALUE> TITLE IDEFINITIONSArticle 1For the purposes of this Directive, the following terms shall... TITLE IISCOPEArticle 2(1) This Directive shall apply to veterinary medicinal products, including...Article 3(1) This Directive shall not apply to: Article 4(1) Member States may provide that this Directive shall not... TITLE IIIMARKETINGCHAPTER 1Marketing authorizationArticle 5(1) No veterinary medicinal product may be placed on the...Article 6(1) A veterinary medicinal product may not be the subject...Article 7Where the health situation so requires, a Member State may...Article 8In the event of serious epizootic diseases, Member States may...Article 9No veterinary medicinal product may be administered to animals unless...Article 10(1) Member States shall take the necessary measures to ensure...Article 11(1) Member States shall take the necessary measures to ensure...Article 12(1) For the purposes of obtaining a marketing authorisation in...Article 13(1) By way of derogation from point (j) of the...Article 13a(1) By way of derogation from point (j) of the...Article 13bIn the case of veterinary medicinal products containing active substances...Article 13cAfter the marketing authorisation has been granted, the marketing authorisation...Article 13dBy way of derogation from point (j) of the first...Article 14The summary of the product characteristics shall contain, in the...Article 15(1) Applicants shall ensure that the detailed and critical summaries...CHAPTER 2Particular provisions applicable to homeopathic veterinary medicinal productsArticle 16(1) Member States shall ensure that homeopathic veterinary medicinal products...Article 17(1) Without prejudice to the provisions of Regulation (EEC) No...Article 18A special, simplified application for registration may cover a series...Article 19(1) Homeopathic veterinary medicinal products other than those referred to...Article 20This Chapter shall not apply to immunological homeopathic veterinary medicinal...CHAPTER 3Procedure for marketing authorizationArticle 21(1) Member States shall take all appropriate measures to ensure...Article 22Where a Member State is informed, in accordance with point...Article 23In order to examine the application submitted pursuant to Articles...Article 24Member States shall take all appropriate measures to ensure that:...Article 25(1) When granting a marketing authorisation, the competent authority shall...Article 26(1) The marketing authorisation may require the holder to indicate...Article 27(1) After a marketing authorization has been issued, the holder...Article 27aAfter a marketing authorisation has been granted, the holder of...Article 27bThe Commission shall adopt appropriate arrangements for the examination of...Article 28(1) Without prejudice to paragraphs 4 and 5, a marketing...Article 29The granting of authorization shall not diminish the general legal...Article 30The marketing authorisation shall be refused if the file submitted...CHAPTER 4 Mutual recognition procedure and decentralised procedure Article 31(1) A coordination group shall be set up for the...Article 32(1) With a view to the granting of a marketing...Article 33(1) If a Member State cannot, within the period allowed...Article 34(1) If two or more applications submitted in accordance with...Article 35(1) Member States or the Commission or the applicant or...Article 36(1) When reference is made to the procedure laid down...Article 37Within 15 days after receipt of the opinion, the Commission...Article 38(1) The Commission shall take a final decision in accordance...Article 39(1) Any application by the marketing authorization holder to vary...Article 40(1) Where a Member State considers that the variation of...Article 41Articles 39 and 40 shall apply by analogy to veterinary...Article 42(1) The Agency shall publish an annual report on the...Article 43Articles 33(4), (5) and (6) and 34 to 38 shall... TITLE IVMANUFACTURE AND IMPORTSArticle 44(1) Member States shall take all appropriate measures to ensure...Article 45In order to obtain the manufacturing authorization, the applicant shall...Article 46(1) The competent authority of the Member State shall not...Article 47The Member States shall take all appropriate measures to ensure...Article 48If the holder of the manufacturing authorization requests a change...Article 49The competent authority of the Member States may require from...Article 50The holder of a manufacturing authorization shall at least be...Article 50a(1) For the purposes of this Directive, manufacturing active substances...Article 51The principles and guidelines of good manufacturing practice for veterinary...Article 52(1) Member States shall take all appropriate measures to ensure...Article 53(1) Member States shall ensure that the qualified person referred...Article 54(1) A person engaging, in a Member State, in the...Article 55(1) Member States shall take all appropriate measures to ensure...Article 56Member States shall ensure that the obligations of qualified persons...Article 57The provisions of this Title shall apply to homeopathic veterinary... TITLE VLABELLING AND PACKAGE INSERTArticle 58(1) Except in the case of the medicinal products referred...Article 59(1) As regards ampoules, the particulars listed in the first...Article 60Where there is no outer package, all the particulars which...Article 61(1) The inclusion of a package leaflet in the packaging...Article 62Where the provisions of this Title are not observed and...Article 63The requirements of Member States concerning conditions of supply to...Article 64(1) Without prejudice to paragraph 2, homeopathic veterinary medicinal products... TITLE VI POSSESSION, DISTRIBUTION AND DISPENSING OF VETERINARY MEDICINAL PRODUCTS Article 65(1) Member States shall take all appropriate measures to ensure...Article 66(1) Member States shall take all appropriate measures to ensure...Article 67Without prejudice to stricter Community or national rules relating to...Article 68(1) Member States shall take all measures necessary to ensure...Article 69Member States shall ensure that the owners or keepers of...Article 70By way of derogation from Article 9 and without prejudice...Article 71(1) In the absence of specific Community legislation concerning the... TITLE VIIPHARMACOVIGILANCEArticle 72(1) Member States shall take all appropriate measures to encourage...Article 73In order to ensure the adoption of appropriate and harmonised...Article 73aThe management of funds intended for activities connected with pharmacovigilance,...Article 74The marketing authorization holder shall have permanently and continuously at...Article 75(1) The marketing authorisation holder shall maintain detailed records of...Article 76(1) The Agency, in collaboration with Member States and the...Article 77(1) In order to facilitate the exchange of information about...Article 78(1) Where, as a result of the evaluation of veterinary...Article 79The Commission shall adopt any amendments which may be necessary... TITLE VIIISUPERVISION AND SANCTIONSArticle 80(1) The competent authority of the Member State concerned shall...Article 81(1) Member States shall take all appropriate measures to ensure...Article 82(1) Where it considers it necessary for reasons of human...Article 83(1) Member States' competent authorities shall suspend, revoke, withdraw or...Article 84(1) Without prejudice to Article 83, Member States shall take...Article 85(1) The competent authority of a Member State shall suspend...Article 86The provisions of this Title shall apply to homeopathic veterinary...Article 87Member States shall take appropriate measures to encourage veterinarians and... TITLE IXSTANDING COMMITTEEArticle 88The Commission shall adopt any changes which are necessary in...Article 89(1) The Commission shall be assisted by a Standing Committee... TITLE XGENERAL PROVISIONSArticle 90Member States shall take all necessary measures to ensure that...Article 91(1) Each Member State shall take all appropriate measures to...Article 92Member States shall communicate to each other all the information...Article 93(1) At the request of the manufacturer or exporter of...Article 94Any decision referred to in this Directive, taken by the...Article 95Member States shall not permit foodstuffs for human consumption to...Article 95aMember States shall ensure that appropriate collection systems are in...Article 95bWhen a veterinary medicinal product is to be authorised in... TITLE XIFINAL MEASURESArticle 96Directives 81/851/EEC, 81/852/EEC, 90/677/EEC and 92/74/EEC referred to in Annex...Article 97This Directive enters into force on the 20th day following...Article 98This Directive is addressed to the Member States. ANNEX I CHEMICAL, PHARMACEUTICAL AND ANALYTICAL STANDARDS, SAFETY AND RESIDUE TESTS, PRE-CLINICAL AND CLINICAL TRIALS IN RESPECT OF TESTING OF VETERINARY MEDICINAL PRODUCTS INTRODUCTION AND GENERAL PRINCIPLES 1.The particulars and documents accompanying an application for marketing authorisation...2.In assembling the dossier for application for marketing authorisation, applicants...3.For veterinary medicinal products other than immunological veterinary medicinal products,...4.The manufacturing process shall comply with the requirements of Commission...5.All information which is relevant to the evaluation of the...6.Pharmacological, toxicological, residue and safety tests shall be carried out...7.Member States shall ensure that all experiments on animals are...8.In order to monitor the risk/benefit assessment, any new information...9.The environmental risk assessment connected with the release of veterinary...10.In cases of applications for marketing authorisations for veterinary medicinal...TITLE IREQUIREMENTS FOR VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL VETERINARY MEDICINAL...PART 1:SUMMARY OF THE DOSSIER A.ADMINISTRATIVE INFORMATION B.SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET C.DETAILED AND CRITICAL SUMMARIES PART 2:PHARMACEUTICAL (PHYSICO-CHEMICAL, BIOLOGICAL OR MICROBIOLOGICAL INFORMATION (QUALITY)) A.QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS 1.Qualitative particulars 2.Usual terminology 3.Quantitative particulars 3.1.In order to give ‘quantitative particulars’ of all the active...3.2.Active substances present in the form of compounds or derivatives...3.3.For veterinary medicinal products containing an active substance which is...4.Development pharmaceutics B.DESCRIPTION OF THE MANUFACTURING METHOD C.CONTROL OF STARTING MATERIALS 1.General requirements 1.1.Active substances 1.1.1.Active substances listed in pharmacopoeias 1.1.2.Active substances not in a pharmacopoeia 1.1.3.Physico-chemical characteristics liable to affect bioavailability 1.2.Excipients 1.3.Container-closure systems 1.3.1.Active substance 1.3.2.Finished product 1.4.Substances of biological origin D.CONTROL TESTS CARRIED OUT AT INTERMEDIATE STAGES OF THE MANUFACTURING...E.TESTS ON THE FINISHED PRODUCT 1.General characteristics of the finished product 2.Identification and assay of active substance(s) 3.Identification and assay of excipient components 4.Safety tests F.STABILITY TEST 1.Active substances(s) 2.Finished product G.OTHER INFORMATION PART 3:SAFETY AND RESIDUES TESTS A.Safety tests CHAPTER I:PERFORMANCE OF TESTS 1.Precise identification of the product and of its active substance(s)...2.Pharmacology 2.1.Pharmacodynamics 2.2.Pharmacokinetics 3.Toxicology 3.1.Single-dose toxicity 3.2.Repeat-dose toxicity 3.3.Tolerance in the target species 3.4.Reproductive toxicity including developmental toxicity 3.4.1.Study of the effects on reproduction 3.4.2.Study of developmental toxicity 3.5.Genotoxicity 3.6.Carcinogenicity 3.7.Exceptions 4.Other requirements 4.1.Special studies 4.2.Microbiological properties of residues 4.2.1.Potential effects on the human gut flora 4.2.2.Potential effects on the microorganisms used for industrial food processing...4.3.Observations in humans 4.4.Development of resistance 5.User safety 6.Environmental risk assessment 6.1.Environmental risk assessment of veterinary medicinal products not containing or...6.2.Environmental risk assessment for veterinary medicinal products containing or consisting...CHAPTER II:PRESENTATION OF PARTICULARS AND DOCUMENTS B.Residue tests CHAPTER I:PERFORMANCE OF TESTS 1.Introduction 2.Metabolism and residue kinetics 2.1.Pharmacokinetics (absorption, distribution, metabolism, excretion) 2.2.Depletion of residues 3.Residue analytical method CHAPTER II:PRESENTATION OF PARTICULARS AND DOCUMENTS 1.Identification of the product PART 4:PRE-CLINICAL AND CLINICAL TRIAL CHAPTER I:PRE-CLINICAL REQUIREMENTS A.Pharmacology A.1.Pharmacodynamics A.2.Development of resistance A.3.Pharmacokinetics B.Tolerance in the target animal species CHAPTER II:CLINICAL REQUIREMENTS 1.General principles 2.Conduct of clinical trials CHAPTER III:PARTICULARS AND DOCUMENTS 1.Results of pre-clinical trials 2.Results of clinical trials TITLE IIREQUIREMENTS FOR IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS PART 1:SUMMARY OF THE DOSSIER A.ADMINISTRATIVE INFORMATION B.SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET C.DETAILED AND CRITICAL SUMMARIES PART 2:CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL/MICROBIOLOGICAL INFORMATION (QUALITY) A.QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS 1.Qualitative particulars 2.‘Usual terminology’ 3.Quantitative particulars 4.Product development B.DESCRIPTION OF MANUFACTURING METHOD C.PRODUCTION AND CONTROL OF STARTING MATERIALS 1.Starting materials listed in pharmacopoeias 2.Starting materials not listed in a pharmacopoeia 2.1.Starting materials of biological origin 2.2.Starting materials of non-biological origin D.CONTROL TESTS DURING THE MANUFACTURING PROCESS 1.The dossier shall include particulars relating to the control tests,...2.For inactivated or detoxified vaccines, inactivation or detoxification shall be...E.CONTROL TESTS ON THE FINISHED PRODUCT 1.General characteristics of the finished product 2.Identification of active substance(s) 3.Batch titre or potency 4.Identification and assay of adjuvants 5.Identification and assay of excipient components 6.Safety tests 7.Sterility and purity test 8.Residual humidity 9.Inactivation F.BATCH-TO-BATCH CONSISTENCY G.STABILITY TESTS H.OTHER INFORMATION PART 3:SAFETY TESTS A.INTRODUCTION AND GENERAL REQUIREMENTS B.LABORATORY TESTS 1.Safety of the administration of one dose 2.Safety of one administration of an overdose 3.Safety of the repeated administration of one dose 4.Examination of reproductive performance 5.Examination of immunological functions 6.Special requirements for live vaccines 6.1.Spread of the vaccine strain 6.2.Dissemination in the vaccinated animal 6.3.Reversion to virulence of attenuated vaccines 6.4.Biological properties of the vaccine strain 6.5.Recombination or genomic reassortment of strains 7.User safety 8.Study of residues 9.Interactions C.FIELD STUDIES D.ENVIRONMENTAL RISK ASSESSMENT E.ASSESSMENT REQUIRED FOR VETERINARY MEDICINAL PRODUCTS CONTAINING OR CONSISTING OF...PART 4:EFFICACY TESTS CHAPTER I1. General principles The purpose of the trials described in...1.General principles 2.Performance of trials CHAPTER IIA. General requirements 1. The choice of antigens or vaccine...A.General requirements 1.The choice of antigens or vaccine strains shall be justified...2.Efficacy trials carried out in the laboratory shall be controlled...3.The efficacy of an immunological veterinary medicinal product shall be...4.The efficacy of each of the components of multivalent and...5.Whenever a product forms part of a vaccination scheme recommended...6.The dose to be used shall be the quantity of...7.If there is a compatibility statement with other immunological products...8.For diagnostic immunological veterinary medicinal products administered to animals, the...9.For vaccines intended to allow a distinction between vaccinated and...B.Laboratory trials 1.In principle, demonstration of efficacy shall be undertaken under well-controlled...2.If possible, the immune mechanism (cell-mediated/humoral, local/general classes of immunoglobulin)...C.Field trials 1.Unless justified, results from laboratory trials shall be supplemented with...2.Where laboratory trials cannot be supportive of efficacy, the performance...PART 5:PARTICULARS AND DOCUMENTS A.INTRODUCTION B.LABORATORY STUDIES C.FIELD STUDIES PART 6:BIBLIOGRAPHICAL REFERENCES TITLE IIIREQUIREMENTS FOR SPECIFIC MARKETING AUTHORISATION APPLICATIONS 1.Generic veterinary medicinal products 2.Similar biological veterinary medicinal products 3.Well-established veterinary use 4.Combination veterinary medicinal products 5.Informed consent applications 6.Documentation for applications in exceptional circumstances 7.Mixed marketing authorisation applications TITLE IVREQUIREMENTS FOR MARKETING AUTHORISATION APPLICATIONS FOR PARTICULAR VETERINARY MEDICINAL PRODUCTS...1.IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS A.VACCINE ANTIGEN MASTER FILE B.MULTI-STRAIN DOSSIER 2.HOMEOPATHIC VETERINARY MEDICINAL PRODUCTS Part 2The provisions of Part 2 shall apply to the documents...(a)Terminology (b)Control of starting materials (c)Control tests on the finished medicinal product (d)Stability tests Part 3The provisions of Part 3 shall apply to the simplified... ANNEX IIPART ARepealed Directives and their successive amendmentsPART BTime-limits for transposition into national law ANNEX IIICORRELATION TABLE 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,

Acting in accordance with the procedure laid down in Article 251 of the Treaty,

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, 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, 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, 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 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, 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.

(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.

(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,

HAVE ADOPTED THIS DIRECTIVE:

OJ C 75, 15.3.2000, p. 11. Opinion of the European Parliament of 3 July 2001 (not yet published in the Official Journal) and Council Decision of 27 September 2001. OJ L 317, 6.11.1981, p. 1. Directive as last amended by Commission Directive 2000/37/EC (OJ L 139, 10.6.2000, p. 25). OJ L 317, 6.11.1981, p. 16. Directive as last amended by Commission Directive 1999/104/EC (OJ L 3, 6.1.2000, p. 18). OJ L 373, 31.12.1990, p. 26. OJ L 297, 13.10.1992, p. 12. OJ L 214, 24.8.1993, p. 1. Regulation as amended by Commission Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p. 7). OJ L 184, 17.7.1999, p. 23. OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1274/2001 (OJ L 175, 28.6.2001, p. 14).
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<ContentsNumber>TITLE I</ContentsNumber>
<ContentsTitle>DEFINITIONS</ContentsTitle>
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<ContentsNumber>Article 1</ContentsNumber>
<ContentsTitle Generated="true">For the purposes of this Directive, the following terms shall...</ContentsTitle>
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<ContentsNumber>TITLE II</ContentsNumber>
<ContentsTitle>SCOPE</ContentsTitle>
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<ContentsNumber>Article 2</ContentsNumber>
<ContentsTitle Generated="true">(1) This Directive shall apply to veterinary medicinal products, including...</ContentsTitle>
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<ContentsNumber>Article 3</ContentsNumber>
<ContentsTitle Generated="true">(1) This Directive shall not apply to: </ContentsTitle>
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<ContentsNumber>Article 4</ContentsNumber>
<ContentsTitle Generated="true">(1) Member States may provide that this Directive shall not...</ContentsTitle>
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<ContentsNumber>TITLE III</ContentsNumber>
<ContentsTitle>MARKETING</ContentsTitle>
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<ContentsNumber>CHAPTER 1</ContentsNumber>
<ContentsTitle>Marketing authorization</ContentsTitle>
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<ContentsNumber>Article 5</ContentsNumber>
<ContentsTitle Generated="true">(1) No veterinary medicinal product may be placed on the...</ContentsTitle>
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<ContentsNumber>Article 6</ContentsNumber>
<ContentsTitle Generated="true">(1) A veterinary medicinal product may not be the subject...</ContentsTitle>
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<ContentsNumber>Article 7</ContentsNumber>
<ContentsTitle Generated="true">Where the health situation so requires, a Member State may...</ContentsTitle>
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<ContentsNumber>Article 8</ContentsNumber>
<ContentsTitle Generated="true">In the event of serious epizootic diseases, Member States may...</ContentsTitle>
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<ContentsNumber>Article 9</ContentsNumber>
<ContentsTitle Generated="true">No veterinary medicinal product may be administered to animals unless...</ContentsTitle>
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<ContentsNumber>Article 10</ContentsNumber>
<ContentsTitle Generated="true">(1) Member States shall take the necessary measures to ensure...</ContentsTitle>
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<ContentsNumber>Article 11</ContentsNumber>
<ContentsTitle Generated="true">(1) Member States shall take the necessary measures to ensure...</ContentsTitle>
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<ContentsNumber>Article 12</ContentsNumber>
<ContentsTitle Generated="true">(1) For the purposes of obtaining a marketing authorisation in...</ContentsTitle>
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<ContentsNumber>Article 13</ContentsNumber>
<ContentsTitle Generated="true">(1) By way of derogation from point (j) of the...</ContentsTitle>
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<ContentsNumber>Article 13a</ContentsNumber>
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<ContentsNumber>Article 13b</ContentsNumber>
<ContentsTitle Generated="true">In the case of veterinary medicinal products containing active substances...</ContentsTitle>
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<ContentsNumber>Article 13c</ContentsNumber>
<ContentsTitle Generated="true">After the marketing authorisation has been granted, the marketing authorisation...</ContentsTitle>
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<ContentsNumber>Article 13d</ContentsNumber>
<ContentsTitle Generated="true">By way of derogation from point (j) of the first...</ContentsTitle>
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<ContentsNumber>Article 14</ContentsNumber>
<ContentsTitle Generated="true">The summary of the product characteristics shall contain, in the...</ContentsTitle>
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<ContentsNumber>Article 15</ContentsNumber>
<ContentsTitle Generated="true">(1) Applicants shall ensure that the detailed and critical summaries...</ContentsTitle>
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<ContentsNumber>CHAPTER 2</ContentsNumber>
<ContentsTitle>Particular provisions applicable to homeopathic veterinary medicinal products</ContentsTitle>
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<ContentsNumber>Article 16</ContentsNumber>
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<ContentsNumber>Article 17</ContentsNumber>
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<ContentsNumber>Article 18</ContentsNumber>
<ContentsTitle Generated="true">A special, simplified application for registration may cover a series...</ContentsTitle>
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<ContentsNumber>Article 19</ContentsNumber>
<ContentsTitle Generated="true">(1) Homeopathic veterinary medicinal products other than those referred to...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-20" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/20" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/20">
<ContentsNumber>Article 20</ContentsNumber>
<ContentsTitle Generated="true">This Chapter shall not apply to immunological homeopathic veterinary medicinal...</ContentsTitle>
</ContentsItem>
</ContentsEUChapter>
<ContentsEUChapter ContentRef="title-III-chapter-3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/title/III/chapter/3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/title/III/chapter/3">
<ContentsNumber>CHAPTER 3</ContentsNumber>
<ContentsTitle>Procedure for marketing authorization</ContentsTitle>
<ContentsItem ContentRef="article-21" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/21" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/21">
<ContentsNumber>Article 21</ContentsNumber>
<ContentsTitle Generated="true">(1) Member States shall take all appropriate measures to ensure...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-22" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/22" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/22">
<ContentsNumber>Article 22</ContentsNumber>
<ContentsTitle Generated="true">Where a Member State is informed, in accordance with point...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-23" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/23" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/23">
<ContentsNumber>Article 23</ContentsNumber>
<ContentsTitle Generated="true">In order to examine the application submitted pursuant to Articles...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-24" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/24" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/24">
<ContentsNumber>Article 24</ContentsNumber>
<ContentsTitle Generated="true">Member States shall take all appropriate measures to ensure that:...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-25" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/25" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/25">
<ContentsNumber>Article 25</ContentsNumber>
<ContentsTitle Generated="true">(1) When granting a marketing authorisation, the competent authority shall...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-26" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/26" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/26">
<ContentsNumber>Article 26</ContentsNumber>
<ContentsTitle Generated="true">(1) The marketing authorisation may require the holder to indicate...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-27" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/27" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/27">
<ContentsNumber>Article 27</ContentsNumber>
<ContentsTitle Generated="true">(1) After a marketing authorization has been issued, the holder...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-27a" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/27a" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/27a">
<ContentsNumber>Article 27a</ContentsNumber>
<ContentsTitle Generated="true">After a marketing authorisation has been granted, the holder of...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-27b" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/27b" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/27b">
<ContentsNumber>Article 27b</ContentsNumber>
<ContentsTitle Generated="true">The Commission shall adopt appropriate arrangements for the examination of...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-28" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/28" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/28">
<ContentsNumber>Article 28</ContentsNumber>
<ContentsTitle Generated="true">(1) Without prejudice to paragraphs 4 and 5, a marketing...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-29" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/29" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/29">
<ContentsNumber>Article 29</ContentsNumber>
<ContentsTitle Generated="true">The granting of authorization shall not diminish the general legal...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-30" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/30" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/30">
<ContentsNumber>Article 30</ContentsNumber>
<ContentsTitle Generated="true">The marketing authorisation shall be refused if the file submitted...</ContentsTitle>
</ContentsItem>
</ContentsEUChapter>
<ContentsEUChapter ContentRef="title-III-chapter-4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/title/III/chapter/4" RestrictStartDate="2009-08-07" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/title/III/chapter/4">
<ContentsNumber>CHAPTER 4</ContentsNumber>
<ContentsTitle> Mutual recognition procedure and decentralised procedure </ContentsTitle>
<ContentsItem ContentRef="article-31" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/31" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/31">
<ContentsNumber>Article 31</ContentsNumber>
<ContentsTitle Generated="true">(1) A coordination group shall be set up for the...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-32" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/32" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/32">
<ContentsNumber>Article 32</ContentsNumber>
<ContentsTitle Generated="true">(1) With a view to the granting of a marketing...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-33" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/33" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/33">
<ContentsNumber>Article 33</ContentsNumber>
<ContentsTitle Generated="true">(1) If a Member State cannot, within the period allowed...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-34" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/34" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/34">
<ContentsNumber>Article 34</ContentsNumber>
<ContentsTitle Generated="true">(1) If two or more applications submitted in accordance with...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-35" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/35" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/35">
<ContentsNumber>Article 35</ContentsNumber>
<ContentsTitle Generated="true">(1) Member States or the Commission or the applicant or...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-36" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/36" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/36">
<ContentsNumber>Article 36</ContentsNumber>
<ContentsTitle Generated="true">(1) When reference is made to the procedure laid down...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-37" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/37" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/37">
<ContentsNumber>Article 37</ContentsNumber>
<ContentsTitle Generated="true">Within 15 days after receipt of the opinion, the Commission...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-38" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/38" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/38">
<ContentsNumber>Article 38</ContentsNumber>
<ContentsTitle Generated="true">(1) The Commission shall take a final decision in accordance...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-39" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/39" RestrictStartDate="2009-08-07" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/39">
<ContentsNumber>Article 39</ContentsNumber>
<ContentsTitle Generated="true">(1) Any application by the marketing authorization holder to vary...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-40" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/40" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/40">
<ContentsNumber>Article 40</ContentsNumber>
<ContentsTitle Generated="true">(1) Where a Member State considers that the variation of...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-41" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/41" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/41">
<ContentsNumber>Article 41</ContentsNumber>
<ContentsTitle Generated="true">Articles 39 and 40 shall apply by analogy to veterinary...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-42" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/42" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/42">
<ContentsNumber>Article 42</ContentsNumber>
<ContentsTitle Generated="true">(1) The Agency shall publish an annual report on the...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-43" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/43" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/43">
<ContentsNumber>Article 43</ContentsNumber>
<ContentsTitle Generated="true">Articles 33(4), (5) and (6) and 34 to 38 shall...</ContentsTitle>
</ContentsItem>
</ContentsEUChapter>
</ContentsEUTitle>
<ContentsEUTitle ContentRef="title-IV" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/title/IV" RestrictStartDate="2009-08-07" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/title/IV">
<ContentsNumber>TITLE IV</ContentsNumber>
<ContentsTitle>MANUFACTURE AND IMPORTS</ContentsTitle>
<ContentsItem ContentRef="article-44" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/44" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/44">
<ContentsNumber>Article 44</ContentsNumber>
<ContentsTitle Generated="true">(1) Member States shall take all appropriate measures to ensure...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-45" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/45" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/45">
<ContentsNumber>Article 45</ContentsNumber>
<ContentsTitle Generated="true">In order to obtain the manufacturing authorization, the applicant shall...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-46" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/46" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/46">
<ContentsNumber>Article 46</ContentsNumber>
<ContentsTitle Generated="true">(1) The competent authority of the Member State shall not...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-47" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/47" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/47">
<ContentsNumber>Article 47</ContentsNumber>
<ContentsTitle Generated="true">The Member States shall take all appropriate measures to ensure...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-48" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/48" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/48">
<ContentsNumber>Article 48</ContentsNumber>
<ContentsTitle Generated="true">If the holder of the manufacturing authorization requests a change...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-49" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/49" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/49">
<ContentsNumber>Article 49</ContentsNumber>
<ContentsTitle Generated="true">The competent authority of the Member States may require from...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-50" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/50" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/50">
<ContentsNumber>Article 50</ContentsNumber>
<ContentsTitle Generated="true">The holder of a manufacturing authorization shall at least be...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-50a" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/50a" RestrictStartDate="2009-08-07" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/50a">
<ContentsNumber>Article 50a</ContentsNumber>
<ContentsTitle Generated="true">(1) For the purposes of this Directive, manufacturing active substances...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-51" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/51" RestrictStartDate="2009-08-07" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/51">
<ContentsNumber>Article 51</ContentsNumber>
<ContentsTitle Generated="true">The principles and guidelines of good manufacturing practice for veterinary...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-52" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/52" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/52">
<ContentsNumber>Article 52</ContentsNumber>
<ContentsTitle Generated="true">(1) Member States shall take all appropriate measures to ensure...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-53" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/53" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/53">
<ContentsNumber>Article 53</ContentsNumber>
<ContentsTitle Generated="true">(1) Member States shall ensure that the qualified person referred...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-54" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/54" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/54">
<ContentsNumber>Article 54</ContentsNumber>
<ContentsTitle Generated="true">(1) A person engaging, in a Member State, in the...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-55" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/55" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/55">
<ContentsNumber>Article 55</ContentsNumber>
<ContentsTitle Generated="true">(1) Member States shall take all appropriate measures to ensure...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-56" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/56" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/56">
<ContentsNumber>Article 56</ContentsNumber>
<ContentsTitle Generated="true">Member States shall ensure that the obligations of qualified persons...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-57" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/57" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/57">
<ContentsNumber>Article 57</ContentsNumber>
<ContentsTitle Generated="true">The provisions of this Title shall apply to homeopathic veterinary...</ContentsTitle>
</ContentsItem>
</ContentsEUTitle>
<ContentsEUTitle ContentRef="title-V" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/title/V" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/title/V">
<ContentsNumber>TITLE V</ContentsNumber>
<ContentsTitle>LABELLING AND PACKAGE INSERT</ContentsTitle>
<ContentsItem ContentRef="article-58" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/58" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/58">
<ContentsNumber>Article 58</ContentsNumber>
<ContentsTitle Generated="true">(1) Except in the case of the medicinal products referred...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-59" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/59" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/59">
<ContentsNumber>Article 59</ContentsNumber>
<ContentsTitle Generated="true">(1) As regards ampoules, the particulars listed in the first...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-60" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/60" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/60">
<ContentsNumber>Article 60</ContentsNumber>
<ContentsTitle Generated="true">Where there is no outer package, all the particulars which...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-61" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/61" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/61">
<ContentsNumber>Article 61</ContentsNumber>
<ContentsTitle Generated="true">(1) The inclusion of a package leaflet in the packaging...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-62" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/62" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/62">
<ContentsNumber>Article 62</ContentsNumber>
<ContentsTitle Generated="true">Where the provisions of this Title are not observed and...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-63" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/63" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/63">
<ContentsNumber>Article 63</ContentsNumber>
<ContentsTitle Generated="true">The requirements of Member States concerning conditions of supply to...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-64" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/64" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/64">
<ContentsNumber>Article 64</ContentsNumber>
<ContentsTitle Generated="true">(1) Without prejudice to paragraph 2, homeopathic veterinary medicinal products...</ContentsTitle>
</ContentsItem>
</ContentsEUTitle>
<ContentsEUTitle ContentRef="title-VI" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/title/VI" RestrictStartDate="2009-08-07" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/title/VI">
<ContentsNumber>TITLE VI</ContentsNumber>
<ContentsTitle> POSSESSION, DISTRIBUTION AND DISPENSING OF VETERINARY MEDICINAL PRODUCTS </ContentsTitle>
<ContentsItem ContentRef="article-65" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/65" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/65">
<ContentsNumber>Article 65</ContentsNumber>
<ContentsTitle Generated="true">(1) Member States shall take all appropriate measures to ensure...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-66" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/66" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/66">
<ContentsNumber>Article 66</ContentsNumber>
<ContentsTitle Generated="true">(1) Member States shall take all appropriate measures to ensure...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-67" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/67" RestrictStartDate="2009-08-07" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/67">
<ContentsNumber>Article 67</ContentsNumber>
<ContentsTitle Generated="true">Without prejudice to stricter Community or national rules relating to...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-68" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/68" RestrictStartDate="2009-08-07" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/68">
<ContentsNumber>Article 68</ContentsNumber>
<ContentsTitle Generated="true">(1) Member States shall take all measures necessary to ensure...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-69" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/69" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/69">
<ContentsNumber>Article 69</ContentsNumber>
<ContentsTitle Generated="true">Member States shall ensure that the owners or keepers of...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-70" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/70" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/70">
<ContentsNumber>Article 70</ContentsNumber>
<ContentsTitle Generated="true">By way of derogation from Article 9 and without prejudice...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-71" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/71" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/71">
<ContentsNumber>Article 71</ContentsNumber>
<ContentsTitle Generated="true">(1) In the absence of specific Community legislation concerning the...</ContentsTitle>
</ContentsItem>
</ContentsEUTitle>
<ContentsEUTitle ContentRef="title-VII" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/title/VII" RestrictStartDate="2009-08-07" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/title/VII">
<ContentsNumber>TITLE VII</ContentsNumber>
<ContentsTitle>PHARMACOVIGILANCE</ContentsTitle>
<ContentsItem ContentRef="article-72" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/72" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/72">
<ContentsNumber>Article 72</ContentsNumber>
<ContentsTitle Generated="true">(1) Member States shall take all appropriate measures to encourage...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-73" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/73" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/73">
<ContentsNumber>Article 73</ContentsNumber>
<ContentsTitle Generated="true">In order to ensure the adoption of appropriate and harmonised...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-73a" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/73a" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/73a">
<ContentsNumber>Article 73a</ContentsNumber>
<ContentsTitle Generated="true">The management of funds intended for activities connected with pharmacovigilance,...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-74" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/74" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/74">
<ContentsNumber>Article 74</ContentsNumber>
<ContentsTitle Generated="true">The marketing authorization holder shall have permanently and continuously at...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-75" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/75" RestrictStartDate="2009-08-07" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/75">
<ContentsNumber>Article 75</ContentsNumber>
<ContentsTitle Generated="true">(1) The marketing authorisation holder shall maintain detailed records of...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-76" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/76" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/76">
<ContentsNumber>Article 76</ContentsNumber>
<ContentsTitle Generated="true">(1) The Agency, in collaboration with Member States and the...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-77" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/77" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/77">
<ContentsNumber>Article 77</ContentsNumber>
<ContentsTitle Generated="true">(1) In order to facilitate the exchange of information about...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-78" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/78" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/78">
<ContentsNumber>Article 78</ContentsNumber>
<ContentsTitle Generated="true">(1) Where, as a result of the evaluation of veterinary...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-79" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/79" RestrictStartDate="2009-08-07" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/79">
<ContentsNumber>Article 79</ContentsNumber>
<ContentsTitle Generated="true">The Commission shall adopt any amendments which may be necessary...</ContentsTitle>
</ContentsItem>
</ContentsEUTitle>
<ContentsEUTitle ContentRef="title-VIII" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/title/VIII" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/title/VIII">
<ContentsNumber>TITLE VIII</ContentsNumber>
<ContentsTitle>SUPERVISION AND SANCTIONS</ContentsTitle>
<ContentsItem ContentRef="article-80" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/80" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/80">
<ContentsNumber>Article 80</ContentsNumber>
<ContentsTitle Generated="true">(1) The competent authority of the Member State concerned shall...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-81" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/81" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/81">
<ContentsNumber>Article 81</ContentsNumber>
<ContentsTitle Generated="true">(1) Member States shall take all appropriate measures to ensure...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-82" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/82" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/82">
<ContentsNumber>Article 82</ContentsNumber>
<ContentsTitle Generated="true">(1) Where it considers it necessary for reasons of human...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-83" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/83" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/83">
<ContentsNumber>Article 83</ContentsNumber>
<ContentsTitle Generated="true">(1) Member States' competent authorities shall suspend, revoke, withdraw or...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-84" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/84" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/84">
<ContentsNumber>Article 84</ContentsNumber>
<ContentsTitle Generated="true">(1) Without prejudice to Article 83, Member States shall take...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-85" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/85" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/85">
<ContentsNumber>Article 85</ContentsNumber>
<ContentsTitle Generated="true">(1) The competent authority of a Member State shall suspend...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-86" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/86" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/86">
<ContentsNumber>Article 86</ContentsNumber>
<ContentsTitle Generated="true">The provisions of this Title shall apply to homeopathic veterinary...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-87" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/87" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/87">
<ContentsNumber>Article 87</ContentsNumber>
<ContentsTitle Generated="true">Member States shall take appropriate measures to encourage veterinarians and...</ContentsTitle>
</ContentsItem>
</ContentsEUTitle>
<ContentsEUTitle ContentRef="title-IX" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/title/IX" RestrictStartDate="2009-08-07" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/title/IX">
<ContentsNumber>TITLE IX</ContentsNumber>
<ContentsTitle>STANDING COMMITTEE</ContentsTitle>
<ContentsItem ContentRef="article-88" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/88" RestrictStartDate="2009-08-07" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/88">
<ContentsNumber>Article 88</ContentsNumber>
<ContentsTitle Generated="true">The Commission shall adopt any changes which are necessary in...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-89" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/89" RestrictStartDate="2009-08-07" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/89">
<ContentsNumber>Article 89</ContentsNumber>
<ContentsTitle Generated="true">(1) The Commission shall be assisted by a Standing Committee...</ContentsTitle>
</ContentsItem>
</ContentsEUTitle>
<ContentsEUTitle ContentRef="title-X" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/title/X" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/title/X">
<ContentsNumber>TITLE X</ContentsNumber>
<ContentsTitle>GENERAL PROVISIONS</ContentsTitle>
<ContentsItem ContentRef="article-90" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/90" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/90">
<ContentsNumber>Article 90</ContentsNumber>
<ContentsTitle Generated="true">Member States shall take all necessary measures to ensure that...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-91" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/91" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/91">
<ContentsNumber>Article 91</ContentsNumber>
<ContentsTitle Generated="true">(1) Each Member State shall take all appropriate measures to...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-92" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/92" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/92">
<ContentsNumber>Article 92</ContentsNumber>
<ContentsTitle Generated="true">Member States shall communicate to each other all the information...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-93" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/93" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/93">
<ContentsNumber>Article 93</ContentsNumber>
<ContentsTitle Generated="true">(1) At the request of the manufacturer or exporter of...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-94" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/94" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/94">
<ContentsNumber>Article 94</ContentsNumber>
<ContentsTitle Generated="true">Any decision referred to in this Directive, taken by the...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-95" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/95" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/95">
<ContentsNumber>Article 95</ContentsNumber>
<ContentsTitle Generated="true">Member States shall not permit foodstuffs for human consumption to...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-95a" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/95a" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/95a">
<ContentsNumber>Article 95a</ContentsNumber>
<ContentsTitle Generated="true">Member States shall ensure that appropriate collection systems are in...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-95b" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/95b" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/95b">
<ContentsNumber>Article 95b</ContentsNumber>
<ContentsTitle Generated="true">When a veterinary medicinal product is to be authorised in...</ContentsTitle>
</ContentsItem>
</ContentsEUTitle>
<ContentsEUTitle ContentRef="title-XI" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/title/XI" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/title/XI">
<ContentsNumber>TITLE XI</ContentsNumber>
<ContentsTitle>FINAL MEASURES</ContentsTitle>
<ContentsItem ContentRef="article-96" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/96" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/96">
<ContentsNumber>Article 96</ContentsNumber>
<ContentsTitle Generated="true">Directives 81/851/EEC, 81/852/EEC, 90/677/EEC and 92/74/EEC referred to in Annex...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-97" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/97" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/97">
<ContentsNumber>Article 97</ContentsNumber>
<ContentsTitle Generated="true">This Directive enters into force on the 20th day following...</ContentsTitle>
</ContentsItem>
<ContentsItem ContentRef="article-98" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/article/98" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/article/98">
<ContentsNumber>Article 98</ContentsNumber>
<ContentsTitle Generated="true">This Directive is addressed to the Member States. </ContentsTitle>
</ContentsItem>
</ContentsEUTitle>
<ContentsSchedules RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I.">
<ContentsSchedule ContentRef="annex-I" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I">
<ContentsNumber>ANNEX I</ContentsNumber>
<ContentsTitle> CHEMICAL, PHARMACEUTICAL AND ANALYTICAL STANDARDS, SAFETY AND RESIDUE TESTS, PRE-CLINICAL AND CLINICAL TRIALS IN RESPECT OF TESTING OF VETERINARY MEDICINAL PRODUCTS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/division/1">
<ContentsTitle Generated="true">INTRODUCTION AND GENERAL PRINCIPLES </ContentsTitle>
<ContentsDivision ContentRef="annex-I-division-1-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/division/1/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/division/1/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">The particulars and documents accompanying an application for marketing authorisation...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-division-1-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/division/1/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/division/1/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">In assembling the dossier for application for marketing authorisation, applicants...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-division-1-division-3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/division/1/division/3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/division/1/division/3">
<ContentsNumber>3.</ContentsNumber>
<ContentsTitle Generated="true">For veterinary medicinal products other than immunological veterinary medicinal products,...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-division-1-division-4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/division/1/division/4" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/division/1/division/4">
<ContentsNumber>4.</ContentsNumber>
<ContentsTitle Generated="true">The manufacturing process shall comply with the requirements of Commission...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-division-1-division-5" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/division/1/division/5" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/division/1/division/5">
<ContentsNumber>5.</ContentsNumber>
<ContentsTitle Generated="true">All information which is relevant to the evaluation of the...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-division-1-division-6" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/division/1/division/6" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/division/1/division/6">
<ContentsNumber>6.</ContentsNumber>
<ContentsTitle Generated="true">Pharmacological, toxicological, residue and safety tests shall be carried out...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-division-1-division-7" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/division/1/division/7" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/division/1/division/7">
<ContentsNumber>7.</ContentsNumber>
<ContentsTitle Generated="true">Member States shall ensure that all experiments on animals are...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-division-1-division-8" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/division/1/division/8" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/division/1/division/8">
<ContentsNumber>8.</ContentsNumber>
<ContentsTitle Generated="true">In order to monitor the risk/benefit assessment, any new information...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-division-1-division-9" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/division/1/division/9" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/division/1/division/9">
<ContentsNumber>9.</ContentsNumber>
<ContentsTitle Generated="true">The environmental risk assessment connected with the release of veterinary...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-division-1-division-10" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/division/1/division/10" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/division/1/division/10">
<ContentsNumber>10.</ContentsNumber>
<ContentsTitle Generated="true">In cases of applications for marketing authorisations for veterinary medicinal...</ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsEUTitle ContentRef="annex-I-title-I" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I">
<ContentsNumber>TITLE I</ContentsNumber>
<ContentsTitle Generated="true">REQUIREMENTS FOR VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL VETERINARY MEDICINAL...</ContentsTitle>
<ContentsEUPart ContentRef="annex-I-title-I-part-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/1">
<ContentsNumber>PART 1:</ContentsNumber>
<ContentsTitle Generated="true">SUMMARY OF THE DOSSIER </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-1-division-A" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/1/division/A" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/1/division/A">
<ContentsNumber>A.</ContentsNumber>
<ContentsTitle Generated="true">ADMINISTRATIVE INFORMATION </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-1-division-B" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/1/division/B" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/1/division/B">
<ContentsNumber>B.</ContentsNumber>
<ContentsTitle Generated="true">SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-1-division-C" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/1/division/C" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/1/division/C">
<ContentsNumber>C.</ContentsNumber>
<ContentsTitle Generated="true">DETAILED AND CRITICAL SUMMARIES </ContentsTitle>
</ContentsDivision>
</ContentsEUPart>
<ContentsEUPart ContentRef="annex-I-title-I-part-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2">
<ContentsNumber>PART 2:</ContentsNumber>
<ContentsTitle Generated="true">PHARMACEUTICAL (PHYSICO-CHEMICAL, BIOLOGICAL OR MICROBIOLOGICAL INFORMATION (QUALITY)) </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-A" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/A" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/A">
<ContentsNumber>A.</ContentsNumber>
<ContentsTitle Generated="true">QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-A-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/A/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/A/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">Qualitative particulars </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-A-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/A/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/A/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">Usual terminology </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-A-division-3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/A/division/3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/A/division/3">
<ContentsNumber>3.</ContentsNumber>
<ContentsTitle Generated="true">Quantitative particulars </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-A-division-3-division-3.1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/A/division/3/division/3.1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/A/division/3/division/3.1">
<ContentsNumber>3.1.</ContentsNumber>
<ContentsTitle Generated="true">In order to give ‘quantitative particulars’ of all the active...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-A-division-3-division-3.2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/A/division/3/division/3.2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/A/division/3/division/3.2">
<ContentsNumber>3.2.</ContentsNumber>
<ContentsTitle Generated="true">Active substances present in the form of compounds or derivatives...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-A-division-3-division-3.3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/A/division/3/division/3.3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/A/division/3/division/3.3">
<ContentsNumber>3.3.</ContentsNumber>
<ContentsTitle Generated="true">For veterinary medicinal products containing an active substance which is...</ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-A-division-4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/A/division/4" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/A/division/4">
<ContentsNumber>4.</ContentsNumber>
<ContentsTitle Generated="true">Development pharmaceutics </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-B" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/B" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/B">
<ContentsNumber>B.</ContentsNumber>
<ContentsTitle Generated="true">DESCRIPTION OF THE MANUFACTURING METHOD </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-C" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/C" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/C">
<ContentsNumber>C.</ContentsNumber>
<ContentsTitle Generated="true">CONTROL OF STARTING MATERIALS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-C-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">General requirements </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-C-division-1-division-1.1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.1">
<ContentsNumber>1.1.</ContentsNumber>
<ContentsTitle Generated="true">Active substances </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-C-division-1-division-1.1-division-1.1.1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.1/division/1.1.1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.1/division/1.1.1">
<ContentsNumber>1.1.1.</ContentsNumber>
<ContentsTitle Generated="true">Active substances listed in pharmacopoeias </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-C-division-1-division-1.1-division-1.1.2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.1/division/1.1.2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.1/division/1.1.2">
<ContentsNumber>1.1.2.</ContentsNumber>
<ContentsTitle Generated="true">Active substances not in a pharmacopoeia </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-C-division-1-division-1.1-division-1.1.3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.1/division/1.1.3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.1/division/1.1.3">
<ContentsNumber>1.1.3.</ContentsNumber>
<ContentsTitle Generated="true">Physico-chemical characteristics liable to affect bioavailability </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-C-division-1-division-1.2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.2">
<ContentsNumber>1.2.</ContentsNumber>
<ContentsTitle Generated="true">Excipients </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-C-division-1-division-1.3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.3">
<ContentsNumber>1.3.</ContentsNumber>
<ContentsTitle Generated="true">Container-closure systems </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-C-division-1-division-1.3-division-1.3.1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.3/division/1.3.1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.3/division/1.3.1">
<ContentsNumber>1.3.1.</ContentsNumber>
<ContentsTitle Generated="true">Active substance </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-C-division-1-division-1.3-division-1.3.2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.3/division/1.3.2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.3/division/1.3.2">
<ContentsNumber>1.3.2.</ContentsNumber>
<ContentsTitle Generated="true">Finished product </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-C-division-1-division-1.4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.4" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.4">
<ContentsNumber>1.4.</ContentsNumber>
<ContentsTitle Generated="true">Substances of biological origin </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-D" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/D" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/D">
<ContentsNumber>D.</ContentsNumber>
<ContentsTitle Generated="true">CONTROL TESTS CARRIED OUT AT INTERMEDIATE STAGES OF THE MANUFACTURING...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-E" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/E" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/E">
<ContentsNumber>E.</ContentsNumber>
<ContentsTitle Generated="true">TESTS ON THE FINISHED PRODUCT </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-E-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/E/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/E/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">General characteristics of the finished product </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-E-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/E/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/E/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">Identification and assay of active substance(s) </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-E-division-3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/E/division/3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/E/division/3">
<ContentsNumber>3.</ContentsNumber>
<ContentsTitle Generated="true">Identification and assay of excipient components </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-E-division-4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/E/division/4" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/E/division/4">
<ContentsNumber>4.</ContentsNumber>
<ContentsTitle Generated="true">Safety tests </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-F" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/F" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/F">
<ContentsNumber>F.</ContentsNumber>
<ContentsTitle Generated="true">STABILITY TEST </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-F-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/F/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/F/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">Active substances(s) </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-F-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/F/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/F/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">Finished product </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-2-division-G" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/2/division/G" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/G">
<ContentsNumber>G.</ContentsNumber>
<ContentsTitle Generated="true">OTHER INFORMATION </ContentsTitle>
</ContentsDivision>
</ContentsEUPart>
<ContentsEUPart ContentRef="annex-I-title-I-part-3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3">
<ContentsNumber>PART 3:</ContentsNumber>
<ContentsTitle Generated="true">SAFETY AND RESIDUES TESTS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A">
<ContentsNumber>A.</ContentsNumber>
<ContentsTitle Generated="true">Safety tests </ContentsTitle>
<ContentsEUChapter ContentRef="annex-I-title-I-part-3-division-A-chapter-I" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I">
<ContentsNumber>CHAPTER I:</ContentsNumber>
<ContentsTitle Generated="true">PERFORMANCE OF TESTS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">Precise identification of the product and of its active substance(s)...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">Pharmacology </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-2-division-2.1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/2/division/2.1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/2/division/2.1">
<ContentsNumber>2.1.</ContentsNumber>
<ContentsTitle Generated="true">Pharmacodynamics </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-2-division-2.2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/2/division/2.2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/2/division/2.2">
<ContentsNumber>2.2.</ContentsNumber>
<ContentsTitle Generated="true">Pharmacokinetics </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3">
<ContentsNumber>3.</ContentsNumber>
<ContentsTitle Generated="true">Toxicology </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-3-division-3.1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.1">
<ContentsNumber>3.1.</ContentsNumber>
<ContentsTitle Generated="true">Single-dose toxicity </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-3-division-3.2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.2">
<ContentsNumber>3.2.</ContentsNumber>
<ContentsTitle Generated="true">Repeat-dose toxicity </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-3-division-3.3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.3">
<ContentsNumber>3.3.</ContentsNumber>
<ContentsTitle Generated="true">Tolerance in the target species </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-3-division-3.4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.4" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.4">
<ContentsNumber>3.4.</ContentsNumber>
<ContentsTitle Generated="true">Reproductive toxicity including developmental toxicity </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-3-division-3.4-division-3.4.1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.4/division/3.4.1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.4/division/3.4.1">
<ContentsNumber>3.4.1.</ContentsNumber>
<ContentsTitle Generated="true">Study of the effects on reproduction </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-3-division-3.4-division-3.4.2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.4/division/3.4.2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.4/division/3.4.2">
<ContentsNumber>3.4.2.</ContentsNumber>
<ContentsTitle Generated="true">Study of developmental toxicity </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-3-division-3.5" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.5" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.5">
<ContentsNumber>3.5.</ContentsNumber>
<ContentsTitle Generated="true">Genotoxicity </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-3-division-3.6" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.6" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.6">
<ContentsNumber>3.6.</ContentsNumber>
<ContentsTitle Generated="true">Carcinogenicity </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-3-division-3.7" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.7" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/3/division/3.7">
<ContentsNumber>3.7.</ContentsNumber>
<ContentsTitle Generated="true">Exceptions </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/4" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/4">
<ContentsNumber>4.</ContentsNumber>
<ContentsTitle Generated="true">Other requirements </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-4-division-4.1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/4/division/4.1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/4/division/4.1">
<ContentsNumber>4.1.</ContentsNumber>
<ContentsTitle Generated="true">Special studies </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-4-division-4.2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/4/division/4.2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/4/division/4.2">
<ContentsNumber>4.2.</ContentsNumber>
<ContentsTitle Generated="true">Microbiological properties of residues </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-4-division-4.2-division-4.2.1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/4/division/4.2/division/4.2.1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/4/division/4.2/division/4.2.1">
<ContentsNumber>4.2.1.</ContentsNumber>
<ContentsTitle Generated="true">Potential effects on the human gut flora </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-4-division-4.2-division-4.2.2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/4/division/4.2/division/4.2.2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/4/division/4.2/division/4.2.2">
<ContentsNumber>4.2.2.</ContentsNumber>
<ContentsTitle Generated="true">Potential effects on the microorganisms used for industrial food processing...</ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-4-division-4.3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/4/division/4.3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/4/division/4.3">
<ContentsNumber>4.3.</ContentsNumber>
<ContentsTitle Generated="true">Observations in humans </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-4-division-4.4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/4/division/4.4" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/4/division/4.4">
<ContentsNumber>4.4.</ContentsNumber>
<ContentsTitle Generated="true">Development of resistance </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-5" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/5" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/5">
<ContentsNumber>5.</ContentsNumber>
<ContentsTitle Generated="true">User safety </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-6" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/6" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/6">
<ContentsNumber>6.</ContentsNumber>
<ContentsTitle Generated="true">Environmental risk assessment </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-6-division-6.1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/6/division/6.1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/6/division/6.1">
<ContentsNumber>6.1.</ContentsNumber>
<ContentsTitle Generated="true">Environmental risk assessment of veterinary medicinal products not containing or...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-A-chapter-I-division-6-division-6.2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/6/division/6.2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/I/division/6/division/6.2">
<ContentsNumber>6.2.</ContentsNumber>
<ContentsTitle Generated="true">Environmental risk assessment for veterinary medicinal products containing or consisting...</ContentsTitle>
</ContentsDivision>
</ContentsDivision>
</ContentsEUChapter>
<ContentsEUChapter ContentRef="annex-I-title-I-part-3-division-A-chapter-II" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/II" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/II">
<ContentsNumber>CHAPTER II:</ContentsNumber>
<ContentsTitle Generated="true">PRESENTATION OF PARTICULARS AND DOCUMENTS </ContentsTitle>
</ContentsEUChapter>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-B" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/B" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/B">
<ContentsNumber>B.</ContentsNumber>
<ContentsTitle Generated="true">Residue tests </ContentsTitle>
<ContentsEUChapter ContentRef="annex-I-title-I-part-3-division-B-chapter-I" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/I" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/I">
<ContentsNumber>CHAPTER I:</ContentsNumber>
<ContentsTitle Generated="true">PERFORMANCE OF TESTS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-B-chapter-I-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/I/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/I/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">Introduction </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-B-chapter-I-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/I/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/I/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">Metabolism and residue kinetics </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-B-chapter-I-division-2-division-2.1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/I/division/2/division/2.1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/I/division/2/division/2.1">
<ContentsNumber>2.1.</ContentsNumber>
<ContentsTitle Generated="true">Pharmacokinetics (absorption, distribution, metabolism, excretion) </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-B-chapter-I-division-2-division-2.2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/I/division/2/division/2.2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/I/division/2/division/2.2">
<ContentsNumber>2.2.</ContentsNumber>
<ContentsTitle Generated="true">Depletion of residues </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-B-chapter-I-division-3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/I/division/3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/I/division/3">
<ContentsNumber>3.</ContentsNumber>
<ContentsTitle Generated="true">Residue analytical method </ContentsTitle>
</ContentsDivision>
</ContentsEUChapter>
<ContentsEUChapter ContentRef="annex-I-title-I-part-3-division-B-chapter-II" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/II" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/II">
<ContentsNumber>CHAPTER II:</ContentsNumber>
<ContentsTitle Generated="true">PRESENTATION OF PARTICULARS AND DOCUMENTS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-3-division-B-chapter-II-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/II/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/B/chapter/II/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">Identification of the product </ContentsTitle>
</ContentsDivision>
</ContentsEUChapter>
</ContentsDivision>
</ContentsEUPart>
<ContentsEUPart ContentRef="annex-I-title-I-part-4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/4" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/4">
<ContentsNumber>PART 4:</ContentsNumber>
<ContentsTitle Generated="true">PRE-CLINICAL AND CLINICAL TRIAL </ContentsTitle>
<ContentsEUChapter ContentRef="annex-I-title-I-part-4-chapter-I" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/4/chapter/I" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/4/chapter/I">
<ContentsNumber>CHAPTER I:</ContentsNumber>
<ContentsTitle Generated="true">PRE-CLINICAL REQUIREMENTS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-4-chapter-I-division-A" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/4/chapter/I/division/A" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/4/chapter/I/division/A">
<ContentsNumber>A.</ContentsNumber>
<ContentsTitle Generated="true">Pharmacology </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-4-chapter-I-division-A-division-A.1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/4/chapter/I/division/A/division/A.1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/4/chapter/I/division/A/division/A.1">
<ContentsNumber>A.1.</ContentsNumber>
<ContentsTitle Generated="true">Pharmacodynamics </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-4-chapter-I-division-A-division-A.2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/4/chapter/I/division/A/division/A.2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/4/chapter/I/division/A/division/A.2">
<ContentsNumber>A.2.</ContentsNumber>
<ContentsTitle Generated="true">Development of resistance </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-4-chapter-I-division-A-division-A.3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/4/chapter/I/division/A/division/A.3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/4/chapter/I/division/A/division/A.3">
<ContentsNumber>A.3.</ContentsNumber>
<ContentsTitle Generated="true">Pharmacokinetics </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-4-chapter-I-division-B" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/4/chapter/I/division/B" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/4/chapter/I/division/B">
<ContentsNumber>B.</ContentsNumber>
<ContentsTitle Generated="true">Tolerance in the target animal species </ContentsTitle>
</ContentsDivision>
</ContentsEUChapter>
<ContentsEUChapter ContentRef="annex-I-title-I-part-4-chapter-II" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/4/chapter/II" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/4/chapter/II">
<ContentsNumber>CHAPTER II:</ContentsNumber>
<ContentsTitle Generated="true">CLINICAL REQUIREMENTS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-4-chapter-II-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/4/chapter/II/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/4/chapter/II/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">General principles </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-4-chapter-II-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/4/chapter/II/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/4/chapter/II/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">Conduct of clinical trials </ContentsTitle>
</ContentsDivision>
</ContentsEUChapter>
<ContentsEUChapter ContentRef="annex-I-title-I-part-4-chapter-III" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/4/chapter/III" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/4/chapter/III">
<ContentsNumber>CHAPTER III:</ContentsNumber>
<ContentsTitle Generated="true">PARTICULARS AND DOCUMENTS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-I-part-4-chapter-III-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/4/chapter/III/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/4/chapter/III/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">Results of pre-clinical trials </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-I-part-4-chapter-III-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/I/part/4/chapter/III/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/4/chapter/III/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">Results of clinical trials </ContentsTitle>
</ContentsDivision>
</ContentsEUChapter>
</ContentsEUPart>
</ContentsEUTitle>
<ContentsEUTitle ContentRef="annex-I-title-II" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II">
<ContentsNumber>TITLE II</ContentsNumber>
<ContentsTitle Generated="true">REQUIREMENTS FOR IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS </ContentsTitle>
<ContentsEUPart ContentRef="annex-I-title-II-part-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/1">
<ContentsNumber>PART 1:</ContentsNumber>
<ContentsTitle Generated="true">SUMMARY OF THE DOSSIER </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-1-division-A" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/1/division/A" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/1/division/A">
<ContentsNumber>A.</ContentsNumber>
<ContentsTitle Generated="true">ADMINISTRATIVE INFORMATION </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-1-division-B" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/1/division/B" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/1/division/B">
<ContentsNumber>B.</ContentsNumber>
<ContentsTitle Generated="true">SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-1-division-C" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/1/division/C" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/1/division/C">
<ContentsNumber>C.</ContentsNumber>
<ContentsTitle Generated="true">DETAILED AND CRITICAL SUMMARIES </ContentsTitle>
</ContentsDivision>
</ContentsEUPart>
<ContentsEUPart ContentRef="annex-I-title-II-part-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2">
<ContentsNumber>PART 2:</ContentsNumber>
<ContentsTitle Generated="true">CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL/MICROBIOLOGICAL INFORMATION (QUALITY) </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-A" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/A" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/A">
<ContentsNumber>A.</ContentsNumber>
<ContentsTitle Generated="true">QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-A-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/A/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/A/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">Qualitative particulars </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-A-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/A/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/A/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">‘Usual terminology’ </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-A-division-3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/A/division/3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/A/division/3">
<ContentsNumber>3.</ContentsNumber>
<ContentsTitle Generated="true">Quantitative particulars </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-A-division-4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/A/division/4" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/A/division/4">
<ContentsNumber>4.</ContentsNumber>
<ContentsTitle Generated="true">Product development </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-B" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/B" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/B">
<ContentsNumber>B.</ContentsNumber>
<ContentsTitle Generated="true">DESCRIPTION OF MANUFACTURING METHOD </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-C" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/C" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/C">
<ContentsNumber>C.</ContentsNumber>
<ContentsTitle Generated="true">PRODUCTION AND CONTROL OF STARTING MATERIALS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-C-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/C/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/C/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">Starting materials listed in pharmacopoeias </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-C-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/C/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/C/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">Starting materials not listed in a pharmacopoeia </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-C-division-2-division-2.1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/C/division/2/division/2.1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/C/division/2/division/2.1">
<ContentsNumber>2.1.</ContentsNumber>
<ContentsTitle Generated="true">Starting materials of biological origin </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-C-division-2-division-2.2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/C/division/2/division/2.2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/C/division/2/division/2.2">
<ContentsNumber>2.2.</ContentsNumber>
<ContentsTitle Generated="true">Starting materials of non-biological origin </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-D" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/D" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/D">
<ContentsNumber>D.</ContentsNumber>
<ContentsTitle Generated="true">CONTROL TESTS DURING THE MANUFACTURING PROCESS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-D-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/D/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/D/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">The dossier shall include particulars relating to the control tests,...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-D-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/D/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/D/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">For inactivated or detoxified vaccines, inactivation or detoxification shall be...</ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-E" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/E" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/E">
<ContentsNumber>E.</ContentsNumber>
<ContentsTitle Generated="true">CONTROL TESTS ON THE FINISHED PRODUCT </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-E-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/E/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/E/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">General characteristics of the finished product </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-E-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/E/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/E/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">Identification of active substance(s) </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-E-division-3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/E/division/3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/E/division/3">
<ContentsNumber>3.</ContentsNumber>
<ContentsTitle Generated="true">Batch titre or potency </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-E-division-4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/E/division/4" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/E/division/4">
<ContentsNumber>4.</ContentsNumber>
<ContentsTitle Generated="true">Identification and assay of adjuvants </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-E-division-5" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/E/division/5" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/E/division/5">
<ContentsNumber>5.</ContentsNumber>
<ContentsTitle Generated="true">Identification and assay of excipient components </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-E-division-6" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/E/division/6" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/E/division/6">
<ContentsNumber>6.</ContentsNumber>
<ContentsTitle Generated="true">Safety tests </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-E-division-7" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/E/division/7" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/E/division/7">
<ContentsNumber>7.</ContentsNumber>
<ContentsTitle Generated="true">Sterility and purity test </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-E-division-8" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/E/division/8" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/E/division/8">
<ContentsNumber>8.</ContentsNumber>
<ContentsTitle Generated="true">Residual humidity </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-E-division-9" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/E/division/9" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/E/division/9">
<ContentsNumber>9.</ContentsNumber>
<ContentsTitle Generated="true">Inactivation </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-F" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/F" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/F">
<ContentsNumber>F.</ContentsNumber>
<ContentsTitle Generated="true">BATCH-TO-BATCH CONSISTENCY </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-G" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/G" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/G">
<ContentsNumber>G.</ContentsNumber>
<ContentsTitle Generated="true">STABILITY TESTS </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-2-division-H" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/2/division/H" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/2/division/H">
<ContentsNumber>H.</ContentsNumber>
<ContentsTitle Generated="true">OTHER INFORMATION </ContentsTitle>
</ContentsDivision>
</ContentsEUPart>
<ContentsEUPart ContentRef="annex-I-title-II-part-3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3">
<ContentsNumber>PART 3:</ContentsNumber>
<ContentsTitle Generated="true">SAFETY TESTS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-A" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/A" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/A">
<ContentsNumber>A.</ContentsNumber>
<ContentsTitle Generated="true">INTRODUCTION AND GENERAL REQUIREMENTS </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-B" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/B" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B">
<ContentsNumber>B.</ContentsNumber>
<ContentsTitle Generated="true">LABORATORY TESTS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-B-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/B/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">Safety of the administration of one dose </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-B-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/B/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">Safety of one administration of an overdose </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-B-division-3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/B/division/3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B/division/3">
<ContentsNumber>3.</ContentsNumber>
<ContentsTitle Generated="true">Safety of the repeated administration of one dose </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-B-division-4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/B/division/4" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B/division/4">
<ContentsNumber>4.</ContentsNumber>
<ContentsTitle Generated="true">Examination of reproductive performance </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-B-division-5" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/B/division/5" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B/division/5">
<ContentsNumber>5.</ContentsNumber>
<ContentsTitle Generated="true">Examination of immunological functions </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-B-division-6" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/B/division/6" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B/division/6">
<ContentsNumber>6.</ContentsNumber>
<ContentsTitle Generated="true">Special requirements for live vaccines </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-B-division-6-division-6.1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/B/division/6/division/6.1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B/division/6/division/6.1">
<ContentsNumber>6.1.</ContentsNumber>
<ContentsTitle Generated="true">Spread of the vaccine strain </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-B-division-6-division-6.2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/B/division/6/division/6.2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B/division/6/division/6.2">
<ContentsNumber>6.2.</ContentsNumber>
<ContentsTitle Generated="true">Dissemination in the vaccinated animal </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-B-division-6-division-6.3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/B/division/6/division/6.3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B/division/6/division/6.3">
<ContentsNumber>6.3.</ContentsNumber>
<ContentsTitle Generated="true">Reversion to virulence of attenuated vaccines </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-B-division-6-division-6.4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/B/division/6/division/6.4" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B/division/6/division/6.4">
<ContentsNumber>6.4.</ContentsNumber>
<ContentsTitle Generated="true">Biological properties of the vaccine strain </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-B-division-6-division-6.5" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/B/division/6/division/6.5" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B/division/6/division/6.5">
<ContentsNumber>6.5.</ContentsNumber>
<ContentsTitle Generated="true">Recombination or genomic reassortment of strains </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-B-division-7" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/B/division/7" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B/division/7">
<ContentsNumber>7.</ContentsNumber>
<ContentsTitle Generated="true">User safety </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-B-division-8" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/B/division/8" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B/division/8">
<ContentsNumber>8.</ContentsNumber>
<ContentsTitle Generated="true">Study of residues </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-B-division-9" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/B/division/9" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/B/division/9">
<ContentsNumber>9.</ContentsNumber>
<ContentsTitle Generated="true">Interactions </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-C" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/C" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/C">
<ContentsNumber>C.</ContentsNumber>
<ContentsTitle Generated="true">FIELD STUDIES </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-D" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/D" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/D">
<ContentsNumber>D.</ContentsNumber>
<ContentsTitle Generated="true">ENVIRONMENTAL RISK ASSESSMENT </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-3-division-E" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/3/division/E" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/3/division/E">
<ContentsNumber>E.</ContentsNumber>
<ContentsTitle Generated="true">ASSESSMENT REQUIRED FOR VETERINARY MEDICINAL PRODUCTS CONTAINING OR CONSISTING OF...</ContentsTitle>
</ContentsDivision>
</ContentsEUPart>
<ContentsEUPart ContentRef="annex-I-title-II-part-4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4">
<ContentsNumber>PART 4:</ContentsNumber>
<ContentsTitle Generated="true">EFFICACY TESTS </ContentsTitle>
<ContentsEUChapter ContentRef="annex-I-title-II-part-4-chapter-I" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/I" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/I">
<ContentsNumber>CHAPTER I</ContentsNumber>
<ContentsTitle Generated="true">1. General principles The purpose of the trials described in...</ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-I-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/I/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/I/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">General principles </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-I-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/I/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/I/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">Performance of trials </ContentsTitle>
</ContentsDivision>
</ContentsEUChapter>
<ContentsEUChapter ContentRef="annex-I-title-II-part-4-chapter-II" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II">
<ContentsNumber>CHAPTER II</ContentsNumber>
<ContentsTitle Generated="true">A. General requirements 1. The choice of antigens or vaccine...</ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-A" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A">
<ContentsNumber>A.</ContentsNumber>
<ContentsTitle Generated="true">General requirements </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-A-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">The choice of antigens or vaccine strains shall be justified...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-A-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">Efficacy trials carried out in the laboratory shall be controlled...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-A-division-3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/3">
<ContentsNumber>3.</ContentsNumber>
<ContentsTitle Generated="true">The efficacy of an immunological veterinary medicinal product shall be...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-A-division-4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/4" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/4">
<ContentsNumber>4.</ContentsNumber>
<ContentsTitle Generated="true">The efficacy of each of the components of multivalent and...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-A-division-5" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/5" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/5">
<ContentsNumber>5.</ContentsNumber>
<ContentsTitle Generated="true">Whenever a product forms part of a vaccination scheme recommended...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-A-division-6" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/6" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/6">
<ContentsNumber>6.</ContentsNumber>
<ContentsTitle Generated="true">The dose to be used shall be the quantity of...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-A-division-7" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/7" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/7">
<ContentsNumber>7.</ContentsNumber>
<ContentsTitle Generated="true">If there is a compatibility statement with other immunological products...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-A-division-8" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/8" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/8">
<ContentsNumber>8.</ContentsNumber>
<ContentsTitle Generated="true">For diagnostic immunological veterinary medicinal products administered to animals, the...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-A-division-9" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/9" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/A/division/9">
<ContentsNumber>9.</ContentsNumber>
<ContentsTitle Generated="true">For vaccines intended to allow a distinction between vaccinated and...</ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-B" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/B" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/B">
<ContentsNumber>B.</ContentsNumber>
<ContentsTitle Generated="true">Laboratory trials </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-B-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/B/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/B/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">In principle, demonstration of efficacy shall be undertaken under well-controlled...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-B-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/B/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/B/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">If possible, the immune mechanism (cell-mediated/humoral, local/general classes of immunoglobulin)...</ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-C" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/C" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/C">
<ContentsNumber>C.</ContentsNumber>
<ContentsTitle Generated="true">Field trials </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-C-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/C/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/C/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">Unless justified, results from laboratory trials shall be supplemented with...</ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-4-chapter-II-division-C-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/C/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/4/chapter/II/division/C/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">Where laboratory trials cannot be supportive of efficacy, the performance...</ContentsTitle>
</ContentsDivision>
</ContentsDivision>
</ContentsEUChapter>
</ContentsEUPart>
<ContentsEUPart ContentRef="annex-I-title-II-part-5" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/5" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/5">
<ContentsNumber>PART 5:</ContentsNumber>
<ContentsTitle Generated="true">PARTICULARS AND DOCUMENTS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-II-part-5-division-A" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/5/division/A" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/5/division/A">
<ContentsNumber>A.</ContentsNumber>
<ContentsTitle Generated="true">INTRODUCTION </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-5-division-B" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/5/division/B" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/5/division/B">
<ContentsNumber>B.</ContentsNumber>
<ContentsTitle Generated="true">LABORATORY STUDIES </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-II-part-5-division-C" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/5/division/C" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/5/division/C">
<ContentsNumber>C.</ContentsNumber>
<ContentsTitle Generated="true">FIELD STUDIES </ContentsTitle>
</ContentsDivision>
</ContentsEUPart>
<ContentsEUPart ContentRef="annex-I-title-II-part-6" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/II/part/6" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/II/part/6">
<ContentsNumber>PART 6:</ContentsNumber>
<ContentsTitle Generated="true">BIBLIOGRAPHICAL REFERENCES </ContentsTitle>
</ContentsEUPart>
</ContentsEUTitle>
<ContentsEUTitle ContentRef="annex-I-title-III" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/III" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/III">
<ContentsNumber>TITLE III</ContentsNumber>
<ContentsTitle Generated="true">REQUIREMENTS FOR SPECIFIC MARKETING AUTHORISATION APPLICATIONS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-III-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/III/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/III/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">Generic veterinary medicinal products </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-III-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/III/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/III/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">Similar biological veterinary medicinal products </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-III-division-3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/III/division/3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/III/division/3">
<ContentsNumber>3.</ContentsNumber>
<ContentsTitle Generated="true">Well-established veterinary use </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-III-division-4" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/III/division/4" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/III/division/4">
<ContentsNumber>4.</ContentsNumber>
<ContentsTitle Generated="true">Combination veterinary medicinal products </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-III-division-5" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/III/division/5" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/III/division/5">
<ContentsNumber>5.</ContentsNumber>
<ContentsTitle Generated="true">Informed consent applications </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-III-division-6" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/III/division/6" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/III/division/6">
<ContentsNumber>6.</ContentsNumber>
<ContentsTitle Generated="true">Documentation for applications in exceptional circumstances </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-III-division-7" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/III/division/7" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/III/division/7">
<ContentsNumber>7.</ContentsNumber>
<ContentsTitle Generated="true">Mixed marketing authorisation applications </ContentsTitle>
</ContentsDivision>
</ContentsEUTitle>
<ContentsEUTitle ContentRef="annex-I-title-IV" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/IV" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV">
<ContentsNumber>TITLE IV</ContentsNumber>
<ContentsTitle Generated="true">REQUIREMENTS FOR MARKETING AUTHORISATION APPLICATIONS FOR PARTICULAR VETERINARY MEDICINAL PRODUCTS...</ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-IV-division-1" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/IV/division/1" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1">
<ContentsNumber>1.</ContentsNumber>
<ContentsTitle Generated="true">IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS </ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-IV-division-1-division-A" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/IV/division/1/division/A" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A">
<ContentsNumber>A.</ContentsNumber>
<ContentsTitle Generated="true">VACCINE ANTIGEN MASTER FILE </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-IV-division-1-division-B" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/IV/division/1/division/B" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/B">
<ContentsNumber>B.</ContentsNumber>
<ContentsTitle Generated="true">MULTI-STRAIN DOSSIER </ContentsTitle>
</ContentsDivision>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-IV-division-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/IV/division/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/2">
<ContentsNumber>2.</ContentsNumber>
<ContentsTitle Generated="true">HOMEOPATHIC VETERINARY MEDICINAL PRODUCTS </ContentsTitle>
<ContentsEUPart ContentRef="annex-I-title-IV-division-2-part-2" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/IV/division/2/part/2" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/2/part/2">
<ContentsNumber>Part 2</ContentsNumber>
<ContentsTitle Generated="true">The provisions of Part 2 shall apply to the documents...</ContentsTitle>
<ContentsDivision ContentRef="annex-I-title-IV-division-2-part-2-division-a" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/IV/division/2/part/2/division/a" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/2/part/2/division/a">
<ContentsNumber>(a)</ContentsNumber>
<ContentsTitle Generated="true">Terminology </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-IV-division-2-part-2-division-b" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/IV/division/2/part/2/division/b" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/2/part/2/division/b">
<ContentsNumber>(b)</ContentsNumber>
<ContentsTitle Generated="true">Control of starting materials </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-IV-division-2-part-2-division-c" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/IV/division/2/part/2/division/c" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/2/part/2/division/c">
<ContentsNumber>(c)</ContentsNumber>
<ContentsTitle Generated="true">Control tests on the finished medicinal product </ContentsTitle>
</ContentsDivision>
<ContentsDivision ContentRef="annex-I-title-IV-division-2-part-2-division-d" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/IV/division/2/part/2/division/d" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/2/part/2/division/d">
<ContentsNumber>(d)</ContentsNumber>
<ContentsTitle Generated="true">Stability tests </ContentsTitle>
</ContentsDivision>
</ContentsEUPart>
<ContentsEUPart ContentRef="annex-I-title-IV-division-2-part-3" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/I/title/IV/division/2/part/3" RestrictStartDate="2009-07-20" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/2/part/3">
<ContentsNumber>Part 3</ContentsNumber>
<ContentsTitle Generated="true">The provisions of Part 3 shall apply to the simplified...</ContentsTitle>
</ContentsEUPart>
</ContentsDivision>
</ContentsEUTitle>
</ContentsSchedule>
<ContentsSchedule ContentRef="annex-II" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/II" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/II">
<ContentsNumber>ANNEX II</ContentsNumber>
<ContentsEUPart ContentRef="annex-II-part-A" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/II/part/A" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/II/part/A">
<ContentsNumber>PART A</ContentsNumber>
<ContentsTitle>Repealed Directives and their successive amendments</ContentsTitle>
</ContentsEUPart>
<ContentsEUPart ContentRef="annex-II-part-B" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/II/part/B" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/II/part/B">
<ContentsNumber>PART B</ContentsNumber>
<ContentsTitle>Time-limits for transposition into national law</ContentsTitle>
</ContentsEUPart>
</ContentsSchedule>
<ContentsSchedule ContentRef="annex-III" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/annex/III" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I." DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/annex/III">
<ContentsNumber>ANNEX III</ContentsNumber>
<ContentsTitle>CORRELATION TABLE</ContentsTitle>
</ContentsSchedule>
</ContentsSchedules>
</Contents>
<EURetained>
<EUPrelims DocumentURI="http://www.legislation.gov.uk/eudr/2001/82/introduction" IdURI="http://www.legislation.gov.uk/id/eudr/2001/82/introduction" RestrictStartDate="2009-03-06" RestrictExtent="E+W+S+N.I.">
<MultilineTitle>
<Text>
<Uppercase>Directive</Uppercase>
2001/82/EC
<Uppercase>of the European Parliament and of the Council</Uppercase>
</Text>
<Text>of 6 November 2001</Text>
<Text>on the Community code relating to veterinary medicinal products</Text>
</MultilineTitle>
<EUPreamble>
<P>
<Text>THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,</Text>
</P>
<P>
<Text>Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,</Text>
</P>
<P>
<Text>Having regard to the proposal from the Commission,</Text>
</P>
<P>
<Text>
Having regard to the opinion of the Economic and Social Committee
<FootnoteRef Ref="f00001"/>
,
</Text>
</P>
<P>
<Text>
Acting in accordance with the procedure laid down in Article 251 of the Treaty
<FootnoteRef Ref="f00002"/>
,
</Text>
</P>
<P>
<Text>Whereas:</Text>
</P>
<Division>
<Number>(1)</Number>
<P>
<Text>
Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products
<FootnoteRef Ref="f00003"/>
, 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
<FootnoteRef Ref="f00004"/>
, 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
<FootnoteRef Ref="f00005"/>
, 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
<FootnoteRef Ref="f00006"/>
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.
</Text>
</P>
</Division>
<Division>
<Number>(2)</Number>
<P>
<Text>The primary purpose of any rules for the production and distribution of veterinary medicinal products must be the safeguarding of public health.</Text>
</P>
</Division>
<Division>
<Number>(3)</Number>
<P>
<Text>However, this objective must be achieved by means which will not hinder the development of industry and trade in medicinal products within the Community.</Text>
</P>
</Division>
<Division>
<Number>(4)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(5)</Number>
<P>
<Text>Such hindrances must, accordingly, be removed; whereas this entails approximation of the relevant provisions.</Text>
</P>
</Division>
<Division>
<Number>(6)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(7)</Number>
<P>
<Text>
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
<FootnoteRef Ref="f00007"/>
, 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.
</Text>
</P>
</Division>
<Division>
<Number>(8)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(9)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(10)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(11)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(12)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(13)</Number>
<P>
<Text>Such marketing authorization should also be refused where the withdrawal period indicated is not long enough to eliminate health hazards arising from residues.</Text>
</P>
</Division>
<Division>
<Number>(14)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(15)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(16)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(17)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(18)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(19)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(20)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(21)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(22)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(23)</Number>
<P>
<Text>Measures should also be taken to ensure that distributors of veterinary medicinal products are authorized by Member States and maintain adequate records.</Text>
</P>
</Division>
<Division>
<Number>(24)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(25)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(26)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(27)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(28)</Number>
<P>
<Text>For public health protection, relevant data on adverse effects in humans related to the use of veterinary medicines should be collected and evaluated.</Text>
</P>
</Division>
<Division>
<Number>(29)</Number>
<P>
<Text>The pharmacovigilance systems should consider the available data on lack of efficacy.</Text>
</P>
</Division>
<Division>
<Number>(30)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(31)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(32)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(33)</Number>
<P>
<Text>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.</Text>
</P>
</Division>
<Division>
<Number>(34)</Number>
<P>
<Text>Holders of marketing authorisations should be proactively responsible for ongoing pharmacovigilance of the veterinary medicinal products they place on the market.</Text>
</P>
</Division>
<Division>
<Number>(35)</Number>
<P>
<Text>
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
<FootnoteRef Ref="f00008"/>
.
</Text>
</P>
</Division>
<Division>
<Number>(36)</Number>
<P>
<Text>
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
<FootnoteRef Ref="f00009"/>
.
</Text>
</P>
</Division>
<Division>
<Number>(37)</Number>
<P>
<Text>The Commission should be empowered to adopt the changes necessary in order to adapt Annex I to scientific and technical progress.</Text>
</P>
</Division>
<Division>
<Number>(38)</Number>
<P>
<Text>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,</Text>
</P>
</Division>
<P>
<Text>HAVE ADOPTED THIS DIRECTIVE:</Text>
</P>
</EUPreamble>
</EUPrelims>
</EURetained>
<Footnotes>
<Footnote id="f00001">
<FootnoteText>
<Para>
<Text>
<Citation id="c00002" Class="EuropeanUnionOfficialJournal" Year="2000" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.C_.2000.075.01.0011.01.ENG" Date="2000-03-15">OJ C 75, 15.3.2000, p. 11</Citation>
.
</Text>
</Para>
</FootnoteText>
</Footnote>
<Footnote id="f00002">
<FootnoteText>
<Para>
<Text>Opinion of the European Parliament of 3 July 2001 (not yet published in the Official Journal) and Council Decision of 27 September 2001.</Text>
</Para>
</FootnoteText>
</Footnote>
<Footnote id="f00003">
<FootnoteText>
<Para>
<Text>
<Citation id="c00003" Class="EuropeanUnionOfficialJournal" Year="1981" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.1981.317.01.0001.01.ENG" Date="1981-11-06">OJ L 317, 6.11.1981, p. 1</Citation>
. Directive as last amended by Commission Directive 2000/37/EC (
<Citation id="c00004" Class="EuropeanUnionOfficialJournal" Year="2000" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2000.139.01.0025.01.ENG" Date="2000-06-10">OJ L 139, 10.6.2000, p. 25</Citation>
).
</Text>
</Para>
</FootnoteText>
</Footnote>
<Footnote id="f00004">
<FootnoteText>
<Para>
<Text>
<Citation id="c00005" Class="EuropeanUnionOfficialJournal" Year="1981" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.1981.317.01.0016.01.ENG" Date="1981-11-06">OJ L 317, 6.11.1981, p. 16</Citation>
. Directive as last amended by Commission Directive 1999/104/EC (
<Citation id="c00006" Class="EuropeanUnionOfficialJournal" Year="2000" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2000.003.01.0018.01.ENG" Date="2000-01-06">OJ L 3, 6.1.2000, p. 18</Citation>
).
</Text>
</Para>
</FootnoteText>
</Footnote>
<Footnote id="f00005">
<FootnoteText>
<Para>
<Text>
<Citation id="c00007" Class="EuropeanUnionOfficialJournal" Year="1990" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.1990.373.01.0026.01.ENG" Date="1990-12-31">OJ L 373, 31.12.1990, p. 26</Citation>
.
</Text>
</Para>
</FootnoteText>
</Footnote>
<Footnote id="f00006">
<FootnoteText>
<Para>
<Text>
<Citation id="c00008" Class="EuropeanUnionOfficialJournal" Year="1992" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.1992.297.01.0012.01.ENG" Date="1992-10-13">OJ L 297, 13.10.1992, p. 12</Citation>
.
</Text>
</Para>
</FootnoteText>
</Footnote>
<Footnote id="f00007">
<FootnoteText>
<Para>
<Text>
<Citation id="c00009" Class="EuropeanUnionOfficialJournal" Year="1993" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.1993.214.01.0001.01.ENG" Date="1993-08-24">OJ L 214, 24.8.1993, p. 1</Citation>
. Regulation as amended by Commission Regulation (EC) No 649/98 (
<Citation id="c00010" Class="EuropeanUnionOfficialJournal" Year="1998" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.1998.088.01.0007.01.ENG" Date="1998-03-24">OJ L 88, 24.3.1998, p. 7</Citation>
).
</Text>
</Para>
</FootnoteText>
</Footnote>
<Footnote id="f00008">
<FootnoteText>
<Para>
<Text>
<Citation id="c00011" Class="EuropeanUnionOfficialJournal" Year="1999" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.1999.184.01.0023.01.ENG" Date="1999-07-17">OJ L 184, 17.7.1999, p. 23</Citation>
.
</Text>
</Para>
</FootnoteText>
</Footnote>
<Footnote id="f00009">
<FootnoteText>
<Para>
<Text>
<Citation id="c00012" Class="EuropeanUnionOfficialJournal" Year="1990" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.1990.224.01.0001.01.ENG" Date="1990-08-18">OJ L 224, 18.8.1990, p. 1</Citation>
. Regulation as last amended by Commission Regulation (EC) No 1274/2001 (
<Citation id="c00013" Class="EuropeanUnionOfficialJournal" Year="2001" URI="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2001.175.01.0014.01.ENG" Date="2001-06-28">OJ L 175, 28.6.2001, p. 14</Citation>
).
</Text>
</Para>
</FootnoteText>
</Footnote>
</Footnotes>
</Legislation>