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Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products

EU Directive 2001/82 · Adopted 6 November 2001 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

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 Committeef1,

Acting in accordance with the procedure laid down in Article 251 of the Treatyf2,

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 productsf3, 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 productsf4, 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 productsf5, 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 productsf6 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 Productsf7, 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 Commissionf8.

(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 originf9.

(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:

Annotations to the whole text

Footnotes

f1

OJ C 75, 15.3.2000, p. 11.

f2

Opinion of the European Parliament of 3 July 2001 (not yet published in the Official Journal) and Council Decision of 27 September 2001.

f3

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).

f4

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).

f5

OJ L 373, 31.12.1990, p. 26.

f6

OJ L 297, 13.10.1992, p. 12.

f7

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).

f8

OJ L 184, 17.7.1999, p. 23.

f9

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).

Contents

  1. Title I: DEFINITIONS
  2. 1Article 1
  3. Title II: SCOPE
  4. 2Article 2
  5. 3Article 3
  6. 4Article 4
  7. Title III: MARKETING
  8. Chapter 1: Marketing authorization
  9. 5Article 5
  10. 6Article 6
  11. 7Article 7
  12. 8Article 8
  13. 9Article 9
  14. 10Article 10
  15. 11Article 11
  16. 12Article 12
  17. 13Article 13
  18. 13aArticle 13a
  19. 13bArticle 13b
  20. 13cArticle 13c
  21. 13dArticle 13d
  22. 14Article 14
  23. 15Article 15
  24. Chapter 2: Particular provisions applicable to homeopathic veterinary medicinal products
  25. 16Article 16
  26. 17Article 17
  27. 18Article 18
  28. 19Article 19
  29. 20Article 20
  30. Chapter 3: Procedure for marketing authorization
  31. 21Article 21
  32. 22Article 22
  33. 23Article 23
  34. 24Article 24
  35. 25Article 25
  36. 26Article 26
  37. 27Article 27
  38. 27aArticle 27a
  39. 27bArticle 27b
  40. 28Article 28
  41. 29Article 29
  42. 30Article 30
  43. Chapter 4: Mutual recognition procedure and decentralised procedure
  44. 31Article 31
  45. 32Article 32
  46. 33Article 33
  47. 34Article 34
  48. 35Article 35
  49. 36Article 36
  50. 37Article 37
  51. 38Article 38
  52. 39Article 39
  53. 40Article 40
  54. 41Article 41
  55. 42Article 42
  56. 43Article 43
  57. Title IV: MANUFACTURE AND IMPORTS
  58. 44Article 44
  59. 45Article 45
  60. 46Article 46
  61. 47Article 47
  62. 48Article 48
  63. 49Article 49
  64. 50Article 50
  65. 50aArticle 50a
  66. 51Article 51
  67. 52Article 52
  68. 53Article 53
  69. 54Article 54
  70. 55Article 55
  71. 56Article 56
  72. 57Article 57
  73. Title V: LABELLING AND PACKAGE INSERT
  74. 58Article 58
  75. 59Article 59
  76. 60Article 60
  77. 61Article 61
  78. 62Article 62
  79. 63Article 63
  80. 64Article 64
  81. Title VI: POSSESSION, DISTRIBUTION AND DISPENSING OF VETERINARY MEDICINAL PRODUCTS
  82. 65Article 65
  83. 66Article 66
  84. 67Article 67
  85. 68Article 68
  86. 69Article 69
  87. 70Article 70
  88. 71Article 71
  89. Title VII: PHARMACOVIGILANCE
  90. 72Article 72
  91. 73Article 73
  92. 73aArticle 73a
  93. 74Article 74
  94. 75Article 75
  95. 76Article 76
  96. 77Article 77
  97. 78Article 78
  98. 79Article 79
  99. Title VIII: SUPERVISION AND SANCTIONS
  100. 80Article 80
  101. 81Article 81
  102. 82Article 82
  103. 83Article 83
  104. 84Article 84
  105. 85Article 85
  106. 86Article 86
  107. 87Article 87
  108. Title IX: STANDING COMMITTEE
  109. 88Article 88
  110. 89Article 89
  111. Title X: GENERAL PROVISIONS
  112. 90Article 90
  113. 91Article 91
  114. 92Article 92
  115. 93Article 93
  116. 94Article 94
  117. 95Article 95
  118. 95aArticle 95a
  119. 95bArticle 95b
  120. Title XI: FINAL MEASURES
  121. 96Article 96
  122. 97Article 97
  123. 98Article 98
  124. Annex I: CHEMICAL, PHARMACEUTICAL AND ANALYTICAL STANDARDS, SAFETY AND RESIDUE TESTS, PRE-CLINICAL AND CLINICAL TRIALS IN RESPECT OF TESTING OF VETERINARY MEDICINAL PRODUCTS
  125. INTRODUCTION AND GENERAL PRINCIPLES
  126. 1Division 1
  127. 2Division 2
  128. 3Division 3
  129. 4Division 4
  130. 5Division 5
  131. 6Division 6
  132. 7Division 7
  133. 8Division 8
  134. 9Division 9
  135. 10Division 10
  136. TITLE IREQUIREMENTS FOR VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS
  137. SUMMARY OF THE DOSSIER
  138. AADMINISTRATIVE INFORMATION
  139. BSUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
  140. CDETAILED AND CRITICAL SUMMARIES
  141. PART 2:PHARMACEUTICAL (PHYSICO-CHEMICAL, BIOLOGICAL OR MICROBIOLOGICAL INFORMATION (QUALITY))
  142. QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS
  143. 1Qualitative particulars
  144. 2Usual terminology
  145. Quantitative particulars
  146. 3.1In order to give ‘quantitative particulars’ of all the active substances of the veterinary medicinal products, it is necessary, depending on the pharmaceutical form concerned, to specify the mass, or the number of units of biological activity, either per dosage-unit or per unit of mass or volume, of each active substance.
  147. 3.2Division 3.2
  148. 3.3Division 3.3
  149. 4Development pharmaceutics
  150. BDESCRIPTION OF THE MANUFACTURING METHOD
  151. CONTROL OF STARTING MATERIALS
  152. 1General requirements
  153. 1.1Active substances
  154. 1.1.1Active substances listed in pharmacopoeias
  155. 1.1.2Active substances not in a pharmacopoeia
  156. 1.1.3Physico-chemical characteristics liable to affect bioavailability
  157. 1.2Excipients
  158. Container-closure systems
  159. 1.3.1Active substance
  160. 1.3.2Finished product
  161. 1.4Substances of biological origin
  162. DCONTROL TESTS CARRIED OUT AT INTERMEDIATE STAGES OF THE MANUFACTURING PROCESS
  163. ETESTS ON THE FINISHED PRODUCT
  164. 1General characteristics of the finished product
  165. 2Identification and assay of active substance(s)
  166. 3Identification and assay of excipient components
  167. 4Safety tests
  168. STABILITY TEST
  169. 1Active substances(s)
  170. 2Finished product
  171. GOTHER INFORMATION
  172. PART 3:SAFETY AND RESIDUES TESTS
  173. Safety tests
  174. CHAPTER I:PERFORMANCE OF TESTS
  175. 1Precise identification of the product and of its active substance(s)
  176. 2Pharmacology
  177. 2.1Pharmacodynamics
  178. 2.2Pharmacokinetics
  179. 3Toxicology
  180. 3.1Single-dose toxicity
  181. 3.2Repeat-dose toxicity
  182. 3.3Tolerance in the target species
  183. Reproductive toxicity including developmental toxicity
  184. 3.4.1Study of the effects on reproduction
  185. 3.4.2Study of developmental toxicity
  186. 3.5Genotoxicity
  187. 3.6Carcinogenicity
  188. 3.7Exceptions
  189. Other requirements
  190. 4.1Special studies
  191. Microbiological properties of residues
  192. 4.2.1Potential effects on the human gut flora
  193. 4.2.2Potential effects on the microorganisms used for industrial food processing
  194. 4.3Observations in humans
  195. 4.4Development of resistance
  196. 5User safety
  197. Environmental risk assessment
  198. 6.1Environmental risk assessment of veterinary medicinal products not containing or consisting of genetically modified organisms
  199. 6.2Environmental risk assessment for veterinary medicinal products containing or consisting of genetically modified organisms
  200. CHAPTER II:PRESENTATION OF PARTICULARS AND DOCUMENTS
  201. Residue tests
  202. PERFORMANCE OF TESTS
  203. 1Introduction
  204. Metabolism and residue kinetics
  205. 2.1Pharmacokinetics (absorption, distribution, metabolism, excretion)
  206. 2.2Depletion of residues
  207. 3Residue analytical method
  208. PRESENTATION OF PARTICULARS AND DOCUMENTS
  209. 1Identification of the product
  210. PART 4:PRE-CLINICAL AND CLINICAL TRIAL
  211. CHAPTER I:PRE-CLINICAL REQUIREMENTS
  212. Pharmacology
  213. A.1Pharmacodynamics
  214. A.2Development of resistance
  215. A.3Pharmacokinetics
  216. BTolerance in the target animal species
  217. CLINICAL REQUIREMENTS
  218. 1General principles
  219. 2Conduct of clinical trials
  220. CHAPTER III:PARTICULARS AND DOCUMENTS
  221. 1Results of pre-clinical trials
  222. 2Results of clinical trials
  223. TITLE IIREQUIREMENTS FOR IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS
  224. SUMMARY OF THE DOSSIER
  225. AADMINISTRATIVE INFORMATION
  226. BSUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
  227. CDETAILED AND CRITICAL SUMMARIES
  228. PART 2:CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL/MICROBIOLOGICAL INFORMATION (QUALITY)
  229. QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS
  230. 1Qualitative particulars
  231. 2‘Usual terminology’
  232. 3Quantitative particulars
  233. 4Product development
  234. BDESCRIPTION OF MANUFACTURING METHOD
  235. CPRODUCTION AND CONTROL OF STARTING MATERIALS
  236. 1Starting materials listed in pharmacopoeias
  237. Starting materials not listed in a pharmacopoeia
  238. 2.1Starting materials of biological origin
  239. 2.2Starting materials of non-biological origin
  240. CONTROL TESTS DURING THE MANUFACTURING PROCESS
  241. 1Division 1
  242. 2Division 2
  243. ECONTROL TESTS ON THE FINISHED PRODUCT
  244. 1General characteristics of the finished product
  245. 2Identification of active substance(s)
  246. 3Batch titre or potency
  247. 4Identification and assay of adjuvants
  248. 5Identification and assay of excipient components
  249. 6Safety tests
  250. 7Sterility and purity test
  251. 8Residual humidity
  252. 9Inactivation
  253. FBATCH-TO-BATCH CONSISTENCY
  254. GSTABILITY TESTS
  255. HOTHER INFORMATION
  256. SAFETY TESTS
  257. AINTRODUCTION AND GENERAL REQUIREMENTS
  258. LABORATORY TESTS
  259. 1Safety of the administration of one dose
  260. 2Safety of one administration of an overdose
  261. 3Safety of the repeated administration of one dose
  262. 4Examination of reproductive performance
  263. 5Examination of immunological functions
  264. Special requirements for live vaccines
  265. 6.1Spread of the vaccine strain
  266. 6.2Dissemination in the vaccinated animal
  267. 6.3Reversion to virulence of attenuated vaccines
  268. 6.4Biological properties of the vaccine strain
  269. 6.5Recombination or genomic reassortment of strains
  270. 7User safety
  271. 8Study of residues
  272. 9Interactions
  273. CFIELD STUDIES
  274. DENVIRONMENTAL RISK ASSESSMENT
  275. EASSESSMENT REQUIRED FOR VETERINARY MEDICINAL PRODUCTS CONTAINING OR CONSISTING OF GENETICALLY MODIFIED ORGANISMS
  276. EFFICACY TESTS
  278. 1General principles
  279. 2Performance of trials
  281. General requirements
  282. 1Division 1
  283. 2Efficacy trials carried out in the laboratory shall be controlled trials, including untreated control animals unless this is not justified for animal welfare reasons and efficacy can be otherwise demonstrated.
  284. 3Division 3
  285. 4Division 4
  286. 5Division 5
  287. 6Division 6
  288. 7Division 7
  289. 8Division 8
  290. 9Division 9
  291. Laboratory trials
  292. 1In principle, demonstration of efficacy shall be undertaken under well-controlled laboratory conditions by challenge after administration of the immunological veterinary medicinal product to the target animal under the recommended conditions of use. Insofar as possible, the conditions under which the challenge is carried out shall mimic the natural conditions for infection. Details of the challenge strain and its relevance shall be provided.
  293. 2Division 2
  294. Field trials
  295. 1Division 1
  296. 2Division 2
  297. PARTICULARS AND DOCUMENTS
  298. AINTRODUCTION
  299. BLABORATORY STUDIES
  300. CFIELD STUDIES
  301. PART 6:BIBLIOGRAPHICAL REFERENCES
  302. REQUIREMENTS FOR SPECIFIC MARKETING AUTHORISATION APPLICATIONS
  303. 1Generic veterinary medicinal products
  304. 2Similar biological veterinary medicinal products
  305. 3Well-established veterinary use
  306. 4Combination veterinary medicinal products
  307. 5Informed consent applications
  308. 6Documentation for applications in exceptional circumstances
  309. 7Mixed marketing authorisation applications
  310. TITLE IVREQUIREMENTS FOR MARKETING AUTHORISATION APPLICATIONS FOR PARTICULAR VETERINARY MEDICINAL PRODUCTS
  311. IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS
  312. AVACCINE ANTIGEN MASTER FILE
  313. BMULTI-STRAIN DOSSIER
  314. 2HOMEOPATHIC VETERINARY MEDICINAL PRODUCTS
  315. Part 2Division Part 2
  316. (a)Terminology
  317. (b)Control of starting materials
  318. (c)Control tests on the finished medicinal product
  319. (d)Stability tests
  320. Part 3Division Part 3
  321. Annex II
  322. ARepealed Directives and their successive amendments
  323. BTime-limits for transposition into national law
  324. Annex IIICORRELATION TABLE