CELEX: 51990PC0283(03)
Language: en
Date: 1990-11-14
Title: PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING DIRECTIVES 81/851/EEC AND 81/852/EEC IN RESPECT OF VETERINARY MEDICINAL PRODUCTS

31. 12. 90                                      Official Journal of the European Communities                               No C 330/25
                 Proposal for a Council Directive amending Directives 81/851/EEC and 81/852/EEC in respect of
                                                         veterinary medicinal products
                                                        COM(90) 283 final — SYN 311
                                            (Submitted by the Commission on 14 November 1990)
                                                                (90/C 330/03)
 THE COUNCIL OF THE EUROPEAN COMMUNITIES,                                  by a rapid procedure ensuring close cooperation between the
                                                                           Commission and the Member States, in particular through
 Having regard to the Treaty establishing the European                     the Standing Committee and the Member States, in
 Economic Community, and in particular Article 100a                        particular through the Standing Committee on Veterinary
 thereof,                                                                  Medicinal Products created by Article 2b of Council
                                                                           Directive 81/852/EEC of 28 September 1981 on the
 Having regard to the proposal from the Commission,                        approximation of the laws of Member States relating to
                                                                           analytical, pharmacotoxicological and clinical standards and
 In cooperation with the European Parliament,                              protocols in respect of the testing of veterinary medicinal
                                                                           products ( 4 ),   as     last    amended      by     Directive
 Having regard to the opinion of the Economic and Social                   87/20/EEC( 5 );
 Committee,
                                                                           Whereas in order better to protect human and animal health
 Whereas it is important to adopt measures with the aim of                 and avoid any unnecessary duplication of effort during the
progressively establishing the internal market over a period               examination of applications for authorization to place
 expiring on 31 December 1992; whereas the internal market                 veterinary medicinal products of the market, Member States
 shall comprise an area without internal frontiers in which the            should systematically prepare assessment reports in respect
 free movement of goods, persons, services and capital is                  of each veterinary medicinal products which is authorized by
ensured;                                                                   them, and exchange the reports upon request; whereas,
                                                                           furthermore, a Member State should be able to suspend the
Whereas despite the progress achieved by Directive                         examination of an application for authorization to place a
 81/851/EEC of 28 September 1981 on the approximation                      veterinary medicinal product on the market which is
 of the laws of the Member States relating to veterinary                   currently under active consideration in another Member
medicinal products ('), as last amended by Directive                       State with a view to recognizing the Decision reached by the
 . . . / . . ./EEC of          ( 2 ), further measures are necessary       latter Member State;
to abolish the remaining barriers to the free movement of
 veterinary medicinal products within the Community;                       Whereas following the establishment of the internal market,
                                                                           specific controls to guarantee the quality of veterinary
Whereas, with the exception of those veterinary medicinal                  medicinal products imported from third countries can only
products which are subject to the centralized Community                    be waived if appropriate arrangements have been made by
 authorization procedure established by Council Regulation                 the Community to ensure that the necessary controls are
(EEC) N o . . . of                      laying down Community              carried out in the exporting country;
procedures for the authorization and supervision of
medicinal products for human and veterinary use and                        Whereas it is desirable to codify and improve the cooperation
establishing a European Agency for the Evaluation of                       and exchange of information between Member States
Medicinal Products ( 3 ), an authorization to place a                      relating to the supervision of veterinary medicinal products
veterinary medicinal product on the market in one Member                   and in particular the monitoring of adverse reactions under
State ought in principle to be recognized by the competent                 practical conditions of use through the national
authorities of the other Member States unless there are                    pharmacovigilance centres;
serious grounds for supposing that the authorization of the
veterinary medicinal product concerned may present a risk to               Whereas in order to improve the protection of public health it
human or animal health, or to the environment; whereas, in                 is necessary to specify that foodstuffs for human
the event of a disagreement between Member States about                    consumption may not be taken from animals which have
the quality, the safety or the efficacy of a veterinary medicinal          been used in clinical trials of veterinary medicinal products
product, a scientific evaluation of the matter should be                   unless a provisional maximum residue level has been laid
undertaken by the Committee for Veterinary Medicinal                       down for residues of the veterinary medicinal product
Products attached to the European Agency for the                           concerned in accordance with the provisions of Council
Evaluation of Medicinal Products, leading to a single                      Regulation (EEC) No 2377/90 laying down a Community
decision on the area of disagreement, binding on the Member                procedure for the establishment of maximum residue levels
States concerned; whereas this Decision should be adopted                  for residues of veterinary medicinal products ( 6 ),
0) OJNoL317, 6. 11. 1981, p. 1.                                            (4) OJNoL317, 6. 11. 1981, p. 16.
(*) OJ No L . . .                                                          (s) OJ No L 15, 17. 1. 1987, p. 34.
(3) See page 1 of this Official Journal.                                   (6) OJ No L 224, 18. 8. 1990, p. 1.
 ---pagebreak--- No C 330/26                                 Official Journal of the European Communities                                     31. 12. 90
HAS ADOPTED THIS DIRECTIVE:                                                 Furthermore, the competent authorities shall draw up
                                                                            an assessment report and comments on the dossier as
                                                                            regards       the     results    of     the      analytical,
                             Article 1                                      pharmaco-toxicological tests and the clinical trials of
                                                                            the veterinary medicinal product concerned. The
Directive 81/851/EEC is hereby amended as follows:                          assessment report shall be updated whenever new
                                                                            information becomes available which is of importance
 1. In Article 4 (1), the first subparagraph is replaced by the             for the evaluation of the quality, safety or efficacy of the
     following:                                                             medicinal product concerned.
     'No veterinary medicinal product may be placed on the                  (*) O J N o L . . . '
     market of a Member State unless an authorization has
     been issued by the competent authority of that Member              5. Article 8 is replaced by the following:
     State or by the Community.'
                                                                             'Article 8
 2. In Article 4 (2), the following subparagraph is inserted                 1.     Member States shall take all appropriate
     at the end:                                                            measures to ensure that the procedure for granting an
     T h e Member States shall not permit foodstuffs for                    authorization to place a medicinal product on the
     human consumption to be taken from test animals                        market is completed within 210 days of the date of
     unless a provisional maximum residue level has been                    submitting the application.
     established by the Community in accordance with the
                                                                            2.      Where a Member State notes that an application
     provisions of Regulation (EEC) No 2377/90 (*) and
                                                                             for authorization submitted after 1 January 1993 is
     an appropriate withdrawal period has been established
                                                                             already under active examination in another Member
     to ensure that this level will not be exceeded in the
                                                                            State, the former Member State may decide to suspend
     foodstuffs.
                                                                            the detailed examination of the application in order to
      (*) O J N o L 224, 18. 8. 1990, p. 1.'                                 await the assessment report prepared by the first
                                                                            Member State in accordance with Article 5b.'
 3. In Articles          (2), point 13    is replaced    by   the
                                                                             The Member State concerned shall inform the first
      following:
                                                                             Member State and the applicant of its Decision to
      '13.     Copy of any authorization in another Member                   suspend detailed examination of the application in
      State or in a third country to place the relevant                      question.
      veterinary medicinal product on the market, together
      with a list of those Member States in which an                         As soon as it has completed the examination of the
      application for authorization submitted in accordance                  application and reached a decision, the first Member
      with this Directive is under examination and copies of                 State shall forward a copy of its assessment report to the
      the summary of product characteristics proposed by the                 Member State concerned.
      applicant in accordance with Article 5a or approved by
                                                                             Within the 90 days of the receipt of the assessment
      the competent authorities in accordance with
                                                                             report, the Member State concerned shall recognize the
      Article 5b, as appropriate, in respect of each Member
                                                                             decision of the first Member State. However, if the
      State concerned. Details of any Decision to refuse
                                                                             Member State concerned considers that there are
      authorization, whether in the Community or a third
                                                                             serious grounds for supposing that the authorization of
      country and the reasons for that Decision.
                                                                             the veterinary medicinal product may present a risk to
                                                                             human or animal health or the environment, it shall
      This information        shall   be updated      at  regular
                                                                             inform the first Member State, the Committee for
      intervals.'
                                                                             Veterinary Medicinal Products and the applicant
                                                                             within the time limit referred to above, stating its
 4. Article 5b is replaced by the following:
                                                                             reasons in detail, and apply the procedures laid down in
       'Article Sb                                                           Chapter IV.'
      When the marketing authorization referred to in
                                                                         6. The following Article 8a is inserted:
      Article 4 (1) is issued, the person responsible for placing
      that product on the market shall be informed, by the                    'Article 8a
      competent authorities of the Member State concerned,
      of the summary of the product characteristics as                        1. With effect from 1 January 1996, where a Member
      approved by them. The competent authorities shall                      State is informed in accordance with point 13 of
      take all necessary measures to ensure that the                         Article 5(2) that another Member State has authorized
      information given in the summary is in conformity with                 a veterinary medicinal product which is the subject of
      that accepted when the marketing authorization is                      an application for authorization in the Member State
      issued or subsequently. The competent authorities shall                concerned, that Member State shall forthwith request
      forthwith forward a copy of the summary to the                         the authorities of the Member State which has granted
      European Agency for the Evaluation of Medicinal                        the authorization to forward to it the assessment report
      Products established by Council Regulation (EEC)                       referred to in the second paragraph of Article 5b.
      N o . . . / . . .(*).                                                  Within 90 days of the receipt of the assessment report,
 ---pagebreak--- 31. 12. 90                                 Official Journal of the European Communities                                   No C 330/27
     the competent authorities of the Member State                        Committee shall be attached to the European Agency
     concerned shall recognize the authorization granted by               for the Evaluation of Medicinal Products established by
     the other Member State.                                              Council Regulation           . . . / . . ./EEC,    hereinafter
                                                                          referred to as the Agency.
     2.      Notwithstanding paragraph 1, if the Member
     State concerned considers that there are serious grounds             2.      In addition to the other responsibilities conferred
     for supposing that the authorization of the veterinary               upon it by Community law, the Committee shall
     medicinal product may present a risk to human or                     examine any question relating to the grant,
     animal health or the environment, it shall inform the                amendment,         suspension          or   withdrawal      of
     Member State which granted the initial authorization,                 authorization for a veterinary medicinal product which
     any other Member States concerned by the application                  is submitted to it in accordance with the provisions of
     and the Committee for Veterinary Medicinal Products                   this Directive.
     and the applicant within the time limit referred to in
     paragraph 1, stating its reasons in detail, and apply the             3.     The Committee shall adopt its own rules of
     procedures laid down in Chapter IV of this                           procedure.
     Directive.'
 7. In Article 14 (1), the first subparagraph is replaced by              Article 17
     the following:
                                                                           1.     In order to obtain the recognition in one or more
     'After an authorization has been issued, the person                   of the Member States of an authorization issued by a
     responsible for placing the product on the market must,              Member State in accordance with Article 4, the holder
     in respect of the methods of production and control                   of the authorization shall submit an application to the
     provided for in points 4 and 9 of Article 5 (2), take                competent authorities of the Member State or Member
     account of technical and scientific progress and                      States concerned, together with the information and
     introduce any changes that may be required to enable                 particulars referred to in Article 5, 5a and 5b. He shall
     the veterinary medicinal product to be manufactured                  testify to the identify of the dossier with that accepted
     and checked by means of generally accepted scientific                 by the first Member State, or shall identify any
     methods. These changes must be accepted by the                        conditions or modifications it may contain. In the latter
     competent authorities of the Member States                            case, he shall certify that the summary of product
     concerned.'                                                           characteristics proposed by him in accordance with
                                                                           Article 5a is identical to that accepted by the first
 8. Article 15 is replaced by the following:                               Member State in accordance with Article 5b.
      'Article IS
                                                                           Moreover, he shall certify that all the dossiers filed as
      1.     Authorization shall be valid for five years and               part of this procedure are identical.
     shall be renewable for five-years periods, on application
     by the holder at least three months before the expiry                 2.     The holder of the marketing authorization shall
     date.                                                                 notify the Committee of this application, inform it of
     2.      In exceptional circumstances, and following                   the Member States concerned and of the dates of
     consultation with the applicant, an authorization may                 submission of the application and send it a copy of the
     be granted subject to such conditions as appear                       authorization granted by the first Member State. He
     necessary to ensure the protection of human and animal                shall also send the Committee copies of any marketing
     health or the environment, including specific                         authorizations which may have been granted by the
     obligations to conduct further studies following the                  other Member States in respect of the product
     granting of authorization and specific obligations in                 concerned, and shall indicate whether any application
     respect of the reporting of adverse reactions to the                  for authorization is currently under consideration in
     medicinal product.'                                                   any Member State.
 9. Chapter IV is replaced by the following:                               3.     The holder of the authorization shall also inform
                                                                          the Member State which granted the initial
     'CHAPTER IV                                                           authorization that an application is being made in
                                                                           accordance with this Directive and shall notify it of any
     Committee for Veterinary Medicinal Products                           additions to the original dossier; that Member State
                                                                           may require the applicant to provide it with all the
     Article 16
                                                                          particulars and documents necessary to enable it to
      1.     In order to facilitate the adoption of common                check the identity of the dossiers filed with the dossier
     Decisions by Member States on the authorization of                   on with it took its decision. In addition that Member
     veterinary medicinal products on the basis of the                     State shall forward to the Member State or Member
     scientific criteria of quality, safety and efficacy, and to           States concerned by the application a copy of the
     achieve thereby the free movement of veterinary                       assessment report established in accordance with
     medicinal products within the Community, a                           Article 5b (2).
     Committee for Veterinary Medicinal Products,
     hereinafter referred to as 'the Committee', is hereby set            4.      Each Member State concerned shall recognize the
     up. The Committee shall consist of representatives of                marketing authorization granted by the first Member
     the Member States and of the Commission. The                         State within 90 days of receipt of the application. It
 ---pagebreak--- No C 330/28                             Official Journal of the European Communities                                   31. 12. 90
    shall inform the Member State which granted the initial            The Member States and the person responsible for
    authorization, the other Member States concerned by                marketing shall forward to the Committee all available
    the application, the Committee, and the person                     information relating to the matter in question.
    responsible for marketing thereof.
                                                                       Article 20
    Article 18
                                                                       The Member States or the Commission may, in specific
     1.    Notwithstanding Article 17(4), where a Member               cases where the interests of the Community are
    State considers that there are serious grounds for                  involved, refer the matter to the Committee for the
    supposing that the authorization of the veterinary                  application of the procedure laid down in Article 21
    medicinal product concerned may present a risk to                  before reaching a decision on a request for a marketing
                                                                        authorization or on the suspension or revocation of an
    human or animal health or the environment, it shall
                                                                        authorization, or on any other amendment to the terms
    forthwith inform the applicant, the Member State
                                                                        of a marketing authorization which appears necessary,
    which granted the initial authorization, any other
                                                                        in particular to take account of the information
    Member States concerned by the application and the
                                                                       collected in accordance with Chapter Via of this
    Committee. The Member State shall state its reasons in
                                                                       Directive.
    detail and shall indicate what action may be necessary
    to correct any defect in the application.
                                                                       The Member State concerned or the Commission shall
                                                                       clearly identify the question which is referred to the
    2.     All the Member States concerned shall use their
                                                                       Committee for consideration and shall inform the
    best endeavours to reach agreement on the action to be
                                                                       person responsible for marketing.
    taken in respect of the application. They shall provide
    the applicant with the possibility to make his point of
    view known orally or in writing. However, if within 60             The Member States and the person responsible for
    days of the expiry of the time limit referred to in                marketing shall forward to the Committee all available
    Article 17 (4), the Member States have not been able to            information relating to the matter in question.
    reach agreement they shall forthwith refer the matter to
    the Committee for the application of the procedure laid            Article 21
    down in Article 21.
                                                                        1.     When reference is made to the procedure
    3.     Within the time limit referred to in paragraph 2,           described in this Article, the Committee shall consider
    the Member State which granted the initial                         the matter concerned and issue a reasoned opinion
    authorization and the other Member States concerned                within 90 days of the date on which the matter was
    by the application shall provide the Committee with a              referred to it.
    detailed statement of the matters on which they have
    been unable to reach agreement and the reasons for                 In case of urgency, on a proposal from its Chairman,
    their disagreement. A copy of this information shall be            the Committee may agree to impose a shorter
    provided to the applicant.                                         deadline.
    4.     As soon as he is informed that the matter has been          2.      In order to consider the matter, the Committee
    referred to the Committee, the applicant shall forthwith           may appoint one of its Members to act as rapporteur.
    forward to the Committee a copy of the information                 The Committee may also appoint individual experts to
    and particulars referred to in Article 17 (1).                     advise it on specific questions. When appointing
                                                                       experts, the Committee shall define their tasks and
                                                                       specify the time limit for the completion of these
    Article 19                                                         tasks.
    If several applications submitted in accordance with               3.      In the cases referred to in Articles 18 and 19,
    Articles 5 and 5 a have been made for marketing                    before issuing its opinion, the Committee shall provide
    authorization for a particular veterinary medicinal                the person responsible for marketing with an
    product, and Member States have adopted divergent                  opportunity to present written or oral explanations.
    decisions concerning the authorization of the veterinary
    medicinal product, or its suspension or withdrawal                 In the case referred to Article 20, the person responsible
    from the market, any Member State or the                           for placing the medicinal product on the market may be
    Commission, or the person responsible for marketing                asked to explain himself orally or in writing.
    may refer the matter to the Committee for the
    application of the procedure laid down in Article 21.              If it considers it appropriate, the Committee may invite
                                                                       any other person to provide information relating to the
    The Member State concerned, the person responsible                 matter before it.
    for marketing or the Commission shall clearly identify
    the question which is referred to the Committee for                The Committee may suspend the time limit referred to
    consideration and, if necessary, shall inform the person           in paragraph 1 in order to allow the person responsible
    responsible for marketing.                                         for marketing to prepare explanations.
 ---pagebreak--- 31. 12. 90                               Official Journal of the European Communities                               No C 330/29
     4.    Where the opinion of the Committee is that:                   points (a), (b) and (c) of Article 21 (4), shall be
                                                                         annexed. The Commission shall transmit the draft
     — the application does not satisfy the criteria for                 Decision to the Member States and to the applicant.
         authorization set out in this Directive, or
                                                                         The Commission shall explain in detail the reasons for
     — the summary of product characteristics proposed by                any differences between the draft Decision and the
         the applicant in accordance with Article 5a should              opinion of the Committee.
         be amended, or
                                                                         2.     The Commission shall adopt the Decision to be
     — the labelling or package of the product is not in                 taken in respect of the application unless, within 30
         compliance with Chapter VII, or                                 days, it has received a reasoned request from a Member
                                                                         State to reconsider the matter. The Member State
     — the authorization       should granted      subject   to
                                                                         concerned shall also transmit a copy of its request to the
         conditions, or
                                                                         other Member States and the applicant within the same
     — an existing marketing authorization should be                     time limit.
         suspended amended or withdrawn,
                                                                         3.     Within the time limit referred to in paragraph 2,
     the Agency shall forthwith inform the person                        the applicant may submit written observations on the
     responsible for marketing. Within 15 days of the receipt            draft Decision for consideration by the Commission.
     of the opinion, the person responsible for marketing
     may provide written notice to the Agency that the                   4.     The Commission shall examine any reasoned
     wishes to appeal. Within 60 days of the receipt of the              request received in accordance with paragraph 2, in
     grounds for appeal, the Committee shall consider                    consultation with the Agency, and after consideration
     whether its opinion should be revised, and the reasons              of any further observations submitted by the
     for the conclusions reached on the appeal shall be                  applicant.
     annexed to the assessment report referred to in
     paragraph 5.                                                        If the Commission considers that the request raises
                                                                         questions of a scientific or technical nature requiring
                                                                         further examination, it may remit the matter to the
     5.     Within 30 days of its adoption, the Agency shall
                                                                         Agency. In this case the Committee shall give a second
     forward the final opinion of the Committee to the
                                                                         opinion within a time limit of 60 days. Within 30 days
     Commission the Member States and the person
                                                                         of the receipt of the opinion, the Commission shall
     responsible for marketing together with a report,
                                                                         adopt the Decision to be taken in respect of the
     describing the assessment of the veterinary medicinal
                                                                         application.
     product and the reasons for its conclusions.
                                                                         Otherwise the Decision shall be taken in accordance
     In the event of an opinion in favour of granting or                 with the procedure laid down in Article 2b and 2c of
     maintaining an authorization to market the veterinary               Directive 81/852/EEC.
     medicinal product concerned, the following documents
     shall be annexed to the opinion:                                    5.     A Decision adopted in accordance with this
                                                                         procedure shall be addressed to the Member States
     (a) a draft summary of the product characteristics, as              concerned by the matter and to the person responsible
          referred to in Article 5a;                                     for marketing. The Member States shall either grant or
                                                                         withdraw marketing authorization, or make any
     (b) details of any conditions or restrictions which
                                                                         adjustment to the terms of a marketing authorization
          should be imposed on the supply or use of the
                                                                         which may be necessary to comply with the Decision
          veterinary medicinal product concerned, including
                                                                         within 30 days of its notification. They shall inform the
          the conditions under which the veterinary
                                                                         Commission and the Committee thereof.
          medicinal product may be made available to
          users;
                                                                         Article 23
     (c) the draft text to the labelling and package leaflet,
          proposed by the applicant presented in accordance              Any application by the person responsible for
          with Chapter VII.                                              marketing to amend the terms of a marketing
                                                                         authorization which has been granted in accordance
                                                                         with the provisions of this Chapter shall be submitted to
     Article 22                                                          all the Member States which have previously authorized
                                                                         the medicinal product concerned.
     1.     Within 30 days of the receipt of the opinion of the
     Committee, the Commission shall prepare a draft of the              The Agency shall, in consultation with the
     Decision to be taken in respect of the application taking           Commission, adopt appropriate arrangements for the
     into account the objectives of Community policies and               examination by the Committee of amendments or
     considering all relevant information. In the event of a             variations to a marketing authorization which has been
     draft Decision which envisages the granting of a                    granted in accordance with the provisions of this
     marketing authorization, the documents referred to in               Chapter.
 ---pagebreak--- No C 330/30                               Official Journal of the European Communities                                    31. 12. 90
     The procedures laid down in Articles 21 and 22 shall            11. The following          Chapter Via      is  inserted     after
     apply mutatis mutandis to variations and amendments                  Article 42:
     of marketing authorizations.
                                                                          'CHAPTER Vfc
     Article 23a                                                          Pharmacovigilance
     1.     Where a Member State considers that the                       Article 42a
     amendment of the terms of a marketing authorization
     which has been granted in accordance with the                        In order to ensure the adoption of appropriate
     provisions of this Chapter or its suspension or                      regulatory Decisions concerning the continued
     withdrawal is necessary, the Member State concerned                  authorization of veterinary medicinal products within
     shall forthwith refer the matter to the Committee for the            the Community, having regard to information obtained
     application of the procedures laid down in Article 21                about adverse reactions to veterinary medicinal
     and and 22.                                                          products under practical conditions of use, the Member
                                                                          States shall establish a pharmacovigilance system for
                                                                          collecting information about adverse reactions to
     2.     In exceptional cases, where action is urgently
                                                                          veterinary medicinal products and for the scientific
     necessary to protect human or animal health or the
                                                                          evaluation of such information.
     environment, until a definitive Decision is adopted, the
     Member States suspend the use of the veterinary
     medicinal product concerned on its territory. It shall               Article 42b
     inform the Commission no later than the following
     working day of the reasons for its action.                           For the purpose of this Directive, the following
                                                                          definitions shall apply:
                                                                          — 'adverse reaction' shall mean a reaction which is
     Article 23b
                                                                              noxious and unintended and which occurs at doses
                                                                              normally used in animals in accordance with the
     Articles 23 and 23a shall apply mutatis mutandis to                      terms of the marketing authorization for the
     medicinal products authorized by Member States                           prophylaxis, diagnosis or therapy of disease or for
     following an opinion of the Committee given in                           the modification of physiological function,
     accordance with Article 4 of Directive 87/22/EEC
     before 1 January 1993.                                               — 'serious adverse reaction' shall mean an adverse
                                                                              reaction which results in death, permanent or
                                                                              prolonged signs or lesions in treated animals.
    Article 23c
                                                                         Article 42c
     1.     The Agency shall publish an annual report on the
    operation of the procedures laid down in this                         The person responsible for marketing shall have
     Chapter.                                                            permanently and continuously at his disposal a person
                                                                         responsible for pharmacovigilance. This person shall be
                                                                         responsible for:
    2.      Within six years of the date referred to in the first
    subparagraph of Article 4 (1), the Commission shall                  (a) the establishment and maintenance of a system
    publish a detailed review of the operation of the                          which ensures that information about all adverse
    procedures laid down in this chapter and shall propose                     reactions which are reported to the personnel of
    any amendments which may be necessary to improve                           the company, including its sales personnel, is
    the operation of these procedures.                                         collected and collated at a single point;
                                                                         (b) the preparation and submission to the competent
    The Council shall decide on the Commission proposal
                                                                               authorities of the reports referred to in Article 42d,
    within one year of its submission.'
                                                                               in such form as may be laid down by those
                                                                               authorities;
10. The third subparagraph of paragraph 1 of Article 30 is               (c) ensuring that any request from the competent
    replaced by the following:                                                 authority for the provision of additional
                                                                               information necessary for the evaluation of the
    'In the case of veterinary medicinal products imported                     benefits and risks of a veterinary medicinal product
    from a third country, where appropriate arrangements                       is answered fully and promptly, including the
    have been made by the Community with the exporting                         provision of information about the volume of sales
    country to ensure that the manufacturer of the                             for the veterinary medicinal product concerned,
    veterinary medicinal product applies standards of good                     where relevant.
    manufacturing practice at least equivalent to those laid
    down by the Community and to ensure that the controls                Article 42d
    referred to under (b) have been carried out in the
    exporting country, the qualified person may be relieved              1.      The person responsible for marketing shall be
    of responsibility for those controls.'                               required to record and to report all suspected serious
 ---pagebreak--- 31. 12. 90                               Official Journal of the European Communities                                 No C 330/31
     adverse reaction which are brought to his attention by a            Commission and interested parties, draw up detailed
     qualified veterinarian to the competent authorities                 guidance on the collection, verification and
     within 15 days of their receipt.                                    presentation of adverse reaction reports.
     2.     In addition, the person responsible for marketing            Article 42h
     shall be required to maintain detailed records of all
                                                                         Where as a result of the evaluation of adverse reaction
     other adverse reactions which are reported to him by a
                                                                         reports, a Member State is considering amending the
     veterinarian health care professional. Unless other
                                                                         terms of a marketing authorization or its suspension or
     requirements have been laid down as a condition of the
                                                                         withdrawal, it shall forthwith inform the Agency.
     granting of authorization, these records shall be
     submitted to the competent authorities immediately                   In case of urgency, the Member State concerned may
     upon request or at least every six months during the first           suspend the marketing of a medicinal product,
     two years following authorization and once a year for               provided the Agency is informed at the latest on the
     the following three years. Thereafter, the records shall             following working day.'
     be submitted at five-yearly intervals together with the
     application for renewal of the authorization, or
     immediately upon request.
                                                                                               Article 2
     Article 42 e                                                   In Directive 81/852/EEC, the Committee referred to in
                                                                    Article 2b is thereby renamed 'the Standing Committee on
                                                                    Veterinary Medicines'.
     The Member States shall take all appropriate measures
     to encourage veterinarians to report adverse reactions
     to the competent authority.
                                                                                               Article 3
     The Member States may impose specific requirements
     on veterinarians, in particular in respect of the              Member State shall take all appropriate measures to comply
     reporting of serious or unexpected adverse reactions, or       with the provisions of this Directive, with the exception of
     where such reporting is a condition of the marketing           Article 1 (6), before 1 January 1993. They shall forthwith
     authorization.                                                 inform the Commission thereof.
                                                                    Member State shall take all appropriate measures to comply
     Article 42/                                                    with Article 1 (6) of this Directive before 1 January 1996.
                                                                    They shall forthwith inform the Commission thereof.
     The Member States shall ensure that report of serious
     adverse reactions are brought to the attention of the          When Member States adopt these provisions, these shall
     Agency and the person responsible for marketing                contain a reference to this Directive or shall be accompanied
     within 15 days of their receipt.                               by such reference at the time of their official publication. The
                                                                    procedure for such reference shall be adopted by Member
                                                                    States.
     Article 42g
     In order to facilitate the exchange of information about                                  Article 4
     pharmacovigilance within the Community, the Agency
     shall, in consultation with Member States, the                 This Directive is addressed to the Member States.