CELEX: 51988PC0779
Language: en
Date: 1989-02-09
Title: Proposal for a COUNCIL REGULATION (EEC) laying down a Community procedure for the establishment of tolerances for residues of veterinary medicinal products#Proposal for a COUNCIL DIRECTIVE amending Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products#Proposal for a COUNCIL DIRECTIVE 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# (presented by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (88) 779
Vol. 1988/0254
 ---pagebreak--- Disclaimer
Conformément au règlement (CEE, Euratom) n° 354/83 du Conseil du 1er février 1983 concernant
l'ouverture au public des archives historiques de la Communauté économique européenne et de
la Communauté européenne de l'énergie atomique (JO L 43 du 15.2.1983, p. 1) modifié en dernier
lieu par le règlement (UE) 2015/496 du Conseil du 17 mars 2015 (JO L79 du 25. 3.2015, p. 1), ce
dossier est ouvert au public. Le cas échéant, les documents classifiés présents dans ce dossier
ont été déclassifiés conformément à l'article 5 dudit règlement ou sont considérés déclassifiés
conformément aux articles 26(3) et 59(2) de la décision (UE, Euratom) 2015/444 de la
Commission du 13 mars 2015 concernant les règles de sécurité aux fins de la protection des
informations classifiées de l'Union européenne.
In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983 concerning
the opening to the public of the historical archives of the European Economic Community and the
European Atomic Energy Community (OJ L 43, 15.2.1983, p. 1), as last amended by Council
Regulation (EU) 2015/496 of 17 March 2015 (OJ L 79, 27.3.2015, p. 1), this file is open to the
public. Where necessary, classified documents in this file have been declassified in conformity
with Article 5 of the aforementioned regulation or are considered declassified in conformity with
Articles (26.3) and 59(2) of the Commission Decision (EU, Euratom) 2015/444 of 13 March 2015
on the security rules for protecting EU classified information.
In Übereinstimmung mit der Verordnung (EWG, Euratom) Nr. 354/83 des Rates vom 1. Februar
1983 über die Freigabe der historischen Archive der Europäischen Wirtschaftsgemeinschaft und
der Europäischen Atomgemeinschaft (ABI. L 43 vom 15.2.1983, S. 1), zuletzt geändert durch die
Verordnung (EU) Nr. 2015/496 vom 17. März 2015 (ABI. L 79 vom 25.3.2015, S. 1), ist dieser Akt
der Öffentlichkeit zugänglich. Soweit erforderlich, wurden die Verschlusssachen in diesem Akt in
Übereinstimmung mit Artikel 5 der genannten Verordnung freigegeben; beziehungsweise werden
sie auf Grundlage von Artikel 26(3) und 59(2) der Entscheidung der Kommission (EU, Euratom)
2015/444 vom      13.   März 2015     über die   Sicherheitsvorschriften für den Schutz von  EU-
Verschlusssachen als herabgestuft angesehen.
 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                COM(88 ) 779 final
 REVISED VERSION                               Brussels , 9 February 1989
                               Proposal for a
                          COUNCIL REGULATION ( EEC )
       laying down a Community procedure for the establishment of
        tolerances for residues of veterinary medicinal products
                                Proposai for a
                              COUNCIL DIRECTIVE
     amending Directive 81 / 851 / EEC on the approximation of the laws
     of the Member States relating to veterinary medicinal products
                                Proposai for a
                              COUNCIL DIRECTIVE
    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
                       ( presented by the Commission )
                                                         \>>"         • /^
                                                   f            ail
                                                  R <!             j? I
                                                    V/A,
                                                                  S
                                                                 «O
                                                                         A?/
                                                                        /AV
                                                              _
 ---pagebreak---                          - z t-CT 6
    AMENDMENT OF THE VETERINARY MEDICINAL PRODUCTS DIRECTIVES
Explanatory memorandum and report to the Council                   . . . p. 7
Proposal for a Council Regulation             ( EEC ) Laying down a
Community procedure for the establishment of
tolerances for      residues of veterinary medicinal
products                                                   .             p . 32
Proposal     for a Council     Directive amending Directive
81 / 851 / EEC on the approximation of the            laws of   the
Member States relating to veterinary medicinal
products                                                   .             p.50
Proposal     for a Council     Directive 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      i mmuno I og i ca I veterinary medicinal
products                                                   .             p.83
Financial statement                                       . p.91
Competitiveness and Employment
Impact     Statement                                                      p . 96
 ---pagebreak---                                              7
AMENDMENT OF THE VETERINARY MEDICINAL PRODUCTS DIRECTIVES
      EXPLANATORY MEMORANDUM AND REPORT TO THE                            COUNCIL
   I NTRODUCT I ON
   In   accordance with Article                   23(1 )   of    Directive        81 / 851 / EEC
   on   the   approximation             of    the    laws      of   the    Member        States
   relating     to     veterinary          medicinal        products        ( O.J.      L  317 ,
   6.11.1981 ,      p.   1 )    and     in   accordance         with     its    legislative
   programme on         the     completion of            the    internal       market ,      the
   Commission         is     expected            to    present         to     the      Council
   proposals       containing           all      appropriate         measures         for    the
   removal of any remaining barriers to the free movement of
   veterinary medicinal               products .         In addition ,        Article 5 of
   Directive       87 / 22 / EEC       on     the    approximation            of     national
  measures      relating         to    the placing on the market                    of    high -
   technology medicinal               products ,      particularly those derived
   from    biotechnology            ( O.J.      no   L    15 ,    17.1.1987 ,        p.    38 ),
  requires the Commission to present proposals to harmonize
  the     conditions           for      authorizing            the     manufacture           and
  placing      on      the      market         of    the       veterinary          medicinal
  products       referred           to      in     Article        2(2 )    of      Directive
  81 / 851 / EEC ,   which       are     currently        excluded       from      the    scope
  of   that   Directive .
  This    package of         three       legislative         proposals         is    intended
  to   represent       a   first       step     towards      the     implementation           of
  these    mandates .        Taken        as   a   whole ,     the    package       has    four
  major objectives           :
 ---pagebreak---                                       δ
a ) The     institution of a centralised Community system for
     determining binding tolerances ( acceptable levels ) for
     residues        of     veterinary           medicinal         products        In
     foodstuffs of animal           origin .
b ) The       improvement        of     the       decentralised           Community
     procedure      which     enables       a    person     who     has    obtained
     authorization to market a veterinary medicinal                         product
     in one Member        State    to apply       for   its extension        to the
     other    Member    States .
c ) The      updating      of    the      detailed        provisions        of   the
     veterinary       medicines        directives ,         in    the     light   of
     developments since 1981 .
d ) The    extension      of   the   veterinary         medicines       directives
     to cover     immunological        veterinary medicinal             products .
The    mandate     conferred      upon     the     Commission       by    Directive
87 / 22 / EEC also refers to homeopathic veterinary medicinal
products and to radiopharmaceuticals .
At   the present      time the Commission has               little    information
available      about    the  basis     for    or   the  extent     of   the  use of
homeopathy       in veterinary medicine ,             or   the   basis on which
such     products      might    be    regulated        in   order      to   protect
public      health .     Although      it   will     keep    the    matter     under
review ,     the   Commission      does    not     intend     to   bring    forward
proposals on these products at                 this time .
Radiopharmaceuticals            are    medicinal        products       based    upon
radionuclides         ( radioactive        isotopes )       which     are    mainly
used     for diagnostic purposes .                Although there          has been
very      considerable        growth        recently         in    the     use    of
 ---pagebreak---                                                9
     r ad lopharmaceut I ca I s         In   human medicine ,              this development
    has    not    yet     been     paralleled         In    veterinary         medicine .      So
    far       as       the        Commission            is        aware ,        hardly      any
    radiopharmaceuticals are authorized for use In veterinary
    medicine       by    the Member         States        at    the     present      time ,  and
    the     limited       uses      which      do    occur        are     for    experimental
    purposes        only .      In    these      circumstances ,             the    Commission
    does      not      consider         it     appropriate             to    bring      forward
    specific       proposals         at    this     time ,      although        it   will   keep
    the situation under              review .
2 . THE    EXPERIENCE WITH THE              EXISTING DIRECTIVES
    The     two      original         directives            relating         to     veterinary
    medicinal        products ( Directives 81 / 851 / EEC and 81 / 852 / EEC )
    were closely modelled on the rules existing at                                   that   time
    for     proprietary             medicinal          products            for     human     use
    ( Directives         65 / 65 / EEC ,    75 / 318 / EEC        and     75 / 319 / EEC ).    In
    particular           the      procedures           laid         down      in    order     to
    facilitate         the    adoption       of    a    common        position       by  Member
    States        in     respect        of      marketing            authorizations          for
    veterinary medicinal               products        in Chapter           IV of    Directive
    81 / 851 / EEC     were      Identical        to     the      procedures        then    laid
    down     in    respect        of   proprietary           medicinal          products     for
    human use by Directive 75 / 319 / EEC .
    In so far as veterinary medicinal                         products are concerned ,
    these     procedures           have     not      been       a    success .       Only    one
    application          has      been     forwarded           to     the    Comm i 1 1 ee   for
    Veter inary        Medic Inal        Products          i n    accordance         with    the
    provisions         of    Article        1 7    of     D i rect i ve      81 / 851 / EEC   i n
    respect      of    a   we I I - known     ant i b i o t  ic    for    use    in   dogs   and
    cats .
 ---pagebreak---                                        10
   The   biotechnology-high           technology       procedure       established
   by Directive 87 / 22 / EEC also applies                to   applications       for
   veterinary     medicinal       products ,     and    although      it   is   still
   too    soon    to    offer      a    definitive        assessment        of    the
   procedure ,    which     only    came    into   effect      on   1   July    1987 ,
   three applications are currently pending .
3. THE   SCOPE   OF   THE    PROPOSALS      AND    THEIR     RELATIONSHIP        WITH
   THE  DIRECTIVES ON MEDICINAL            PRODUCTS      FOR   HUMAN USE
   Because of     the   very    limited use which            has   been made ,      in
   particular of the procedures              in Directive 81 / 851 / EEC ,        the
   Commission     has   had    to    consider     whether      it   would     not  be
   more appropriate        to create an alternative               system    for   the
   approval of veterinary medicines within the Community .
   Many   of   the   principles         involved      in   the     regulation      of
   veterinary      medicinal        products       are     the     same     as    for
   proprietary medicinal           products .      Indeed ,     in   this   package
   the   Commission       is   proposing       that    a   number      of   changes
   which   have been made or          proposed     to    the  rules     applicable
   to  proprietary      medicinal       products     should      be   extended     to
   cover   veterinary      medicinal      products .       Nevertheless         there
   are fundamental       differences resulting from the widespread
   use of medication for prophylactic prurposes ,                      concern for
   the  safety    of   the    persons     handling       veterinary      medicinal
   products    and   administering        them    to    animals ,     the   need   to
   consider     the    impact       of   veterinary        medicines        on    the
   environment ,    and to take account of             the practical        farming
   conditions     under      which     medicines        are    administered        to
   animals .
 ---pagebreak---  In addition ,     account must        be   taken of      the    fact    that    the
use  of   veterinary medicinal             products       In   food    producing
animals   will     result     in  residues       in   foodstuffs       of   animal
origin .    Differing assessments of the safety of residues
which may create problems not only for                     the   free movement
of  veterinary       medicinal      products      but   also     for    the     free
movement    of   the    foodstuffs concerned .
During the preparation of this package of proposals , the
services of the Commission Invited the Member States , the
 Industry ,    consumer      groups ,     and    interested        professional
organizations        to   submit     comments       on   the     choice      of   an
appropriate       system      for    authorizing         the     marketing        of
veterinary medicinal products within the Community .                           As a
result   of   these consultations ,           it   is clear      that    there    is
substantial        support        for      the      establishment           of     a
centralised      Community      procedure       for   the   authorization of
major new products .           Nevertheless ,       many questions remain
open on the manner          in which such a system would operate ,
the  resources       which    would     be  made     available       to   It ,   and
the   interrelationships           between       national       and    Community
responsibilities .         There is also concern that the running
in period for such a system would                  Inevitably be a period
of uncertainty and some confusion .
Moreover ,    a   number    of   the    Member      States     have    requested
that  any    decisions      about     the   choice     of    a  future      system
for  the    free    movement     of    veterinary       medicinal        products
should be made        in parallel with the choice of a system to
guarantee      the     free   movement       of    proprietary         medicinal
products     for    human     use .     The    Commission         is   currently
engaged   in detailed consultations on this matter , and in
accordance      with      its    obligations         under       the     existing
pharmaceutical       directives and         its White Paper          programme ,
 ---pagebreak---  the Commission       intends to present proposals               In the Autumn
of  1989 .
 In these circumstances ,           the Commission considers             that    it
would    be    premature       at   the    present      time    to    propose     a
definitive procedure for the authorization of veterinary
medicinal     products at        the Community       level .     It   intends to
continue      consultations ,        with    a   view    to   completing       its
proposals within one year .
Nevertheless ,       the     Commission       considers      that     there    are
other     major       changes        to    the      veterinary         medicir
directives       which    should    be   proposed      now and     on   which    it
should     be     possible       to   reach      rapid     agreement .      These
changes     concern ,      in   particular ,      residues      of   veterinary
medicines      and   the operation of          the   decentralised       " multi -
state "     procedure         for      authorization          of     veterinary
medicinal     products under        directive 81 / 851 / EEC .
RESIDUES    OF    VETERINARY      MEDICINAL     PRODUCTS
As   noted        above ,     the     administration          of     veterinary
medicinal products to food producing animals Is likely to
result     in     very     small     quantities        of    the     veterinary
medicinal      product     being    present      in  foodstuffs       of   animal
origin .    Although         the    potential         risk     presented        by
residues       has     been      recognised        for     some     time ,    the
analytical        methods       available       were      not     sufficiently
sensitive      to   detect     residues     at   the    very   low    levels    at
which   there are encountered .             It  was   therefore     sufficient
to provide      that   no detectable         residues     should    be   present
in   foodstuffs         and     to    establish        withdrawal        periods
accord i ng I y .
 ---pagebreak---  However ,       In      recent        years     there      have      been       remarkable
 development          in analytical          techniques which mean that ,                     in
 some     cases ,       it     is   now   possible       to     detect        residues       at
  levels as       low as one part per               billion ,      or   even      to detect
 whether a single molecule of a given compound                                   is present
 In a carcass .            As a result of           these developments ,               It   has
 been     possible           to     conduct      pharmacokinetic               studies        In
 animals        treated           with      certain         veterinary            medicinal
 products which            have shown that           an    initial       rapid decrease
of    drug     concentration             in   the     animal      is     followed        by    a
 longer and much slower phase of depletion .
 It  Is    therefore          clear     that    the   notion      of    a   zero     residue
 is no     longer      adequate either            as a    regulatory          tool ,    or   as
an   instrument          for consumer protection .                  In reality a zero
 tolerance         is     today       no    more     than     a     function         of    the
sensitivity         of      the    analytical       method      used ,     on     the   basis
 that    the   more       one      looks    for    something ,        the     more     likely
one    is   to   find      it .
 In  these      circumstances ,            contemporary          scientific          opinion
suggests that            the concept of the zero tolerance has to be
replaced        by      a     careful       scientific          evaluation          of     the
potential         risks         presented        by    residues         of      veterinary
medicinal        products          in   foods .     This     evaluation ,          which     is
conducted        in    accordance         with     broadly       similar        principles
to   those     used       for     assessing      food    additives ,         entails       the
conduct       of    toxicological            tests      in     laboratory          animals .
Using     the    results of           these studies ,        the     toxicological           no
effect      level      in    the most      sensitive       species        is    determined
and     expressed            in     terms     of     milligrams           per      kilogram
bodyweight .          The     no    effect     level    is    then     divided       by    the
appropriate safety factor ,                   usually between 100 and                   1000 ,
to   determine          the     acceptable        daily      intake        in    man .    The
 ---pagebreak---  acceptable      daily      Intake     is    then      divided     between      the
 various     foodstuffs        concerned ,      on     the   basis     of    usual
 dietary    intakes ,    to arrive at a tolerance for each of the
 food products of animal origin concerned ( muscle tissue ,
 liver , kidney , eggs , milk etc .)
 In assessing the safety of residues , other potential risk
factors     must     also    be  taken     into     consideration        such    as
 immunological        effects      ( allergic        reaction      or     immuno ¬
suppression )       and    microbiological          effects ,     such    as   the
effects on microbial           resistance .
 In addition ,      the   effects     that     residues     may    have    on  the
 industrial      processing         of     foodstuffs         must      also     be
considered ,      for     example      in    the    manufacture        of    dairy
products such as yoghurt and cheese .
Differences       in   the    laws   of   countries       about    residues      of
veterinary medicines           can have a profound            impact    not only
on the free movement of veterinary medicinal                      products but
also on the free movement of foodstuffs of animal origin ,
which      are ,     of     course ,      of      far     greater       economic
significance .        For    this     reason ,      at    the    international
level ,    increasing       importance       has    been    atached      to   this
problem ,    culminating ,      in 1986 ,     in the establishment of a
Codex    Alimentarius       Committee       for    Residues     of   Veterinary
Drugs   in Foods .
At   the    Community       level ,    the    Committee       for    Veterinary
Medicinal     products       has   set    up    a   working     party     on   the
safety of residues to provide the Commission with advice .
Following the general           approach outlined above ,             the group
has   prepared        recommendations         on     chloramphenicol ,         the
sulfonamide group , the nitrofuran group , trimethoprim and
dapsone . These           recommendations            will      be     finalised
 ---pagebreak---                                          15
 shortly ,    and    the Commission will              publish       them once        they
are   available .          In   addition ,      work    on    a   number       of  other
compounds        Is      at     an     advanced       stage ,        Including         the
benzimidazole and the n I t ro I m I dazo I e groups .
At   the   present        time ,    however ,      there     is   no    mechanism       by
which     thes       recommendations            can     be     given       legislative
effect     throughout         the   Community ,      other      than      by   a  series
of  ad    hoc   directives          to   be   adopted      by    the     Council .      In
order    to ensure         the    proper     protection of           public      health ,
and   in order       to progress          towards     an    Internal       market     for
this    sector ,      the     Commission       considers         it    i nd I spens I b I e
that   an   appropriate          procedure      shoud     be established which
will   result     in the progressive              implementation of approved
tolerances         for       all     substances         which        are       used     in
veterinary       medicinal         products       within      the    Community .        In
view of     the    fact     that     some   150    compounds        may    need    to   be
assessed ,        it      seems        appropriate          to      allow        for      a
transitional        period       of   about    8   years     for     the    completion
of  this     work .     Moreover        the   establishment           of    tolerances
at   the   Community          level     will   enable       the    Commun i t y     as    a
whole    to    play     a    full     role    In    the    work      in    this    field
current ly           being           undertaken            by          internat iona I
organizat ions .
In the case of new veterinary medicinal                         products        intended
for use     in food producing animals ,                the establishment of a
tolerance      by    the     Community       will    be    required        before     any
Member     State      may      authorize       the    product .         In    order     to
alleviate any burden which this requirement may                               impose on
the   industry ,       it    is   proposed       that    such     products        should
also     be     automatically             eligible        for       the      Community
coordination procedure estalished by Directive 87 / 22 / EEC .
 ---pagebreak---                                           16
So   far   as    the     procedure        Is    concerned ,     the    Commission       is
proposing        that      the     actual      task    of   evaluating       the   risks
presented        by    residues         should      continue      to   be   undertaken
within     the     Committee          for   Veterinary        Medicinal       Products .
This    Committee            Is    made    up     of    representatives         of    the
Member     States ,        usually      of    the    officials      responsible       for
the    registration             of    veterinary         medicinal       products       in
their    own    countries .           In order      to assist      the Committee        in
 its  work ,     a    technical         secretariat        will     be   established .
Following        examination           of    a   substance ,       it   is    envisaged
that      the        conclusions            of      the     Committee         will     be
communicated          to the person responsible for marketing the
substance       concerned          and   to    the Member      States     for   comment
before      a    definitive            decision        is    reached .      The    final
decision       on     the     establishment           of   a   tolerance       will    be
taken    by     the     Commission          in   close     cooperation        with    the
Committee for Veterinary Medicinal                        Products , using the so
called regulatory committee procedure which                             requires      the
approval        of     a      qualified         majority       of     Member     States
( Procedure       III ,    variant a of Council              Decisions 87 / 373 / EEC
of   13    July       1987       laying      down     the    procedures        for    the
exercise        of        implementing           powers       conferred        on     the
Commission , O.J.            No L 197 of 18.7.1987 ,             p.   33 ).
Once    a     tolerance           is    agreed ,      the    Commission        will    be
required to publish a summary assessment of the safety of
residues of         the compound concerned .
There    are    a    limited        number     of   compounds      for    which    it   is
not   necessary           to    establish        a   tolerance       either     because
their toxicity            is very      low or because they are substances
which      occur         naturally          in     the     treated       animal .     The
Commission         is    propositng         that     these    products       should    be
included        in     a     list      in    an     additional        annex     to    the
regulation which would be adopted in accordance with the
 ---pagebreak---                                            17
    procedure described above .
5.  THE      MULTI-STATE             PROCEDURE          FOR        VETERINARY            DRUG
    REG I STRAT ION
   Various reasons have been advanced for                        the failure of           the
   multi-state registration procedure created by Chapter                                    IV
   of Directive 81 / 851 / EEC .             In particular ,         the procedure          is
   said     to   be   unattractive          to   the    industry       because       of   the
   h I gh-t h r esho I d     number       of     Member      States         to     whom     an
   application          must      be   addressed        and    the      fact      that    the
     industry has no right to a hearing before the Committee .
   As     an    interim        measure ,       the    Commission          is      therefore
   proposing         to    transpose        into     Directive         81 / 851 / EEC     the
   multi-state            procedure          established           for        proprietary
   medicinal       products for          human use by Directive 83 / 570 / EEC
    ( O.J.   No    L    332     of   28.11.1983 ,        p.   1 ).     This      directive
   requires Member            States     to take      the authorization granted
   by the original Member State                    into due cons i der a t i on when
   considering          subsequent        applications          in    respect       of    the
   same product .          Only     in exceptional         cases should the other
   Member       States        not      be    able      to     accept         the      inital
   authorization ,          in    which    case     the   matter       is    referred      to
   the     Committee         for     Veterinary        Medicinal          Products        for
   opinion .       in    addition ,       the    threshold        number        of   Member
   States      to  which       an   application        must    be    made      is   reduced
   from    five    to    two    and    the   company      is   given      a   right     of   a
   hearing before the Committee .
   The Commission           is also proposing that the Council                       should
   increase       the     weight      of   opinions       of    the      Committee        for
   Veterinary Medicinal              Products by        requiring Member             States
   to    implement       the    opinions      with    60   days .     Thus      where     the
   opinion of       the Committee          is favourable ,         the Member States
 ---pagebreak---                                          18
   concerned         by     the    application         will     be     expected     to
   authorize       the    product     within      this    timelimit ,    subject    to
   the    conditions        laid   down     in    the  opinion .     On    the   other
   hand ,    where     the    opinion     Is    a   negative     one ,   the   Member
   State which originally authorized the product will be
   expected to reconsider Its position and withdraw the
   product from the market .
   in addition to these             legislative changes ,          the Commission
   intends       to     increase      the     resources       available       to   the
   Committee       so that work on the preparation of                    guidelines
   on the assessment of veterinary medicinal                      products can be
   i ntens i f i ed .
6. THE    DETAILED       PROPOSALS       FOR     AMENDMENT      OF   THE     EXISTING
   D I RECT I VES
   The     proposal         for     a    Directive         amending      Directives
   81 / 851 / EEC ,    81 / 852 / EEC   and     87 / 22 / EEC   also    contains     a
   number      of     proposals       for    the     amendment      of    the    rules
   applicable         to     veterinary        medicinal       products       in   the
   Community .        While certain of          these proposals are           for  the
   extension      to    the veterinary medicinal              products sector       of
   changes which have previously been adopted or proposed in
   respect of proprietary medicinal                   products     for   human use ,
   other are specific to veterinary medicinal                      products .      The
   main changes can be summarized as follows .
 ---pagebreak---                                         19
6 . 1     The    relationship          between       the   veterinary       medicines
          directives        and    the   rules      relating      to   additives    for
          use   In   animal      feed
As     a    result       of      technological          developments ,         certain
practical         difficulties          have      arisen       in    distinguishing
between      products         which    should      be   regarded      as   veterinary
medicinal       products and products which should be                        regarded
as    additives       for     animal    feedingstuffs           which    fall    within
the      scope     of     Directive         70 / 524 / EEC     ( O.J.    No    L   270 ,
1 4.1 2.1 970 , p .     1 ) .
 in   order     to     clarify       the    situation ,       the     Commission      is
proposing       that     the     definition of         a   veterinary       medicinal
product      should      be    amended      to   expressly        exclude    products
which are administered to animals orally and are                              intended
for      long    term-use         in   healthy       animals       for   nutritional
purposes .       The        Commission            is      currently         preparing
amendements         to    Directive        70 / 524 / EEC    to   ensure     that   all
such products are covered by that directive .
6 . 2     The   distribution of           veterinary medicinal             products
Within      the    Member       States ,    veterinary        medicinal      products
are    distributed         through a       variety of        different      channels .
 In some Member         States ,      the veterinarian has a predominant
role     in distribution ,           in other ,      the   pharmacist ,      while    in
certain       Member         States      a     considerable          proportion      of
veterinary         medicinal         products        are    distributed        through
specialist          animal          health       product         distributors        or
agricultural cooperatives .                  This matter was considered in
detail     by the European Parliament                  in  its resolution of 13
April     1984    on   the     basis of      a   report     prepared      by  Mr   Hord
( O.J. No C 127 , 4.5.1984 , p.                193 ).
 ---pagebreak---                                        20
After       careful        consideration           of      the      problem ,     the
Commission has decided that                  it would not be appropriate ,
at     the    present       time ,     to     include       in    the    directives
relating to veterinary medicinal products detailed rules
 laying down which professions should be permitted to
distribute       veterinary medicinal              products .        Nevertheless ,
 in   the   interests of         public     health     and    in order     to avoid
distortions       of     competition ,       the    Commission        considers     it
necessary      to bring        forward proposals            to ensure      that   the
distribution of veterinary medicinal                      products takes place
only      through      officially         authorized         channels      In    each
Member State . To this end , the Commission is proposing
that a new Chapter on the distribution of veterinary
medicinal       products        should      be    inserted        into    Directive
81 / 851 / EEC    which        will      require       all     distributors        to
maintain detailed           records of       all   transactions and         to hold
these      record       open      for     inspection        by     the    competent
authorities        for      a    period      of    at     least      three    years .
Similar      obligations        are    also    imposed on        manufactures      of
veterinary       medicinal         products      by    Article      27(f )   and   on
manufacturers        and    distributors of          active     substances which
may    be   used    in    the   manufacture        of    veterinary       medicinal
products by Article 1(5 ).
6.3      Administration_of_non-aut hor i zed_veter inary
         medicinal       products      to animals
At   the present       time ,    Article 4(2 )      of Directive 81 / 851 / EEC
prohibits       any     administration          to    animals      of    veterinary
medicinal       products        which     have     not    been     authorized      by
Member      States      except      during      the     conduct       of   clinical
trials ,    or   in    the    case    of   veterinary       medicinal      products
 ---pagebreak---                                             21
which     have not         been prepared           In advance and             are   Intended
 for    the     treatment           of    a   particular          animal       or   a   small
number        of       animals .          Experience         suggests           that      some
amendment        to these provisions                Is required .
 In the first          Instance , the Commission considers that as a
matter     of     principle           the exemption          In    favour      of  products
prepared extemporaneously for a                         limited number of animals
should be        restricted            to products which            are     prescribed by
a  veterinarian            In    respect      of   animals which           are under       his
direct personal care .
Secondly ,        the      Commission           Is    aware       that      a    number     of
farmers      have       been     diversifying           into     new    activities        such
as   fish-farming or               the     rearing of       goats       or   other     exotic
species .        Inevitably              the     development             of      veterinary
medicinal         products           intended      for    the      treatment        of   such
species takes some time , and                     In certain         instances may not
even    be    economically              viable .    Thus      the     veterinarian         may
not   have an authorized remedy available for                               the treatment
of    sick       animals          under       his     care .       In     these      special
circumstances , Member States should be able to permit                                     the
veterinarian           to   administer         veterinary          medicinal       products
which     have        been       authorized         for     use       In    other     animal
species or medicinal                  products authorized for use                  in human
beings     provided          that       detailed      records       are     kept    and ,    in
the case of          food-producing animals ,                  a   lengthy withdrawal
period     is applied to avoid any risk to the consumer .
Thirdly ,      the Commission has become aware that                             the strict
application            of      Article         4(2 )      is      causing         practical
difficulties for veterinarians who are providing services
on    a     t r a n s f r on t i e r     basis       in    accordance            with      the
 ---pagebreak---                                        22
provisions of Directive 78 / 1026 / EEC concerning the mutual
recognition of diplomas , certificates and other evidence
of     formal        qualifications            in    veterinary            medicine ,
 including measures to facilitate the effective exercise
of the right of establishment and freedom to provide
services .    ( O.J. No L 362 , 23.12.1978 , p.               1 ) Veterinarians
usually     carry        a   stock      of    medicines       with       them    when
providing       veterinary          services .     In    order        to    avoid    a
situation      where        the    veterinarian        is    obliged        to    hold
separate     stocks       of   medicines       in  each    Member       State ,    the
Commission        is    proposing        a   very     limited       exception       to
Article 4(2 ) which will              enable the veterinarian to carry
with   him   and     administer        to   animals    veterinary         medicinal
products which are authorized                  in the country where he              is
established ,       and    although       not   authorized       in    the   country
in    which       he      provides        services      are ,      nevertheless ,
therapeutically          equivalent        to other    veterinary medicinal
products which are authorized                 in that country .
6.4     Environmental          risk
As noted above ,          the use of       veterinary medicinal             products
may   in   certain        instances      result    in   potential         risks    for
the   environment .           In   an    amendment      to    Article        (7)    of
Directive        81 / 851 / EEC ,      the     Commission         is       therefore
proposing     that     where      necessary ,     manufacturers           should    be
required     to    include       in   their     application       for     marketing
authorization          a     discussion        of    the     potential          risks
presented by the product               to the environment which                can be
considered        by      the     competent       Community          or     national
authorities        when       deciding       whether      or     not      to    grant
aut hor i zat ion .
 ---pagebreak---                                      23
 6.5     Protection of        Innovation
 Like   other     medicinal      products ,       the   developement        of   new
 veterinary       medicinal      products        has    become       increasingly
 time   consuming     and     risky .    In    order    to   complete      all    the
 tests   and    trials    which     are     required ,     about     eight     years
 research     is   required     for   the     development       of   a major     new
 product    together     with     an   investment        in   the    order    of   50
million     ECUs .    Products       derived       from     biotechnology        are
 having an     Increasing       impact ,     and according to one recent
estimate , by 1995 they will account for approximately one
 third of    the market .
Within the Community ,          the market        for veterinary medicinal
products     is about 5 %-10 % of the size of                    the market      for
medicinal     products for human use .               It  is ,   in many sectors
a highly competitive market .                The funds available for the
developement of new products are therefore limited , and
the   number     of  major     new    products       being     introduced       into
the market      Is relatively        low .
If   the   European     industry       Is    to   remain     competitive        with
third    countries ,       it    Is    important        that      it   should      be
offered    equivalent       prospect       for    the   developement        of   new
products .      The establishment of an efficient procedure of
obtaining a marketing authorization valid                        throughout      the
Community      will   make     an    important       contribution         in    this
respect .     However     the     problem       of   the     so-called      second
applicant must also be considered .
When    an    application        for     a    new     veterinary        medicinal
product    is submitted ,       the applicant must provide not only
 ---pagebreak---                                           24
the results of            the anatytlcal          tests but also the results
of the pharmaco-tox I co I og i ca I              and clinical            studies which
demonstrate the efficacy of the product and its safety in
animals and human beings .                   By way of an exception another
company         way       submit        an     application             for        marketing
authorization             In     respect       of     a    veterinary             medicinal
product which           is similar to a medicine already authorized
by submitting a summary dossier consisting of                                    references
to published           literature about           the safety and efficacy of
the product         together with a complete analytical                             dossier ,
and   the    results         of   any    necessary       b i o va i I i b I I I t y   studies
which show that            the products have equivalent effects .
In    fact ,      however ,        the    published          literature            is    often
incomplete or           inappropriate .          Confronted by this problem ,
certain      national         authorities        have     tended        to     be    not    too
demanding          as       regards        the     bibliographical                  evidence
submitted          by       the     second        applicant .          This         practice
seriously        penalises         the    innovatory        manufacturer             who    has
had    to   meet      the     high   costs     of    conducting           the     pharmaco -
tox i co I og i ca I    and clinical         studies , while his product can
be copied within a short                  period and at           a   very much          lower
costs .     Moreover            the      protection           of      an         innovatory
veterinary         medicinal         product       by    patent         is     not     always
possible ,       either       because of        the     limited      scope        of   patent
protection         or     because      a   substantial          proportion            of    the
effective        patent         life   has     been      lost     due       to     the     time
necessary          to      complete        development           work        and       obtain
authorization .
The    proposed          amendment        to    point      10    of      Article         5   of
Directive         81 / 851 / EEC      is     intended        to     rationalise             the
present situation along the                    lines that have already been
 ---pagebreak---                                        25
 accepted       for    proprietary medicinal           products      In Directive
 87 / 21 / EEC ( O.J.      No L 15 ,   17.1.1987 , p.      36 ).
  «
 The second applicant will only be permitted to present an
 abridged         application ,        omiting       the     results        of     the
 pharmaco-tox I co I og I ca I      tests     and    clinical     trials       if   he
 can    :
- obtain the consent of the original manufacturer , or
-   provide        a   complete    bibliography        which    covers      all    the
points       necessary       for   the    assessment      of    the    safety     and
efficacy        of     the   product     ( In   practice      such     a   complete
bibliography is rarely available ).
Otherwise he will            be obliged to wait until            ten years have
elapsed since the authorization of the original                          product .
This      ten year      period will      enable     the partial       recovery of
the       research       investment ,     hlch    might     not    be    protected
otherwise ,        for example by a patent .
Although        In    the case proprietary medicinal                products      for
human use ,         the Council     decided     that    this ten year         period
should       in    certain     cases    be    reduced     to   six    years ,     the
Commission             is     of     the      opinion        that        different
considerations            apply  in   the   case   of   veterinary       medicinal
products ,        which     are  not    usually       the   subject      of     price
controls         and     whose   costs      are    not    covered       by   public
funding .
6.6        Information about         veterinary medicinal           products
A    series       of     amendments      to    Directive       81 / 851 / EEC     are
designed         to     improve    the     information        available        about
 ---pagebreak---                                   26
veterinary medicinal products . The competent authorities
of the Member States or the Community will be required to
establish    a   summary of     the essential         characteristics of
each authorized product .          This summary will          serve as the
basis   for     verifying     the    accuracy       of   the    information
Included    on      the    labelling       of     veterinary      medicinal
products   and on      package    leaflets ,     the use    of  which will
be  made   compulsory      unless    all    the    relevant     information
can be provided on the         labels .
In  addition      a  series   of   amendments        to  Article    14  will
require the person responsible for marketing to keep the
competent      authorities      of     the     Member     States    or   the
Community properly        informed of any changes            in the status
of the veterinary medicinal           product , or of any additional
information      which   might    lead   to   the   reassessment     of  the
product .
6.7    Exports of veterinary medicinal               products
In May 1988 the World Health Assembly approved a proposal
to  extend    the   scope   of   the    WHO   Certification      Scheme   on
the   quality       of    pharmaceutical          products      moving    in
international        trade     to    cover       veterinary       medicinal
products .     In    the    light     of      this     development ,     the
Commission is       proposing that the amendments previously
proposed in respect of exports of medicinal products for
 ---pagebreak---                                     27
human    use    ( C0M(87)697         final )      should       also      apply     to
veterinary medicinal          products .
At  the   present    time ,    Article       24   of    Directive      81 / 851 / EEC
requires    that   all    manufacturers           of    veterinary       medicinal
products    must    be   In   possession         of    an   authorization .        To
avoid any ablguity ,         the Commission           Is proposing that           the
Directive    should expressly           provide       that    authorization         is
required ,   even    though     all     the    products       manufactured        are
 intended   for    export .      Thus      the    existing       provisions        of
Community    legislation ,      and the new requirements discussed
 In section 6.8 below will            apply .    At   the request of either
the   manufacturer       or    the     authorities          of   the     recipient
country ,    the     Member       State       concerned         will      Issue      a
certificate     in accordance with the arrangements agreed by
the  World    Health     Organisation          that      the   manufacturer         is
authorized    to manufacture           veterinary         medicinal      products .
 In  addition ,     the     Member       States       will      annexe      to    the
certificate         the       approved            summary          of       product
characteristics       mentioned        in   the   previous       section .      This
summary    will    enable      the     competent         authorities         in   the
recipient     country       to     verify        rapidly       the     authorized
conditions for use of a product                 in the exporting country .
Conversely ,    the    absence       of    a   summary       will     immediately
alert   the   autorities        to    the     fact     that     the    veterinary
medicinal    products     concerned         are    not    authorized       for   use
in  the  exporting      Member      State     and    they     will    be   able    to
draw   the   appropriate        conclusions          in    the    light     of   the
explanations      given     by    the     company       and    the     prevailing
conditions    in the recipient country .
 ---pagebreak---                                        28
    6.8     Obllaatlons o n manufacture r s
    At    the   present       time ,    authorization             to    manufacture
    veterinary medicinal products Is granted by the competent
    authorities     of   the   Member     State     in   which     a   manufacturer
    is established , who are responsible for ensuring that the
    manufacturer     satisfies     the     legal    requirements           laid down .
    The    Commission        is    proposing          to     supplement           these
    provisions     by    introducing        into    Directive         81 / 851 / EEC   a
    specific requirement for manufacturers to comply with the
    principles of good manufacturing practice for veterinary
    medicinal    products .      The    detailed        requirements          of   good
    manufacturing      practice      would      be   adopted        in   a    specific
    Directive     to be adopted by the so-called regulatory
    committee    procedure , which requires the agreement of a
    qualified    majority     of  Member       States ,     in   accordance        with
    the provisions of Directive 81 / 852 / EEC .                In fact , work on
    the preparation of a code of good manufacturing practices
    for   medicinal      products       is    at     an    advanced         stage    of
    preparation ,    and this could ,         after     suitable adjustments ,
    also    provide    the     basis      for     a    future      code      of    good
    manufacturing         practices         for       veterinary            medicinal
    products .
7 . THE    PROPOSAL      TO     EXTEND       THE      DIRECTIVES           TO     COVER
    IMMUNOLOGICAL     PRODUCTS
    The  proposal     to   extend     the    scope     of    the    Directives       to
    cover     immunological          veterinary          medicinal           products
    establishes     the    principle       that     these      products        may   be
    placed on the market only after an authorization has been
    granted   by   the   competent      authorities .          In    addition ,     the
 ---pagebreak---                                           29
 proposal      lays    down      certain       fundamental         requirements          for
 the    category        of      products        concerned .         However ,       it     is
 envisaged         that      the       Council         will      delegate         to     the
 Commission the power               to adopt      the detailed changes which
 are     necessary          to     Directive          81 / 852 / EEC      relating         to
 analytical , pharmaco-tox i co I og i ca I                and clinical        standards
 and   protocols         in    respect       of   the      testing     of    veterinary
medicinal         products          to    take      account        of     the     special
 characteristics of these products .                        In order      to   implement
 these     changes ,      the     Commission         will      act    in    cooperation
with      the     Committee          on     the     Adaptation          to    Technical
Progress      of     the    Directives on            the    removal      of   Technical
Barriers       to    Trade      in    the    Veterinary         Medicinal       Products
Sector      created       by     Directive        87 / 20 / EEC ,     using      the    so -
called regulatory committee procedure , which requires the
approval of a qualified majority of                         the Member States for
the adoption of the measures by the Commission ( Procedure
III ,   variant      a of Council           Decision 87 / 373 / EEC of            13 July
1987    ( O.J.    No   L    197 ,    18.7.1987 ,        p.   33 )   laying     down     the
procedures          fo     the      exercise         of      implementing          powers
conferred on         the Commission .)              It   is envisaged         that     work
on    the    preparation          of    these     detailed         changes      will      be
undertaken       during       1989 ,     In   parallel        with    the    discussion
of   these    proposals ,        so    that     the    changes      can    be   formally
adopted       immediately            after      the      Council        approves        the
framework       Directive          and    come      into     effect      at    the     same
time .     If   for    any     reason ,       this     work     is   delayed ,       it   is
envisaged       that      the     entry      Into      force     of    the    framework
Directive will         be postponed until               it   is complete .
In addition to certain detailed changes which are made to
the rules governing the declaration of the composition of
veterinary        medicinal           products        to     take     account of the
 ---pagebreak---                                            30
    biological origin of these products , there are two major
    areas where the regulation of Immunological veterinary
    medicinal products requires a somewhat different approach
    from the regulation of other categories of veterinary
    medicinal      products      :
     i)       it is important to ensure that manufacturers of
              immunological veterinary medicinal products are
             able    to      attain       high      levels      of    ba t ch - to - ba t ch
             consistency In their manufacturing operations , and
             the proposal          contains specific provisions                  to this
             effect    ;
    ii )     the    immunization          of     animals       agains      disease        is
             closely      linked with the overall               pattern of       disease
             existing        within        a     given       territory .       Thus       in
             addition       to   the    criteria        of   quality ,     safety      and
             efficacy ,       Member      States       should     be   empowered          to
             prohibit        the     use      of      immunological         veterinary
            medicinal        products      for    other    objectively        Justified
             reasons .
   The other changes which are necessary to take account of
    the     particular         nature        of       immunological         veterinary
   medicinal       products ,        for     example       the   wide     variety        of
   pharmaceutical          forms used and the risk of                the    " shedding "
   of    vaccines        into    the     environment         will    be     considered
   during       discussions         on    the     amendment       of    the     testing
   requirements       in the annexe to Directive 81 / 852 / EEC .
8. CONCLUSIONS
   In accordance with the provisions of Articles 8A and 8C
   of     the     Treaty       establishing            the     European        Economic
   Community , the Commission requests the Member States to
   take    the measures necessary to comply with                       this package
   of           proposals              by           1          January             1992 .
 ---pagebreak---                                   31
The Commission has taken           Into account the requirements of
Article    8C   of    the    Treaty    and   has  concluded    that  no
special provision seems to be Justified at this stage .
The   Commission has also studied the question of the high
levels   of    health ,     safety ,    environmental    and   consumer
protection      equired       by   the   terms   of  Article    100  A,
paragraph    3.    It   has    done   so  following   consultation   of
the  industrial     and social      partners concerned ,    and  in the
light of an analysis of the risks              inherent   in this area
and of the current       technical     capabilities of the European
Industry .    The    proposals       take   full   account   of   these
considerations        In the    light of the overall objectives of
this provision of the Treaty .
 ---pagebreak---                                               32
                                          Proposai     for a
                                     C OU N' CIL REGULATION ( EEC )
     laying down a Community procedure for the establishment of
      tolerances for residues of veterinary medicinal products
 THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
 Having regard to the Treaty establishing the European Economic
Community , and In particular Article 43 thereof ,
Having regard to the proposal from the Comm I s s I on ( 1 ) ,
Having regard to the opinion of the European Pa r II ament < 2 ) ,
Having       regard     to   the   opinion       of    the   Economic     and   Social
Comm I 1 1 ee (3 ) ,
Whereas       the    use   of  veterinary        medicinal      products     in   food -
producing animals may result in the presence of                          residues     in
foodstuffs obtained from treated animals ,
Whereas      In accordance with the principles                laid down by Council
Directive 8 1 / 85 1 / EEC ( 4 )    it    is necessary        to ensure     that    the
withdrawal         period     between       the     last    administration       of    a
veterinary medicinal product to food-producing animals and the
production of         foodstuffs     from such animals           is  long enough     to
ensure     that    such   foodstuffs do not          contain any     residues which
might       constitue       a    health        hazard      to    the    consumer
(1 )
(2)
(3)
(4)    O.J. No L 317 , 6.11.1981 , p. 1
 ---pagebreak---                                                  33
  Whereas ,    as a result of scientific and technical                             progress       It
  is   possible      to detect        the presence of           residues of          veterinary
  medicines      in foodstuffs at ever               lower    levels     ;
  Whereas    it    is   therefore necessary to establish                      tolerances        for
  the    maximum       levels      of    residues        which     may      be    accepted        in
  foodstuffs       of    animal        origin       in    accordance         with     generally
  recognised principles of safety assessment                         ;
 Whereas     the     establishment           of   different        tolerances         by    Member
  States    may    hinder      the     free    movement      of    veterinary         medicinal
 products and of foodstuffs of animal origin ;
 Whereas     therefore        it   is necessary         to   lay down a         procedure       for
  the   establishment          of    tolerances         for    residues        of    veterinary
 medicinal        products        by     the     Community ,        following         a     single
 scientific assessment of the highest possible quality                                  ;
 Whereas     the    need     for    the    establishment          of    tolerances         by   the
 Community       Is    recognised         in    the    Community       rules      relating       to
 trade    In foodstuffs of animal origin ;
 Whereas       therefore          no      new     veterinary         medicinal            product
 containing a new active substance not previously used                                  In food -
 producing        animals        should       be     authorized         for      use      In    the
 Community      unless      a    tolerance        for    residues      of     that    substance
 has    been   established          by    the    Community       ;   whereas        the     person
 responsible        for   marketing        a    new veterinary          medicinal         product
 of    this   nature      should      be    permitted       to   avail       himself       of   the
 procedures       established          by    Council      Directive        87 / 22 / EEC     of  22
 December       1986     on      the     approximation          of     national         measures
 relating      to     the    placing        on    the    market      of     high-technology
 medicinal         products ,           particularly            those         derived          from
 biotechnology ^ ;
( 5 ) OJ No L 15 , 17.1.1987, p.38 .
 ---pagebreak---                                          34
Whereas arrangements must also be made for                       the establishment
of tolerances for substances which are currently used In
veterinary medicines administered to food-producing animals ;
whereas however In view of the complexity of this matter and
the     large     number    of substances        Involved ,      long    transitional
arrangements are required ;
Whereas the tolerances should be adopted by a rapid procedure
which ensures close cooperation between the Commission and the
Member      States     through  the Committee         for Veterinary Medicinal
Products        established    by   Directive        81 / 851 / EEC   ;    whereas   an
urgent procedure          Is also required to ensure the swift                  review
of any tolerance which may not be sufficient to protect public
health      ;
Whereas       the     Information   necessary        to   assess     the    safety  of
residues should be presented in accordance with the principles
 laid    down     by   Council   Directive       81 / 852 / EEC   of    28   September
1981     on   the    approximation of     the      laws of      the Member      States
relating       to    analytical ,   pharmaco-tox I co I og I ca I       and   clinical
standards         and    protocols    In    respect         of    the     testing   of
veterinary         medicinal    products ( 6 ) ,    as    amended       by   Directive
87 / 20 / EEC < 7 > ;
HAS ADOPTED THIS REGULATION           :
( 6 ) O.J. No L 317 , 6.11.1981 , p. 16 .
( 7 ) O.J. No L 15 , 17.1.1987 , p. 34 .
 ---pagebreak---                                                35
                                         Article       1
For the purposes of this Regulation ,                      the following definitions
shall    apply    :
1 .    " residues       of   veterinary        medicinal         products ",       all    active
        Ingredients           of     veterinary            medicinal          products         or
      metabolites            thereof      which        remain        In    meat      or     other
      foodstuffs           originating from           the      animal       to     which      the
      medicinal         product     in question has been administered .
2.    " tolerance ",        the maximum         level     or    residues of         veterinary
      medicinal         products which may be accepted by the Community
      and which         do not     present      a    hazard      for    the   health      of  the
      consumer of foodstuffs of animal origin .
                                         Article       2
A   tolerance         shall     be    established           In    accordance          with    the
provisions       of      this     Regulation ,         having      regard        to    all    the
Information         available ,        and      in     accordance          with      generally
recognised      principles         of   safety       assessment .         A   tolerance       may
be  reduced     to     take    account     of    the     level    of    residues       which   is
expected     to      result      from    the     correct        administration           of   the
veterinary     medicinal         product      to    the   animal      species       concerned .
It  may    also      be   reduced      where       it    appears       that    residues       may
cause      difficulties            for      the        Industrial           processing         of
foodstuffs .        A    tolerance       shall        be    expressed          In    terms     of
micrograms per kilogram ( parts per billion ) on a                              fresh weight
basis .    Where        necessary ,       a     separate          tolerance          shall     be
establlshed         for     each     foodstuff         of     anlmal       orlgin       ( muscle
tissue ,    Ilver ,      kidney ,     fat ,    skin ,     mllk ,     eggs ,    honey      etc .).
 ---pagebreak---                                             36
The     list     of     substances       used      as     active       Ingredients         in
veterinary        medicinal      products      in respect of which tolerances
have  been established            shall    be   contained        in Annex       I   to  this
Regulation ,       which     shall    be   adopted        in   accordance         with   the
procedure      laid down       in Article 9 .          Except as provided for              in
Article     10 ,    any   amendments      to    Annex      I  shall     be    adopted      in
accordance with the same procedure .
                                       Article      3
Where ,   having      regard     to  the    nature      and   pattern      of     use  of   a
substance used as an active              Ingredient        in veterinary medicinal
products ,     it    is   not   necessary       to    establish      a   tolerance       for
residues      of      that     constituent         or     its     metabolites ,         that
substance     shall      be   included      In   a    list    In   Annex     li     to  this
Regulation . Annex II shall be adopted in accordance with the
procedure laid down in Article 9 . Except as provided for in
Article 10 , any amendments to Annex II shall be adopted in
accordance with the same procedure .
                                      Article      4
A provisional tolerance may be adopted for a substance used as
an active ingredient In veterinary medicinal products provided
that there are no grounds for supposing that residues of the
substance concerned at the level proposed present a hazard for
the health of the consumer . A provisional tolerance shall
apply for a defined period of time , which shall not exceed
three years , and shal I not be renewed more than once .
The    list      of     substances       used      as     active       ingredients        in
veterinary medicinal products in respect of which provisional
tolerances        have     been     established          shall      be contained          in
 ---pagebreak---                                                37
Annex    III      to    this     Regulation ,         which      shall      be    adopted     In
accordance with           the procedure         laid down         In Article 9 .        Except
as   provided        for    In   Article     10 ,    any    amendments         to   Annex   III
shall   be adopted          In accordance with the same procedure .
                                         Art Icle 5
Where     It    appears       that   a   tolerance         cannot      be   established       In
respect of a substance used as active                        Ingredient        In veterinary
medicinal          products        because        residues          of     the     substances
concerned ,       at whatever        level ,     In    foodstuffs of          animal    origin
constitute a          hazard      to    the     health       of     the     consumer ,     that
substance        shall     be    Included      In   a     list     In   Annex     IV  to   this
Regulation .         Annex     IV shall     be adopted          In accordance with the
procedure        laid    down    in Article        9.     Except      as   provided    for    in
Article      10 ,   any    amendements       to    Annex      IV    shall     be   adopted    in
accordance with the same procedure .
The   administration           of   the   substances           listed      In    Annex   IV  to
food-producing           animals       shall     be      prohibited         throughout      the
Commun I t y .
                                         Article       6
A   Member        State      shall     not    authorize           the     marketing      of    a
veterinary        medicinal       product       Intended        for    administration        to
food-producing          animals      containing          an   active       substance     which
was   not    authorized         for   use    in    veterinary         medicinal      products
intended      for     administration        to    food-producing            animals    in   the
Member State concerned on the date of entry                            into force of      this
Regulation unless the substance concerned has been included in
Annex   I ,   II   or   ill .
 ---pagebreak---                                            38
Unless       It   Is   developed       by    one     of     the      biotechnological
processes        listed     In   Part     A   of     the     Annex        to    Directive
87 / 22 / EEC , a veterinary medicinal product covered by the
provisions of the preceding paragraph shall be regarded as a
high-technology medicinal product to which Part B of the Annex
to Directive 87 / 22 / EEC applies .
                                     Article 7
1 .     In order     to obtain     the   inclusion of          an   active      substance
        referred to       in Article 6      in Annex       I ,   II    or   III   to this
        Regulation ,     the person responsible              for marketing shall
       submit an application to the Commission .                      The application
       shall contain the         information and particulars referred to
        in Annex V and shall         conform to the principles                  laid down
        In Directive 81 / 852 / EEC .
2.     After     verifying      that   the    application           is    submitted       in
       correct     form ,   the   Commission      shall     forthwith        submit     the
       application         for    examination         by     the       Committee        for
       Veterinary      Medicinal     Products      established          by   Article     16
       of   Directive 81 / 851 / EEC     ( hereinafter         referred      to as    " the
       Committee ").       The    Committee       may     request         one     of    its
       Members to act as rapporteur and to undertake an                            initial
       evaluation of the application .
3.     Within 120 days of referral of the application to the
       Committee ,      and     having      regard       to       the      observations
       formulated       by     the    members       of     the       Committee ,        the
       Commission shall prepare a draft of the measures to be
       taken . However If , after consulting the Committee , the
       Commission      considers     that     the    information          submitted      by
       the     person     responsible for marketing is insufficient to
 ---pagebreak---                                              39
       enable    such    a    draft    to   be    prepared ,      the    Commission      may
       request     that      person     to   provide       additional        Information .
       If the person responsible for marketing agrees to provide
       such   Information ,        the Commission will            prepare      a   draft   of
       the measures to be taken within 90 days of                         its receipt .
 4.    The    draft     of       the    measures         to    be    taken       shall     be
       communicated        forthwith       by   the     Commission        to  the    Member
       States    and     to     the    person       responsible         for    marketing .
      Within     a    further       60    days     the    person      responsible        for
      marketing may ,         at   his request ,        explain himself orally or
       In writing before           the Committee .          The Commission may ,           at
      the request of          the applicant , extend this time                  limit .
5 .   Within a      further      60 days     the Commission shall             submit     the
      draft     measures          to     the    Committee          for     adoption        In
      accordance with          the procedure          laid down     in Article 9 .
                                       Article      8
The  following provisions            shall     apply     in   respect     of  substances
which    are    authorized          for    use      as     active      ingredients         in
veterinary medicinal           products on        the    date of     entry     into   force
of this Regu I at i on     :
1 .   After    consulting          the    Committee ,        the    Commission        shall
      publish      a   timetable         for     the     consideration           of   these
      substances ,      including        time    limits     for           submission      of
      the    Information          referred      to     in   Annex      V.    The     Member
      States      and      persons        responsible          for     marketing         the
      veterinary       medicinal         products        concerned        shall      ensure
      that       all           relevant       information             is         submitted
 ---pagebreak---                                           40
   to the Commission In accordance with the requ I rements of
   Annex V and In conformity with the principles laid down
   In Directive 81 / 852 / EEC before the relevant time limits .
2. After      verifying        that    the     information        Is    submitted        In
   correct      form ,     the   Commission       shall     forthwith       submit     the
   Information           to    the     Committee         for     examination .         The
   Committee        may     request      one    of    its     members      to     act   as
   rapporteur         and    to   undertake        an     Initial     evaluation        of
   Information .
3. Having regard to the observations formulated by the
   members of the Committee , the Commission shall prepare a
   draft     of    the     measures      to   be   taken .     However       if ,   after
   consulting         the   Committee ,      the   Commission        considers        that
   the    information        submitted      by   the    person      responsible        for
   marketing        is    insufficient       to   enable      such   a    draft     to  be
   prepared ,        the    Commission        may    request       that     person      to
   provide       additional           Information ,        within       a    specified
   per I od .
4. The     draft        of   the     measures        to     be    taken      shall      be
   communicated          forthwith      by   the    Commission        to   the     Member
   States      and     those    persons     responsible         for   marketing        who
   have     submitted         information        to     the    Commission .         These
   persons may , at their request , explain themselves orally
   or In writing before the Committee .
5. The Commission shall              forthwith submit the draft measures
   to    the    Committee        for    adoption       in    accordance       with     the
   procedure laid down in Article 9 .
 ---pagebreak---                                             41
                                    Article 9
1 . Where   the   procedure         laid      down    in   this    Article      Is   to   be
    followed ,   matters       shall        be   referred      to   the   Committee       by
    the  chairman        either      on      his    own     Initiative       or    at    the
    request of a Member State .
2.  The representative of              the Commission shall             submit      to the
    Committee     a    draft     of     the     measures      to   be   adopted .       The
    Committee shall        deliver         Its opinion on the draft within a
    time-limit      set     by    the      chairman ,      having      regard      to   the
    urgency    of     the    matter .         It    shall     act    by   a   qualified
    majority ,   the     votes of         the Member        States     being weighted
    as  provided      for     In   Article         148(2 )    of   the    Treaty .      The
    chairman   shall      not   vote .
3.  (a)    The   Commission         shall        adopt   the    measures      envisaged
          where      they     are      In    accordance       with    the   opinion       of
           the  Comm I 1 1 ee .
    (b)   Where      the measures envisaged are not                     In accordance
          with the opinion of the Committee , or                        If no opinion
           Is   adopted ,        the       Commission        shall     without       delay
          propose       to   the Council           the measures       to   be   adopted .
          The   Counc i I     sha I I     act   by a qua I I f i ed major I t y .
    (c)    I f  within        three        months      of     the    proposa I       being
          subm I 1 1 ed     to    It ,     the    Counc I I    has   not    acted ,     the
          proposed          measures           shall      be      adopted       by      the
          Comm I ss I on .
 ---pagebreak---                                         42
                                  Article     10
1 . Where a Member State , as a result of new Information or a
    reassessment of existing Information , considers that the
    urgent amendment of a provision contained In Annexes I to
    IV   is    necessary      in   order     to   protect      human   or   animal
    health , and therefore requires swift action to be taken ,
    that Member State may temporarily suspend the operation
    of the provision concerned In its own territory .                      In that
    case ,   It shall     Immediately notify the other Member States
    and the Commission of the measures , attaching a statement
    of  the   reasons    therefor .
2.  The    Commission      shall     as   soon    as   possible     examine     the
    grounds      given   by   the    Member     State     concerned    and   shall
    consult     the  Member     States    within     the   Committee    and  shall
    then    deliver     its opinion      forthwith       and   take  appropriate
    measures .      The   Commission       shall     immediately     notify     the
    Council     and the Member States of any measures taken .                   Any
    Member State may refer the Commission 's measures to the
    Council       within     15     days     of    such      notification . The
    Council ,      acting    by    a   qualified       majority     may    take   a
    different      decision within         15   days of      the  date on which
    the matter was referred           to   It .
3.   If the Commission considers that               it   is necessary to amend
    the provision of Annexes I to IV concerned in order to
    resolve the difficulties referred to                    In paragraph 1      and
    to ensure the protection of human health , it shall
     initiate the procedure laid down in Article 11 with a
    view to adopting those amendments ; the Member State
 ---pagebreak---                                           43
    which   has    taken measures under              paragraph       1   may maintain
    them   until      the   Council       or    the    Commission        has   taken     a
    decision    in accordance with the abovement i oned procedure .
                                   Art icle     11
1 . Where   the    procedure        laid    down    in   this    Article      is   to  be
    followed ,    matters shall          be referred         to the Committee by
    the   chairman      either       on    his    own    Initiative        or    at   the
    request of a Member State .
2.  The  representative of            the Commission shall             submit     to the
    Committee     a   draft     of   the    measures       to   be  adopted .         The
    Committee shall        deliver      Its opinion on the draft within a
    time-limit      set    by    the     chairman ,      having      regard      to   the
    urgency    of     the    matter .       It   shall      act    by    a   qualified
    majority ,    the    votes of       the Member        States     being weighted
    as  provided       for    In   Article       148(2 )    of    the    Treaty .     The
    chairman    shall     not   vote .
3.  (a)    The Commission shall               adopt    the measures envisaged ,
           where      they    are    in   accordance        with    the    opinion     of
           the   Comm I 1 1 ee .
    (b)    Where      the measures envisaged are not                   In accordance
           with the opinion of             the Committee , or          If no opinion
            Is   adopted ,       the     Commission        shall      without      delay
           propose      to   the Council        the measures        to be     adopted .
           The Council        shall     act by a qualified majority .
    (c)    If    within 15 days of the proposals being submitted
           to    it ,   the    Council       has    not     acted ,     the   proposed
           measures shall          be adopted by        the Commission .
 ---pagebreak---                                          44
                                   Article     12
Any   changes    which     are   necessary      to    adapt     Annex    V   to    take
account of scientific and technical progress shall be adopted
 In accordance with the procedure               laid down       In Article 2c of
Directive 81 / 852 / EEC .
                                   Article     13
As soon as possible after the amendment of Annexes I ,                        II ,   III
or  IV ,  the Commission       shall   publish      a   summary assessment            of
the   safety    of    the    substances      concerned .        The    confidential
nature of any proprietary data shall be respected .
                                   Article    14
Member States shall       ensure that      the withdrawal         periods between
the  last   administration       of  a  veterinary         medicinal     product      to
animals and the production of           foodstuffs from such animals are
established    In  such    a  manner   as   to   ensure      that   the  tolerances
provided    for    in   accordance      with      this      Regulation      are     not
exceeded .
                                  Article     15
Member   States    may    not   prohibit     or    impede      the    putting      into
circulation    within     their   territories       of     foodstuffs     of   animal
origin on the ground that they contain residues of veterinary
medicinal products if the quantity of residue does not exceed
the tolerance provided for In Annex I or III , or if the
substance concerned        is  listed   in Annex      II .
 ---pagebreak---                                     45
                               Article     16
With  effect    from 1  January    1997 ,    the   administration       to    food
producing animals of veterinary medicinal              products containing
active substances which are not mentioned              In Annexes     I ,   II  or
 III shall   be  prohibited   within    the    Community ,     except     In   the
case   of   clinical   trials    which     have     been    notified      to    or
approved by the competent authorities .
                               Article     17
This  Regulation shall     In no way prejudice          the   application of
Community   legislation prohibiting the use           In   livestock farming
of certain substances having a hormonal action .
                               Article    18
This Regulation shall enter       Into force on 1 January 1992 .
This Regulation shall     be binding      in   its entirety and directly
applicable   In all Member States .
Done at   Brussels                  For   t he   Counc I I
 ---pagebreak---                                                46
                                          ANNEX V
 Information and particulars to be                      Included In an application
for   the   establishment             of    a     tolerance      for    residues    of   a
veterinary medicinal            product .
1 .       Administrative particulars
1.1 .     Name    or    corporate        name       and   permanant     address   of   the
          person         responsible            for      placing      the     veterinary
          medicinal        product on the market
1.2 .     Name of      the veterinary medicinal               product
1.3 .     Qualitative          and   quantitative          composition     in   terms   of
          active      principles ,        with       mention   of   the   International
          non-proprietary            name     recommended       by   the  World   Health
          Organization where such name exists
1.4 .     Manu f a c t u r I ng a u t ho r i z a t i on
1.5 .     Marketing authorizations
1.6 .     Summary of the characteristics of the veterinary
          medicinal product prepared in accordance with Article
          5a of    Directive 81 / 851 / EEC
 ---pagebreak---                                     47
2.     I den t I t y
2.1 .  International       non-p ropr I e t a r y name
2.2 .  I UPAC    name
2.3 . CAS name
2.4 . Classification
      - therapeutlc
      - pharmaco log I ca I
2.5 . Synonyms and abbreviations
2.6 . Structural       formula
2.7 . Molecular       formula
2.8 . Molecular weight
2.9 . Degree of       Impurity
2.10  Qualitative and quantitative composition of           impurities
2.11  Description of physical properties
           fusion point
           bo i I i ng point
           vapour     pressure
           solubility      in water   and organic solvents expressed
           In g / I with    indication of temperature
           density
           spectra of refraction ,         rotation , etc .
 ---pagebreak---                                        48
 3 .    Tox I co I og i ca I studles
 3.1 .  Short term toxicological studies
 3.2 .  Long term studies
 3.3 .  Studies on reproduction
 3.4 .  Studies on teratogenicity
 3.5 .  Studies on mutagenicity
3.6 .  Studies for carcinogenicity
3.7 .  Studies of        immunological effects
3.8 .  Studies of microbiological effets
3.9 .  Observations         in humans
3.10 . Other biological effects .
4 .    Metabolic       and   residue  studies
4.1 .  Absorption ,             distribution ,   excrétion and
       biotransformat ions .
4.2 .  Determination of         residues
4.3 .  Methods of       residue analysis
4.4 .  National     maximum residue       limits
 ---pagebreak---                                  49
5 .   Recommendations
5.1 . Level  causlng no tox i co I og I ca I  effect
5.2 . Estimate of     temporary acceptable daily        Intake for man
5.3 . Estimate    of   maximum  residue      levels  In  food  with the
      specification of      the residue of      concern
5.4 . Methods of     residue analysis
5.5 . Further   work   or  Information
      - requ I red
      - désirable
6 .   References .
 ---pagebreak---                                         50
                                    Proposai for a
                                  COUNCIL DIRECTIVE
 amending Directive 81 / 851 / EEC on the approximation of the laws
 of the Member States relating to veterinary medicinal
 product s .
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic
Community , and In particular Article 100a thereof ,
Having regard to the proposal from the Comm i s s I on ( 1 ) ,
 In cooperation with the European Par I I ament ^ 2 ^ ,
Having     regard     to   the  opinion    of   the  Economic    and      Social
Comm I t tee ( 2 ) ,
Whereas      Article     23(2 )  of   Council    Directive   8 1 / 85 1 / E EC ( 4 )
provides      that   the  Commission    should   submit  to the     Council        a
proposal containing appropriate measures leading towards the
elimination of any remaining barriers to trade or to the free
movement of veterinary medicinal products not later than four
years after the Implementation of the abovement i oned Directive;
(1 )
(2)
(3)
( 4 ) O.J. No L 317 , 6.11.1981 , p. 1
 ---pagebreak---                                                  51
Whereas the Directives on the approximation of                                   laws relating
 to veterinary medicinal              products must be adapted to scientific
progress         and      Improved     to     take     account          of     the   experience
acquired since their adoption                    ;
Whereas       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       ;
Whereas       the       approximation         of     laws     brought          about     in    this
connection          must       enable      a     veterinary            medicinal        product ,
manufactured          and    marketed     In   one    Member       State      on  the   basis    of
harmonized          provisions ,       to     be    allowed         into       another      Member
State ,    taking due consideration of                   the      initial       authorization ,
save    In exceptional           cases submitted           for      a   binding opinion          to
the    Committee          for   Veterinary         Medicinal          Products      set     up   by
D I rect I ve 81 / 851 / EEC ;
Whereas       the       system     for       leaflets       accompanying             veterinary
medicinal        products should be            Improved      ;
Whereas      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         firms       are      not    placed     at   a
disadvantage          ;   whereas ,   however ,       there       are     reasons     of   public
policy for not repeating tests carried out on animals without
over-r I d I ng cause ;
 ---pagebreak---                                                52
Whereas the guarantees of the quality of veterinary medicinal
products          manufactured            within    the    Community     should    be
maintained by requiring compliance with the principles of good
manufacturing practice for medicinal products                       Irrespective of
the final destination of the products ;
Whereas the Commission should be empowered to define In detail
the principles of good manufacturing practice                        for  veterinary
medicinal        products        In close cooperation with the Committee for
Adaptation          to     Technical       Progress   of   the  Directive    on   the
Removal       of      Technical         Barriers  to   Trade   In   the   Veterinary
Medicinal Products Sector established by Article 2c of Council
Directive 81 / 852 / EEC of 28 September                1981 on the approximation
of    the     laws      of    the      Member  States    relating   to   analytical ,
ph a r ma co - 1 o x i co I og i c a l and clinical standards and protocols in
in respect of the testing of veterinary medicinal products
( 5 ), as amended by Directive 87 / 20 / E EC ( ® ;
Whereas measures should be taken to                     improve   the provision of
Information for third countries about the conditions of use of
veterinary medicinal products within the Member States and the
Commun i t y ;
Whereas measures should be taken to ensure that distributors
of    veterinary          medicinal        products   are   authorised    by  Member
States and maintain adequate records ,
HAS ADOPTED THIS             DIRECTIVE :
( 5 ) O.J. No L 317 , 6.11.1981 , p.16
( 6 ) O.J. No L 15 , 17.1.1987 , p. 34
 ---pagebreak---                                          53
                                    ARTICLE    1
Directive 81 / 851 / EEC   Is hereby amended as follows                :
1 .      In Article     1(2 ),     the   first    Indent     Is   replaced      by   the
        following :
        "- 'veterinary        medicinal         product'        shall      mean      any
        medicinal     product      Intended for animals .
        However    products or         substances which          are   intended      for
        long     term    use     by    oral     administration           to    healthy
        animals      for      nutritional         purposes         shall      not     be
        considered as veterinary medicinal                  products ."
2.        Article 1(5 )     Is replaced by the following :
        "5 .    Member     States     shall    take all      necessary measures
                to   ensure       that     no   person      shall     have     on   his
                premises       or    under     his     control      any     substance
                which     may     be   used    as    a    veterinary        medicinal
                product      unless      expressly       authorised        under    the
                 legislation of the Member State concerned .
                For the purposes of           Implementing this provision ,
                Member      States      shall      maintain       a   register        of
                producers      and    dealers     and other       persons who       are
                permitted         to    be     In     possession         of     active
                substances which may be used                 in   the manufacture
                of    veterinary         medicinal        products       which      are
                available only on veterinary prescription .                        Such
                persons     shall     be    required     to   maintain       detailed
                records     of     all    dealings      in   active       substances
 ---pagebreak---                                           54
                  which may be used in the manufacture of
                  veterinary medicinal products and to make these
                  records available for                   Inspection by the
                  competent authorities for a period of at least
                  three years .
                  Before the date of implementation of this
                  Directive , Member States shall communicate to
                  the     Commission         a    list    of     the   veterinary
                  medicinal       products which are available without
                  veterinary prescription ."
3.  In    Article      2,    the      fourth    indent     of   paragraph    2    is
   de I e t e d .
4. Article 4 is replaced by the following :
                                    " Article   4
   1 . No     veterinary      medicinal       product    may  be marketed      in  a
        Member     State    unless      authorization      has   previously    been
        granted      by    the    competent       authority     of   that  Member
        State .
   2 . No veterinary medicinal product may be administered to
        animals unless        the authorization          referred    to above has
        been      issued ,    except       for    the    tests    of   veterinary
        medicinal      products referred to            in point    10 of Article
        5    which    have    been      notified     to   or   approved   by    the
        competent national            authorities      in accordance with the
        national     rules     in  force .
   3 . However Member States may permit veterinary medicinal
        products prepared extemporaneously by a veterinarian
 ---pagebreak---                                           55
        or  In   a   pharmacy        In   accordance        with    the    terms    of    a
        veterinary       prescription or           an    official      formula     to   be
        administered        to a particular animal               or   a small     number
        of  animals       by    a    veterinarian          or    under     his    direct
        personal     responsibility .
        Moreover ,     Member     States may permit             the   administration
        to animals of
           veterinary medicinal              products authorized for use                 In
           the   Member       State     concerned        In   accordance       with    the
           provisions        of    this      Directive       for    use     In  another
           animal      species     ;
           medicinal       products        which     have    been    authorized       for
           use    in    the Member        State     concerned       in   human    beings
           In    accordance          with      the      provisions        of    Council
           Directive        65 / 65 / EEC     of    26    January       1965    on    the
           approximation           of    provisions          laid     down     by    law ,
           regulation        or     administrative           action      relating       to
           proprietary medicinal products ^
       which have been prescribed by a veterinarian , provided
       that   the    animals      to    be   treated      have    been    examined      by
       the    veterinarian           personally          and     the     veterinarian
       concludes       that    there      is   no    authorized        therapy     which
       will   be    effective        for     the    treatment       of    the   animals
       concerned .       The     veterinarian           shall     be     required       to
       maintain      adequate       records      of    the   date    of   examination
       of  the animals ,        the clinical          diagnosis ,      the medicinal
       products      prescribed ,         the     dosages      administered ,         the
       duration       of    treatment         and     the     withdrawal        periods
       recommended ,       and    to   make    these      records      available      for
( )
    OJ No L
 ---pagebreak---                                    56
    Inspection by the competent authorities for a period
    of at   least    three years .
    Where the administration of such medicinal products to
    food producing animals Is permitted , the veterinarian
    shall be responsible for ensuring that the withdrawal
    period applied Is sufficient to ensure that foodstuffs
    derived     from     treated      animals       do    not   contain    any
    residues    which     might    constitute        a   health   hazard   for
    the consumer .
4 . Notwithstanding            paragraph     2,     Member     States    shall
    ensure     that      veterinarians         providing        services     in
    another   Member     State    can  take with        them and  administer
    to animals under         their   direct   care small       quantities of
    veterinary medicinal          products other than          Immunological
    veterinary medicinal          products which are not authorized
    for use    in   the  Member     State   In    which    the  services   are
    provided      ( host     Member    State ),      providing      that   the
    following conditions are satisfied :
    (a)    the      marketing      authorization          provided    for    In
           paragraph       1   has been granted by the competent
           authorities         of  the   Member       State    in  which   the
           veterinarian         is established        ;
    (b)    the        veterinary         medicinal           products      are
           transported by the veterinarian in the original
           manufacturer 's packaging            ;
 ---pagebreak---                               57
(c)  in  the    case       of    veterinary       medicinal       products
     Intended     for      administration          to   food– producing
    animals ,      the      products      carried       have     the    same
    qualitative           and     quantitative         composition         in
    terms      of        active        principles          as     products
    authorized         In    accordance      with     paragraph       1  for
    use In the host Member State ;
(d) prior    to   the      administration of          the    products     to
    animals ,    the      veterinarian        shall     be   required     to
    ascertain         the       conditions        for     use      of    the
    corresponding           veterinary      medicinal        products      In
    the host Member            State ,   Including the withdrawal
    period ,    and     the     veterinarian       shall     be   required
    to   take     all       measures      incumbent        upon     him   to
    ensure     that       the     rules    applying        In   the     host
    Member State are complied with ;
(e) the     veterinarian             shall       not       furnish       any
    veterinary        medicinal        product      to    the    owner    or
    keeper of     the animals treated              In the host Member
    State unless this            is permissible on the basis of
    Community        law    or    the   law   of    the    Member      State
    concerned      ;
(f) the   veterinarian            shall     be     required       to    keep
    detailed      records        of   the    animals       treated ,     the
    clinical      diagnosis ,         the    veterinary         medicinal
    products     administered ,         the dosage        administered ,
    the   duration         of    treatment      and    the    withdrawal
    period       applied .         These      records         shall       be
    available         for      inspection        by     the     competent
    authorities for a period of at                  least three years ;
 ---pagebreak---                                     58
        (g)    the overall range and quantity of veterinary
               medicinal products carried by the veterinarian
               shall not exceed that generally required by good
               veterinary practice ."
5. Article 5 Is replaced by the following :
                              " Art le le 5
   For the purpose of obtaining the authorization provided
   for in Article 4 , the person responsible for marketing
   shall    lodge an application with the competent authority
   of  the Member    State .
   The following particulars and documents shall be provided
   by the applicant      :
   1 . name    or   corporate      name   and   permanent      address   or
       registered place of business of the person responsible
       for marketing and ,       If  different ,   of   the manufacturer
       or   manufacturers       Involved    and  of    the   sites    where
       manufacturing operations are carried out ;
   2 . name of    the veterinary medicinal        product    ( brand name ,
       non-proprietary name , with or without a trade-mark or
       name of the manufacturer ; scientific name or formula ,
       with    or    without     a    trade-mark     or    name    of   the
       manufacturer )    ;
   3 . qualitative and am    quantitative particulars of all            the
       constituents     of    the    veterinary     medicinal     product ,
       using the usual terminology but not empirical chemical
 ---pagebreak---                                       59
     formula    and   giving       the    International           non-proprietary
    name   recommended by           the World Health Organisation ,                    if
    such a name exists           ;
4.  description of the method of preparation                          ;
5.  therapeutic      Indications ,         cont r a - I nd 1 cat I ons     and    side -
    effects    ;
6 . dosage for the various species of animal                         for which the
    veterinary         medicinal             products            Intended ,          Its
    pharmaceutical           form ,          method          and         route        of
    administrât ion      and proposed shelf              1 1 fe   ;
     if  applicable ,       reasons         for    any       precaut lonary         and
    safety   measures       to     be   taken     for     the     storage      of   the
    product , during       Its     administration          to animals ,       and   for
    the   disposal      <of     waste      products ,        together        with     a n
     Indication     of   any      potential       risks       presented        by   the
    product    to   the   environment          and   the      health      of  humans ,
    animais or plants         ;
8.  indication of       the    withdrawal        period       necessary       between
    the   last    administration           of   the     veterinary         medicinal
    product    to animals under            normal    conditions of            use   and
    the   production       of      foodstuffs       from       such      animals      in
    order   to   ensure     that      such    foodstuffs          do    not   contain
    any residues which might constitute a health hazard to
    the  consumer .      Where       necessary ,      and      in   particular        in
    the  case    of   veterinary         medicinal        products        containing
    an active     substance not          previously used             in   veterinary
    medicine ,     which    are       the    subject        of    a     request     for
    marketing authorization              In the Member States concerned
 ---pagebreak---                                    60
     for the first time , the applicant shall propose and
     Justify a tolerance level for residues which may be
     accepted In foodstuffs without risk for the consumer ,
     together      with      appropriate      validated         analytical
     detection methods .
9 . description of the control testing methods employed by
     the     manufacturer        ( qualitative     and       quantitative
     analysis of the constituents and the finished product ,
     specific     tests ,   e.g.    sterility   tests ,     test    for     the
     presence     of    pyrogens ,    for   the   presence       of     heavy
     metals ,    stability      tests ,   biological        and    toxicity
     tests ,  tests on     Intermediate products )      ;
10 . results   of   :
         physico – Chemical ,      blologlcal    or     m I crob I o I og I ca I
         tests ,
     -   toxicological and pharmacological tests ,
         clinical     trials .
     However , and without prejudice to the law relating to
     the protection of industrial and commercial property :
     a ) The applicant shall not be required to provide the
         results of toxicological and pharmacological tests
         and clinical trials if he can demonstrate :
         i)      either that the veterinary medicinal product
                 Is essentially similar               to a product
                 authorized in the country concerned by the
                 application and that the person responsible
                 for the marketing of the original veterinary
 ---pagebreak---                                   61
             medicinal         product        has       consented           to   the
             toxicological ,           pharmacological              or    clinical
             references         contained         In      the      file     on   the
             original       veterinary        medicinal           product      being
             used      for      the      purpose         of      examining       the
             application         in question        ;
    il )     or   by   detailed        references          to    the   scientific
              literature       presented        In     accordance         with   the
             second      paragraph        of   Article         1   of    Directive
             81 / 852 / EEC        that        the          constituent           or
             constituents           of     the     veterinary            medicinal
             product       have     a    well    established             medicinal
             use ,     with        recognized            efficacy          and    an
             acceptable        level    of safety         ;
    III )    or   that     the    veterinary       medicinal          product      Is
             essentially         similar      to    a     product      which     has
             been     authorized          within        the      Community ,       In
             accordance        with     the   Community           provisions       In
             force ,    for     not     less   than        ten    years      and   is
            marketed        in    the    Member      State       for   which     the
            application         is made .
b)  In   the    case    of   new     veterinary         medicinal         products
   containing known constituents not                        hitherto used         in
   combination        for     therapeutic        purposes ,          the    results
   of    toxicological         and    of    pharmacological             tests    and
   of    clinical       trials       relating       to      that     combination
   must    be provided ,        but    It   shall      not    be   necessary      to
   provide       references          relating         to     each      individual
   cons t I tuent .
 ---pagebreak---                                    62
   11 .    a summary In accordance with Article 5a of the
           product characteristics , one or more specimens or
           mock-ups     of     the    sales      presentation        of    the
           veterinary      medicinal       product     together       with    a
           package   insert where one        Is to be enclosed .
   12 .    a   document     showing       the   that    manufacturer         Is
           authorized In his own country to produce veterinary
           medicinal   products .
   13 .    any   marketing       authorization       for     the     relevant
           veterinary     medicinal    product     which   may     have   been
           obtained    In   another    Member     State   or    in   a   third
           country  together     with   a   list of   those   countries     to
           which  an   application       for   marketing     authorization
           has been made and an explanation of            the reasons for
           which any Member State or third country has refused
           to grant authorization for the veterinary medicinal
           product concerned ."
6. The following Article 5a Is inserted :
                             " Article    5a
   The summary of the product characteristics referred to In
   point 11 of the second paragraph of Article 5 shall
   contaln the followlng Information :
   1 . Name of the veterinary medicinal product ,
   2 . Qualitative and quantitative composition In terms of
        the active ingredients and constituents of the
 ---pagebreak---                                       63
    excipient ,     knowledge of which             is essential     for    proper
    administration            of     the     medicinal      product      ;     the
     International non-proprietary names recommended by the
    World   Health       Organization         shall    be  used ,  where     such
    names exist , or falling this ,               the usual common name or
    chemical   description .
3 . Pharmaceutical          form .
4 . Pharmacological           properties        and ,   in  so   far   as    this
     Information         Is     useful       for    therapeutic      purposes ,
    pharmacokinetic particulars .
5 . Clinical   Particulars
    5.0    target species ,
    5.1    therapeutic            indications ,      specifying    the    target
           species ,
    5.2    con t r a - I nd I ca t I ons ,
    5.3    undeslreable effets ( frequency and s e r I ou s ne s s ) ,
    5.4    spécial       précautions for use ,
    5.5    use during pregnancy and                lactation ,
    5.6    Interaction           with      other   medicaments      and     other
           forms of         interaction ,
    5.7    posology and method of administration ,
    5.8    overdose            ( symptoms ,       emergency       procedures ,
           ant I dotes )( I f necessary ),
    5.9    special warnings for each target species ,
    5.10   withdrawal         periods ,
    5.11   special        safety      precautions      to  be  taken    by    the
           person administering the product to animals .
 ---pagebreak---                                          64
    6 . Pharmaceutical Particulars :
        6.1     ! ncompat I b i I I t I es ( major ),
        6.2    shelf life , when necessary after reconstitution
               of the product or when the container is opened
               for the f I rst t Ime ,
        6.3    special precautions for storage ,
        6.4    nature and contents of container ,
        6.5    name or style and permanent                        address     or
               registered place of business of the holder of
               the marketing authorization ,
        6.6   special precautions for the disposal of unused
              product or waste materials , if any ."
7. The following Article 5b Is Inserted :
                                " Art iele     5b
   When the marketing authorization referred to                    In Article
   4(1 )   Is Issued ,    the person responsible for             placing that
   product on the market shall              be   informed , by the competent
   authorities of the Member State concerned , of the summary
   of   the product     characteristics as approved by             them .   The
   competent      authorities       shall     take  all  necessary   measures
   to ensure that the        information given In the summary             is In
   conformity       with     that        accepted     when    the   marketing
   authorization      is  issued or subsequently ."
8. The last paragraph of Article 7 Is amended as follows :
   " The experts' detailed reports shall form a part of the
   documentation which the applicant shall lodge with the
 ---pagebreak---                                              65
      competent       authorities .         A   brief     curriculum      vitae    of    the
     expert shall be appended to each expert report ."
9.     Article 9(2 )        Is replaced by the following :
      ”2 .     may     submit       the     medicinal         product .     Its    active
               principles        and    It    necessary       Intermediate      products
               or   other      constituent          materials      for   testing      by   a
               State     laboratory or          by a    laboratory designated           for
               that    purpose .      In order        to ensure      that  the   control
               testing      methods      employed        by   the    manufacturer       and
               described          in     the       application         documents ,        In
               accordance with point               9 of    the second paragraph of
               Article 5 , are satisfactory ."
10 . Article 14        is replaced by the following
                                     " Article       14
     1 .   After    an    authorization           has    been    Issued ,    the   person
           responsible        for    placing        the    product     on   the    market
           must ,   in   respect     of    the     control     methods    provided      for
           In point 9 of         the second paragraph of Article 5 ,                   take
           account      of    technical          and    scientific       progress       and
           Introduce      any    changes       that    may   be  required     to   enable
           the    veterinary        medicinal         product     to   be   checked       by
           means of generally accepted scientific methods .                         These
           changes must        be accepted by           the   competent     authorities
           of  the   Member     States     concerned .
     2 . The    person      responsible          for   marketing      shall    forthwith
           inform       the      competent           authorities        of     any      new
 ---pagebreak---                                  66
    Information which might entail                  the amendment or
    further examination of the particulars and documents
    referred to      In Article 5 or the approved summary of
    the product characteristics referred to In Article 6b .
    In   particular     the   person      responsible     for    marketing
    shall   forthwith     Inform     the   competent     authorities      of
    any    prohibition       or    restriction        imposed       by   the
    competent     authorities      of    any    country   In    which    the
    veterinary     medicinal     product      Is marketed     and of     any
    serious    unexpected      reaction      occurlng    In   animals     or
    human beings .
3 . The person responsible for marketing shall be required
    to maintain     records of     all    reported   suspected       adverse
    reactions     arising    In   animals      and  human   beings .     For
    the purpose of this provision , a failure of the
    veterinary medicinal product to achieve the expected
    therapeutic effect shall be considered an adverse
    reaction .    These   records     shall     be  kept   for    at   least
    five    years    and    shall     be    made    available       to   the
    competent authorities upon request .
4 . The person responsible for marketing shall Immediately
    inform    the   competent      authorities ,      with    a    view   to
    authorization , of any alteration he proposes to make
    to   the   particulars       and    documents      referred       to  in
    Article 5 . "
 ---pagebreak---                                                 67
11 .  Chapter     IV is replaced by the following :
                                       " CHAPTER       IV
             Committee for Veterinary Medicinal                       Products
                                        Article       16
      1 .  In   order      to     facilitate           the     adoption     of     a   common
          position by the Member States with regard to decisions
          on   the     Issue          of     marketing         authorizations         and    to
          promote       thereby          the      free     movement       of     veterinary
          medicinal         products ,           a     Committee        for      Veterinary
          Medicinal       Products ,          hereinafter        referred       to   as   " the
          Committee ",         Is    hereby        set    up .   The    Committee        shall
          consist    of    representatives of               the Member     States      and of
          the   Comm I s s I on .
     2 . The     Committee 's         task       shall      be    to   examine ,      at    the
          request     of     a   Member        State     or    the   Commission       and    in
          accordance           wlth       Articles          17     to    22 ,      questions
          concerning the application of Articles 11 ,                           36 and 49 .
     3.   The    Committee           shall        draw      up     Its   own      rules      of
          procedure .
                                       Article       17
     1 .  In   order     to     make       It    easier      to    obtain     a   marketing
          authorization           In    at      least     two    other    Member       States
          taking    Into due consideration an authorization                            Issued
          In one Member State               In accordance with Article 4 ,                 the
 ---pagebreak---                                      68
     holder of the latter authorization may submit an
     application to the competent authorities of the Member
     States concerned together with the Information and
     documents referred to in Articles 5 , 5a and 5b . He
     shall testify to Its identity with the dossier
     accepted by the first Member state , specifying any
     additions It may contain , and shall certify that all
     the dossiers filed as part of this procedure are
      Identical .
2 . The holder of the marketing authorization shall notify
     the   Committee of        this    application ,      Inform     It  of     the
    Member     States     concerned      and    send   It   a   copy    of     this
    authorization .        He shall      also     Inform the Member          State
    which granted him the Initial authorization and notify
     it  of   any   additions       to   the    original     dossier      ;   that
    State may require the applicant                to provide      it with all
    the   particulars       and   documents       necessary     to   enable       It
    to   check   the    identity of        the   dossiers     filed    with     the
    dossier    on which      took   its   decision .
3 . The holder of the marketing authorization shall notify
    the    dates    on    which    the     dossiers     were    sent     to     the
    Member    States concerned .          As soon as the Committee has
    noted    that     all    the   Member      States    concerned       are     in
    possession of        the dossier ,       it   shall   forthwith         inform
    all   the Member States and the applicant of the date on
    which    the    last    Member      State    concerned      received        the
    dossier .     The    Member    State(s )      concerned     shall     either
    grant the authorization valid for their markets within
    a   period     of    120    days    of   the    aforementioned           date ,
    taking into due consideration the authorization Issued
    within the meaning of paragraph 1 , or put forward a
    reasoned objection .
 ---pagebreak---                                        69
                                 Article      18
 1 . Where   a   Member       State    considers        that    it   Is  unable      to
     grant   a marketing authorization ,                  It   shall    forward      to
     the   Committee          and    to     the     person      responsible        for
     placing the veterinary medicinal product on the market
     Its  reasoned objection              In accordance with Article               11 ,
     within the time          limits stipulated           In Article 17       ( 3 ).
2.   Upon   the   expiry       of   this     period ,     the   matter     shall     be
     referred     to     the   Committee        and   the   procedure      referred
     to  in Article 21         shall     be applied .
3 . On   receipt       of    the   reasoned       objection      referred      to    In
     paragraph      1 ,    the   person      responsible        for   placing      the
     product     on      the    market       shall     Immediately        send     the
     Committee       a    copy    of     the    particulars        and   documents
     enumerated       In Article      17(1 ).
                                 Article      19
If    several     applications            submitted       In    accordance       with
Articles      5    and      5a    have      been     made     for    a   marketing
authorization           for    a    particular         veterinary        medicinal
product ,    and one or         more Member         States     have    granted     and
authorization          while     one     or    more    of    the    other    Member
States     have       refused       It ,    one     of     the    Member     States
concerned     or    the     Commission may          refer    the   matter    to    the
Committee for application of                  the procedure referred to              In
Article    21 .
 ---pagebreak---                                       70
 The same shall apply where one or more Member States have
 suspended or revoked a marketing authorization while one
or more Member States have not done so .
 In both cases , the person responsible for placing the
veterinary medicinal product on the market shall be
 Informed of any decision of the Committee to apply the
procedure     laid down In Article 14 .
                                Article     20
The competent authorities of Member States may , In
specific cases where the Interests of the Community are
 Involved ,     refer      the    matter        to    the      Committee       before
reaching      a    decision        on    a     request         for     a   marketing
authorization        or   on    the   suspension or             revocation of       an
author Izat Ion .
                               Article      21
1 . The  competent        authorities        shall      draw up       an   assesment
    report     and    comments       on    the     dossier        as    regards    the
    results     of    the    analytical        and    t ox I co-p ha r maco I og I ca I
    tests    on ,    and     clinical       trials        of ,    any     veterinary
    medicinal      products       containing        a   new     active     substance
    which   are     the    subject      of   a    request        for    a  marketing
    authorization         In   the   Member      States      concerned       for   the
    first   time .
2 . As soon as the notification referred to                          in Article 17
    is    received ,          the      competent           authorities          shall
    Immediately communicate to the Member States concerned
 ---pagebreak---                                       71
 any assessment          report        accompanied by a summary of                    the
 dossier     relating        to a       particular      veterinary medicinal
 product .      This     report         shall     also     be    communicated          to
 the    Committee         where        a    matter      is     referred        to     the
Committee pursuant              to Article 18 .
The    assessment        report         shall    also    be    forwarded        to    the
other     Member     States       concerned        and    to    the   Committee        as
soon    as    a  matter        Is     referred      to   the     Committee        under
 the procedure         laid down          In Article 19 .          Any assessment
report so forwarded shall                    remain confidential .
The    competent       authorities            shall    bring      the    assessment
report     up    to   date      as     soon    as   it   is    In   possession         of
 information       which       is    of    Importance       for    the   evaluation
of   the   balance      between         effectiveness         and   risk .
                              Article       22
Where     reference        Is   made      to   the   procedure        described        In
this Article ,        the      Committee        shall    consider        the matter
concerned       and    Issue      a    reasoned opinion within 60 days
of   the   date    on   which       the    matter    was    referred       to   It .
In    the    case     referred           to   In   Article        18    the     person
repons I b I e   for    placing         the product        on    the market        may ,
at   his    request ,      explain         himself     orally      or    In   writing
and      provide         additional             Information           before         the
Committee         Issues        Its       opinion .      The      Committee          may
extend     the     time      limit       referred      to     in   the    preceding
paragraph        to    give        the      applicant        time      to     explain
himself orally or             In writing .
 ---pagebreak---                                    72
     In the case referred to In Article 19 , the person
     responsible for placing the product on the market may
    be asked to explain himself orally or in writing .
2 . The Committee 's opinion shall concern the grounds for
    the objection provided for In Article 18(1 ) and the
    grounds on which the marketing authorization has been
    refused , suspended or withdrawn In the cases described
     In Article    19 .
    The Committee shall immediately inform the competent
    authorities and the person responsible for placing the
    product on the market of            Its opinion .
3 . The competent authorities shall               Implement    the opinion
    of the Committee with 60 days of              its receipt .
4 . Where    an  application        for   marketing    authorization     is
    submitted    In respect of a product which            is the subject
    of   an   opinion      of   the    Committee     and  the    competent
    authorities     have    reasons     for not    applying   the opinion
    of   the   Committee ,      they    shall   forthwith     request  the
    Committee     to     reconsider      its   opinion ,   in   accordance
    with the procedure         laid down     in this Chapter .
                              Article    23
The    Commission       shall    report     to   the   Council    and  the
European Parliament every two years on the operation of
the procedure      laid down      in this Chapter ."
 ---pagebreak---                                            73
12 .   Article 24(1 )        Is replaced by the following :
      "1 .     Member     States     shall    take     all  appropriate      measures
               to    ensure      that     the     manufacture        of   veterinary
               medicinal products           is subject to the holding of an
               authorization .         This     manufacturing          authorization
               shall       be     required       notwithstanding           that     the
               veterinary        medicinal       products        manufactured       are
               Intended for export ."
13 . The following Article 24a               Is  inserted :
                                   " Article    24   a
     At    the   request      of  the   manufacturer ,       the   exporter     or  the
     authorities of          an  importing      third country ,       Member    States
     shall     certify that a manufacturer of veterinary medicinal
     products       Is   In   possession      of   the    authorization      referred
     to    In Article 24 .        When    Issuing such certificates , Member
     States shall        comply with the following conditions                 :
     1 . Member       States     shall     have    regard      to   the   prevailing
           administrative          arrangements         of     the    World     Health
           Organ l zat ion .
     2.    For  veterinary medicinal            products      intended    for   export
           which   are    already     authorized on        their   territory ,     they
           shall       supply         the      summary        of      the     product
           characteristics as approved              in accordance with Article
           5b or, in the absence thereof , an equivalent document .
 ---pagebreak---                                         74
      Where the "manufacturer is not in possession of a marketing
      autnon zation , he shall provice the authorities responsible
       for establishing the certificate referred to in the first
      paragraph with a declaration explaining why no marketing
      authorization is available ."
14 .  In Article 27 , the following Is added :
     "f)      comply        with the principles and the guidelines of
             good manufacturing practice for medicinal                   products
              laid down by Community law.”
15 . In Article 27 , the following            is added :
     g ) maintain detailed records of all              veterinary medicinal
          products supplied by him to wholesalers or , where this
          Is   permitted       by   the     laws   of    the   Member       State
          concerned ,        to      retailers ,        veterinarians          or
          farmers .   The   following      Information    shall   be     recorded
          In  respect    of   each  transaction ,     whether   or     not  it  Is
          made for payment        :
             date   ;
             name of the veterinary medicinal product                ;
             quant I ty supp lied     ;
             name and address of         the recipient .
          These records shall be available for             Inspection by the
          competent authorities for a period of 3 years .
 ---pagebreak---                                             75
16 . The following Article 27a                Is   Inserted      :
                                   " Article      27  a
     The     principles        and     guidelines         of    good     manufacturing
     practices       for   medicinal        products      referred      to     In  Article
     27(f )     should     be    adopted       in    the     form    of    a    Directive
     addressed         to   Member       States       in     accordance         with    the
     procedure        laid   down     In   Article      2c   of    Council      Directive
     81 / 852 / EEC ,   after    taking      Into consideration           the specific
     nature      of      veterinary        medicinal        products         ;    detailed
     guidelines         shall    be     published        by    the    Commission        and
     revised       as     appropriate          to    take       Into     consideration
     scientific and technical               progress ."
17 . In   Article     34
          The first paragraph            Is replaced by the following :
          " The competent       authority of         the Member State concerned
          shall    ensure by means of             repeated      Inspection        that  the
          legal     requirements         relating       to    veterinary        medicinal
          products are complied with ."
          The following third paragraph                 Is added :
          " The   officials       representing          the    competent        authority
          shall    report     after     each     of  the     Inspections        mentioned
          in   the    first     paragraph        on   whether       the   manufacturer
          complies      with    the    principles        and    guidelines        of   good
 ---pagebreak---                                             76
         manufacturing practice                 laid down by Community             law .
         The manufacturer shal I be informed of the content of
         such reports and shal I be entitled to request a second
         Inspect ion . "
18 . In Article 39 , the following second paragraph is added                           :
     " Upon  reasoned         request ,       Member     States     shall    forthwith
     communicate        the      reports        referred       to     in   the    third
     paragraph    of     Article       34   to   the   competent      authorities of
     another Member State .              If , after considering the reports ,
     the Member State receiving the reports considers that                           It
     cannot   accept       the    conclusions         reached     by   the   competent
     authority     of    the     Member      State     in   which    the   report   was
     established ,        it   shall       Inform      the    competent      authority
     concerned      of       its     reasons       and     may     request     further
     Information .        In     the     case     of     prolonged       disagreement
     between Member          States ,     the Member       State(s )     shall  Inform
     the  Comm I ss I on . M
19 . Article     42     becomes        Article       42(1 )    and    the    following
     paragraphs are added            :
     “2.    The person responsible for the marketing of a
            veterinary medicinal product shall be obliged to
            notify the Member States forthwith of any action
            taken by him to suspend the marketing of a product
            or to withdraw a product from the market , together
            with     the     reasons       for    such    action .     Member   States
            shall      ensure that           this    information       Is brought    to
            the attention of the Committee forthwith .
 ---pagebreak---                                           77
     3.       Member        States     shall       ensure      that      appropriate
               Information        about       actions       taken     pursuant      to
               paragraphs 1       and 2 which may effect            the protection
               of  health     In   third countries         Is   forthwith     brought
               to   the     attention      of    the   relevant       International
              organisations , with a copy to the Committee ."
20 .  In  the    first    paragraph of Article 43 ,           points 2 ,     7 and 8
     are replaced by the following , and the following point 9a
      I s I nser ted   :
     "2.      A   statement      of    the    active      Ingredients      expressed
              qualitatively and quantitatively per dosage unit or
              according       to    the    form    of    administration        for   a
              particular          volume        or      weight ,        using      the
               International       non-proprietary         names   recommended      by
              the    World     Health    Organization ,        where     such   names
              exist ,     or   where    no    such    names    exist ,    the   usual
              common     names .
     7.       The withdrawal        period ,    even    If  this   Is nil .    In  the
              case of      veterinary medicinal           products     administered
              to food-producing animals .
     8.       Expiry date ,      In plain      language .
     9a .     Special      precautions      for   disposal     of  unused    product
              or waste material ,        if any ."
 ---pagebreak---                                     78
21 .  In Article 48 , the first paragraph Is replaced by the
     following    :
     " The Inclusion of a package insert in the packaging of
     veterinary medicinal products shall be obligatory unless
     all the Information required by this Article can be
     conveyed on the packaging Itself . Member States shall
     take all        appropriate measures to ensure that the
     Information Included on a package Insert of a veterinary
     medicinal product relates solely to the veterinary
     medicinal    product   concerned ."
22 . In   the   second    paragraph   of   Article      48 ,  point   (e)  Is
     replaced by the following and the following point                 (h) Is
     added :
     "e)     the withdrawal    period ,  even     if  this   Is nil ,  in the
             case   of  veterinary  medicinal       products    administered
             to food-producing animals       ;
     h)      special    precautions    for     the    disposal    of  unused
             product or waste materials ,        if any ."
23 . The final paragraph of Article 48 is deleted .
 ---pagebreak---                                           79
24 . The following Chapter VIII               Is   Inserted :
                                  " CHAPTER     VIII
          Distribution of veterinary medicinal                    products
                                    Article      51
     1 . Member    States      shall     take    all  appropriate        measures      to
         ensure    that     wholesale dealing          in veterinary medicinal
         products    Is subject to the holding of an authorization
         and   to  ensure       that    the    time   taken     for   the    procedure
         for   granting       this     authorization        does     not    exceed     90
         days   from     the    date    on   which    the   competent        authority
         receives the application .
     2 . In  order    to     obtain     the    authorization        referred       to  in
         paragraph     1 ,   the applicant         shall  have at      his disposal
         suitable     and     sufficient        premises     complying       with     the
         legal    requirements           laid    down    In     the   Member       State
         concerned       as    regards      the     storage      and    handling       of
         products .
     3 . The    holder       of    the     authorization          referred        to   in
         paragraph      1    shall     be   required     to     maintain      detailed
         records .    The     following       Information       shall    be   recorded
         In respect of each           incoming or outgoing transaction :
         (a)     date     ;
         (b)     name of the veterinary medicinal                  product      ;
         (c)     name of the manufacturer              ;
         (d)     manufacturers batch number , expiry date                     ;
         (e)     quantity received or supplied                ;
         (f)     name and address of the supplier or recipient .
 ---pagebreak---                                    80
    At   least   once     a    year ,   a   detailed      audit   shall    be
    carried out , and Incoming and outgoing supplies shall
    be reconciled with supplies currently held in stock
    and any discrepancies recorded .
    These records shall be available for Inspection by the
    competent authorities for a period of three years .
4 . Member   States shall        take all     appropriate measures         to
    ensure   that     wholesalers       supply     veterinary     medicinal
    products only to persons permitted to carry out retail
    activities      in    accordance        with     the    provisions    of
    Article    52 ,   or    to   other     persons      who  are    lawfully
    permitted     to    receive     veterinary        medicinal     products
    from wholesalers .
                             Article    52
1 . Member   States     shall    take   all   appropriate      measures   to
    ensure  that    the   retail    supply of       veterinary medicinal
    products     Is     conducted       only     by    persons     who   are
    expressly    permitted       to   carry   out     such  operations    by
    the legislation of the Member State concerned .
2 . Any retailer of veterinary medicinal products shall be
    required to maintain detailed records . The following
    Information      shall     be   recorded       in    respect   of   each
    Incoming or outgoing transaction :
    (a)    date   ;
    (b)    name of the veterinary medicinal product ;
    (c)    name of     the manufacturer        ;
 ---pagebreak---                                       81
    (d)       manufacturers       batch     number , expiry date           ;
    (e)       quant 1 1 y received or supplied              ;
    (f )      name  and   address      of   the supp Iler or         recipient     ;
    (g)       name  and   address      of   the prescr i b i ng veterinarian
              If any ,   date of      prescription       ;
   At    least one a year , a detailed audit shall                     be carried
   out ,     and    Incoming       and     outgoing      supplies       shall     be
    reconciled      with     supplies       currently       held    In  stock    and
   any discrepancies recorded .
   These records shall            be available for            inspection by the
   competent authorities for a period of three years .
   However ,       Member      States       may     dispense       retailers      of
   veterinary       medicinal       products        from    the   obligation      to
   maintain        detailed       records        In   respect       of    products
   supplied        by    them      In    small       transactions         for    the
   treatment        of     companion         animals       such     cats ,     dogs ,
   aquarium       fish ,   cage    birds ,     homing      pigeons ,    terrarium
   animals      and   small     rodents      provided      that   such    products
   do    not    contain     substances        the    use    of  which      requires
   veterinary control            and all     possible measures have been
   taken      to prevent      the unauthorized use of               the   products
   for    other    animals .
                               Article     53
Where ,    in   accordance       with     the     legislation       of   a   Member
State ,   a    person    responsible         for    marketing      a   veterinary
medicinal      product     is   permitted       to   supply     samples      of  the
product     directly      to   a   veterinarian        or     other    authorized
person ,   the veterinarian or other authorized person shall
 ---pagebreak---                                     82
     be required to maintain the              records referred to In
     Article 52(2 )       In respect of        medicines received and
     subsequently supplied by him , whether or not such supply
      Is made for payment.”
25 . Chapter VIII becomes Chapter IX and Articles 51 , 52 and
     53 become Articles 54 , 55 and 56 respectively .
                                Article  2
     1 . Member    States   shall   take   the   necessary   measures  to
         comply   with   this   Directive    not   later  than   1 Januay
         1992 .  They    shall    forthwith     Inform   the   Commission
         thereof .
     2 . Requests for marketing authorization lodged from             the
         date set out in paragraph 1 must comply with                 the
         provisions of this Directive .
     3 . Within four years of the date set out in paragraph 1,
         Article 1 where relevant , shall be progressively
         extended to existing veterinary medicinal products .
                                Article  3
     This Directive is addressed to the Member States .
                                    Done at   Brussels ,
                                    For t he Counc I I ,
                                    The President
 ---pagebreak---                                                   83
                                              Proposai for a
                                           CUUNCIL      DIRECTIVE
 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 .
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic
Community ,        and     in particular Article 10 0a               thereof ,
Having regard to the proposal from the Commission ^ ) ,
 In cooperation with the European Par I I ament S 2 ) ,
Having       regard         to    the    opinion      of   the    Economic      and    Social
Comm I 1 1 e e S 3 ) t
Whereas        disparities            In   the    provisions        laid    down    by   law ,
regulation          or      administrative          action     by    Member     States    may
hinder      trade       In     Immunological         veterinary      medicinal      products
wlthin the Communlty                ;
Whereas        the        essential        aim     of    any    rules      governing      the
production ,           distribution          or     use    of    veterinary       medicinal
products        must       be    to   ensure     a    high    level    of   protection     of
public health           ;
(1 )
( 2)
( 3)
 ---pagebreak---                                            84
 Whereas the provisions of Council Directive 81 / 851 / EEC ( 4 )
 although appropriate , are not adequate for veterinary
 medicinal products used in order to produce active Immunity ,
 to diagnose the state of Immunity and to produce passive
 Immunity ( Immunological veterinary medicinal products ) ;
 Whereas In accordance with Article 5 of Council Directive
 87 / 22 / EEC of 22 December 1986 on the approximation of national
 provisions relating to the placing on the market of high-
 technology medicinal products , particularly those derived from
 biotechnology ^) ,          the     Commission    Is   required      to     submit
 proposals to harmonize the conditions for authorizing the
manufacture and placing on the market of Immunological
veterinary medicinal products ;
Whereas ,       before   an   authorization     to market    an   immunological
veterinary medicinal           product    can be granted ,   the manufacturer
must       demonstrate        his     ability   to    attain    ba t ch - to - ba t ch
cons i s t ency    ;
Whereas      the   competent     authorities should also be empowered               to
prohibit        the  use    of    an   immunological    veterinary      medicinal
product        when   the     immunological     responses    of    the     treated
animals       will   interfere      with  the  operation   of   a   national        or
Community programme           for    the eradication or control        of animal
disease      ;
Whereas changes will be required to the requirements for the
testing of veterinary medicinal products laid down In Annex I
to Council Directive 81 / 852 / EEC of 28 September                1981 on the
approximation of the laws of the Member States                     relating to
(4)     o.j . No L 317 , 6.11.1981 , p. 1
(5)     O.J. No L      15 , 17.1.1987 , p. 38
 ---pagebreak---                                         85
analytical ,     pharmaco-tox I co I og I ca I   and clinical      standards and
protocols     In   respect     of  the  testing        of  veterinary  medicinal
products^® ),     as amended by Directive 87 / 20 / E EC ^ 7 ^ ,         to take
account    of    the    special    nature     of     Immunological    veterinary
medicinal      products       ;   whereas       the     Commission    should   be
empowered    to adopt      the necessary changes           In close cooperation
with the Committee for the Adaptation to Technical                   Progress of
the  Directives      on   the   Removal    of   Technical     Barriers  to  Trade
 In the   Veterinary       Medicinal    Products         Sector , thus  ensuring
greater quality , safety and effectiveness ,
HAS ADOPTED THIS DIRECTIVE           :
(6)  O.J.   No L 317 ,          6.11.1981 ,   p.   16 .
(7)  O.J.   No L 15 ,         17.1.1 987 ,   p.   34 ,
 ---pagebreak---                                         86
                                   Article 1
1. Subject        to the provisions of this Directive ,                   Directive
   81 / 851 / EEC      shall     apply     to      Immunological        veterinary
   med I c I na I   products .
2. For the purposes of this Directive " Immunological
   veterinary medicinal product " shall mean a veterinary
   medicinal         product     used     In     order      to   produce       active
    Immunity ,       diagnose     the    state     of     Immunity     or    produce
   pass I ve i mmun I ty .
3. This    Directive       and   Directive      81 / 851 / EEC   shall    not   apply
   to   autogenous        vaccines     which     are   manufactured        from   the
   organisms found           in discharges from the body of an animal
   and   used      for  the   treatment    of    the   individual     animal     from
   which the organisms are derived .
                                   Article    2
1. The      quantitative          particulars         of      an    immunological
   veterinary medicinal product shall be expressed by mass
   or by International units or by units of biological
   activity or by specific protein content where possible as
   appropriate to the product concerned .
2. In     respect         of    Immunological          veterinary         medicinal
   products ,         in Directive 81 / 851 / EEC the expressions
   " qualitative          and     quantitative          particulars         of    the
   constituents” shall              Include particulars relating to
   biological           activity      or     to       protein       content       and
   " qualitative and quantitative composition " shall include
   the composition of the product expressed in terms of the
 ---pagebreak---                                           87
     biological       activity or of protein content .
3.   In any document          established       In accordance with              Directive
     81 / 851 / EEC     In    which     the     name        of     an      Immunological
     veterinary medicinal            product     Is expressed ,           the   common or
     scientific       name    of  the  active      constituents           shall    also   be
     Included      at    least    once   ;   it    may    be    abbreviated         In   the
     remaining references .
                                     Article     3
1 .  The     competent          authorities         shall        ensure        that      the
    manufacturing           processes       used      In     the      manufacture         of
     immunological         veterinary medicinal             products       are   properly
    validated and attain ba t ch - to - ba t ch consistency .
2.  For    the    purpose of       Implementing Article               35   of   Directive
    81 / 851 / EEC ,   the competent authorities may require persons
    responsible           for     marketing         immunological             veterinary
    medicinal        products      to  submit       to    a    competent        authority
    copies of ail         the control      reports signed by the qualified
    person       in    accordance       with       Article         30    of    Directive
    81 / 851 / EEC .
    The    person     responsible      for   marketing          may    be   required      to
    provide      the   competent      authorities         with      a  sample     of   each
    batch      of     immunological        veterinary          medicinal         products
    manufactured ,        or   to hold such       samples        in   stock    up   to  the
    expiry     date    for    provision     upon     request        to   the   competent
    authorities .
3.  Where     In   the     Interests    of    human      or    animal       health ,    the
    legislation of          a Member    State so provides ,              the competent
 ---pagebreak---                                             88
      authorities may require persons responsible for marketing
      the Immunological veterinary medicinal products to submit
      to a competent authority samples from each batch of the
      bulk and / or finished product for examination by a State
       laboratory or a laboratory designated for this purpose
      before release onto the market , unless another competent
      authority within the Community has previously examined
      the batch in question and declared It to be in conformity
      with    the     approved       specification .       Any   such   examination
      shall be completed within 60 days of the receipt of the
      samp I es .
                                        Article   4
In   the   absence        of    specific      Community      legislation     and    in
accordance        with      national        legislation ,      the    use    of    an
immunological        veterinary       medicinal      product   may   be  prohibited
in  the   whole     or  part     of   the   territory     of  the  Community    or   a
Member   State     If  it   is  established      that   :
a)    the    administration            of    the    product     to   animals     will
      Interfere with          the operation of         a national     or  Community
      programme        for     the     control     or   eradication      of   animal
      disease , or ,
b)    the disease against which the product is Intended to
      confer        immunity        Is    substantially        absent     from    the
      territory       in question , or ,
c)    the administration of the product will cause difficulties
      In certifying the absence of contamination of foodstuffs
      obtained      from    treated animals .
 ---pagebreak---                                             89
The    competent       authorities      of   the    Member     States      shall     Inform
the    Commission       of   all   Instances        In   which    the    provisions      of
this Article are applied .
                                       Article 5
The amendments which are necessary In the testing requirements
for    veterinary       medicinal      products        set  out     In   the    Annex    to
Directive      81 / 852 / EEC  to   take    account      of   the   extension       of  the
scope       of     Directive       81 / 851 / EEC      to     cover       Immunological
veterinary        medicinal     products      shall     be  adopted      in   accordance
with     the     procedure     laid     down     In    Article      2c   of    Directive
81 / 852 / EEC .
                                       Article     6
1 .    Member States shall           take the necessary measures to comply
       with    this Directive not          later     than   1   January      1992 .    They
        shall     forthwith    Inform    the   Commission       thereof .
        In   the   event   of   the   amendments        referred     to    in  Article     5
       not being adopted by 1             January 1991 ,       the date set out           in
        the   first    subparagraph       shall     be postponed        to a    date one
       year    later    than the date of adoption of               those amendments .
2.     Requests for marketing authorization for products covered
       by    this    Directive     lodged     after     the   date    set    out    In  the
       first      subparagraph      of   paragraph        1 must     comply     with    the
       provisions of        this Directive .
 ---pagebreak---                                 90
3.   Within three years of the date set out in the first
     subparagraph of paragraph 1 this Directive shall be
     progressively     extended    to existing     Immunological
     veter Inary products .
                            Article 7
This Directive Is addressed to the Member States .
Done at Brussels                               For  t he Counc I I
 ---pagebreak---                                      91
                          FINANCIAL   STATEMENT
 relating to the Commission proposals for        the amendment of the
             veterinary medicinal     products directives
1 .   Budget  head I nas
      N° A  1100     salaries of official    and temporary agents
      N° A  2510     travelling      expenses      of    members    of
                     Institutionalized    committees
      N° B  7750     action  for the   Internal market
2 .   Legal  basis
      Article  100 A of   the EEC Treaty
 ---pagebreak---                                         92
3. Description of the project
   3.1   General   objective
         - the realisation of the                 Internal market       in the
         veterinary medicinal           products sector
   3.2   Spécifie objectives
         a)   the  establishment           of   a   centralized     Community
         procedure    for    determining safe          levels   for   residues
         of   veterinary      medicines        in   foodstuffs     of    animal
         origin
         b)  improvement        of      the     Community      authorization
             procedure      for     veterinary        medicinal     products ,
             based on     the  extension of        authorization     from one
             Member   State     to   the    other    Member   States    of  the
             Commun i t y
         c ) the updating of the detailed provisions of the
             veterinary medicinal products directives in the
             light of de ve l opeme n t s since 1981
         d ) the    extension        of      the    veterinary      medicines
             directives to cover veterinary vaccines ( mandate
             from the       Council , Article 5            paragraph 2       of
             Directive        87 / 22 / EEC ,     O.J.    No     L     15    of
             17.01 . 1987 ) .
 ---pagebreak---                                       93
4 . Justification of      the  Project
    4.1    Justification of the Type of Project Proposed
           The   limited experience acquired              from the existing
           Community      procedures        for     the     coordination         of
           national      decisions        on     the      authorization          of
           veterinary     medicinal       products     suggests         that   real
          progress towards and          internal market         in this sector
          can     only     be     made     by    the      establishment          of
          centralised Community procedures for                 the assessment
          of   the  quality ,     safety     and efficacy        of    veterinary
          medicinal     products      and    for   the    assessment        of  the
          potential      risks     to   the    consumer      of     residues     of
          veterinary        medicines       in    foodstuffs          of     animal
          origin .
          The   present      proposals     constitute       an    Interim      step
           intended    to    resolve     the   problem      of    residues      and
           improve    the     operation       of     existing        procedures .
          Further     proposals       for    the    establishment          of   new
          procedures will       be presented as soon as possible .
    4.2   Interest of the project at Community                 level
          The  realisation of        the   internal    market      implies     that
          all   categories of       industrially       prepared       veterinary
          medicinal     products       should     be    able     to     circulate
          throughout       the    Community .      Moreover ,       differences
          between    the    rules    of   the   Member     States       regarding
          the    acceptance      of    veterinary      medicinal         products
          must    also     be    reconciled       in    order       to     prevent
          repercussions          on      Intra-Community             trade       in
          foodstuffs      of    animal      origin ,     which       is   of    far
          greater economic significance .
 ---pagebreak---  Financial    Implications
5.1     General Considérations
        The major financial implications result from an
        Intensification of cooperation with Member States
        through     :
       -    the examination together of applications for
           authorization           to     market       veterinary     medicinal
           products
           es t ab I i shment      of     to I erances     for     residues   of
           approximately           150     active       substances     used    i n
           veter inary          medici ne         over     an     eight     year
           transitional         per i od   from     1992 onwards
           drug-mon I tor i ng activités .
5.2    Particular       Financial       Considération
       a)   Progressive         establishment           of  a   technical    and
       scientific       secretariat        for    the   Scientific Committee
       for    Veterinary          Medicinal         Products      through    the
       recruitment            of       the         following         additional
       personnel , to      be    found     by    internal     redeployment    or
       throug normal        budgetary process .
       1991          2 administrators           ( A7 )
                      1 assistant      ( B5 )
                     1  secretary ( C5 )
 ---pagebreak---                                 95
 1992         1  administrator            ( A7 )
              1  secretary         ( C5 )
b ) Appropriations for additional meetings estimated
at ( the provisions of funding will                       be considered In
the    context       of    the     overall       budget       which      will    be
granted       by      the      budgetary          authority        under        the
head !    js '^SIO ").
    6     additional          meetings         of     the     Committee         for
Veterinary           Medicinal           Products          each        year      (2
representatives           per      Member       State )     ( currently        ±  3
meetings a year at 10,500 ECU per meeting ).
    9     additional         meetings          of    scientific           working
parties     a   year     (1    representative           per    Member      State )
( currently      ±     5    meetings         a   year     at    540      ECU    per
meet i ng ) .
- 2 meetings a year of the Committee referred to                                 in
Art i c I e   2b      of     Directive           81 / 852 / EEC      ;     trave I
expenses      of     t wo    representat ives           per     Member      State
( this committee has not yet                   been convened ).
c ) Appropriations            for contracts with expert outside
consultants        ;   approximately            50,000     ECU    in    1992 ,   to
be   granted      by     the     budgetary        authority ,        under      the
heading “ B 7 7 5 0 M .
d)   Appropriations             for    missions ,        participation           in
scientific symposia etc.
 ---pagebreak---                                      96
          COMPETITIVENESS AND EMPLOYEMENT IMPACT ST AT FM P MT
      What Is the main reason for Introducing the measure ?
      Realisation of the internal market ;                Improvement of the
      protection       of   public     health   ;    updating    of   existing
      Community      legislation      relating    to   veterinary    medicinal
      products .
II .  Features of the businesses           in question
      Because of the relatively small size of the market , and
      the high costs of developing new products , only a limited
      number of      large-sized companies are capable of producing
       innovatory      veterinary      medicinal     products .   However ,   a
      number    of  smaller    and medium sized companies manufacture
      copies of well-established products which are off-patent .
      The    number   of  small   and   medium   sized    companies   involved
       in   the  distribution     of   veterinary    medicinal    products   is
      much greater as in the role of self-employed professional
      persons ,    such as veterinarians and pharmacists .
      So far as the Commission          is aware ,   there   is no particular
      concentration of       the businesses concerned         in the regions .
III . What     direct    obligations      does  this     measure    impose  on
      businesses     ?
      Manufacturers of veterinary medicinal products :
      –    obligation to submit data on the safety of residues of
           veterinary medicines in foodstuffs of animal origin to
 ---pagebreak---                                             97
         the    Commission       to      permit       the    establishment        of
         harmonised     residue     tolerances        by   the   Community .     The
         submission of such data              is already required by Member
         States .
         various additional obligations designed to                    improve the
         protection      of     public         health     In    the     veterinary
         medicines     sector ,      in      particular       through     somewhat
         Increased    obligations         to     submit   data    In   support    of
         applications      for    authorization          and   compliance       with
         principles      of    good      manufacturing         practice .    These
         provisions     are     already         applied    by   certain     Member
         States ,   and     in   many        instances      are    analagous      to
        measures     applied     to    the       manufacturers      of   medicinal
         products for human use .
     Distributors        of       veterinary           medicinal         products ,
     wholesalers    and   retailers       :
         for     wholesalers ,          the        obligation        to     obtain
        authorisation        to     distribute          veterinary       medicinal
        products ,   to have appropriate premises and to maintain
        distribution records for a period of                  three years     ;
         for  retailers ,    to maintain distribution records for                  a
        period of    three years .
     These   requirements are        intended       to prevent     the   diversion
     of   veterinary     medicinal          products     from    the    legitimate
     distribution circuit        into the grey and black market zones
     of   illicit   non-aut hor i zed         used   and    to   facilitate      the
     detection    of    abuses .     Certain        of    these    controls      are
     already applied by Member States .
IV . What indirect obligations are local authorities likely to
     impose on businesses ?
     None  foressen .
 ---pagebreak---                                          98
V.    Are there any special measures In respect of SMEs ?
      No .
VI .  What is the likely effect on :
      a)   the compe t i t i veness of business
           The     greater       degree      of      harmonisation            of   the
           requirements for authorization of veterinary medicinal
           products     should    help   Improve      the      competitiveness      of
           both      innovatory      and       generic          manufacturers       of
           veterinary medicinal        products .
           The   provisions     relating     to   distribution ,          which  apply
           equally    to  all   types of      distributor ,          should  not  have
           any significant effect on competitiveness .
      b)   Employment
           No significant effets are anticipated .
VII . Have     both    sides    of   Industry       been      consulted       on  this
      proposa I    ?
      In addition to the European federations representing the
      manufacturers of pharmaceuticals , veterinary medicinal
      products        and      animal       f eed i ng s t u f f s ,     associations
      representing pharmacists and veterinarians have been
      consulted on these proposals . There is general support
      for the principles underlying the proposals . However ,
      the pharmacists and veterinarians would prefer stricter
      controls on distribution , each emphasising the role of
      its profession .