CELEX: 51991PC0245(02)
Language: en
Date: 1991-07-18
Title: Amendment to the proposal for a COUNCIL DIRECTIVE on the legal status for the supply of medicinal products for human use

COMMISSION OF THE EUROPEAN COMMUNITIES
                                               C0M(91) 245 final - SYN 229/230/231/273
                                               Brussels, 18 July 1991
                              Amendment to the proposal for a
                                                                         SYN 229
                                      COUNCIL DIRECTIVE
                                 on the wholesale distribution
                             of medicinal products for human use
                              Amendment to the proposal for a
                                                                         SYN 230
                                      COUNCIL DIRECTIVE
                               on the legal status for the supply
                              of medicinal products for human use
                              Amendment to the proposal for a
                                                                         SYN 231
                                      COUNCIL DIRECTIVE
                      on the labelling of medicinal products for human use
                                      and on package leaflets
•.'$§s$*ç
                              Amendment to the proposal for a
                                                                         SYN 273
                                      COUNCIL DIRECTIVE
                                        on advert ising
                            of medicinal products for human use
       PRE
                 (presented by the Commission pursuant to Article 149(3)
                                     of the EEC-Treaty)
 ---pagebreak---   Amendment to the proposal for a
         COUNCIL DIRECTIVE
   on the wholesale distribution
of medicinal products for human use
                                    b
 ---pagebreak---                                •2-
                           EffldMKTOKr MBBRrtMPBi
At its plenary session on 12 June 1991 the European Parliament approved the
Commission proposal on the wholesale distribution of medicinal products for
human use (0CM(89)607 final, SXN 229 of 26 January 1990).
Pursuant to Article 149(3) of the EEC Treaty, the Commission has decided to
make 11 amendments to its proposal.
First, the Commission has included Parliament's amendments concerning the
public service obligations of wholesalers supplying pharmacies. Since not
all the Member States apply this system, it was found inappropriate to
introduce it throughout the Community. On the other hand, the new rules
must allow the Member States which practise this system to retain it.
Many of the amendments adopted by Parliament are designed to tighten up the
obligations imposed on all wholesale distributors of medicinal products.
The Commission feels that these obligations come under the guidelines on
good distribution practices. The Commission has accepted Parliament's
amendment calling for these guidelines to be published within two years of
adoption of the Directive and the amendment requiring all wholesale
distributors of medicinal products to give an undertaking to comply with
them.
The Commission has not accepted the amendments stipulating that all
wholesale distributors of medicinal products must have a pharmacist at
their disposal. This requirement would have posed serious problems in at
least half the Member States and cannot be justified on public health
grounds.
                                                                            3
 ---pagebreak---                                                           -3-
                                    Amendment to the proposal for a
                                               COUNCIL DIRECTIVE
                                     on the wholesale distribution                       SYN 229
                                of medicinal products for human use
                       (Presented by the Commission in accordance with
                           Article 149 paragraph 3 of the EEC Treaty)
       Original proposal                                          Amended proposal
                                         Titel    and visas unchanged
                                            First recital unchanged
                                              First recital a (new)
                                                             Whereas, according to Article 100a,
                                                             the c o m p ^ H n n   of the internal
                                                             market must h* based on the highest
                                                             possible level of environmental,
                                                             public      health       and     consumer
                                                             protection;
                                                  Second recital
  Whereas the wholesale distribution                         Whereas the wholesale distribution
  of medicinal products for human use                        of medicinal products for human use
  is at present subject to different                          is at present subject to different
  provisions in the various Member                           provisions in the various Member
  States; whereas               many        operations       States; whereas         many    operations
  involving the wholesale distribution                       involving the wholesale distribution
 of medicinal              products may cover                of medicinal products cover and will
  simultaneously                several         Member       increasingly       cover simultaneously
 States;                                                     several Member States;
                                               Third recital unchanged
                                                    Fourth recital
Whereas any person involved in the                          Whereas any person involved in the
wholesale distribution of medicinal                         wholesale distribution of medicinal
products should be in possession of                         products should be in possession of
a     speci al       authorization; whereas                 a speci fie authorization; whereas
gharmacists and persons authorized                          the definition of distribution does
to      supply          medicinal            products       not cover d j y_jd i n g up, p a cka g i nc; and
djjrectly to the public, a n d _ w h o                     presentation operations referred to
confine themselves to this actiyity,                        in Article 16 of Directive            75/319
should be exempt from obtain 1jTQt_J,jTJs                   and 1n the amendments thereto or
authorization; whereas 1t is alwa)^                         operations 1 Inked to direct '.u<>p!y
necessary in order to control the                           to_the public;
Ç-ÇIPPJJ^.VÊ..- -Çll^J.D. _. °_f_ _d 1 strlbut jon of
medici nal products, that Phaxmjxjsts^
and persons authorized to del 1ver
medicinal         products to the public
lie e_p_ r e c o r d s         s h o w i n g __§I!_tr y
transacti ons;
 ---pagebreak---                                     -A-
Or Iginat proposal                            Amended proposal
                     Fourth recital a (new)
                                    Whereas it is necessary to lay down
                                    uniform rules applicable throughout
                                    the    Community    with      a    view    to
                                    establishing     the     conditions       fo r
                                    obtaining          a u t h o r i z a t i on ,
                                    arrangements     1n    connection        with
                                    transport , personnel and premises,
                                    and the procedures for the checks to
                                    be carried out by the Member States;
                       Fifth recital unchanged
               Article 1 paragraph 1 and 2 unchanged
                           Article l(2a)(new)
                                        2a.      For  the     purposes of this
                                        directive         'public           service
                                        obligations'       shall      include      the
                                        obligation      for     wholesalers         to
                                        guarantee     a    constant        range    of
                                        medicinal products to meet the needs
                                        of    a   geographically          determined
                                        territory and to ensure the supply
                                        at very short notice of the products
                                        requested throughout the territory
                                        In question.
                   Articles 2, 3 and 4 unchanged
                                                                                       r
 ---pagebreak---                                             -5-
         Original proposaj_                            Amended proposai
                            Article 5 (a) and (b) unchanged
                                     Article 5 (c)
  (c)   they must undertake to fulfil         (c) they must undertake to comply
        the obligations incumbent on               with      sound       distribution
        them   under    the   terms   of           practices and to establish that
        Article 6.                                 they have the requisite means at
                                                   their disposal to apply them in
                                                   practice.
                                Article 6 (a) unchanged
                                     Article 6 (b)
(b)   to obtain medicinal products           (b) to obtain medicinal products
      only   from   persons who are              only from persons who hold an
      themselves in possession of the            authorization as referred      to in
      authorization referred to in               Article 16 et seg of Directive
      Article 3(1) or who are exempt             7 _5/_3 19/ E E C ,    or   who   arc
      from      obtaining        this            themse Ives In possession of th<?
      authorization under the terms              authorization      referred   to in
      of Article 3(2);                           Article 3(1) or who are exempt
                                                 from        obtaining          this
                                                 authorization under the terms
                                                 of Article 3(2) ;
                                Article 6 (c) unchanged
                                     Article 6 (d)
  (d)   to have an emergency plan which        (d) to accept an emergency plan
        allows participation in any                which allows participation in
        action of withdrawal from the               any action of withdrawal from
        market ordered by the competent             the   market     ordered   by the
        authorities or initiated by the            competent authorities of the
        manufacturer of the medicinal              Member State or initiated by the
        product concerned;                         manu facturer/ importer of the
                                                   medicinal product concerned;
                         Article 6 (e). (f) and (g) unchanged
                                                                                       è
 ---pagebreak---                                                                     -G-
         Original proposal                                                    Amended propesai
                                                            Art icle 7
With regard to the supply of medicinal products to                            The public servi_çg_ o b_l \g z 11 o n s
pharmacists snd persons authorized to supply medicinal                imposed by certain Hemberj;ta_ceT]on
products to the public, Member States shall not impose upon           wholesalers        establish i ed           in t ! i s i r
the holder of an authorization referred to in Article 3 (1),          territories shall not be affocted by
which has beer granted by another Member State, any                   this directive.
obligation strict :r than those .they impose on persons which
they have themselves authorized to carry out equivalent
                                              Articles 8 and 9 unchanged
                                                          Article 10
                                                                       W i t h i n a p e r i o d o f two yoa^s from
     I f a p p r o p r i a t e , t h e Commission s h a l l             the       date   of        a d o p t i on  of    ^ii : ;
     TuTlish             guidelines               on       good         dlrectlve,        the         Comm1 -s 1 on     s h a 11
     distribution              practices.             j "   **at        publish         guidelines                on    good
     case t h e          pharmaceutical              committee          distribution         practices.            It  shal1
     T T T I t l t u t e d            by          C o u n c i l        update t h i s        publication           annually.
     D e c i s i o n 75/320/EEC1                 shall        be
                                                                        I t s h a l l c o n s u l t f o r t h i s purpose
     consul t e d .                                                     the        pharmaceutical                 committee
                                                                         instituted          by       Council        Decision
                                                                        75/320/EEC.
                                         A r t i c l e s 11 and 12 unchanged
                                                                                                                                 1-
 ---pagebreak---    Amendment to the proposal for a
          COUNCIL DIRECTIVE
 on the legal status for the supply
of medicinal products for human use
                                    9
 ---pagebreak---                                   •2-
                           ICTPT.AWA'Trar WWyttAHmif
At its plenary session on 12 June 1991 the European Parliament approval the
Commission proposal concerning the legal status for the supply of medicinal
products for human use (OOM(89)607 final, SÏN 230 of 26 January 1990).
Pursuant to Article 149(3) of the EEC Treaty, the Commission has decide! to
make 13 amendments to its proposal.
In its opinion, Parliament proposed a system for the classification of
medicinal products very different to the system envisaged by the
Commission. The Commission has decided to accept Pari 1 ament's suggestion
and has therefore included all the amendments concerning the classification
system. The title of the proposal for a Directive has also been amended,
as requested by Parliament. As a result, the suggested amendments to
Article 4 of the Commission's original proposal are no longer necessary
since the classification criteria are now included in Article 3 of the
amended proposal.
The Commission has also accepted Parliament's amendments allowing a time
limit of five years from the date of adoption of the Directive to draw up a
list of the medicinal products available without medical prescription and a
list of products available on medical prescription only.
                                                                              i
                                                                              i
                                                                            3 4
 ---pagebreak---                                     -3-
                    Amendment to the proposal for a
                                                                  SYN 230
                           COUNCIL DIRECTIVE
                     on the legal status for supply
                  of medicinal products for human use
            (Presented by the Commission in accordance with
              Article 149 paragraph 3 of the EEC Treaty)
  Original proposal                           Amended proposal
                                  Titel
  Proposal for a Council directive           Proposal for a Council directive
  concerning the legal status for the        concerning the legal status for the
  supply of medicinal products for           supply of medicinal products for
                                             human use and their classification.
  human use.
                Visas and three first recitals unchanged
                                 Fourth recital
 Whereas, moreover, persons moving          Whereas, moreover, persons moving
 around within the Community have the       around within the Community have the
 right to carry a reasonable quantity       right to carry a reasonable quantity
 of medicinal products legitimately        of medicinal products legitimately
 obtained for their personal use;          obtained for their personal use;
whereas it must also be possible for       whereas it must also be possible for
a person established in one Member         a person established in one Member
State to receive from another Member       State to receive from another Member
State a reasonable quantity of             State a reasonable quantity of
medicinal products intended for his        medicinal products intended for his
personal u s e ; whereas it is             personal use;
important therefore to harmonize the
conditions of delivery of medicinal
products to the public;
                   Fifth and sixth recitals unchanged
                                                                                 >
 ---pagebreak---                                   -4-
   Qriginal proposal                          Amended proposal
                              Article 1
 1.    This Directive concerns the         1.    This Directive concerns       the
 legal status for the supply of           legal status for the supply           of
medicinal products for human use in       medicinal products for human use     and
the Community.                            their c l a s s i f i c a t i o n in the
                                          Community as:
                                          - medicinal products subject to
                                             medical prescription.
                                          - medicinal products not subject
                                             to medical prescription.
2. For the purpose of this Council        2. For the purpose of this Council
Directive, the definition of              Directive, the definition of
'medicinal product' in Article 1 of       •medicinal product' set out in
Council Directive 65/65/EEC shall        Article 1 of Council Directive
apply.                                   65/65/EEC shall apply.
                                          In addition.
                                         'medical prescription' shall
                                        mean: any prescription emanating
                                        from a professional qualified to
                                        prescribe medicinal products.
                                                                                   M
 ---pagebreak---                         -5-
nriginal proposal               Amended proposal
                  Article 2
                           When a marketing authorization is
                           granted, the competent authority
                           shall specify the classification
                           of the medicinal product:
                           medicinal product subject to
                           medical prescription.
                           medicinal product not subject to
                           medical prescription.
                       To this end the criteria laid down
                       in Article 3(1) shall apply.
                        2. The competent authorities shall
                            specify the subcategories of
                            medicinal products which can only
                            be   supplied      on   medical
                            prescription. In this case thev
                            shall    usev the     following
                            classification:
                         (a)medicinal products available on
                            renewable or non-renewable
                            medical prescription.
                         (b)medicinal products subject to
                            special medical prescription.
                        (c)medicinal products available on
                            restricted medical prescription
                            reserved for certain specialized
                            areas.
                                                              P
 ---pagebreak---                                                           -6-
        /^ iff rna I- proposal                                  Amended proposa
                                                  Article 3
1      When a marketing authorization is granted, the           1.Medicinal products hall be subject
competent authority shall specify the Jcgal status for the     to medical prescription where:
supply of the medicinal product:                               - thev present a danger, directly
— medicinal ponluct not subjca to medical prescription,             or indirectly, even under normal
                                                                    conditions of use if taken
— medicinal product subjea to medical prescription,                 without medical supervision or
   mentioning one of the categories referred to in             - they are used frequently and to a
   Anicic 2.                                                        very large extent under the wrong
                                                                    conditions and this is likely to
To this end, the criteria laid down in Article 4 shall              cause a direct or indirect danger
apply.                                                              to health or
                                                               " they contain substances or
                                                                    preparations based on substances
                                                                   whose effects and/pr side effects
                                                                    require more detailed research or
                                                              - they are, with certain exceptions,
                                                                 administered parenterally or
                                                               " • thev              are       administered
                                                                    p a r e n t e r a l l v or
                                                              - thev cause addiction and/or
                                                                   dependence.
   2. All medical products containing a                        2.       Where Member States specify a
                                                               subcategory of medicinal product
   new chemical s h a l l be subject £s
                                                               subject               to special        medical
   medical p r e s c r i p t i o n . and classed,             p r e s c r i p t i o n , account shall be taken
   in one of the c a t e g o r i e s referred to              of the following elements:
   in A r t i c l e 2.                                              the p r e s e n c e in the medicinal
                                                                   product of a non-exempted dosage
                                                                   of a substance c l a s s i f i e d as a
                                                                   p s y c h o t r o p i c or a n a r c o t i c
                                                                   substance within the meaning of
                                                                   the r e l e v a n t          international
                                                                   c o n v e n t i o n s (United Nations
                                                                   Conventions of 1961 and 1971) or
                                                              - the p o s s i b i l i t y           that       the
                                                                   m e d i c i n a l p r o d u c t c o u l d , if
                                                                   improperly used, give r i s e to
                                                                   major r i s k s of medicinal abuse.
                                                                   cause addiction or be misused for
                                                                   i l l e g a l purposes.or
                                                                                                                   A3
 ---pagebreak---                                           ~r-
                                                       Amended proposal
   Original propos»I
                                                    frhe presence in the medicinal
                                                    product of a substance which,
                                                    b e c a u s e of i t s n o v e l t y or
                                                    properties, could be included in
                                                    frhat category as a precautionary
                                                    measure.
                                                    2a.          In cases where Member States
                                                    specify a subcategory of medicinal
                                                    products subject to limited medical
                                                    p r e s c r i p t i o n , thev s h a l l take
                                                    account of the following elements
                                                    - medicinal products which, bv
                                                           reason of their pharmacological
                                                           characteristics or their novelty
                                                          or in the i n t e r e s t of public
                                                          health, are reserved for use in
                                                           treatments which can only be
                                                          carried out in hospitals.
                                                    - medicinal products employed in
                                                          the treatment of i l l n e s s e s which
                                                          require diagnosis in a hospital
                                                          or o t h e r i n s t i t u t i o n      with
                                                          a de c uate            facilities         for
                                                         diagnosis.                   but      where
                                                          administration and follow-up can
                                                         be c a r r i e d o u t o u t s i d e the
                                                         h o s p i t a l or in e s t a b l i s h m e n t s
                                                         equipped with adecuate diagnostic
                                                          faci1 i t i e s .
                                                         medicinal products for use bv
                                                         o u t - p a t i e n t s which could produce
                                                         severe adverse e f f e c t s and which
                                                         t h e r e f o r e c a l l for supervised
                                                         treatment.
3.    The competent authority shall          3 , The competent a u t h o r i t y s h a l l
publish at least annually the l i s t            publish a t l e a s t annually the l i s t
of medicinal products subject to                 of medicinal products subject tc
medical prescription, specifying the             medical prescription specifying the
category of c l a s s i f i c a t i o n .        c a t e g o r y of c l a s s i f i c a t i o n and
                                                 circulate this l i s t to the medical
                                                 professionals in their territory.
 ---pagebreak---                                                                  -8-
                 Original proposal                                     Amended proposa
                                                             Article 4
   1.       Mrdio'na! products which contain substances which             The legal status of supply of_
   arc likely to present a direct or indirea danger to human             a medicinal product shall be
  health, even under normal conditions of use, shall not be
  supplied to the public without medical prescription. The               set out in the market ing
  following criteria shall be taken into consideration in this
  respect:                                                               authorization and included jn_
                                                                         the summary of the product_
  (a) potential risks appearing during the preclinical and
       clinical tests and trials;                                        character 1st ics.
 (b) novelty of the aaive principle, as stared in Article 3,
       ;-..: ô:-ph2;
 (c) possibility of serious side effects in normal conditions of
       use;
(d) serious risks associated with contra-indications and
      precautions for use;
(c) indications requiring a medical diagnosis or special
      medical supervision;
' f) harmfulness of constituents under normal conditions of
      use, taking into account posology, pack size or possible
      excessively extended treatment;
(g) parenteral administration, except when very long term
      illness requires an active participation by the patient in
      the treatment (for example: diabetes);
                                                                                                         :
                                                                                                           *<•*-.r . . . ^
(h) important risk of abuse, addiction or misuse for criminal
      purposes.
2.        Moreover, medical products which may be available
without prescription shall show a substantial safety in use in
the treatment of minor ailments or symptoms, usually
capable of rapid and spontaneous relief, which are easily
 identifiable by users and do not justify a medical
 consultation.
                                                                                                             M
 ---pagebreak---                                                             -9-
              Original proposal                                        Amended proposal
                                                        Article 5
 1.   Within two years of adoption of this Directive, the        1. Unchanged
Member States shall communicate to the Commission and to
the other Member States, the list of medicines which are
available only on medical prescription on their territory,
mentioning the category of classification.
     2.     Each year Member States shall                     2.    Each year Member States shall
     communicate to the Commission and to                     communicate to the Commission and to
     the other Member States the changes                      the other Member States the list
     that have been made to the list                          referred to in paragraph 1 and the
    referred to in paragraph 1.                               changes that have been made thereto.
    3. Within four years of adoption of                       3. Within five years of adoption of
    this Directive, the Commission shall                      this Directive, the Commission shall
    submit a report to the Council on                        draw up a list of the medicinal
    the application of this Directive.                       products in all Member States which
    This report will be accompanied, if                      are available only on medical
    necessary, by appropriate proposals.                     prescription. The list shall apply
                                                             to all Member States.
                                                                    Within five years of adoption
                                                             of this Directive, the Commission
                                                             shall draw U P a list of the
                                                             medicinal products in all the Member
                                                             States which are available without
                                                             medical prescription.      This list
                                                             shall apply to all the Member
                                                             States.
                                           Articles 6 and 7 unchanged
 ---pagebreak---           Amendment to the proposal for a
                  COUNCIL DIRECTIVE
on the labelling of medicinal products for human use
               and on package leaflets
                                                     # •
 ---pagebreak---                                 -2-
                           ECTIANATORy MBOtAMDOM
At its plenary session on 12 June 1991 the European Parliament approved the
Commission proposal on the labelling of medioijnal products for human use
and on package leaflets (OOM(89)607 final, SYN 231 of 26 January 1990).
Pursuant to Article 149(3) of the EEC Treaty, the Commission has decided to
make 16 amendments to its proposal.
The Commission has accepted the two amendments clarifying the definitions
of terms used in the proposal, the amendment stipulating that only the
excipients that should be known about to ensure safe and effective use of
the medicinal product need appear on the label and the amendment removing
the obligation to indicate the name of the manufacturer, if other than the
person responsible for placing the product on the market.   It has not
included the other amendments on labelling, since care must be taken to
avoid putting too much on the label and making it impracticable for
manufacturers or incomprehensible for consumers.
The Commission has included several of the amendments adopted by Parliament
on small outer packaging.
As regards the package leaflet, the Commission has included the amendments
made by Parliament to bring the text of the proposal into line with the
rules on labelling plus two other major additions: details of the nature
and expected effect of using the medicinal product and specification of the
date on which the package leaflet was last revised.
Finally, two amendments to the general guidelines have also been accepted.
                                                                           / \
 ---pagebreak---                                                                 -3-
                                        Amen<'<?:';r»l to the proposal               for a
                                                   COUNCIL DIRECTIVE                                                 SYN 231
                       on the labelling of medicinal products for human use
                                              and on package leaflets
                           (Presented by the Commission In accordance with
                              Article 149 paragraph 3 of the EEC Treaty)
             Original proposal                                                  Amended proposal
                                           Titels and visas unchanged
                                                  Recitals unchanged
                                                         CHAPTER I
                                               Scope and definitions
                                                         Article 1
 1.      This Directive deals with the labelling of medicinal        1.     This Directive deals with the labelling of medicinal
products lor human use and leaflets inserted in packages of          products lor huma;? use and leaflets inserted in packages of
such products.                                                      such products.
2.       For the purposes of this Directive, the definition of      2.      l o r the purposes ol this Directive, the definition of
•medicinal product' laid down in Article 1 of Directive             'medicinal prodtic:' laid down in Article 1 of Directive
6.S/65/l-"l"C shall apply. In addition to this:                     65/6.5/I;IX' shall apply. In addition to this:
 -     "name     of the médicinal               product"            - "name of the medicinal product"
      shall mean          the name given to a                           ohall mean the name given to a
     medicinal product, which may be an                                 medicinal product, which may be an
       invented name or a common chemical                               invented name or a common chemical
     name together with a trademark or                                  name together with a trademark or
     the name of the manufacturer;                                      the name of the manufacturer; in
                                                                        the case of an invented name, this
                                                                        n.hj\l_l not bo confused with the
                                                                        common name;
      'common     name' shall mean the international                 — 'common            name' shall        mean the international
     non-proprietary name recommended by the Work!                        nou-proprieiarv u.ime recommended by the World
      Health Organisation, or. if one does not exist, the usual           Health Organization, or, if one does not exist, the usual
     common name,                                                         common name.
     'immediate packaging* shall mean the container or other         — 'immediate packaging" shall mean the container or other
     form ol packaging immediately in contact with tlte                   form of packaging immediately in contact with the
     medicinal product;                                                   medicinal product;
    'outer packaging' shall mean the packaging into which is         — 'outer packaging" shall mean the packaging into which is
    placed the immediate packaging,                                      placed the immediate packaging,
    'package leaflet' shall mean a leaflet containing               — 'package leaflet* shall mean a leaflet containing
    information for the user which accompanies the                       information lo; the user which accompanies the
    medicinal product to which it refers.                                medicinal product to which it refers.
                                                                     -    "labelling"                 9 ha 11     mean      the
                                                                         p a r t i c u l a r s p r o v i d e d on t h e o u t e r
                                                                                                                                    M
                                                                         o r immediate p a c k a g i n g ;
 ---pagebreak---                                                                                                  -4-
                Original proposal                                                                                Amended proposal
                                                                        Article 2 unchanged
                                                                                CHAPTER II
                                                       Labelling of medicinal products
                                                                                 Article 3
       The      following           particulars     shall     appear      on     the       outer        The f o l l o w i n g particulars shall appear o n the outer
       packaging o f medicinal p r o d u c t s o r , where there is no outer                            packaging o f medicinal products o r . where there is no outer
      p a c k a g i n g , o n the i m m e d i a t e p a c k a g i n g :                                 p a c k a g i n g , o n the i m m e d i a t e packaging:
      (a) the name o f the m e d i c i n a l p r o d u c t , i n c l u d i n g o r f o l l o w e d      (a) the name o f the medicinal p r o d u c t , i n c l u d i n g o r f o l l o w e d
            by the c o m m o n name i f the p r o d u c t contains o n l y one                                by the c o m m o n name if the product contains only one
            active i n g r e d i e n t ;                                                                      active ingredient;
      (b) a statement o f the active ingredients expressed                                             (b) a statement o f the active ingredients expressed
            qualitatively a n d q u a n t i t a t i v e l y per dosage unit o r                               qualitatively and quantitatively per dosage unit or
            according t o the f o r m o f a d m i n i s t r a t i o n f o r a given                           according to the f o r m o f a d m i n i s t r a t i o n for a given
            volume o r w e i g h t , using their c o m m o n names;                                           volume or w e i g h t , using their c o m m o n names;
     (c) the pharmaceutical f o r m .snd the contents by w e i g h t , by                              (c) the pharmaceutical f o r m and the contents by weight, bv
           volume or n u m b e r o r doses o f the p r o d u c t ;                                            volume or number o r doses of the p r o d u c t ;
     d) a list of the excipients;                                                                       d) the excipients that should be
                                                                                                                known                    about        to     en su re             an
                                                                                                                effective use of the medicinal
                                                                                                                product;
                                                                                                      (e) the route and m e t h o d of a d m i n i s t r a t i o n ;
     (e) the route and m e t h o d o f a d m i n i s t r a t i o n ;
                                                                                                      (f) a special w a r n i n g that the product must In- stou-d m i l ot
     (f) a special w a r n i n g that the product must be stored out o f
                                                                                                             reach o l c h i l d r e n ;
           reach o l c h i l d r e n ;
                                                                                                      (g) the e x p i r y date in clear terms ( m o n t h , vear).
    (g) the expiry date in clear terms ( m o n t h / y e a r ) ;
                                                                                                     (h) special storage precautions, if an\ ;
    (h) special storage precautions, if a n y ;
                                                                                                     (i)    special precautions for disposal of unused médicinal
    (i)    special precautious for disposal o f unused medicinal
                                                                                                            products t u waste materials derived f r o m such products,
          products or waste materials derived f r o m such p r o d u c t s ,
                                                                                                            if a p p r o p r i â t : ' ;
          if a p p r o p r i a t e ;
   j) the name and address of the person                                                              j) the name and address                                      of the
           responsible                       for            placing                the                        person responsible for                                placing
          medicinal product on the market                                                                     the medicinal produ -                                on the
          and, where                        different, of                          the                       market;
          manufacturer;
                                                                                                     (k) the number of the a u t h o r i z a t i o n to put the medicinal
( k ) the n u m b e r o f the a u t h o r i z a t i o n t o put the m e d i c i n a l                       p r o d u c t o n the m a r k e t ;
        product o n the m a r k e t ;
                                                                                                     (I)    the manufacturer's batch number.
(I) the manufacturer's batch n u m b e r .
 ---pagebreak---                                                      -5-
      Original proposal                                       Amended proposa I
                                                Art icle 4
1. The following particulars shall                          At     least          the        following
   appear on          immediate packagings                  particulars           shall       appear on
   placed in an outer packaging which                       immediate packagings placed in ah
   complies       with the requirements                     outer packaging which complies
   laid down in Article 3:                                  with the requirements laid down
                                                            in Article 3:
   — name of the medicinal product,                         — name of the medicinal product,
   — quantity of active constituents, using common names,   — quantity of active constituents, using common names,
   — route and method of administration,                    — route and method of administration,
   — expiry date,                                           — expiry date,
   — batch number.                                          — batch number.
  2. Paragraph 1 shall not apply to                        2. Immediate packagings which are
      immediate packagings containing a                       too small to carry all the
     single dose which are too small to                       particulars listed in Article 3
     contain all the particulars listed                       shall        carry        at      least     the
     in paragraph 1.                                          following particulars:
                                                           - name of the medicinal product,
                                                           - route             and         method          of
                                                              administration,
                                                           - expiry date,
                                                           - batch number,
                                                           - contents by weight, by volume or
                                                             by number of do3cs.
                                                           3. Immediate packagings other than
                                                               those referred in paragraphs
                                                               1 and 2 shall carry the
                                                              particulars laid down in Article 3.
                                                                                                                   M
 ---pagebreak---                                                               •6-
      Or iginal proposal                                                Amended proposal
                                         Ar t i cIe S and 6 unchanged
                                                    CHAPTER III
                                                   User leaflet
                                                      Article 7
The inclusion in the packaging of                                 The inclusion in the packaging of
medicinal          products of a package                          medicinal products of a package
leaflet for the information of users                              leaflet for the information of users
shall be obligatory unless all the                                shall be obligatory unless all the
information required by Article 8 is                              information required by Article 8 is
directly          conveyed          on the outer                  directly          conveyed      on the outer
packaging           or        on    the      immediate            packaging             or   on    the       immediate
packaging.                                                        packaging or unless the medicinal
                                                                  product may be administered only by
                                                                  a health professional.
                                                       Article 8
                                                                  1. The l e a f l e t s h a l l be drawn up ir.
1. The leaflet shall include, usually
                                                                     a c c o r d a n c e w i t h t h e summary of
   in the following order:
                                                                     product c h a r a c t e r i s t i c s ; i t shall
                                                                     contain,              usually            in    the
                                                                     following order:
                                               of       the       a) for the identification                    of   the
a) for the identification
                                                                     medicinal product:
   medicinal product:
                                                                         name of the medicinal product
   name of the medicinal product
                                                                         in        accordance        with       Article
   quantitative                 and      qualitative
   composition in terms of active                                        3(a),
   ingredients,                using     the      common                 full            quantitative               and
   names,                                                                qualitative             composition         in
                                                                         terms of active ingredients and
                                                                         excipients, using the common
                                                                         names,
                                                                        pharmaceutical form and contents
                                                                        by weight, by volume or by dosage
                                                                        units,
                                                                        pharmaco-therapeutic group, o^
 - pharmaco-therapeutic                     group,         if           type of action, if there exists a
   there          exists          a     term        easily              term easily comprehensible for
   c o m p r e h e n s i b l e for t h e p a t i e n t ,                the patient,
                                                                        indication of
 ---pagebreak---                                                                 -7-
             Original proposal                                             Amended proposal
     — name and address of the holder of the marketing
                                                                          — name and address of the holder of the marketing
         authorization, and, where different, of the
                                                                              authorization, and. where different, of the
         manufacturer;
                                                                              manufacturer;
(b) the therapeutic indications;
                                                                    •(b) the therapeutic indications;
(c) a list of information which is useful before taking a
                                                                    (c) a list of information which is useful before taking a
     medicinal product.
                                                                         medicinal product:
     — contra-indications,
                                                                         ;— contra-indications,
    — appropriate precautions for use,
                                                                         — appropriate precautions for use,
    — interactions with other medicinal products and other               — interactions with other medicinal products and other
        forms of interaction (for example, alcohol, tobacco)                 forms of interaction (for example, alcohol, tobacco)
        which may affect the use of the medicine,                           which may affect the use of the medicine,
    — special warnings.                                                 — special warnings.
    this list must:                                                     this list must:
    — take into account the particular condition of certain             — take into account the particular condition of certain
        categories of users (e.g. children, pregnant or                     categories of users (e.g. children, pregnant or
        breastfeeding women, the elderly, persons with                      breastfeeding women, the elderly, persons with
        specific pathological conditions),                                  specific pathological conditions),
    — mention, if appropriate, potential effects on the                 — mention, if appropriate, potential effects on the
        ability to drive vehicles or to operate machinery,                  ability to drive vehicles or to operate machinery,
    — refer to the excipients knowledge of which is                     — refer to the cxcipier.tN knowledge of which is
        important for a safe and effective use of the medicinal             nnpon. : .::t toi a safe and effective useo* ihe medicinal
        product;                                                            product:
   d) the necessary                  instructions           for     d) the necessary instructions                             for
         proper use, in particular:                                       proper use, in particular:
         the usual dose and maximum dose,                                   the usual dose, together with
                                                                            wording indicating that this
                                                                             does not apply for different
                                                                             doses being prescribed, and, if
                                                                             possible,              the maximum dose
                                                                             together with a warning that
                                                                             the         dose         and        therapeutic
                                                                             procedure may be modified by
                                                                             the prescriber;
          the        method          and        route         of              the        method          and        route      of
          administration,                                                     administration,
     -     the frequency of administration,                                   the              frequency                       of
           specifying            if     necessary           the               administration, specifying if
           appropriate time at which the                                      necessary the appropriate time
          medicinal product should or must                                    at which the medicinal product
           be administered;                                                   should or must be administered;
     and, as appropriate, depending                           on     and, as appropriate, depending                             on
     the nature of the product                                       the nature of the product
                                                                                                                                       Zi
 ---pagebreak---                                                                  -8-
                Or i g i'na I proposal                                          Amended proposal
             the duration of treatment, when it                                  the duration of treatment, when
             should be limited,                                                  it should be limited,
                                                                                 the nature and expected effect
                                                                                of using the medicinal product,
             the action to undertake in the                                     the action to undertake in the
             case       of      overdose          (symptoms,                    case of overdose (symptoms,
             emergency procedures, antidotes),                                  emergency               procedures           and
                                                                                antidotes           where they exist
                                                                                together           with        an       express
                                                                                recommendation not to use them
                                                                                except u"iu£r medical control),
            the course of action to take when                                   the course of action to take
            a dose has not been taken,                                         when a dose has not been taken,
            the way the treatment should be                                    the way the treatment should be
            stopped, if stopping the treatment                                 stopped,            if       stopping         the
            may lead to withdrawal effects;                                    treatment                 may        lead       to
                                                                               withdrawal effects;
      e) a description of the undesirable                          e) a d e s c r i p t i o n of t h e u n d e s i r a b l e
           effects which can occur under                                 e f f e c t s which can o c c u r when t h e
           normal        use       of    the medicinal                   medicinal product i s used, with
          product,           with       indication            if         i n d i c a t i o n i f p o s s i b l e of t h e i r
          possible of their importance, and                              i m p o r t a n c e , and i f n e c e s s a r y t h e
           if necessary the action to be                                 a c t i o n t o be t a k e n in such c a s e ;
          taken        in     such      case;        if the              t h e p a t i e n t s h o u l d be e x p r e s s l y
          medicine         is new, the patient                           invited              to     communicate            any
          should be expressly invited to                                 u n d e s i r a b l e e f f e c t which i s not
          communicate any undesirable effect                            m e n t i o n e d in t h e l e a f l e t t o h i s
          which is not mentioned in the                                 doctor or to hi3 pharmacist;
          leaflet to his doctor or to his                            (f) a reference to the expirv date indicated on the label,
          pharmacist;                                                     with:
                                                                          — a w a r m m ; against       using the product   after   this
 (f) a reference to the expiry date indicated on the label,
                                                                               date.
     with:
                                                                          — where appropriate, special storage precautions,
     — a warning      against  using the product    after  this
         date,                                                            — if neceNs.it » a warning         against visible signs of
                                                                              deterioration;
     — where appropriate, special storage precautions,
     — i(   necessary  a warning against     visible signs   of     (g) all other inforn-.ation compatible with the summary of
        deterioration;                                                   product characteristics of the product, useful for health
                                                                         education,       and   on condition    that it  is not   of  a
(g) all other information compatible with the summary o f                promotional n.:,;re.
     product characteristics of the product, useful for health
     education, and on condition that it is not o f a             i) the date on which the package
     promotional nature.
                                                                        leaflet was last revised
                                                                                                                                         ZH
 ---pagebreak---                                                                 -9-
              Original proposal                                             Amended proposal
                                                           Article 9
      The package leaflet must be written                            The package leaflet must be written
      in clear and understandable terms for                          in such a way that it is c 1 e ar ,
      the patient, in the official language                         easily legible and understandab'*>
      or languages of the Member State                               for the patient, in the official language
      where the medicinal product is put on                                or languages of the Member Sta.te
      the market. This provision does not                                 where the medicinal product is put on
      prevent the leaflet being printed in                                the market. This provision does not
      several languages, provided that the                                prevent the leaflet being printed in
      same information is given in all the                                several languages, provided that the
      languages used.                                                     same information is given in all the
                                                                          languages used.
                                                  Article 10 unchanged
                                                          CHAPTER IV
                                           General and final provisions
                                           Articles 11 and 12 unchanged
                                                          Article 13
    As necessary, the Commission                        shall      No later than two years after the
    publish guidelines concerning:                                 adoption of this Directive, the
                                                                  •Commission shall publish guidelines
                                                                   for the various leaflet sections, in
                                                                   particular concerning:
 — the formulation of certain warnings for certain categories
                                                                     — the formulation of certain warnings tor certain catégorie*
    of medicinal products,                                               of medicinal products,
 — the      particular       information needs   relative   to
                                                                     — the       particular    information    needs    relative   to
     self-medication,
                                                                         sclf-medica:ion.
— the readability of particulars on the labelling and               — the readabii::\       of particulars on the labelline, .\nd
   leaflet.                                                             leaflet.
— utih/ation of bar codes for the identification of medicinal       — utilization <•: bar codes for the identification of medicinal
   products.                                                            products.
                                                                    -     excipient» that must be indicated
                                                                          on the packaging and warnings
                                                                          referring to them that must be
                                                                          carried on the packaging.
                                                                      For this purpose, ihe Commission shalf «.«insult in»
h.r this purpose, the Commission shall consult the
                                                                      Committee for Pr«ipnetarv Medicinal Products instituted r*.
Committee for Proprietary Mcdicin.il Products instituted by
                                                                      Directive 7.S/3H '-.EC.
Directive 7 5 / 3 1 9 / E E C .
                                          Articles 14, 15 and 16 unchanged
                                                                                                                                     zs
 ---pagebreak---   Amendment to the proposal for a
         COUNCIL DIRECTIVE
           on advert ising
of medicinal products for human use
                                    M
 ---pagebreak---                               -2-
                            EKPIflMPQEff WtBBfflML
At its plenary session on 12 June 1991 the European Parliament approved the
Qaramission proposal on advertising of •medicinal products for human use
(OOM(90)212 final, SYN 273 of 6 June 1990).
Pursuant to Article 149(3) of the EEC Treaty, the Coitimission has decided to
make 19 amendments to its proposal.
The Commission has accepted the amendments prohibiting advertising to the
general public of medicinal products which are habit-forming and/or
addictive, of perforiiïtanoe-enhancing products or of medicinal products
subject to reimbursement by the social security system.     It has also
accepted the amendments prohibiting the distribution of free gifts and
bonuses and making it compulsory to include an express instruction to read
the label and the package leaflet carefully. The other amendments on
advertising to the general public have not been included:     the Commission
feels that there is no need for a Community Directive to lay down the
smallest details on the advertising of medicinal products, where such
advertising is allowed.
As regards advertising to health care professionals, the amended proposal
includes the amendment omitting the exception for objects of an
insignificant intrinsic value and incorporates the rules proposed by
Parliament on the sponsorship of scientific congresses. However, the
Coramission could not accept the procedures advocated by Parliament to
monitor this point. As regards the measures to control free samples, the
Commission felt that it was inappropriate to replace the cfuantitative limit
which it had proposed by a time limit.
Finally, the Commission has accepted none of the amendments on monitoring
and penalties. Since the rules proposed have been harmonized with the
 existing Coranunity legislation it saw no need to depart from them.
                                                                             •Cq
 ---pagebreak---                                                -3-
                          Amendment to the proposal for a
                                   COUNCIL DIRECTIVE
                                                                           SYN 273
                                    on advert ising
                        of medicinal products for human use
                 (Presented by the Commission      in accordance with
                    Article 149 paragraph 3 of the EEC Treaty)
      Original proposal                               Amended proposal
                              Titel and visas unchanged
                           Three first recitals unchanged
                                        Fourth recital
  Whereas advertising to the general               Whereas advertising to the general
  public    even     of   non-prescription         public   even   of   non-prescription
  medicinal     products     could    affect       medicinal products may affect public
  public health, if it was excessive               health,   if it does      not   satisfy
  and     ill-considered;          whereas         certain   essential   criteria    which
  advertising of medicinal products to             ought to be defined;
  the general      public, where      it is
  permitted,      ought     therefore     to
  satisfy certain essential criteria
  which ought to be defined;
                    Fifth, sixth and seventh recitals unchanged
                                      Eighth recital
Whereas      persons"     qualified      to       Whereas    persons    qualified      to
prescribe medicinal products must be              prescribe medicinal products must be
able to carry out these functions                 able to carry out these functions
objectively without being influenced              objectively without being influenced
by   direct    or    indirect    financial        by direct or indirect financial - or
inducements;                                      other - inducements;
                                                                                           M
 ---pagebreak---                                                              -A-
           Or iginal proposal                                          Amended proposa I
                                                       Ninth recital
       Whereas it should be possible within                         Whereas it should be possible within
       certain       restrictive •conditions to                     certain       restrictive conditions to
       provide          samples        of      medicinal            provide          samples        of      medicinal
       products free of charge to persons                           products free of charge to persons
       qualified        to prescribe          or 'supply            qualified        to prescribe          or supply
       them so that they can familiarize                            them so that they can familiarize
       themselves with new products                      and        themselves with new products and
       acquire experience in dealing with                           acquire experience in dealing with
       them;                                                        them;       these       free       samples          of
                                                                    medicinal products must, of course,
                                                                    not be sold;
                                 Tenth and eleventh recital» unchanged
                                                 Twelfth recital
       Whereas        each       undertaking         which          Whereas        each      undertaking           which
       manufactures         or imports          medicinal           manufactures         or    imports      medicinal
       products should set up a mechanism                           products should set up a mechanism
       to    ensure        that     all     information             to    ensure        that     all     information
       supplied about a medicinal product                           supplied about a medicinal product
       conforms           with       the       approved             corresponds           to     the     information
       conditions of use,                                           provided        in    the     summary      of the
                                                                    characteristics of the product, as
                                                                    approved            by      the       competent
                                                                    authori ties ;
                                                      CHAPTER I
                             Scope, definitions and general principles
                                              Article 1 unchanged
                                                      Art icle 2
  1   Any advertising of a medicinal product in respect of     1.    Any advertising of a medicinal product in respect of
 which a marketing authorization has not been granted in       which a marketing authorization has not been granted in
 accordance with Community law is prohibited.                  accordance with Community law is prohibited.
*L\ All parts of the advertising of a                        3-« All parts of the advertising of a
    medicinal product must be compatible                          medicinal       product must conform to
    with the particulars listed in the                            the particulars ... (rest unchanged)
     summary of product characteristics.
                                                                                                                          &
 ---pagebreak---                                                                  -5-
                  Orig nal proposal                                        Amended proposal
                                                         CHAPTER   M
                                      Adver t î s Ing to the genera I pub1ic
                                                          Article 3
1.      Member Su es shall prohibit the advertising to the             I.       Member States shall prohibit the advertising to the
general public of:                                                     general public of:
— medicinal products which contain psychotropic or                     — medicinal products which contain psychotropic or
    narcotic substances, within the meaning of the inter-                   narcotic substances, within the meaning of the inter-
    national conventions,                                                   national conventions,
— other medicinal products which are only available on                 — other medicinal products which are only available on
    prescription, in accordance with Council Directive                      prescription, in accordance with Council Directive
     . . . / . . ./EEC.                                                     . . . / . . ./EEC.
                                                                          -       medicinal products and products
                                                                                  which are habit-forming and/or
                                                                                  addictive,
                                                                                  any performance-entrancing drug or
                                                                                  product,      as     defined        by      the
                                                                                  Council      of     Europe        and       the
                                                                                   International Olympic Committee,
                                                                             - medicinal products which
                                                                                    are reimbursed by the social
                                                                                    secur ity.
                                                                      2.       Member States shall prohibit the mention in adver-
2.       Member States shall prohibit the mention in adver-           tising to the general public of therapeutic indications for
tising to the general public of therapeutic indications for           which sclt'-mcdicaiion is not suitable, in particular:
which self-medication is not suitable, in particular:
                                                                     — tuberculosis,
— tuberculosis,
                                                                     — sexually transmitted diseases,
— sexually transmitted diseases,
                                                                     — other serious infectious diseases,
— other serious infectious diseases,
                                                                     — cancer,
— cancer,
                                                                     — chronic insomnia,
— chronic insomnia,
                                                                     — diabetes and other metabolic illnesses.
— diabetes and other metabolic illnesses.
                                                                     3.      The prohibition referred to in paragraph 1 shall not
3.      The prohibition referred to in paragraph 1 shall not         apply to vaccination campaigns approved by the
apply to vaccination campaigns approved by the                       competent authorities of the Member States.
competent authorities of the Member States.
                                                                     4.      The prohibition referred in paragraph 2 shall apply
4.      The prohibition referred in paragraph 2 shall apply          without prejudice to Articles 2, 3 and 14 of Directive
without prejudice to Articles 2, 3 and 14 of Directive               89/552/EEC.
89/552/EEC.
                                                                        5. Members States shall prohibit
                                                                                the free distribution of
5.       Member States shall prohibit the free distribution of
                                                                               medicinal products to the public
medicinal products to the public for promotional
                                                                                for promotional purposes,
purposes.
                                                                                as well as the offering of
                                                                               gifts or bonuses^
 ---pagebreak---                                                                     -6-
             Or iginal proposal                                                 Amended proposal
                                                            Article 4
                                                                       Without prejudice to Article 3, all advertising to the
  Without prejudice to Article 3, all advertising to the
                                                                       general public of a medicinal product shall:
  general public of a medicinal product shall:
                                                                    a) be set out in such a fashion that
     be set out in such a fashion that                                   it is clear that the message                          ^
a)
     it is clear that the message is                                     an advertisement, and that the
     an advertisement, and that the                                      product is clearly P_resented. as a
     product is clearly identified as                                    medicinal product;
      a medicinal product,
 (b) include the following minimum information:                      (b) include the following minimum information:
     — the name of the medicinal product, incorporating                  — the name of the medicinal product, incorporating
          or followed by the common name if the                               or followed by the common name if the
          medicinal product contains only one active                          medicinal product contains only one active
          ingredient,                                                         ingredient,
      — the information necessary for correct usage of                   — the information necessary for correct usage of
          the medicinal product, such as indications for use                  the medicinal product, such as indications for use
           and special precautions, or, failing this, an                      and special precautions,
           express invitation to read the package leaflet
           carefully.                                                           an express invitation to read the
                                                                                label     and      the package             leaflet
                                                                                careful 1 y.
                                                             Art icle 5
     The advertising of a medicinal product to the general               The advertising of a medicinal product to the genera'
      public shall not contain any material which:                       public shall not contain any material which:
      (a) gives the impression that a medical consultation or            (a) gives the impression that a medical consultation or
            surgical operation is unnecessary, in particular by                surgical operation is unnecessary, in particular by
            offering a diagnosis or by suggesting treatment by                 offering a diagnosis or by suggesting treatment by
            mail;                                                              mail;
        b) suggests           erroneously            that      the         b) suggests                                             that
              effects of taking the medicine                                      the      effects          of      taking          the
              are guaranteed,             or are          better                  medicine are guaranteed, or are
              than another treatment;                                             better        than       the       effects         of
                                                                                  another treatment;
      (c) suggests that the normal good health of the subject              (c) suggests that the normal good health of the subject
           can be enhanced by taking the medicine, or that it                    can be enhanced by taking the medicine, or thai it
           could be affected by not taking the medicine;                         could be affected by not taking the medicine;
      (d) is directed solely or mainly at children;                        (d) is directed solely or mainly at children;
      (e) refers to a recommendation by scientists or health                (e) refers to a recommendation by scientists or health
            professionals;                                                       professionals;
       (0 suggests that the medicinal product is a foodstuff or             (0 suggests that the medicinal product is a foodstuff cr
            a cosmetic, or vice versa;                                            a cosmetic, or vice versa;
       (g) suggests that the safety or efficacy of the medicinal            (g) suggests that the safety or efficacy of the median:!
            product is due to the fact that it is 'natural'.                      product is due to the fact that it is 'natural'.
                                                                                                                                        H
 ---pagebreak---                                                                        -7-
                  Original proposa I                                             Amended proposa.l
                                                           CHAPTER 111
                                      Advertising to health professionals
                                                            Ar t i cIe 6
   Anyi advertising              of a medicinal                     Any       advertising         of     a medicinal
   product to persons qualified to                                  product         to persons qualified to
   prescribe or supply such products                                prescribe or supply or dispense such
   shall include:                                                   products shall include:
   — the particulars listed in the summary of product
                                                                    — the particulars listed in the summary of product
       ..._r ..-.;;;isticS,                                              characteristics,
 — the legal prescription status of the medicinal product,          — the legal prescription status of the medicinal product,
 — the retail price of the various presentations,                   — the retail price of the various presentations,
 — if appropriate, conditions of coverage by the social
     security systems.                                              — if appropriate, conditions of coverage by the social
                                                                         security systems.
 2.    The advertising of a medicinal product to persons
 qualified to prescribe or supply such products may,                2.     The advertising of a medicinal product to persons
 notwithstanding paragraph 1, include only the name of              qualified to prescribe or supply such products may,
 the medicinal product, if its sole object is to recall to the      notwithstanding paragraph 1, include only the name of
 latter.                                                            the medicinal product, if its sole object is to recall to the
                                                                    latter.
                                            Articles 7 and 8 unchanged
                                                           Art icle 9
/*    In the course of promoting medicina}                         A» In        the       course      of      adverti sing
      products to persons qualified to*                                medicinal            products        to       persons
      prescribe             them,     it      shall         be         qualified           to prescribe them, it
      prohibited            to give,        proffer         or         shall be prohibited to give, proffer
      promise to such persons, directly                                or promise to such persons, directly
      or indirectly, any gifts, pecuniary                              or indirectly, any gifts, pecuniary
      advantages or benefits in kind, with                             advantages or benefits in kind.
      the . exception of objects of an                                  (rest deleted)
      insignificant intrinsic, value.
                                                                                                                                  &
 ---pagebreak---                                                                      -8-
              OrIginal proposai                                               Amended proposal
2    Persons qualified to prescribe or supply medicinal                2.    Persons qualified to prescribe or supply medicinal
                                                                       products shall not solicit or accept any inducement
products shall not solicit or accept any inducement
                                                                       prohibited under paragraph 1.
prohibited under paragraph 1.
3    The prohibition referred to in paragraph ' applies                3.    The prohibition referred to in paragraph " *pp!i:s
without prejudice to the regulations of the vlember                    without prejudice to the regulations of th* vlember
Sûtes concerning prices, profit margins and discounts.                 States concerning prices, profit margins and discounts.
                                                     A r t i c l e 9a (new)
                                                                        1. The provisions of Article 9 shall
                                                                            not prevent            undertakings         which
                                                                            produce          or      import      medicinal
                                                                             products             from        organizing
                                                                            congresses          intended       solely for
                                                                          ' the, further scientific training
                                                                            of health care professionals.
                                                                        2. In this case, the                   hospitality
                                                                            extended to participants must be
                                                                             subordinate               t o - the         m a in
                                                                             scientific objective of the event
                                                                            during         which      it    is    provided.
                                                                             Such        hospitality            shall        be
                                                                             extended         only     to    health       care
                                                                             professional s.
                                                         Art icle 10
        Where medicinal products are being                                Where medicinal products are being
        promoted       to persons          qualified          to          adverti sed to persons qualified to
        prescribe         or     supply      them,        free            prescribe or supply or di spose them,
        samples shall be provided to such                                 free samples shall be provided to
        persons         only      on    the       following               such persons only on the following
        conditions :                                                      conditi ons:
     (a) two samples at the most may be provided every year                 (a) two samples at the most may be provided every year
         to any person qualified to prescribe or to supply                       to any person qualified to prescribe or to supply
          medicinal products;                                                    medicinal products;
     (b) any supply of samples must be in response to a                     (b) any supply of samples must be in response to a
          written request, signed and dated, of the recipient;                   written request, signed and dated, of the recipient;
     (c) the samples shall be identical to the smallest presen-              (c) the samples shall be identical to the smallest presen-
          tation on the market;                                                   tation on the market;
          d) the samples shall be marked "free                              d,) the       samples        shall    be     marked,
               medical sample - not for resale"                                   clearly        and      indelibly,         ' free
                or    with        another        legend           of              medical sample - not for resale'
                analogous meaning;                                                or      with      another        legend        of
                                                                                  analogous meaning;
                                                                                                                                   »
 ---pagebreak---                                                         -9-
       Or iginal proposal                                    Amended proposal
(e) the samples shall be accompanied by a copy of the       (e) the samples shall be accompanied by a copy of the
    summary of product characteristics;                         summary of product characteristics;
(0 no samples of medicinal products containing psycho-      (0 no samples of medicinal products conuining psycho-
    tropic or narcotic substances within the meaning of         tropic or narcotic substances within the meaning of
    international conventions may be supplied.                  international conventions may be supplied.
                                               CHAPTER IV
                                     Monitoring of advertising
                              Articles 11, 12, 13 and 14 unchanged
                                                                                                                w
 ---pagebreak---                                                                      ISSN 02544475
                                                              COM(91) 245 final
                                                      DOCUMENTS
EN                                                                             05
                                Catalogue number : CB-CO-91-324-EN-C
                                                             ISBN 92-77-74649-1
Office for Official Publications of the European Communities
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