CELEX: 51980PC0267
Language: en
Date: 1980-05-28
Title: Proposal for a COUNCIL DIRECTIVE amending Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (presented by the Commission to the Council)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (80) 267
Vol. 1980/0101
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In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983
concerning the opening to the public of the historical archives of the European Economic
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file have been declassified in conformity with Article 5 of the aforementioned regulation.
In Übereinstimmung mit der Verordnung (EWG, Euratom) Nr. 354/83 des Rates vom 1.
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                 COM(80)267 final
                                                 Brussels , 28 May 1980
                            Proposal for a
                          COUNCIL DIRECTIVE
           amending Directives 65 / 65 / EEC and 75 / 319 / EEC on
           the approximation of provisions laid down by law ,
           regulation or administrative action relating to
                     proprietary medicinal products
                              H
                               Ϊ
              ( presented by the Commission to v the Council )
                                         V
                                            file
                                            Is
 C0M(80 ) 267 final
                                               I
 ---pagebreak---  7«»e pptiontC . prov ■ ~i">n£     'f-o to ■ f~hs» v^oo"v: and ftarkPt im, '.or
 proprietary medicirsl products ^ 3ve been the subject o ? a series o* '
 Council Directives ( 65 / 65 / EtC of 26 January 1965 ,, 75 / 31 8 / 2EC and
 75 / 3'^ / PEC of ?0 May 197S )„
  In a judgment of 26 Ms y 1^76 ( Case 10& / 75 ^ De Peijper ) - /19767 ECR 613 /,
  the Court of Justice' was called upon to decide on the compatibility wit <)
  the Treaty , and in particular with Articles 30 et seq ., of certain
  national practices which lead to channelling imports in such a way that
  only certain economic operators can undertake them , others beimj excluded
   from doing so .
   In accordance with the Court 's judgment , steps must be taken to prevent
   the regulations and practices allowing " the manufacturer of the
   pharmaceutical product in question and his duly appointe'd' representatives
    simply by refusing to produce the documents retating to the medicinal
   preparation in general or to>a specific batch of that preparation , to
   enjoy a monopoly of the importing and marketing of the product ." It must
                                               '                       '          >  <
    also be ensured that the health and life of persons can be protected             j
   effectively by measures which are less restrictive to intra-Community             '
    trade without it "obviously being beyond the means which can reasonably
   be expected of an - admini stration operating in a normal manner ".
. It appears that the Member States have not all drawn the same conclusions
    from this judgment of the Court of Justice . Some have amended their laws ;
    others , without amending them , have been tacitly in favour of removing
   the monopoly position in respect of the import and marketing of
   proprietary medicinal products of the manufacturer and his approved
    representatives .
   Under . these conditions , even if , as the Court has pointed out , the Member
   States cannot invoke directives in order to avoid the obligations Laid           '
   down in the Treaty , it seems advisable to supplement the Community              }
   Directives in order to remove the barriers .                                 -
 ---pagebreak---  To attain these ends , the provisions of Directive 65 / 65 / EEC must be
 supplemented by a system of registration of parallel importers : the
parallel importers are registered as the persons responsible for marketing
when the product imported and the product authorized are identical
 ( first subparagraph of Article 1(4 )). Thus , one can draw a clear
distinction between the product which receives a marketing authorization
and the persons responsible for its marketing , who are registered .
The applicant for registration supplies the information he has readily
available ( second subparagraph of Article 1(4 )).
The competent authority will be able to examine without delay the
conformity of the product imported in parallel with the authorized
product : it will be obligatory for the applicant for the marketing
authorization to show in his file any changes made to the product in the
various Member States and to supply the particulars and . documents
concerning ^ uch changes and to keep his file up to date ( Article 1(1 )).
               I
             •                       '                                       ι
In order to avoid purely formal changes in products , which would make
the supervision of the market that devolves on the competent authorities
in accordance with the provisions of Chapter V of Directive 75 / 319 / EEC
more difficult , new cases for refusal of authorization to market are
proposed in Article 1(2 ) and ( 3 ): changes in composition must be justified
therapeutically , changes of name must be for legitimate reasons and must'
not cause any risk of confusion or lead to mistakes as to the qualities
                                                                            I
or properties of the product .
After the person responsible for marketing has been registered , the
authorities must still be able to check at any time and ascertain whether
the imported medicine is in conformity with the particulars shown in the
file . In the case of products imported by the manufacturer or the approved
importer , this conformity is proved by the control reports signed by the
qualified person , which accompany the product . In the case of products
imported in parallel , other methods of proof are provided for in
Article 1(2 ) at the discretion of the person responsible for marketing .
 ---pagebreak---   : THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
      Having regard to the Treaty establishing the European Economic Community ,
      and in particular Article 100 thereof ,
      Having regard to the proposal from the Commission ,
  i Having regard to the opinion of the European Parliament ,
  !                              .   . ,         j •'
    •   •        -                       c       <                      '
  : Having regard to the opinion of the Economic and Social Committee ,
                                                           1
      Whereas Article 4 of Council Directive 65 / 65 / ^EC   as amended
                                   2
      by .Directive 75 / 319 / EEC provides that in, order
      to obtain marketing authorization the person responsible for marketing
 1 shall make an application to the competent authority of the Member State
      concerned ; whereas Article 22 of Directive 75 / 319/ EEC as amended by
      Directive 78/ 420/ EEC -"* makes exemption from controls subject to the
     presentation of control reports signed by the qualified person ;
■ Whereas it is " advisable to prevent the manufacturer from being able to
     monopolize the importation and marketing of proprietary medicinal product
| by merely refusing to produce - the documents relating to the proprietary
     product in general or to a specific batch of that proprietary product ;
     Whereas it is consequently necessary to supplement the provisions of
     Directive 65 / 65 / EEC to- allow the registration of parallel importers as
    persons responsible for marketing , which is necessary for the proper
     supervision of the market by the competent authorities ; whereas , in order
    to avoid purely formal changes in proprietary medicinal products , it is
     also advisable to provide for new cases of refusal of marketing
    authorization ;                         .  '
                                                                              • • •/«
' ■ 0J N° 22 ,      9 February 1965 , p. 369/65
: 20J N° L 147,          9 June 1975, p. 13
       0J N° L 123, . 11 May 1978, p. 26
 ---pagebreak---                                            - 4 -
    Whereas it is necessary to amend the provisions of Directive 75 / 319 / EEC to
    facilitate proof of the conformity of the imported proprietary product with
   the particulars shown in the file ,
   HAS ADOPTED THIS DIRECTIVE :
  Article 1
  Directive 65 / 65 / EEC shall be amended as follows :
 1 . Point 11 of the second paragraph of Article. 4 shall be replaced by the
       following :
       " 11 . An authorization obtained in another Member State or in a non-member
              country to place the relevant proprietary medicinal product on the
              market , provided that such authorization exists , with specification
              of the changes made to this proprietary product in the various
              Member States and the particulars and documents concerning such
              changes ."
2 . The following two paragraphs shall be added to Article 4 :
    " The holder of the marketing authorization shall forthwith communicate
      to the competent authorities any new factor which involves a change
      in the particulars and documents listed in the second paragraph nn
      additional instruction , apd in particular any prohibiten or restriction
      laid down by the competent authorities of the States where the medicine
      is marketed .
      The holder of the marketing authorization shall forthwith communicate
      to the competent authorities any amendment which he proposes to make to
      the particulars and documents listed in the second paragraph ."
3 . The first paragraph of Article 5 shall be replaced by the following :
    " The authorization provided for in Article 3 shall be refused if , after
      verification of the particulars and documents listed in Article 4 , it
      proves that the proprietary medicinal product is harmful in the
      normal conditions of use , or that its therapeutic efficacy is lacking
      or is insufficiently substantiated by the applicant , or that its
      qualitative or quantitative composition is not as declared , or that
   . the qualitative or quantitative composition of the proprietary product
      has been changed , without therapeutic justification , compared with
      that authorized in another Member State ."
 ---pagebreak--- The following third paragraph shall be added to Article 5 :
" Lastly ,      marketing authorization shall be refused if the name of the
  proprietary product risks causing confusion with a proprietary product
  which has already been registered and which has a different qualitative'
  composition as far as the active principles are concerned , or if the
  name of the proprietary product is liable to induce misunderstandings
                                                                                ■■    i
  as to its qualities on properties , or if1 the name requested is different
  from that used in the other Member States for the same proprietary                    ■
  product , unless legitimate reasons justify the use of . such different              ;
  name ."                                1  •
The following Articles 10a and 10b shall be inserted after Article 10 :
" Article 10a
  The competent authorities shall register the other, persons responsible
  for marketing who so request , within 45 days of such request , except
  where the proprietary product they wish to place On the market is not
  authorized in the Member State from which it comes or if it has not been manu
  factured by the same manufacturer or the same group of manufacturers or
  if , in comparison with the authorized proprietary product , it presents ;
  differences which affect its therapeutic effect or harmfulness .
  The following particulars shall be appended to this request :
  1 . Name or business name and address of the person responsible
      for placing the product . on the market ,                                     j
                    -                ■ "j '                             • \          '
  2 . Member State    from which  the proprietary product to be imported comes
                                                          " • -       _     . .    -I
  3 . Name of the proprietary product in the Member State from which it
  - comes and number of the marketing authorization ,                               !
  4 . Name of the proprietary product in the Member State to which the              I
      application for registration is addressed and number of the marketing
      authorization ,                   ;     v                                     !
                                       )      ,                 . · .        ,      ) :
  5 . Pharmaceutical form .                                                         f
 ---pagebreak---         Article 10 b
        The competent authorities shall cancel the registration provided for in
        Article 10a where it appears that the proprietary medicinal product in
 ;      question no longer satisfies the conditions referred to in that Arti cle . 1
 | 6.    The first sentnece of the first paragraph of Article 12 shall be
                                      7                                                i
         replaced by the following :
                                                                                     ■
I     " All decisions taken pursuant to Articles 5 , 6, 10a , 10b and 11 shall
t       state in detail the reasons on which they are based ."
| Article 2
.
. The following Article 22a shall be inserted after Article 22 of
! Directive 75 / 319 / EEC :            .
        Article 22 a
        1 . Where the person responsible for marketing pursuant to Article
             10a does not have the control reports referred to in the second sub­
            paragraph of Article 22(1 ), he may require from the competent authorities
            ( a ) that the control reports be supplied to him ;                        j
            ( b ) that the controls determined by the competent authorities in         j
                  accordance with the provisions of this Chapter be carried out ;      \
            ( c ) that the controls be carried out by a laboratory designated for ;
                                                                 ■
                  this purpose by the competent authorities .    '                     \
        2 . Member States shall adopt all appropriate provisions to ensure that I-
            the manufacturer supplies them forthwith , upon request , with the
            control reports referred to in paragraph 1
                           for any batch or part of a batch of proprietary products ,
 ---pagebreak---      3 . Upon request , the competent authorities concerned shall forthwith
         communicate to each other the control reports referred to in
                                        ι
         paragraph 1 ."                                   *                      i
Article 3                               |                        '
Member States shall bring into force the provisions necessary in order to        .
comply with this Directive within six months of its notification and shall 1
forthwith inform the Commission thereof .                       v      . *. "
Member States shall communicate to the Commission the text of the provisions
of national law which they adopt in the field covered by this Directive .
                                        I                            . .         !
                      •      ■v                  '       . •  •    •          -  r
Arti ele 4      .   '   - -           .1                                         !'
This Directive is addressed to the Member States . .                            J