CELEX: 51977PC0358
Language: en
Date: 1977-07-22
Title: PROPOSAL FOR A COUNCIL DIRECTIVE amending the Directive of 20 May 1975 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (77) 358
Vol. 1977/0118
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                     COM(77)358 final.
                                                     Brussels . 22 July 1977
              PROPOSAL FOR A COUNCIL DIRECTIVE.
      amending the Directive of 20 May 1975 75/319/EEC on the approximation
      of provisions laid down "by law , regulation or administrative action
      relating to proprietary medicinal products
                   ( submitted to the Council "by the Commission)
 COM(77) 358 final
 ---pagebreak--- t
  1 . In Art . 9 and 10 of Directive 75/319 /EEC of 20 May 1975 on the
        approximation of provisions laid down by lawf regulation or
        administrative action relating to proprietary medicinal products
         (O.J. L 147 of 9 June 1975 ) it is stated that a Member State which
        has issued a marketing authorization for a proprietary medicinal
        product shall forward to the Committee a copy of the authorization
        together with the documentation material if the person responsible
        for marketing has required to apply for     marketing authorization
        for the product in at least five other Member States through the
        Committee procedure . The Committee shall hereafter without delay
        retransmit the dossiers to the Member States specified which trans­
        mission shall be deemed equivalent to a formal application for
      - marketing authorization .
  2 . During the discussions on the Rules of Procedure within the Committee
        it has become clear that the obligation that the dossiers in all
        cases shall pass through the Committee instead of being sent directly
        to the Member States concerned, will give rise to severe administrative
        problems for the Secretariati.'and be very, time consuming as the dossiers
        are often very voluminous . In addition to this , the Secretariat   of
        the Committee will not carry out any examination of the dossiers before
        the transmission to the Member States .
  3 . It is therefore proposed (see annex ) to amend Art . 9 and 10 of Directive
        75/319/EEC so that the dossiers will be forwarded directly to the
        Member States specified by the Member State which has already granted
       the marketing authorization .
  4 « The Pharmaceutical Committee set up by Council Decision 75/320/EEC
       has agreed in principle on the amendment and the present text has got
       unanimous approuval by a working party of national experts on
       29 June I977 .
 ---pagebreak---                           PROPOSAL FOR A COUNCIL DIRECTIVE
      amending Second Directive 75 / 319 / EEC on the approximation of provisions
       Laid down by Law ; regulation or administrative action relating to
      proprietary ipedicinal products
      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 ,
      Having regard to the Opinion of the European Parliament ( 1 ),
      Having regard to the Opinion of the Economic and Social Committee ( 2 ),
      Whereas , a Committee for Proprietary Medicinal Products has been set up
      by Second Council Directive 75 / 319 / EEC of 20 Mai 1975 ( 3 ) with the
      responsibility to give an opinion as to whether a particular proprietary
      medicinal product complies with the requirements set out in Council Directive
      65 / 65 / EEC of 26 January 1965 on the approximation of provisions laid down
      by law, regulation or administrative action relating to proprietary medicinal
      products ( 4 );
      Whereas it is stated in Articles 9 and .10 of Directive 75 / 319 / EEC that ,
      in cases where the Community-procedure is to be applied , the Member State
      which has issued the marketing authorization shall forward the dossier
      to the Committee which shall forthwith forward the dossier to the Member
      States specified by the person responsible for marketing ;
      Whereas experience has shown that the provision that the dossiers shall pass
      through the Committee instead of being sent directly to the Member States
      concerned results in administrative problems in processing the voluminous
      documentation and in delays in the work of the Committee ;
( 1 ) 0J No
( 2 ) 0J No
( 3 ) 0J No L 147 , 9.6 . 1975 , p 13
( 4 ) 0J No 22 , 9.2.1965 , p 369 / 65
 ---pagebreak---                                 - 2 -
  Whereas , -j n order to solve these problems and to reduce the delays it is
' necessary to amend These provisions to enable the Hember State which
  has initially issued the marketing authorization to send the dossier
  directly to the Member States specified as well as to the Committee .
 ---pagebreak---    HAS ADOPTED THIS DIRECTIVE :
                          Article 1
   Article 9 of Directive 75 / 319 / EEC is hereby amende'd
   as follows :
   1 . The Member State which has issued a marketing authorization, for
        a proprietary medicinal product shall forward , if the person
        responsible for marketing has requested the forwarding to at least
        five other Member States , a dossier containing a copy of this
        request and a copy of the authorization together with the particulars
       and documents mentioned in Article 4» second paragraph of Directive
       65/65/ESC to the Committee and to the competent authorities of the
       Member States specified .
  2 . Such forwarding shall be deemed to be equivalent to submitting an
       application for marketing authorization, within the meaning of
       Article 4 of Directive 65/65/EEC , to the said authorities®
  3 . The Committee shall forthwith inform the Member States concerned
      that the case has been referred to the Committee .
                         Article 2
  In Article 10 <<|) 0f Directive -75/319/EEC-the words "forwarding referred
to in Article 9 (2 )" are hereby replaced by "transmission of the information
referred to in Article 9 ( 3 )".
                         Article Ï
 This Directive is addressed to the Member States .