CELEX: 51981PC0819
Language: en
Date: 1982-01-11
Title: Amendment to the Proposal for a COUNCIL DIRECTIVE amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (submitted by the Commission to the Council pursuant to Article 149, second paragraph, of the EEC Treaty)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (81) 819
Vol. 1981/0229
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In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                           COM ( 81 ) 819 final
                                           Brussels / 11 January 1982
                                    Amendment to the
                                     Proposal for a
                                    COUNCIL DIRECTIVE
            amending Directives 65 / 65 / EEC , 75 / 318 / EEC and 75 / 319 / EEC
             on the approximation of provisions laid down by law ,
                 regulation or administrative action relating to
                             proprietary medicinal products
                   A>s ^
              ( submitted "by the Commission to the Council pursuant
              to Article 149 / second paragraph , of the EEC Treaty )
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   C0M(81 ) 819 final
 ---pagebreak---                               Explanatory Memorandum
1 . On 4 December 1980 , the Commission put forward a proposal for a
    Directive to the Council amending Directives 65 /65 / EEC , 75 /318 / EEC and
    75 /319 / EEC on the approximation of provisions laid down by law ,
    regulation or administrative action relating to proprietary medicinal
    products ( OJ C 355 , 31.12.1980 ).
2 . In conformity with Article 100 of the Treaty the Economic and Social
    Committee and the European Parliament adopted an opinion on the
    proposal on 29 June 1981 ( doc . CES 676 / 81 ) and 16 October 1981 ( Doc .
    P.E. 74.859 ) respectively . These opinions contained certain amendments .
3 . The Commission is willing to accept certain of these amendments and
    proposes the following amendments to its proposal :
          - In the English text , substitute the expression 'data-sheet'
              for 'product-summary' .
          - Arti c le 1 :
              paragraph 2 , points 5.7 and 5.10
              paragraph 5 .
          - Article 2 , paragraph 2 .
          - Article 3
              " Article 9 , point 3
                Article 13 , point 1
                Article 14 , point 1 ."
 ---pagebreak---                                              - 2 ~
Amend rr.gnt to the proposal for a Council Directive amending Directives
65 / 65 / EEC , 75 /318 / EEC and 75 / 31 9 / EEC on the approximation of provisions
laid down by law , regulation or administrative action relating to
proprietary medicinal products
1 . In the English version the expression 'data-sheet' which appears in
     the 3rd recital as well as in Article 1 , paragraph 2 , 2nd subparagraph ,
     and paragraph 3 , 2nd and 4th subparagraph , shall be replaced by the
     expression 'product-summary' .
2 . Article 1 , paragraph 2 , shall be amended as follows :
            5.7    Posology and method of administration for chi Idren and
                   adults respectively
            5.10 Effect on ability to drive a vehicle and operate machinery
3 . Article 1 , paragraph 3 , shall be amended as follows :
           The following Article 9a shall be "Inserted after Article 9 :
           " After an authorization has been issued , the person responsible
           for placing the product on the market must , in respect of the
           control method provided for in Article 4 , point 7 , take account
           of technical and scientific progress and introduce any changes
           that may be required to enable the proprietary medicinal product
           to be checked in accordance with generally recognized scientific
           methods ."
4 . Article 2 , paragraph 2 , shall be amended as follows :
           In part I , C , the following paragraph 3 shall be inserted :
           " 3 . Physico-chemical characteristi cs liable to affect bio-availability
                 The following items of information concerning active principles ,
                 whether or not listed in the pharmacopoeias , shall be provided
                 as part of the general description of the active principles "i f
                 they relate to the bio-availability of the medicinal product :
                 - crystalline form and solubility coefficients ,
                 - particle size , where necessary after pulverization ,
                 - state of hydration ,
                 - oil / water partition coefficient ,
                 the requirements of the first three indents not being applicable
                 to substances used solely in solution ."
                                                                               ./.
 ---pagebreak---                                       - 3 -
5 . Article 3 shall be amended as follows :
       " Article 9
         3 . The Committee shall forward this information immediately to
             the Member States .
         Article 13
         1 . In order to facilitate any discussions by the Committee , the
             competent authorities shall draw up a report to assess the
             results of the analytical and toxi co~pharmacologi ca I tests and
             clinical trials of any proprietary product containing a new
             active substance which is the subject of an application for a
             marketing authorization in the Member States concerned for the
             first time or of any other proprietary product that they may
             choose , parti cular ly when the holder of the marketing authorization
             whishes to follow the procedure described in Article 9 =
         Article 14
         1 . When reference is made to the procedure described in this
             Article , the Committee shall consider the matter and express a
             reasoned opinion within 60 days of the date on which the matter
             was referred to it .
             The person responsible for placing the product on the market
             may , at his request ,, explain himself verbally or in writing
             before the Committee expresses its opinion . He may also obtain
             the suspension of the above-mentioned time limit ."