CELEX: 51974PC0096
Language: en
Date: 1974-01-04
Title: Amendment to the proposal for a Council Directive on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products#Amendment to the proposal for a Council Directive on the approximation of the laws of the Member States relating to publicity for proprietary medicinal products and to package leaflets#Amendment to the porposal for a Council Directive on the approximation of the laws of the Member States relating to matter which may be added to proprietary medicinal products for colouring purposes (Presented by the Commission to the Council pursuant to the second paragraph of Article 149 of the EEC Treaty)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (74) 96
Vol. 1974/0016
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 ---pagebreak--- COMMISSION OF THE EUitOIEAN COMMUMTES
                                                          COM(74)96 final
                                                          Brussels , 4 January 1974
    Amendment to the proposal for a Council Directive on the approximation
    of the laws of the Member States relating to analytical , pharmaco-
    toxicological and clinical standards and protocols in respect of the
    testing of proprietary medicinal products
    Amendment to the proposal for a Council Directive on the approximation
    of the laws of the Member States relating to publicity for proprietary
    medicinal products and to package leaflets
    Amendment to the porposal for a Council    Directive on the approximation
    of the laws of the Member States relating to matter which may "be added
    to proprietary medicinal products for colouring purposes
            ^Presented "by the Commission to the Council pursuant to
             the second paragraph of Article 149 of the EEC Treaty)
  C0M(74 ) 96 final
 ---pagebreak---                       EXPLAÎTATORY ÎIEMORAUTOM
As in other sectors , the problem arises in connection with Directives
concerning medicinal products of the adaptation of these texts to take
account of technical progress .
In the Explanatory Memorandum to the proposal for a Directive on the
approximation of the laws of Member States relating to - analytical ,
phar.maco-toxicological and clinical standards and protocols in respect
of the testing of proprietary medicinal products ( Doc . C0M(70)99 final ),
the Commission emphasized its intention of presenting a proposal on the
matter . The national delegations , during discussion of this proposal
at Council level , asked that provision be made for a decision-making
procedure for such technical adaptation more rapid than that available
under Article ICO .
A similar problem arises in connection with the measures for implementing
Directives , Some Directives define principles , with provision for the
highly technical arrangements for implementation to be adopted at a later
date . This is true of the proposal for the Directive on the approximation
of the laws of the Member States relating to the matter which may be
added to proprietary medicinal products for colouring purposes ( O.J.
of 28 January 1967 ). Article 3 provides that the Commission is to
determine , by a Directive , the methods of analysis to be used for purity
control . The same is true of the proposal for a Directive on the approx­
imation of the laws of Member States relating to publicity for propriet­
ary medicinal products and to package leaflets ( 0,J . of 13 October 1967 ,
as amended by Doc , COM(68)832 ). Under Article 12 ( 2 ) the Commission may
amend the list of diseases annexed to the Directive in order to prevent
self-medication and commercial abuses , where such practices might endanger
public health .
 ---pagebreak---                                     - 2 -
3 . For the adaptation of texts to technical progress , which may require
    great speed , and for the implementing measures , which are generally
    of a highly technical nature , a committee seems to "be the most suitable
    instrument . The procedure already adopted in a number of Council Direc­
    tives appears suitable also in this field . The Commission adopts the
    measures proposed if they are approved by the Committee . If the Committee
    does not agree with the measures , or expresses no opinion , the Commission
    submits a proposal to the Council . The latter then decides by a qualified
    majority ; if within a certain time it has taken no decision , the Commission
    adopts the measures initially proposed ,
4 . Although the establishment of a " Committee on Proprietary I'edicinal
    Products " is discussed in the proposal for a second Directive on
    proprietary medicinal products , it does not seem advisable to assign
    these new duties to it as well . As regards implementing measures and
    adaptation to technical progress , the Committee will bo required to
    give an opinion that would have' effects on the domestic laws of the I'!ember
    States ; it would thus belong to thc/t class known as " legislation
    committees ". Under the second Directive however , it will be called upon
    to give an opinion on individual applications for marketing authorization ,
    and thus its function would be more that , as it were , of a "management
    committee ". Moreover , if its powers are to be subsequently extended ,
    as envisaged in the second Directive , it seems wiser to preserve its
    independence .
                                                                        ./•
 ---pagebreak---                 Amendment to the proposal for a Council Directive
                on the approximati on of the laws of the Member States
                relating to analytical , ph armac o- -t o xi co 1o gi ca,l and
                clinical standards and protocols in rospoct of the
                testing of proprietary medicinal, products
1 .) The following article is inserted in the proposed Directive :
                                    .Article 3
1 . A Standing Committee for Medicinal Products ( hereinafter called "the
     Committee") is hereby set up . It shall consist of representatives of
     the Member States , with a representative of the Commission as Chairman .
2 . The Committee shall adopt its own rules of procedure .
3 . The Committee may examine any question concerning ths operation of this
     Directive raised by its Chairman either on his own initiative or at the
     request of a representative of a Member State .
4. Any amendments needed to adapt the Annex to this Directive to technical
     progress shall be adopted in accordance with the procedure laid down
     in paragraph
5 . The representative of the Commission shall submit to the Committee a
     draft of the measures to be taken . The Committee shall deliver its opinion
     on this draft within a time liiait set by the Chairman having regard to
     the urgency of the matter . It shall act by a majority of forty-one , the
     votes of the Member. States being weighted as specified in Article I4S ( 2 )
     of the EEC Treaty . The Chairman shall not vote .
6 . a) The Commission shall adopt the measures envisaged where they are in
        accordance with the opinion of the Committee .
    b ) Where the measures envisaged are not in accordance with the opinion
        of the Committee , or if no opinion is delivered , the Commission shall
        without delay submit to the Council a proposal for the measures to be
        adopted. The Council shall act by a qualified majority.
 ---pagebreak---     c ) If within three months of the proposal feeing submitted, to it the
        Council has not acted } the measures proposed, shall be adopted by
        the Commission .
2 .) The former Articles 3 and 4 shall become Articles 4 and. 5 »
 ---pagebreak---             Amendment to the proposal for a Council Directive
            on the app roximation of the laws of the Member . States
            relating to publicity for' proprietary medicinal products
            and to package leaflets
The second paragraph of Article 12 is replaced "by the following :
" The list of diseases set out in the Annex referred to in the first
paragraph may be amended for the purpose of preventing an3r such self-
medication or commercial abuses as might endanger public health . Such
amendments shall be adopted under the procedure laid down in Article 3
paragraph 5 and 6 of the Council Directive of                 on analytical ,
pharmaco-toxico logical and clinical standards and protocols in respect
of the testing of proprietary medicinal products .
The Committee referred to in Article 3 of the aforecited Directive may
examine any question concerning the operation of this Directive raised by
its Chairman either on his own initiative or at the request of a represen­
tative of a Member State ."
 ---pagebreak---         Amendment to the proposal for a Council Directive on the
        approximation of the laws of the Ilomher States relating
        to natter which may he added to pro rrletary medicinal products
        for colouring purposes
Article 3 of the proposed Directive is replaced "by the following :
                                  " Article 3
The methods of analysis to "be used for purity control in accordance with
the standards laid down in Annex III shall "be adopted under the procedure
laid down in Article 3 » paragraph 5 and- 6 of the Council Directive of
 ........... on analytical , pharmaco-toxicological and clinical standards
and protocols in respect of the testing of proprietary medicinal products .
The Committee referred to in Article 3 of the aforecited Directive may
 examine any question concerning the operation of this Directive raised
"by its Chairman either on his own initiative or at the request of a
 representative of a ilernber State ."